Abstract Supplement

Transcription

Abstract Supplement

ABSTRACTS
Oral Paper Presentations
Presentation Number: Paper 1
Effect of Weight Change on Natural History of Pelvic Organ
Prolapse
B. Kudish,* C. B. Iglesia,* S. L. Hendrix,† B. Cochrane,‡ H. Richter,§
G. S. McNeeley,† J. Larson,¶ and R. J. Sokol储 *Washington Hospital
Center, Washington, DC, †Detroit Medical Center, Detroit, MI,
‡University of Washington, Seattle, WA, §University of Alabama,
Birmingham, AL, ¶Women’s Health Initiative, Seattle, WA, 㛳Wayne
State University, Detroit, MI
Objective: According to the National Center for Health Statistics, an
estimated 66% of U.S. adults are either overweight or obese, the
majority being female. The purpose of this secondary analysis was to
evaluate the relationship between change in weight and pelvic organ
prolapse (POP) progression/regression in postmenopausal women
over a 5-year period.
Methods: Women with a uterus (N ⫽ 16,608), ages 50 to 79,
enrolled in the Women’s Health Initiative Estrogen plus Progestin
Clinical Trial between 1993 and 1998 were included in the study.
Demographic, medical history, and clinical data on age, race, body
mass index, waist circumference, parity, major medical morbidities,
and Baden-Walker classification (Grades 0 –3), assessing for uterine
prolapse, cystocele, and rectocele, were extracted from baseline and
yearly examinations and questionnaires. Descriptive statistics, ordinal
and logistic regression methods were used to identify factors
associated with POP.
Results: Over the 5-year time period, the majority of women (55.7%)
gained weight (mean 4.43 kg, ⫾5.95 kg), while the overall rate of
prolapse (Grades 1–3) increased by 4%, from 40.9% at baseline to
44.7% at year 4 of evaluation. After controlling for age, parity, race,
and other health/physical variables, being overweight (BMI ⱖ 25, ⬍30
kg/m2) and obese (BMI ⬍ 30 kg/m2) at baseline was associated with
progression in cystocele, rectocele, and uterine prolapse (Table 1)
compared to women with normal BMI of ⬍25 kg/m2 over the average
follow-up of 5.6 years. We then adjusted for prolapse at baseline and
baseline BMI to evaluate an effect of weight change on POP. A 10%
weight change was associated with minimal change in POP. For
example, a 10% weight loss was associated with a borderline
worsening of uterine prolapse (OR 1.08, 95% CI 1.03–1.11) and a
minimal regression of cystocele (OR 0.97, 95% CI 0.95–1.00) and
rectocele (OR 0.96, 95% CI 0.93– 0.99).
Conclusions: Being overweight or obese is highly associated with
progression of POP. However, regression of POP does not appear to
be significantly associated with weight loss, suggesting that damage to
the pelvic floor, related to weight gain, might not be reversible.
Therefore, avoidance of weight gain may prevent progression of POP.
Disclosures: B. Kudish, None; C.B. Iglesia, None; S.L. Hendrix,
None; B. Cochrane, None; H. Richter, None; G.S. McNeeley, None; J.
Larson, None; R.J. Sokol, None.
TABLE. Effect of Baseline BMI on Change in Pelvic Organ
Prolapse
BMI
Normal
Overweight
Obese
Cystocele
(OR)
Rectocele
(OR)
Uterine
Prolapse (OR)
1.0
1.31
(1.22–1.41)
1.46
(1.32–1.6)
1.0
1.37
(1.25–1.49)
1.57
(1.4–1.76)
1.0
1.42
(1.29–1.57)
1.67
(1.45–1.91)
The Association of Urethral Sphincter Morphology in Magnetic
Resonance Images with Urethral Function
D. M. Morgan,* W. Umek,† K. Guire,* H. K. Morgan,* and J. O.
DeLancey* *University of Michigan, Ann Arbor, MI, †University of
Vienna, Vienna, Austria
Objective: We recently reported that maximum urethral closure pressure
(MUCP) is 42% lower in cases than a group of matched controls.1 This study
analyzes the relationship between anatomical measures of the urethral
sphincter using magnetic resonance (MR) images and urethral function.
Methods: Women with SUI symptoms and daily demonstrable stress
incontinence (n ⫽ 103) were recruited from outpatient urogynecology
and urology clinics and from local advertisements. Asymptomatic
continent controls (n ⫽ 108) were recruited by advertisement to
match for age, race, parity and hysterectomy status using group
matching. The testing protocol included determination of urethral axis
with Q-tip testing, MUCP and Kegel augmentation of urethral closure
pressure (KUCP). Axial proton-density MR images were obtained at 5
mm intervals. The lengths of the striated urethral sphincter (SUS) and
vesical neck (VN) (from internal urinary meatus to the top of the
striated sphincter) were determined by multiplying the number of
images in which these structures were identified by the 5 mm slice
interval. The inner and outer diameters of the SUS were measured,
and the difference between them was calculated as SUS thickness.
The inner diameter represents the region containing urethral smooth
muscle layers, submucosa, and lumen. Spearman correlation
coefficients were used on pooled data from the two groups to
evaluate the relationship between anatomical and physiological data.
Comparisons between cases and controls were performed with t-tests.
Results: SUS thickness is associated with higher MUCP (r ⫽ 0.14, p ⫽ .036)
and better elevation of the urethral axis during Q-tip testing (r ⫽ ⫺.17,
p ⫽ .016). A longer SUS is associated with a higher MUCP (r ⫽ 0.18,
p ⫽ .014) and a higher KUCP (r ⫽ 0.21, p ⫽ .004). VN length is associated
with lower MUCP (r ⫽ .⫺16, p.017). Aging correlates with a shorter SUS
length (r ⫽ ⫺.26, p ⬍ .001) and increasing VN length (r ⫽ .19, p ⫽ .006).
Stress incontinent and continent women did not differ significantly in SUS
thickness (2.9 ⫾ 1.6 mm v 3.3 ⫾ 1.8 mm, p ⫽ .079), SUS length (13.2 ⫾ 3.4
mm v. 14.0 ⫾ 3.8 mm, p ⫽ .114) and inner urethral diameter (12.3 ⫾ 1.71
mm v 11.8 ⫾ 1.5 mm, p ⫽ .085).
Conclusions: The associations of striated urethral sphincter thickness
and length with MUCP and aging are in the expected directions and are
physiologically consistent. However, the differences in MR imaged
measurements of urethral anatomy are not as remarkable for cases and
controls as are those reported for MUCP. Comment: Differences in
urethral anatomy do not fully account for the differences in function
observed amongst women with and without stress incontinence.
Disclosures: D.M. Morgan, None; W. Umek, None; K. Guire, None;
H.K. Morgan, None; J.O. DeLancey, None.
The support of ORWH and NICHD P50 HD 044406 is gratefully
acknowledged.
1
(J Urol April 2008 e-pub).
The Minimum Important Differences for the Urinary Scales of
the Pelvic Floor Distress Inventory and Pelvic Floor Impact
Questionnaire
M. D. Barber, for the Pelvic Floor Disorders Network Cleveland
Clinic, Cleveland, OH
Journal of Pelvic Medicine & Surgery • Volume 14, Number 4, July/August 2008
217
Abstracts
TABLE. MID of UDI, UDI-Stress and UIQ using Anchor- and Distribution-Based Methods
Anchor-Based methods
PGI-I, patient global impression of
improvement
Change in UIE, urinary
incontinence episodes
Incontinence Severity Index
Distribution-based methods
Effect size
Standard error of Measurement
(SEM)
Criteria
Difference in scores between patients
reporting “Better” and those reporting
“About the Same”
with ⬎ 25% improvement and those
with no change*
with one level of improvement on ISI
and those with no change
0.5 SD (standard deviation)
1 SEM
Change from Baseline to 3
Months after Treatment in
UDI
UDI-Stress
UIQ
⫺6.4
⫺22
⫺11
UDI
⫺20.3
⫺15.6
⫺4.6
⫺16
⫺7.5
Baseline
UDI-Stress
⫺18.2
⫺24.4
⫺6.5
⫺17
⫺16
UIQ
⫺19.4
⫺7.9
* No change defined as ⫾25% change from baseline to 3 months in UIE.
Objective: To determine the minimum important difference (MID)
for the urinary scales of the Pelvic Floor Distress Inventory (PFDI) and
Pelvic Floor Impact Questionnaire (PFIQ).
Methods: 444 subjects enrolled in a multi-center randomized trial
comparing behavioral therapy to an incontinence pessary for stress
urinary incontinence completed baseline and 3 month follow-up visits.
Eligibility criteria included: age ⱖ18 years, stress-predominant urinary
incontinence, ⬎2 stress incontinence episodes on a 7-day bladder
diary, and patient desire for non-surgical treatment. At baseline and
3 month follow-up, subjects completed the 7-day diary, the Incontinence
Severity Index (ISI), PFDI, and PFIQ. The Patients Global Impression
of Improvement (PGI-I) was completed at 3-months. The MID of the
Urinary Distress Inventory (UDI), the UDI-stress subscale of the PFDI,
and the Urinary Impact Questionnaire (UIQ) of the PFIQ were
assessed using anchor- and distribution-based approaches. Higher
scores on these measures indicate more distress/impact. Anchors
included the PGI-I, ISI, and incontinence episodes on the bladder
dairy. Distribution-based measures included effect size and standard
error of measurement. Treatment assignment remained blinded and
was not assessed in these analyses.
Results: Mean (SD) changes from baseline to 3 months after
treatment in UDI, UDI-stress and UIQ scores were ⫺33 (39), ⫺19
(22), and ⫺33 (44) points, respectively. The MID based on the PGI-I
(difference in scores between subjects who indicated they were
“better” vs. those who responded “about the same”) was ⫺6.4, ⫺4.6
and ⫺6.5 for the UDI, UDI-stress and UIQ, respectively. MID
determined by the other anchor-based methods (ISI and bladder diary)
were greater than those for the PGI-I and similar to the distributionbased findings (Table).
Conclusion: The MID of the urinary scales of the PFDI and PFIQ are
smaller from a patient’s perspective than when objective criteria are
used. While differences in scores of the UDI, UDI-stress and UIQ
greater than 11, 7.5, and 16 points respectively should be considered
clinically important, incontinent women may be able to perceive
smaller differences. The impact of these smaller differences on quality
of life improvement requires further study.
Disclosures: M.D. Barber for the Pelvic Floor Disorders Network,
American Medical Systems, Grant/Research Support.
218
The Anal Continence Trial: A Randomized Comparison of
Overlapping vs End to End Repair of 3rd Degree Obstetrical
Lacerations
S. A. Farrell, D. Gilmour, G. Turnbull, M. Schmidt, G. Flowerdew, T.
F. Baskett, and C. Fanning Dalhousie University, Halifax, NS,
Canada
Objective: To compare rates of flatal and fecal incontinence in the
two surgical groups; to correlate symptoms with external anal
sphincter anatomy (endoanal ultrasound) and function (anal
manometry).
Methods: 62 women in each group were required to detect a
difference in flatal incontinence rates of 25%. Vaginally primparous
women who suffered 3rd or 4th degree tears of the external anal
sphincter (EAS) were randomized. Women and evaluators were
blinded to intervention. Standardized and validated questionnaires
were administered at baseline and repeated at 6 months. At 6 months
participants were evaluated using endoanal U/S and anal manometry.
The primary outcome measure was the rate of flatal incontinence at 6
months. Longer term follow-up continues. Appropriate statistical
analysis was used.
Results: Follow-up at 6 months included questionnaires, anal
ultrasound and anal manometry. 127 vaginally primiparous patients
completed the 6 month follow-up, 65 in the end to end group and 62
in the overlapping group. Baseline demographic and obstetrical
variables were not different in the groups. The flatal incontinence rate
was higher in the overlapping group (60%) compared to the end to
end group (37%) (OR 2.5, CI 1.2, 5.2). Obstetrical factors didn’t
influence outcome. Fecal incontinence rates were overlapping 15%
and end-to-end 8% which did not achieve statistical significance (OR
2.04, CI .64, 6.5) Poor sustained voluntary contraction of EAS on anal
manometry was associated with higher rates of flatal incontinence.
There was no association between symptoms and endoanal ultrasound
findings.
Conclusions: The end to end repair of a 3rd or 4th degree obstetrical
laceration in primiparous women results in lower rates of flatal
incontinence at 6 months.
© 2008 Lippincott Williams & Wilkins
Disclosures: S.A. Farrell, Canadian Institutes of Health Research,
Grant/Research Support; D. Gilmour, None; G. Turnbull, None; M.
Schmidt, None; G. Flowerdew, None; T.F. Baskett, None; C. Fanning,
None.
Significant Linkage Evidence of a Predisposition Gene for Pelvic
Floor Disorders on Chromosome 9
P. Norton, K. Allen-Brady, and L. Cannon-Albright University of Utah
School of Medicine, Salt Lake City, UT
Objective: Pelvic floor disorders (PFDs), including pelvic organ
prolapse (POP), stress urinary incontinence (SUI), and hernias are
common, multifactorial conditions with possible heritable
contributions. Linkage analysis of affected sibling pairs has been used
widely to identify genetic components in other common disorders
such as diabetes, obesity, and Alzheimers disease. The aim of this
study was to identify linkage evidence for a predisposition gene for
pelvic floor disorders in a set of affected sister pairs.
Methods: Women who underwent surgical repair of PFDs at our
University from 1996 –2006 were invited to participate. Sisters of
probands were surveyed for surgical repair of PFDs or evidence of
PFDs on standardized questionnaires (PFDI). Those sisters who were
likely affected with PFDs diagnosed in probands (POP, SUI, or mixed)
were seen and examined along with the probands for phenotyping
(POP-Q) and blood sampling for genotyping. Medical reports were
obtained to confirm surgeries. For this analysis, a strict phenotype was
used: individuals requiring surgery or repeat surgery for PFDs were
defined as affected, and over 90% of individuals so defined had stage
III or IV POP documented. Genotyping was performed for the POP
phenotype using the Illumina 1 million SNP market set, and linkage
analysis was tested by the log10 of the odds for linkage, or lod score,
calculated by computer using the McLINK analysis package.
Results: Of the 553 women contacted, 297 had surgery for POP and
256 had surgery for both SUI and POP at our University. Of these 553,
140 could not be contacted, had died, or did not respond, 94 declined
or withdrew or did not have a sister who agreed to participate, and
195 had no living sisters. One hundred twenty-two probands provided
information on 1 to 8 sisters. Sisters were identified as probably
affected and were recruited for study if there was 1) evidence of
moderate to severe PFDs, usually surgery for the condition 2) high
homogeneity with the type of PFD in the proband and 3) in a few
families, less affected sisters were included if there was a large
pedigree. A total of 209 women were evaluated and phenotyped with
collection of blood for DNA testing. After prioritizing for the most
affected pairs of proband and sister/s, genotyping was performed on
96 total women from 38 families, representing 35 sets of sisters and 3
extended pedigrees. Of these 96 women, 75 were surgically treated
POP cases, 65% were also affected with surgically treated SUI, and 8%
with surgically treated hernia. Significant genome-wide evidence for
linkage was identified on chromosome 9q21 with a lod score of 3.51
(p ⫽ 0.000037) under the recessive model. Seventeen of our 38
pedigrees had evidence for linkage.
Conclusions: Using linkage analysis, we have found significant
evidence for a predisposition gene for PFDs on chromosome 9.
Increased understanding of the genetic predisposition for PFDs may
help localize the gene of interest and provide insight into the
pathogenesis, prevention, and intervention of these conditions.
Disclosures: P. Norton, None; K. Allen-Brady, None; L. CannonAlbright, None.
Abstracts
Allogenic Myoblast Transplantation in the Rat Anal Sphincter
J. B. Craig, F. Lane, G. Nistor, S. Motakef, K. Noblett, and H.
Keirstead University of California-Irvine, Orange, CA
Objective: The purpose of this study is to determine the feasibility of
injecting myoblasts into the anal sphincter complex as a potential
treatment for anal incontinence. Anal Incontinence (AI) affects 2–15%
of the general population. Both surgical and non-surgical treatments
for AI show limited long-term effectiveness. Muscle progenitor cells or
myoblasts have been used in the urethral sphincter as a treatment for
urinary incontinence. Studies have shown these cells to stimulate
increases in muscle volume and regeneration of injured muscle fibers.
The aim of this study is to determine if rat myoblasts will propagate
within the sphincter complex.
Methods: A three-phase study using non-pregnant female Sprague
Dawley rodents of approximately 8 –10 weeks of age has been initiated.
Phase I involved 16 rodents randomly assigned to receive injections of
either human or rodent myoblasts. Four animals received Green
Fluorescent Protein (GFP) labeled rat myoblasts. A 1 mm ⫻ 2 mm ⫻ 2
mm biopsy of skeletal muscle was harvested from a study animal.
Recovered myoblasts were expanded in vitro over 10 days, then tagged
with GFP using Cytomegalovirus as a viral vector. Under general
anesthesia, a 10 micro liter Hamilton syringe with a 33-gauge needle was
used to inject the cell aspirate into the anal sphincter. In animals
receiving GFP-labeled cells, two animals received 1.5 ⫻ 106 microliter of
cells and two animals received a dose of 4.5 ⫻ 106. The cells were
injected into the external anal sphincter using direct visualization and
EMG identification, dividing the dose between three injection sites.
Remaining myoblasts were plated and remained viable at 21 days post
harvest.
Results: Euthanasia was performed on day 10 and the anal sphincter
complex was surgically extracted, fixed, cryoprotected and cut in 20
␮m sections. The tissue was quantified for the presence of
transplanted cells by identifying the presence of fluorescence. The
bioluminescence of the GFP permitted confirmation that GFP-labeled
myoblasts were present in the external anal sphincter and had fused
with host tissue. In Phase II myoblasts will be injected into rodents
with surgically-induced anal sphincter rupture. Functional studies will
be performed to establish regeneration of the sphincter complex
following myoblast transplantation. Phase III will evaluate safety and
migration.
Conclusions: Rodent myoblasts incorporated into the anal sphincter
as evidenced by the presence of GFP-labeled cells in the external anal
sphincter. This demonstrates that myoblasts can successfully be
introduced and fuse with host tissue.
Disclosures: J.B. Craig, None; F. Lane, None; G. Nistor, None; S. Motakef,
None; K. Noblett, Medtronics, Paid Instructor; H. Keirstead, None.
Fibrillar Collagen Degrading Matrix Metalloproteinases are
Increased in Vaginal Connective Tissue of Women with Prolapse
W. Zong, S. E. Stein, and P. A. Moalli University of Pittsburgh,
Pittsburgh, PA
Objective: Collagen III has been shown to be elevated in vaginal
connective tissue of women with advanced prolapse independent of
hormonal status (Obstet. Gynecol 2005; 106: 953). Here we sought to
determine whether this increase, indicative of tissue remodeling, is
associated with quantitative differences in the fibrillar collagen
219
Abstracts
degrading enzymes MMPs-1 and -13, and whether the expression of
these enzymes is impacted by hormonal status.
Methods: Following IRB approval and informed patient consent, 65
full-thickness vaginal biopsies were procured at time of surgery from
premenopausal control women with ⬍stage II prolapse (N ⫽ 16) and
women with prolapse (N ⫽ 49). The latter were divided into 3 groups
- premenopausal (N ⫽ 16), postmenopausal not on hormone therapy
(HT, N ⫽ 16), and postmenopausal on HT for ⬎1 year (N ⫽ 17). The
epithelium was excised leaving the subepithelium, muscularis and
advendtitia for biochemical analysis. The amount of MMP-1 and -13
was determined for each sample in duplicate by Western
immunoblotting and quantitated by densitometry. The values were
expressed as arbitrary units relative to an internal control (1 unit).
Equal loading was insured by normalizing to the same blot stained
with Coomassie blue. Data were analyzed using the Kruskal-Wallis test
and post hoc analysis using the Mann-Whitney U test.
Results: Premenopausal women with and without prolapse had
similar age, gravidity, parity and BMI. These parameters were also
similar in the menopausal women with prolapse on and off HT.
Among the women with prolapse, the median stage of prolapse was
III. Relative to control, active MMP-1 and active MMP-13 were
increased in all prolapse groups (p ⬍ 0.001) while the amount of the
proenzyme forms was not different (p ⫽ 0.23, 0.15, respectively).
Analysis of the independent effect of hormones in tissues from
women with prolapse showed no impact on either the proenzyme or
active form of MMP-1 or MMP-13 (p ⬎ 0.05).
Conclusion: Active MMP-1 and MMP-13 are increased in the vagina of
women with advanced prolapse relative to controls indicating a rapid
remodeling of these tissues with prolapse progression. The absence of an
impact of hormones suggests that hormones are not effective in delaying
prolapse progression in women with advanced prolapse.
Disclosures: W. Zong, None; S.E. Stein, None; P.A. Moalli,
R01HD045590, Grant/Research Support.
The Collagen Degrading Matrix Metalloproteinase-1 is Increased
in the Arcus Tendineous Fasciae Pelvis of Menopausal Women
W. Zong, S. E. Stein, and P. A. Moalli University of Pittsburgh,
Pittsburgh, PA
Objective: Collagen I is decreased in the arcus tendineous fasciae pelvis
(ATFP) of postmenopausal women with prolapse not on hormone therapy
220
TABLE.
Median
(Interquartile
Range)
Active MMP-1
a
Preb
Post-, no HT
c
Post-, HT
Active MMP-13
PrePost-, no HT
Post-, HT
Overall p
Post-hoc p
⬍ 0.001
0.53 (0.32, 0.65)
0.76 (0.66, 0.88)
0.36 (0.26, 0.49)
0.003 (a vs b)
⬍ 0.001 (b vs c)
0.085 (a vs c)
0.857
0.17 (0.15, 0.20)
0.21 (0.12, 0.24)
0.20 (0.14, 0.22)
(HT) relative to premenopausal women and post menopausal women on HT
(Am J Obstet Gynecol 2004; 190: 620). The aim of this study was to
determine whether the decreased collagen I is associated with an increased
amount of the proteolytic (active) form of the fibrillar collagen degrading
matrix metalloprotienases (MMPs)-1 and -13.
Methods: Following IRB approval and informed patient consent, 45
biopsies were procured from an intact portion of the ATFP in patients
undergoing a surgical repair of prolapse. Patients were divided into 3
groups-premenopausal (N ⫽ 15), postmenopausal not on HT (N ⫽ 15),
and postmenopausal on HT for ⬎1 year (N ⫽ 15). The expression of
MMPs-1 and -13 was determined by Western immunoblotting, using
monoclonal antibodies recognizing both proenzyme and active forms.
The antibodies were validated with appropriate positive and negative
controls prior to the tests. The immunoreactive bands were quantified by
densitometry. The values were expressed as arbitrary units relative to an
internal control (1 unit) loaded in duplicate on each gel. Equal loading
was insured by normalizing to the same blot stained with 0.2%
Coomassie brilliant blue. The test was performed at least in duplicate for
each sample. Data were analyzed at 0.05 level of significance using
Kruskal-Wallis test and post hoc analysis using Mann-Whitney U test.
Results: Subjects in the 3 groups had similar gravidity, parity, BMI and
stage of prolapse. Although premenopausal women were younger, there
was no difference in age in the postmenopausal women on and off
hormones. Proezyme forms of MMP-1 and MMP-13 were not adequately
detected in all specimens, therefore, only the active forms were included
in the final analysis. Active MMP-1 was higher in specimens from
postmenopausal not on HT relative to those from both premenopausal
women and postmenopausal women on HT. The amount of active MMP13 was not different among the 3 groups.
Conclusion: Menopause in the absence of HT is associated with an
increase in active MMP-1 and a decrease in collagen I in ATFP. This
may compromise the integrity of ATFP and contribute to the onset of
prolapse in menopausal women.
Disclosures: W. Zong, None; S.E. Stein, None; P.A. Moalli,
R01HD045590, Grant/Research Support.
Changes in Sexual Function in Women 2 Years After Sling or
Burch Colposuspension: Results from the Sister Trial
L. Brubaker,* A. Stoddard,† H. Johnson,‡ H. Zyczynski,§ J. Shaffer,¶
D. Kalinoski,储 S. Chiang,** J. Kusek,†† W. Steers,‡‡ and Urinary
Incontinence Treatment Network†† *Loyola University Chicago,
Maywood, IL, †New England Research Institute, Boston, MA,
‡University of Maryland, Baltimore, MD, §University of Pittsburgh,
Abstracts
TABLE.
Success N,
mean (sd)
Overall outcome (includes stress test,
pad test, diary, re-treatment and
symptoms)
Stress-specific outcome (includes stress
test, re-treatment and symptoms)
Stress test
Pad test
Diary
Re-treatment
Urodynamic stress incontinence
p-value
(t-test)
118, 5.77 (6.16)
153, 3.79 (5.54)
0.006
175, 5.32 (6.08)
112, 3.67 (5.82)
0.02
248, 5.07 (5.94)
261, 4.90 (5.81)
180, 5.33 (6.19)
280, 4.92 (5.85)
28, 5.89 (6.72)
45, 2.09 (5.64)
32, 2.31 (6.96)
113, 3.48 (5.48)
9, ⫺3 (6.16)
262, 4.48 (5.9)
Pittsburgh, PA, ¶University of Texas Southwestern, Dallas, TX,
㛳University of California San Diego, San Diego, CA, **University of
Washington, Seattle, WA, ††NIDDK, Bethesda, MD, ‡‡University of
Virginia, Charlottesville, VA
Objective: To describe changes in sexual function and correlates of
change 2 years after surgery for stress urinary incontinence (SUI).
Methods: We report this planned secondary analysis of women
who were randomized to Burch or fascial sling for predominant
SUI. The methods of this trial have been previously described,
including the sexual function assessment at baseline and at 2 years
post surgery, or prior to SUI re-treatment by the Pelvic Organ
Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ). All
analyses were carried out using SAS software Ver. 9.1 (SAS
Institute, Inc, Cary, NC). Statistical significance was defined by a pvalue ⬍ 0.05.
Results: Of 655 women enrolled, 450 reported sexual activity with
a partner at baseline and answered ⱖ10 of 12 PISQ items. At
baseline sexually active women were younger (49.5 vs. 57.4 yrs, p
⬍ 0.001), and had a significantly lower body mass index (BMI 29.2
vs. 31.6, p ⬍ 0.001), lower total MESA scores (25.4 vs. 26.7,
p ⫽ 0.05), lower MESA urge subscale scores (6.2 vs. 7.1,
p ⫽ 0.007) and lower pad weights (38.2 vs. 55.3 grams, p ⫽ 0.04)
than women who reported they were not sexually active. In
women reporting activity at 2 years, the mean PISQ total score
increased from 32.23 ⫾ 6.85 to 36.85 ⫾ 5.89. Compared to baseline,
fewer sexually active subjects reported incontinence (53% vs. 9%, p ⬍
0.0001), restriction of sexual activity due to fear of incontinence (52%
vs. 10%, p ⬍ 0.0001), avoidance of intercourse because of vaginal
bulging (24% vs. 3%, p ⬍ 0.0001) or negative emotional reactions
during sex (35% vs. 9%, p ⬍ 0.0001) at 2 years. There was no
significant change in frequency of orgasm, or sexual desire,
excitement, or satisfaction after surgery. Improvement was associated
with surgical success (Table) and did not differ by surgical group
assignment, baseline POP-Q stage or concomitant POP surgery (p ⬍
0.05). PISQ Score Change (Two Years - Baseline) by Outcome (Higher
score ⫽ improved function).
Conclusion: Sexual function in women undergoing either a Burch
colposuspension or fascial sling with a successful surgical outcome
improved by two years post-operatively.
Disclosures: L. Brubaker, Pfizer, Grant/Research Support; Allergan,
Grant/Research Support; A. Stoddard, None; H. Johnson, None; H.
Zyczynski, None; J. Shaffer, None; D. Kalinoski, None; S. Chiang,
None; J. Kusek, None; W. Steers, None; &. Urinary Incontinence
Treatment Network, None.
Failure N,
mean (sd)
0.002
0.02
0.01
⬍.0001
0.23
Relationships of Anterior Vaginal Wall to the Vaginal Apex
After Apical Prolapse Procedures
L.A. McGuire*, I. Wilkinson-Ryan†, and K. Strohbehn* *DartmouthHitchcock Medical Center, Lebanon, NH, †Dartmouth Medical
School, Hanover, NH
Objective: To determine the relationship between the anterior and
apical Pelvic Organ Prolapse Quantification (POP-Q) values before and
after isolated apical vaginal support procedures.
Methods: Following IRB approval, 244 patients undergoing apical
vaginal suspensions (sacral colpopexy; transvaginal intraperitoneal or
extraperitoneal colpopexy) without anterior support procedures from
January 1, 2004 through December 31, 2006 were retrospectively
identified. A chart review was performed to extract preoperative and
postoperative POP-Q values, age, parity, prior surgeries, BMI, primary
surgeon and POP-Q examiner. Twenty-nine subjects were excluded due
to concomitant surgeries on the anterior wall, including 22 paravaginal
repairs, six pubovaginal slings and one anterior colporrhaphy. One
patient was excluded as her apical suspension was performed
prophylactically. Two other patients were excluded, one patient with
didelphis uterus and duplicate vagina, and one patient with a clearly
erroneous medical record that could not be rectified. Correlations
between POP-Q values, both pre and post-operatively, for the remaining
212 patients were then analyzed.
Results: 212 patients were analyzed using linear regression with a
Pearson correlation coefficient. Preoperative vaginal apex support
(point C) correlated with the most prolapsed portion of the anterior
vaginal wall (point Ba) with a linear relationship. A linear regression
analysis yields an equation of: Y ⫽ 0.87 ⫻ ⫺3.47 with a correlation
coefficient of 0.58 (p-value ⬍ 0.0001). Postoperative vaginal apex and
anterior wall values were less linear, Y ⫽ 0.24 ⫻ ⫺7.5 with a
correlation coefficient of 0.17 (p-value 0.0199), with most Point C
values clustered at ⫺8. The post-operative changes in C and Ba again
correlate well, Y ⫽ 0.91 ⫻ ⫺2.42 with a correlation coefficient of
0.55 (p-value ⬍ 0.0001) (Fig.1).
Conclusions: This study corroborates previous findings of a linear
relationship between the vaginal apex and the anterior vaginal wall
in women with pelvic organ prolapse. Furthermore, it
demonstrates that a linear relationship remains postoperatively
when evaluating the change of the vaginal apex and anterior
vaginal wall in women undergoing an isolated apical support
procedure.
221
Abstracts
Disclosures: L.A. McGuire, None; I. Wilkinson-Ryan, None; K.
Strohbehn, DuraMed, Grant/Research Support.
Prophylactic Castration at the Time of Hysterectomy in the
United States, 1979 –2004
J. L. Lowder*, L. J. Burrows†, S. Oliphant,‡ and L. Meyn *Division of
Urogynecology, Department of Obstetrics and Gynecology,
University of Pittsburgh, Pittsburgh, PA, †The Center for
Vulvovaginal Disorders, Washington, DC, ‡Department of Obstetrics
and Gynecology, University of Pittsburgh, Pittsburgh, PA, §Division
of Infectious Diseases, Department of Obstetrics and Gynecology,
University of Pittsburgh, Pittsburgh, PA
Objective: To describe the national rates and trends of prophylactic
castration (bilateral oophorectomy or removal of remaining ovary) at the
time of hysterectomy in women without ovarian or other gynecologic
pathology. To determine if a change in trend for castration occurred after
the release of the Women’s Health Initiative (WHI) in 2002.
Methods: Data from the National Hospital Discharge Survey (NHDS),
a federal database that samples inpatient hospitals in the United States,
were analyzed from 1979 to 2004 for diagnosis and procedure codes
using the ICD-9-CM classification system. After excluding women with
diagnoses of ovarian pathology (benign and malignant) and
gynecologic diagnoses that usually warrant ovarian removal (e.g.,
endometriosis, upper genital tract cancer), two groups of women
were created: (1) hysterectomy with bilateral oophorectomy or
removal of remaining ovary (castration); and (2) hysterectomy with or
without other procedures with at least one ovary remaining. Ageadjusted rates were calculated using 2000 census population data and
compared for change over time with the score for linear trend.
ANOVA with Dunnett’s post-hoc analysis was used to evaluate change
in trend between 1979 –2002 and 2003–2004.
Results: The estimated number of hysterectomies with castration
performed from 1979 to 2004 was 3, 686, 785 and ranged per year
from a low of 111, 504 in 1989 to a high of 177, 112 in 2002. The
age-adjusted rate of hysterectomy with castration was comparatively
stable during this period, from lows of 1 per 1,000 women in 1989,
2003, and 2004 to a high of 1.5 per 1,000 in 1980. In comparison, the
number of hysterectomies without castration was 5, 461, 078 and
ranged per year from a low of 153, 513 in 1997 to a high of 309, 327
in 1981. The rate of hysterectomy without castration decreased
significantly, from 2.9 per 1,000 women in 1979 –1981 to 1.1 per
1,000 women in 2001 and stabilized at 1.2 per 1,000 women through
222
2004 (p ⬍ .001). In women ⬍50 years, the proportion castrated
increased from 26% in 1979 to 37% in 2004. In women ⱖ 50 years,
the proportion castrated nearly doubled, increasing from 43% in 1979
to 93% in 2004. After initial results from WHI were released in 2002, a
decrease in castration of 28 women per 100,000 women occurred in
2003–2004. Women undergoing castration at hysterectomy were older
(47.4 years) than women who had at least one ovary preserved (41.7
years, p ⬍ .001). Castration at hysterectomy was associated with
higher incidence of cardiovascular, respiratory, gastrointestinal, organ
injury, and postoperative infection complications (all p-values ⬍.01).
Conclusions: While the age-adjusted rate of prophylactic castration
decreased from 1979 to 2004, the actual proportion of women
undergoing castration at hysterectomy increased. The largest increase
was in women ⱖ 50 years old. There was a decrease in the rate of
prophylactic castrations performed between 1979 –2002 and
2003–2004, consistent with the release of the WHI results.
Disclosures: J.L. Lowder, None; L.J. Burrows, None; S. Oliphant,
None; L. Meyn, None.
Cesarean Section Delays the Development of Pelvic Organ
Prolapse When Compared to Spontaneous Vaginal Delivery in
Lysyl Oxidase like-1 Knockout Mice
A. M. Gustilo-Ashby*, U. Lee*, D. Vurbic†, D. Sypert*, F. Daneshgari*,
M. D. Barber*, and M. S. Damaser* *The Cleveland Clinic, Cleveland,
OH, †Louis Stokes Cleveland VA Medical Center, Cleveland, OH
Objective: Female pelvic floor dysfunction (FPFD) is a complex
group of conditions which include urinary incontinence, voiding
dysfunction, pelvic organ prolapse (POP), and rectal prolapse.
Pregnancy and childbirth are well documented risk factors for FPFD,
yet it is unclear whether this is due to the effects of pregnancy,
delivery or both. Mice lacking the protein Lysyl Oxidase Like-1
(LOXL1 KO) have abnormal elastic fiber homeostasis and frequently
develop FPFD after vaginal delivery. This finding suggests that elastic
fiber defects underlie the primary pathophysiology of FPFD. The
objective of this study was to test the hypothesis that tissue trauma
resulting from vaginal delivery leads to FPFD as a result of abnormal
elastic fiber homeostasis in this mouse model.
Methods: Age-matched primigravid female LOXL1 KO mice were
allowed to have a spontaneous vaginal delivery (SVD) at term or were
delivered by cesarean section (CS) at 18 –20 days gestation. After delivery,
mice were observed weekly for the development of POP using the
Mouse Pelvic Organ Prolapse Quantification (MOPQ) system. KaplanMeier time to prolapse curves were created to describe the development
of POP. At 12 weeks post-partum, lower urinary tract function was
assessed by conscious cystometry (CMG) and leak point pressure (LPP)
testing. Statistical analysis was performed using the two-way ANOVA test.
Pairwise comparisons were performed with the Tukey-Kramer
adjustment. Urethrovaginal cross-sections were stained for elastin and
analyzed semiquantitatively using a histological grading scale to assess
extent of elastin fiber disorganization and fragmentation.
Results: Thirty-nine mice were delivered by SVD and 36 delivered by
CS. Twelve weeks after SVD or CS, 23 (59%) and 11 (31%) mice had
developed Grade 2 or 3 POP, respectively. The mean time to develop
POP was 7.2 weeks after SVD and 10.5 weeks after CS (log rank,
p ⫽ 0.0008). The Cox proportional hazard ratio was 0.55 (95% CI:
0.38 – 0.79). Mice with POP had increased bladder contractility as
evidenced by a significant increase in nonvoiding contractions during
CMG (p ⫽ 0.02). Neither POP nor route of delivery were associated with
differences in voided volume, voiding pressure, voiding time or leak
point pressure. POP, but not mode of delivery, was associated with a
significant increase in disorganization and fragmentation of elastic fibers.
Conclusions: Cesarean section delays, but does not prevent, the
development of POP when compared to SVD in LOXL1 KO mice. POP is
associated with increased bladder contraction frequency and increased
elastic fiber fragmentation and disorganization in the urethra and vagina.
SVD leads to an increased incidence of POP in the setting of abnormal
elastic fiber homeostasis. The mechanisms underlying the role of elastin
and mode of delivery in FPFD warrants further investigation.
Disclosures: A.M. Gustilo-Ashby, None; U. Lee, None; D. Vurbic,
None; D. Sypert, None; F. Daneshgari, None; M.D. Barber, None; M.S.
Damaser, None.
Remodeling of the Vaginal Muscularis During Estrogen
Withdrawal
S. M. Roshanravan, P. Keller, J. F. Acevedo, and R. A. Word UT
Southwestern Medical Center, Dallas, TX
Objective: Epidemiologic evidence indicates that menopause is an
independent risk factor for pelvic organ prolapse. Symptomatic pelvic
organ prolapse commonly develops in the perimenopause. The biologic
mechanisms that lead to loss of pelvic organ support during this time are
not well understood. The goal of this study, therefore, was to test the
hypothesis that estrogen withdrawal disturbs homeostatic pathways that
maintain extracellular matrix in the vaginal wall.
Methods: Ovariectomized (OVX) mice were used as a model system to
study the effects of estrogen withdrawal on elastic fiber homeostasis in
the vaginal wall. Mice (C3B6 at 6 – 8 wks, n ⫽ 70) in metestrous were
ovariectomized, and sham procedures were conducted on a subset of
mice (n ⫽ 25). After removal of epithelium, vagina was collected at 9
time points (0, 6, 24, 48, 72 h, and 5, 7, 14, and 28 d). Real time PCR,
quantitative zymography, and immunoblot analyses were conducted to
assess levels of MMP2, MMP9, LOX and LOXL1.
Results: Zymography revealed dramatic time-dependent changes in
protease activation in the vaginal wall with a burst of pro- and active
MMP9 after OVX. Increases in both forms of MMP9 began within
24 h, peaked at 48 –72 h (4 – 6-fold, p 0.01), falling below baseline
levels 28 d after OVX. Pro and active MMP2 remained constant
gradually decreasing to below baseline from 14 –28 d post OVX.
Messenger RNA levels of both MMP2 and MMP9 progressively
decreased 5-fold in the vaginal wall after OVX, suggesting that the
post-OVX burst in protease activity was due to posttranscriptional
mechanisms. Expression of LOX mRNA decreased dramatically as a
function of time after OVX to levels 8- (LOX, p ⬍ 0.01) and 5-fold
(LOXL1, p ⬍ 0.01) less than shams. These changes were fully reversed
by estrogen replacement. Increased protease activity, together with
decreased LOX and LOXL1, was accompanied by marked loss of vaginal
weight (from 70.4 ⫾ 4.9 to 37.0 ⫾ 1.0 mg) and protein content (from
1852 ⫾ 149 to 613 ⫾ 116 ␮g/vagina) at 48 h decreasing to 18.7 ⫾ 2.1
mg and 241 ⫾ 51 ␮g/vagina 14 d after surgical-induced estrogen
withdrawal. Immunoblot analysis of LOXL1 indicated that pro LOXL1 was
maintained at steady state levels from 6 h to 5 d before a sharp decline at
7–14 d. Interestingly, disappearance of proLOXL1 was accompanied by
increased expression of mature LOXL1 at 14 d.
Conclusions: Estrogen withdrawal results in dramatic, rapid, and
progressive disruption of the balance between matrix degradative and
synthetic components in the vaginal wall. Numerous studies have
shown that bone loss increases at the time of menopause with the
Abstracts
acute phase lasting 4 –5 years that slows subsequently. These studies
in ovariectomized mice suggest that a similar phenomenon may occur
in the vaginal wall after menopause with an acute phase of
remodeling followed by reduced basal levels of vaginal extracellular
matrix. Estrogen withdrawal, therefore, may lead to symptomatic
pelvic organ prolapse in the perimenopausal years especially in
women with borderline or compromised pelvic organ support.
Disclosures: S.M. Roshanravan, None; P. Keller, None; J.F. Acevedo,
None; R.A. Word, None.
Effect of Estrogen on Processing of Procollagen and Lysl
Oxidases in the Vaginal Wall
S. M. Roshanravan, P. Keller, P. G. Drewes, and R. A. Word UT
Objective: Bone morphogenic protein-1 (BMP1) has been identified
as procollagen C proteinase, a secreted metalloprotease needed for
bone formation. BMP-1 and tolloid like-1 (TLL1) are crucial for
processing fibrillar collagen precursors by cleaving the C-terminal
propeptides of procollagen I, II, and III. BMP1 and TLL1 are also
important in processing precursors of lysyl oxidases to mature
enzymes that cross-link both collagen and tropoelastin in the
extracellular matrix. The goal of this study was to determine the
effect of ovariectomy and estrogen replacement on BMP1, TLL1, lysyl
oxidases, and collagen and elastin metabolism in the vaginal wall.
Methods: Mice (C3B6 at 6 – 8 wks, n ⫽ 70) in metestrous were
ovariectomized. Sham procedures were conducted on a subset of
mice (n ⫽ 25). After removal of epithelium by sharp dissection,
vaginal muscularis was collected at 9 time points after ovariectomy (0,
6, 24, 48, 72 h, and 5, 7, 14, and 28 d). For some experiments, fullthickness tissues were used. For estrogen reversal experiments,
ovariectomized mice (14 d) were treated with vehicle or estradiol (E2)
for 14 d (n ⫽ 5–10 for each group). Real time PCR was used to quantify
relative mRNA levels of LOX, LOXL1, MMP-3, procollagen 1␣, BMP-1, and
TLL1. The housekeeping gene ␤2-microglobulin (B2M) was used as an
endogenous control for RNA input. Immunoblotting was performed to
compare protein levels and processing of LOX and LOXL1.
Results: Ovariectomy, but not sham operation, resulted in significant
time-dependent decreases in the procollagen peptidases BMP-1 and TLL1
(1.0 ⫾ 0.27 compared with 0.18 ⫾ 0.03 units/B2M at 14 d, BMP-1; 1.0 ⫾
0.3 vs 0.35 ⫾ 0.08 TLL1, both p ⬍ 0.05). Further, LOX and LOXL1
mRNA and protein were also decreased significantly after ovariectomy.
Procollagen 1␣ mRNA was decreased in the postmenopausal vagina
whereas the major mouse collagenase (MMP3) was increased after
ovariectomy compared with sham-operated controls (0.65 ⫾ 0.28
compared with 0.18 ⫾ 0.03, p ⬍ 0.05). All of these negative effects of
ovariectomy on collagen and elastin metabolism were reversed fully by
physiological estrogen replacement (15 ␮g/kg/d). Moreover, estrogen
therapy suppressed MMP3 activity 16-fold.
Conclusions: Ovariectomy has negative consequences on collagen
and elastin homeostatic pathways in the vaginal wall. Furthermore,
estrogen therapy fully reverses these effects. Although long term
effects of estrogen replacement on the vaginal matrix are not known,
these experiments suggest that estrogen improves collagen and elastin
synthesis by inhibiting the collagenase MMP3 and increasing
procollagen peptidases, procollagen 1␣, and lysyl oxidases in the
fibromuscular layer of the vaginal wall. These results may thereby
contribute to our understanding of the mechanisms by which
menopause and antiestrogens adversely affect pelvic organ support.
223
Abstracts
Disclosures: S.M. Roshanravan, None; P. Keller, None; P.G. Drewes,
Discontinuation Rates in Women Treated with Anticholingeric
Medications
M. Gopal, K. Haynes, S. Bellamy, and L. Arya University of
Pennsylvania, Philadelphia, PA
Objective: To determine the discontinuation rates of anticholingeric
medications used for the treatment of lower urinary tract symptoms.
Methods: The Health Improvement network (THIN), an electronic
medical record database containing 4.77 million patient records from the
United Kingdom was analyzed. Women ⱖ 18 years old who were
prescribed anticholingeric medications between January 1991 and
December 2005 were included in the study. An episode of drug therapy
represented the time from initial prescription to drug discontinuation.
Medication discontinuation was defined as when no anticholingeric
prescriptions were issued within 90 days following the end of the last
anticholingeric drug prescription. An overall discontinuation rate for
all anticholingeric medications was determined. A class specific
discontinuation rate was also determined for nine different types (classes)
of anticholingeric medications. For the class specific analysis, the
cumulative incidence of discontinuation was adjusted for age, number of
prior episodes, number of anticholingeric drug classes used, switch status
(drug therapy switched to another medication) and year of initiation.
Kaplan-Meier method was used to determine an overall discontinuation
rate. A Cox multivariable regression was performed for the class-specific
analysis.
Results: There were 49,419 episodes (contributing a total of 530, 498
person-time months) of anticholingeric therapy available for analysis from
29, 369 women. The mean age of women prescribed anticholingeric
medication was 63.9 ⫾ 16. The average number of treatment episodes
and number of drug classes prescribed per patient was 1.6 ⫾ 1.3 and 1.5
⫾ 0.57 respectively. The median time for overall anticholingeric drug
discontinuation was 4.8 months. The percentage of episodes where
women switched to another medication was 16%. The overall cumulative
incidence of discontinuation increased with duration of prescription use.
The discontinuation rate was 41.6% (95%CI: 41.2, 42.1) at 4 months,
58.8% (95%CI: 58.4, 59.3) at 6 months, 77.2% (95%CI: 76.8, 77.6) at 12
months and 87.5% (95%CI: 87.3, 87.9) at 24 months. The median time for
drug discontinuation was highest for Tolterodine Tartrate and Tropsium
(5.5 months each). The drugs with the shortest median time to
discontinuation were Teroldine and Flavoxate (4 months each). At 6
months, the adjusted cumulative incidence of discontinuation were as
follows: extended release Oxybutynin 57% (95%CI: 55.1, 59.4), extended
release Tolterodine Tartrate 54% (95%CI: 52.3, 57.7), Oxybutynin 71%
(95%CI: 68.4,73.5) and Tolterodine Tartrate 61% (95%CI: 59.4, 64.3). By
24 months, the adjusted cumulative incidence of discontinuation was
⬎90% for all nine drug classes.
Conclusion: Discontinuation rates for anticholingeric medications
are high.
Disclosures: M. Gopal, None; K. Haynes, None; S. Bellamy, None; L.
Arya, None.
Weight Loss Improves Urinary Incontinence in Overweight &
Obese Women Through 18 Months
R. R. Wing*, D. Smith West†, D. Grady‡, J. M. Creasman‡, D. Myers§,
K. L. Burgio¶, F. Franklin¶, A. A. Gorin*, E. Vittinghoff‡, J. Macer‡, J.
224
W. Kusek,储 and L. L. Subak‡ *The Miriam Hospital, Providence, RI,
†University of Arkansas Medical School, Little Rock, AR, ‡University
of California, San Francisco, San Francisco, CA, §Brown University,
Providence, RI, ¶University of Alabama at Birmingham,
Birmingham, AL, 㛳NIDDK, Bethesda, MD
Objective: To determine the effect of weight loss on urinary
incontinence (UI) among obese and overweight women at 18 months.
Methods: The Program to Reduce Incontinence by Diet and
Exercise (PRIDE) is a multi-center, randomized clinical trial in 338
overweight and obese women experiencing ⱕ10 UI episodes per
week at screening on a 7-day voiding diary. Women were
randomized to either an intensive 6-month weight loss program
including diet, exercise, and behavior modification followed by a
12-month weight maintenance program (intervention; N ⫽ 226) or
to a structured education program (control; N ⫽ 112). Number and
type of incontinent episodes was determined by voiding diary. The
primary analysis used GEE negative binomial models for repeated
measurements to estimate the effect of weight change on change
of weekly frequency of incontinent episodes.
Results: Mean (⫾SD) age (53 ⫾ 11 years), weight (97 ⫾ 17 kg), BMI
(36 ⫾ 6 kg/m2) and weekly number of UI episodes (24 ⫾ 18) were
similar for both groups at baseline. Overall, 86% of the women
completed the 18-month trial. The mean weight loss at 18 months in the
intervention and control groups was 6.5 kg and 1.7 kg, respectively (p ⬍
0.001). Despite large differences in weight loss and improvement in UI
within each group (p ⬍ 0.01 vs. baseline for all), there were no
significant differences between the intervention and control groups in
decreased total (61% vs. 55%), stress (70% vs. 64%) or urge (55% vs. 50%)
incontinent episode frequency at 18 months. However, when the
treatment groups were combined, there was a strong dose-response
relationship between magnitude of weight loss and UI
improvement. Comparisons of women who gained weight from
baseline to 18 months, lost 0 to ⬍5%, 5 to ⬍10% or ⱕ10% of initial
body weight, showed a significant association between weight loss
category and decreased total, stress and urge incontinent episodes
(all p ⬍ 0.002). This effect was independent of treatment group or
initial BMI. Compared to women who gained weight (reference
group), the odds of having at least 70% improvement in overall
total UI episode frequency was 1.8 (95% CI 1.1, 3.1) in women
who lost 0 –5%, 2.0 (95% CI 1.0, 4.0) in women who lost 5–10%
and 2.6 (95% CI 1.5, 4.6) in women who lost ⬎10% (p ⬍ .05).
Conclusions: There is a strong and continuous dose-response
relationship between weight loss and decreased frequency of UI
among overweight and obese women. Even modest weight loss
appears to have significant benefits for UI through 18 months of
follow-up. Thus, weight loss should thus be considered as a first-line
treatment for overweight/obese women with UI.
Disclosures: R.R. Wing, None; D. Smith West, None; D. Grady,
None; J.M. Creasman, None; D. Myers, None; K.L. Burgio, Pfizer, Inc.,
Grant/Research Support; Astellas: ; Ortho McNeil; GlaxoSmithKline,
Consultant; F. Franklin, None; A.A. Gorin, None; E. Vittinghoff, None;
J. Macer, None; J.W. Kusek, None; L.L. Subak, Pfizer, Inc.,
Grant/Research Support.
A Randomized Controlled Trial Comparing Traditional Pelvic
Muscle Rehabilitation to a Pilates Exercise Program for
Strengthening Pelvic Floor Muscles
P. Culligan*, J. Scherer*, K. Dyer*, J. Priestley†, G. Guingon-White‡,
D. DelVecchio,‡ and M. Vangeli§ *Atlantic Health Division of
Urogynecology, Morristown, NJ, †Kennesaw State University Dept of
Math and Statistics, Kennesaw, GA, ‡Atlantic Rehab Institute,
Morristown, NJ, §Bodies in Balance, Madison, NJ
Objective: To compare pelvic floor muscle strength between groups
of women participating for 12 weeks in either in a structured Pilates
exercise program or a pelvic muscle rehabilitation (PMR) program.
Methods: Adult women with POP-Q stage ⱕ 1 were eligible for
enrollment. A blocked random assignment technique was used to
determine the allocation sequence, and opaque sealed envelopes were
used to conceal the group assignments. After randomization, baseline
pelvic floor muscle strength (our main endpoint) was measured via a
computerized vaginal pressure sensor (PathwayTM CTS 2000, The
Prometheus Group, Dover NH). Muscle strength measurements were
repeated after participants had completed a total of 24 one-hour sessions
(i.e. twice weekly for 12 weeks) in either the Pilates or PMR program.
Both exercise programs were standardized, and all sessions were
conducted in a one-on-one fashion by either a certified pelvic floor
Physical Therapist or a certified Pilates instructor. The Pilates instructors
led participants in a “full body” program emphasizing ’core muscles’
including the pelvic floor muscles. These instructors used only verbal
cues while the Physical Therapists used computerized biofeedback and
‘invasive’ vaginal manipulation techniques to focus training solely on the
pelvic floor. PFDI and PFIQ scores were secondary endpoints. Baseline
group characteristics and outcome measures were compared using ␹2,
Mann-Whitney U tests or t-tests as appropriate. A prospective sample size
calculation called for 24 patients in each group to have 80% power for
detecting a 25% difference in muscle strength between groups.
Results: 62 women were enrolled (30 and 32 in Pilates and PMR
groups respectively). There was a differential dropout rate between
groups-leaving 28 and 24 participants in the Pilates and PMR groups
respectively. There were no differences between either the original
randomized groups or the subsets of those groups who actually
completed the study in terms of age, BMI, parity, pre-treatment muscle
strength, PFDI scores or PFIQ scores. Mean pre-treatment muscle
strength for the Pilates and PMR groups were 14.9 ⫾ 12.5 cmH2O and
12.5 ⫾ 10.4 cmH2O respectively (p ⫽ 0.43). Both groups demonstrated
improved strength at the end of the study. Mean improvement in the
Pilates group was 6.6 ⫾ 7.5 cmH2O (p ⫽ 0.0001); and in the PMR group
was 6.1 ⫾ 7.5 cmH2O (p ⫽ .001). However, comparison of these
improvements between groups failed to demonstrate significance
(p ⫽ 0.8). Improvements in PFIQ scores approached significance in both
groups (p-values 0.053 and 0.082). These differences were not significant
between groups (p ⫽ 0.86). The PFDI scores, however, did improve
significantly in both groups (p-values 0.001 and 0.0001). These PFDI
improvements were not significant between groups (p ⫽ 0.93).
Conclusions: There was no difference in pelvic muscle strength
improvement or PFDI score improvement between women who
completed a ‘full body’ Pilates exercise program and women who
underwent a focused, ‘invasive’ PMR program.
Disclosures: P. Culligan, CR BARD; Solace; Novasys, Grant/Research
Support; CR BARD; Ethicon Women’s Health & Urology; Intuitive
Surgical, Consultant; Enturia, Speaker’s Bureau; CR BARD; Intuitive
Surgical, Paid Instructor; J. Scherer, None; K. Dyer, None; J. Priestley,
None; G. Guingon-White, None; D. DelVecchio, None; M. Vangeli, None.
Epidemiology of Nocturia and Night-Time Urinary Frequency in
Women: What is Normal?
E. S. Lukacz,* E. L. Whitcomb,* J. M. Lawrence,† C. W. Nager,* and
K. M. Luber‡ *UCSD, La Jolla, CA, †Kaiser Permanente Southern
California, Pasadena, CA, ‡Kaiser Permanente San Diego, San
Diego, CA
Abstracts
Objective: The objective of this study was to assess the prevalence
of nocturia and degree of bother from night-time urinary frequency in
a community-based population of women, and to propose evidence
based definitions of normal and abnormal night-time urinary
frequency.
Methods: The voiding habits of 4,061 women from a communitybased sample recruited for an epidemiologic study were analyzed. The
validated questionnaire to identify pelvic floor disorders included
questions related to nocturia and night-time frequency. Nocturia was
assessed with the question: “Do you awaken during your normal
sleeping hours to urinate?” Night-time urinary frequency was assessed
with the question: “How many times on average do you need to
empty your bladder during sleeping hours?” Degree of bother related
to each category of night-time voiding frequency was assessed using a
100 mm visual analog scale (VAS). We defined ‘frequent night-time
voiding’ as ⱖ 2 voids per night. Degree of bother was compared using
ANOVA and Student’s t-tests. Associations with a two-sided p-value of
⬍0.05 were considered significant.
Results: The mean age of the subjects in the study was 56.5 ⫾ 15.8
years, 72% reported nocturia and 33% had 2 or more episodes per
night (⬘frequent night-time voiding’). Degree of bother increased with
each interval increase in night-time frequency (Figure, p ⬍ 0.001).
Mean VAS was 27.3 ⫾ 26.3 for 1 time vs. 57.3 ⫾ 28.5 for ⱖ 2 times
per night, p ⬍ 0.001.
Conclusions: In this cohort of women from a community-dwelling
sample, nearly three quarters reported nocturia, suggesting that it is
very common and not pathologic. One third of women reported
night-time voiding frequency of 2 or more times and these women
were more than twice as bothered by their frequency than those with
only one episode per night. Based on these findings, for
epidemiologic research, increased night-time frequency should be
defined as 2 or more voids per night.
Disclosures: E.S. Lukacz, Pfizer Inc, Consultant; Medtronic Corp.,
Consultant; Novartis Pharmaceuticals, Speaker’s Bureau; Proctor &
Gamble Pharmaceuticals, Speaker’s Bureau; Intuitive Corp.,
Speaker’s Bureau; E.L. Whitcomb, None; J.M. Lawrence, None;
C.W. Nager, None; K.M. Luber, Pfizer Inc., Consultant; Watson
Pharmaceuticals, Consultant; Astellas, Consultant; Pfizer, Inc,
Speaker’s Bureau; Watson Pharmaceuticals, Speaker’s Bureau;
Astellas, Speaker’s Bureau.
225
Abstracts
Incidence and Remission of Urinary Incontinence in a
Community Based Population of Women 50 Years and Older
Y. M. Komesu, R. G. Rogers, R. M. Schrader, and C. Lewis Univ of
New Mexico Health Sciences Center, Albuquerque, NM
Objectives: To determine incidence and remission rates of urinary
incontinence (UI) and predictors of severe UI, in women ⱖ 50 years
enrolled in a community based population.
Methods: We analyzed data collected between 1993–2006 in the Health
and Retirement Study (HRS), a NIH funded publicly available database.
Respondents are retirees and their spouses who were queried regarding
sociologic, economic and health issues every two years. UI questions
were asked in 1993, 1995, 1996 and every 2 years thereafter. For
incidence we evaluated women who initially reported no UI and for
remission we evaluated women who initially did report UI. All women
had at least 4 years of follow-up and were ⱖ 50 years at enrollment. We
tracked risk factors previously associated with severe UI; age, Basal
Metabolic Index (BMI), parity, ethnicity, medical co-morbidities
(hypertension, diabetes, lung disease, heart disease, cancer, stroke,
arthritis), current history of smoking, and history of psychiatric illness
(including depression). UI was defined as any urinary leakage in the last
year, and severe UI was defined as urinary leakage ⬎15 days in the last
month. Identified variables were used in a repeated measures logistic
regression model to determine which were most closely associated with
severe UI using GEE analysis (PROCGENMOD, SAS version 9.1).
Results: 14,246 women reported UI status and met our study criteria.
Of these, 5293 (37.2%) were in their 5th decade at initial evaluation,
3376 (23.7%) in their 6th, 3920 (27.5%) in their 7th, 1441 (10.12%) in
their 8th and 216 (1.52%) were in their 9th decade of life. The 4 year
incident rate of UI increased from 13.8% for women in their 5thdecade
to 41.2% in their 9th decade of life. Severe UI incidence was lower,
but also increased with each decade; from 4.5% in the 5th to 29.4% in
the 9th decade of life. Factors most closely associated with incident
severe UI were age (9th compared to 5th decades OR ⫽ 14.8, 95%
CI ⫽ 8.8 –24.9), ethnicity (Blacks compared to Whites OR ⫽ 0.6,
CI ⫽ 0.6 – 0.7), history of psychiatric illness (OR ⫽ 1.4, CI ⫽ 1.3–1.6),
increased BMI (BMI ⱖ 35 OR ⫽ 2.3, CI ⫽ 1.7–3.1), and increasing
number of medical co-morbidities (3 co-morbidities OR ⫽ 2.2, CI
1.6 –3.1). In contrast to incidence, UI remission rates fell with
increasing age, decreasing from 37.6% in the 5th to 24.3% in the 9th
decade. Remission rates for severe UI were also age dependent, 54.6%
for patients in the 5th and declining to 36.9% in the 9th decade.
Conclusions: In this community based population of women, UI and
severe UI incidence rates increased with age. Predictors of severe UI
include age, high BMI, ethnicity, history of psychiatric illness, and
presence of medical co-morbidities, but did not include parity. Remission
rates of both UI and severe UI are high, particularly in younger patients.
Disclosures: Y.M. Komesu, None; R.G. Rogers, None; R.M. Schrader,
None; C. Lewis, None.
Post Partum Fecal Incontinence: Exam & Ultrasound
Characteristics
M. A. Denman, T. Gregory, P. Osterweil, H. Li, and J. Guise Oregon
Health Sciences University, Portland, OR
Objective: To compare physical exam and ultrasound findings of
recent post partum primiparous women complaining of fecal
incontinence (FI) with a similar cohort of primiparous women
without complaints of FI.
226
Methods: This is a nested case control study within a statewide post
partum fecal incontinence symptom survey. From a total of 5,491
subjects who participated and agreed to further participation, seventy
six participants who lived within 30 miles of the exam site were
selected for a longitudinal clinical examination study. Cases were defined
as a positive response to one of 3 questions regarding fecal incontinence
following delivery. All subjects underwent a comprehensive pelvic
examination including POPQ, pelvic muscle strength testing using the
Brink scale, rectal examination, and endoanal ultrasound in both 2-D and
3-D modalities by a blinded examiner trained in these examinations.
Results: In total, 48 cases and 28 asymptomatic controls participated.
Subjects were seen between six and nine months postpartum (mean 7.8
months ⫾0.7). Of the 48 cases, 31 (65%) had FI to flatus only. Cases
were older (31.5 vs. 28.4 years, p ⫽ 0.02) and had higher Body Mass
Index (26.2 vs. 23.6, p ⫽ 0.01). Seven cases had 4th degree lacerations
compared with no controls. Otherwise, baseline characteristics did not
differ between groups for infant weight, duration of 2nd stage, assisted
delivery, episiotomy, cesarean delivery, or smoking.
The total Brink score was 9.1 (SD ⫽ 2.6) in cases and 9.6 (SD ⫽ 2.2) in
controls (p ⫽ 0.41). Though not statistically significant, cases comprised
the majority of the “none/weak” Brink scores for pelvic floor muscle
duration (71%), pressure (69%), and displacement (71%). An absent
bulbocavernosous reflex was seen in 6 cases and was present in all 28
controls. A total of ten women had sphincter disruptions seen on 2D
ultrasound, nine of them in the case group (19.2% vs. 3.6%, p ⫽ 0.08).
Paradoxically, 3-D ultrasound revealed increased external anal sphincter
volume in cases (8.2 cc ⫾ 4.3) compared with controls (6.3 cc ⫾ 2.6,
p ⫽ 0.04).
Conclusions: Results from this small case-control study suggest that
childbirth may disrupt multiple functional areas of the pelvic floor and
potentially contribute to postpartum fecal incontinence. These results
suggest a potential opportunity for multiple modalities of early
intervention and further evaluation to decrease the long-term impact
of the physical and neurological insult.
Disclosures: M.A. Denman, Spouse is a paid Instructor for Depuy
Spine., Other (please specify type of relationship and company name);
T. Gregory, Intuitive Surgical, Consultant; P. Osterweil, None; H. Li,
None; J. Guise, None.
Bowel Symptoms in a Longitudinal Cohort of Women During
Pregnancy and Postpartum
C. A. Brincat, C. Lewicky-Gaupp, D. Patel, C. Sampselle, J. Miller, and
D. E. Fenner University of Michigan, Ann Arbor, MI
Objective: The aim of this secondary analysis is to assess the
prevalence of fecal incontinence (FI) at various time points during
pregnancy and at one year post partum, and to determine associations
with demographic and birth variables.
Methods: We conducted a secondary analysis of a randomized
controlled trial of 240 primiparous women during pregnancy and one
year post-partum. The primary aim of the parent study was to
determine the effect of pelvic floor exercises in conjunction with
spontaneous pushing with or without perineal massage (intervention
group) or directed pushing with or without perineal massage (control
group) on pelvic floor function at several time points. Inclusion
criteria were the following: 18 years of age or older, negative history
of genitourinary pathology, plans to remain in the region for at least
one year after the birth of the infant and ability to read and understand
English. Women were queried at the following time points: 20 and 35
weeks gestation and 6 weeks, 6 months and 1 year postpartum. At each
of these time points, women were asked if they had lost control over
stool or bowel movements, and if they were practicing Kegel exercises.
Associations of bowel symptoms with demographic and birth data were
determined using Fisher’s exact tests for categorical variables and
Student’s t-tests for continuous variables.
Results: Most participants were Caucasian (87%), with a median age of
30 years (range 18 – 42). Of the initial 240 women, at one year postpartum, 151 were available for follow-up. 5.3% (8/151) answered
affirmatively to the question, “Have you lost control over your stools or
bowel movements, that is, have you had any bowel accidents?” However,
at 20 weeks of pregnancy, there was a self-reported fecal incontinence
rate of 1.3% (3/240). FI was most common at 6 weeks post-partum
(6.4%–11/173). At one year, there was no difference in the number of
patients who reported fecal incontinence in the control group 5.3%
(4/76) and the intervention group 5.3% (4/75). Additionally, there were
no statistically significant differences in patient demographics (age, bodymass index) and infant data (weight, head circumference) between those
who reported FI at one year post-partum and those who did not. Also,
there was no significant association between practicing Kegel exercises
or delivery data (mode of delivery, episiotomy or laceration, and the
presence or absence of FI at one year post-partum.
Conclusions: Women should be reassured that the prevalence of
bowel accidents is low after delivery whether or not pelvic floor
exercises are performed. We found no predictors for fecal
incontinence in this low-risk cohort of primiparous women.
Disclosures: C.A. Brincat, None; C. Lewicky-Gaupp, None; D. Patel,
None; C. Sampselle, None; J. Miller, None; D.E. Fenner, None.
Prevalence of Fecal Incontinence in Overweight and Obese Women
with Urinary Incontinence and Effect of Dietary Fiber Intake
A. D. Markland,* H. E. Richter,* K. L. Burgio,* C. Bragg,* A.
Hernandez,† and L. L. Subak† *University of Alabama at
Birmingham, Birmingham, AL, †University of California, San
Francisco, San Francisco, CA
Background: Obesity is a risk factor for both urinary incontinence
(UI) and fecal incontinence (FI). Stool consistency may play an
important role in the development of FI. Increasing dietary fiber
intake is often used to improve stool consistency.
Objectives: To evaluate the prevalence of monthly FI in obese and
overweight women with UI and to compare dietary fiber intake levels
in subjects with and without FI.
Methods: Baseline data from 336 overweight and obese women with ⱖ
10 UI episodes per week who were enrolled in the Program to Reduce
Incontinence by Diet and Exercise (PRIDE) study were analyzed. PRIDE is
a multi-center, randomized, clinical trial that evaluated the effect of
weight reduction on UI. FI was defined as the loss of mucous, liquid, or
solid stool at least monthly as reported on the Fecal Incontinence Severity
Index (FISI). The Block Food Frequency Questionnaire (FFQ) was
used to quantify total energy (kcal), fat, cholesterol, protein,
Abstracts
carbohydrate and dietary fiber intake. Low fiber intake was defined as
⬍10 gm fiber/day. Potential confounding variables were assessed by
self-report questionnaires and examination, including sociodemographic factors, medical history, body mass index (BMI), UI
severity (Sandvik Severity Scale), lower urinary tract symptoms
(American Urologic Association Symptom Index (AUASI) score),
depression (Beck Depression Inventory (BDI) score), and quality of
life (MOS SF-36). Multivariable logistic regression analysis was used to
identify independent risk factors for FI.
Results: Complete data on the FFQ and the FISI were obtained in
336 (99%) women. They had a mean (⫾SD) age of 53 ⫾ 10 years,
BMI 36 ⫾ 6, and 19% were African American. Overall prevalence of FI
was 16%. Compared to women without FI (n ⫽ 281), women with FI
(n ⫽ 55) had a significantly higher prevalence of severe UI (p ⫽ .013)
and flatal incontinence (p ⬍ .001), higher mean AUASI (p ⫽ .001),
and BDI scores (p ⫽ .009), and lower mean SF-36 mental component
score (p ⫽ .001). More women with FI had low fiber intake than
women without FI (29% vs. 15%, p ⫽ 0.01) yet no differences were
seen in other dietary intake variables. In multivariable analyses, the
prevalence of FI increased significantly with low fiber intake (OR 2.5,
95% CI 1.3, 5.1), higher BDI scores (OR 2.1 per 10 point increase in
score, 95% CI 1.3, 3.4), and increased AUASI scores (OR 1.9 per 10
point increase in score, 95% CI 1.1, 3.3).
Conclusions: Overweight and obese women report a high
prevalence of FI at least monthly (16%) compared to population-based
rates of FI in women (5– 6%). An increase in fiber intake may improve
FI in overweight and obese women with urinary incontinence.
Disclosures: A.D. Markland, None; H.E. Richter, None; K.L. Burgio,
Pfizer, Astellas, Consultant; C. Bragg, None; A. Hernandez, None; L.L.
Subak, Pfizer, Grant/Research Support.
Constrictor and Elevator Functions of the Pelvic Floor are Distinct:
Evidence from Studies in Patients with Fecal Incontinence
V. Raizada, M. M. Weinstein, V. Bhargava, D. H. Pretorius, J. Wan, and
R. K. Mittal Pelvic Floor Function & Disease Group, San Diego, CA
Objective: Pelvic floor muscles provide elevator function (support to
pelvic organs) and constrictor function (continence to anal canal/
urethra) to the pelvic viscera. We hypothesize that fecal incontinence
patients (FI) have normal elevator but impaired constrictor function.
Methods: Ultrasound (US) measurements were validated using MRI in
5 subjects. Vertical and horizontal movements of the Anorectal angle
(ARA) were used as surrogate for elevator and constrictor function
respectively. Patients with fecal incontinence (FI) and age as well as
parity matched asymptomatic controls (C) were studied. Images were
acquired at rest (R) and sustained squeeze (S) using Philips 3D US
system. For constrictor function, the horizontal distances between a
fiducial point on pubic symphysis and ARA, and for elevator function
the vertical distances between the perineal skin and the ARA were
measured.
TABLE. Table Shows the Horizontal and Vertical Measurements Obtained from US Images
Horizontal (mm)
Rest
C
FI
51.0 ⫾ 9.2
54.5 ⫾ 12.6
Squeeze
Delta
Vertical (mm)
Rest
Squeeze
Delta
39.8 ⫾ 8.8*
47.1 ⫾ 12.0
11.1 ⫾ 5.0*
7.4 ⫾ 5.1
26.7 ⫾ 7.3
25.7 ⫾ 8.9
32.4 ⫾ 6.8
30.2 ⫾ 9.1
5.7 ⫾ 2.8
4.5 ⫾ 3.2
* unpaired t-test with unequal variances vs FI: p ⬍ 0.01; n ⫽ 26 in each group.
227
Abstracts
Results: Vertical distances at R, S, and their difference (⌬) were similar
in the C and FI groups. Horizontal distance at R was also similar in C and
FI groups. During S horizontal distance was smaller in FI than C. ⌬ for
horizontal distance in C was larger than FI. This indicates a stronger
constrictor function in asymptomatic C compared to FI patients.
Conclusions: Our data support the hypothesis that constrictor but not
the elevator function of the pelvic floor muscles is compromised in fecal
incontinence patients. We propose that elevator and constrictor functions
are due to different components of the pelvic floor muscle.
maximum squeeze pressures and were hypersensitive to rectal distention
with decreased tolerable rectal volumes and urges to defecate at lower
volumes (Table). FISI scores were higher in OI group compared to both
OC and YC group; no difference was found between OC and YC groups
(total patient scores: OI ⫽ 34.8 ⫾ 4.7, OC ⫽ 8.2 ⫾ 2.2, YC ⫽ 8.11 ⫾
3.7, p ⬍ 0.001). Similarly, FIQOL scores in all scales were significantly
lower in the OI group compared to the OC and YC groups, but no
difference was found between OC and YC groups (data not shown).
Conclusion: Structural changes (increased thickness) of the IAS smooth
muscle occur with aging, regardless of continence status. Fibrosis of the
smooth muscle may explain the increased thickness and decreased resting
pressures. Thinning of the striated EAS and a corresponding drop in squeeze
pressure correlated with FI, but not with aging. Rectal hypersensitivity
appears associated with FI symptoms rather than aging and may play a role
in the mechanism of fecal incontinence.
Disclosures: C. Lewicky-Gaupp, None; Q. Hamilton, None; M.
Huebner, None; J. Ashton-Miller, Johnson & Johnson, Consultant; J.O.
DeLancey, Johnson & Johnson, Consultant; D.E. Fenner, None.
Disclosures: V. Raizada, None; M.M. Weinstein, None; V. Bhargava,
None; D.H. Pretorius, None; J. Wan, None; R.K. Mittal, None.
Anal Sphincter Structure and Function Relationships in Aging
and Fecal Incontinence
C. Lewicky-Gaupp*, Q. Hamilton*, M. Huebner†, J. Ashton-Miller*, J.
O. DeLancey*, and D. E. Fenner* *University of Michigan Hospital,
Ann Arbor, MI, †University of Tuebingen, Tuebingen, Germany
Objective: To determine the extent to which age and incontinence
status affect the structure and function of the external (EAS) and
internal (IAS) anal sphincters.
Methods: Young women (YC) aged 20 – 41 years and older women
(OC) aged 60 – 88 years without fecal incontinence (FI) were
compared to older women aged 63– 85 years with fecal incontinence
(OI). Continence was defined as a Wexner score of ⬍ 4, and women
were considered incontinent if they had a score ⬎ 8. Women were
excluded if they had: prior sphincter or posterior vaginal wall surgery,
IBS, pelvic radiation, pregnancy within the past year, or neuromuscular
disease. Patients completed the Fecal Incontinence Quality of Life scale
(FIQOL) and the Fecal Incontinence Severity Index (FISI) and had
anorectal manometry (ARM) as well as transanal ultrasound.
Results: 9 YC, 9 OC, and 8 OI women were studied. Median vaginal
parity was significantly higher in the older women compared to the
young (OC ⫽ 2, OI ⫽ 3 v. YC ⫽ 0, p ⫽ ⬍0.001). The number of bowel
movements per week was similar among the groups (range 7–10/week).
The IAS was thicker in older women compared to younger but similar in
the two older groups. Resting pressure was lower in women with FI. The
EAS was thinner in the OI group. These women (OI) also had decreased
228
Urinary Peptides Differentiate Interstitial Cystitis Subjects from
Asymptomatic Controls
M. P. Canter*, C. A. Graham†, M. H. Heit†, L. S. Blackwell†, D. W.
Wilkey‡, J. B. Klein‡, and M. Merchant‡ *Urogynecology and Pelvic
Surgery Center, Arlington, VA, †Urogynecology Specialists of
Kentuckiana, Louisville, KY, ‡Clinical Proteomics Center, University
of Louisville, Louisville, KY
Objective: To identify differences in urinary peptides between
interstitial cystitis (IC) subjects and asymptomatic controls (AC).
Methods: Eighteen women with IC (mean voiding frequency ⱖ 10
times/day, mean nocturnal voids ⱖ 1, and bladder pain for ⱖ six
months) were recruited with age, race, and sex matched AC. Subjects
volunteered a first morning void urine specimen and completed the
Urge Urogenital Distress Inventory, the Urge Incontinence Impact
Questionnaire, the IC Symptom and Problem Questionnaire, the Pelvic
Pain and Urinary/Frequency Patient Symptom Scale and Short Form
36. Urine specimens were dialyzed and separated into low and high
molecular weight protein fractions using a 10,000 Dalton molecular
weight cut-off membrane. The low molecular weight protein fraction was
used in this study. These peptides were concentrated and desalted using
solid phase extraction methods and then separated using High Profile Liquid
Chromatography and robotically spotted onto MS target plates; an approach
useful for low abundant peptides. Positive ion MALDI-TOF MS mass spectra
were data acquired with a mass to charge ratio (m/z) of 700 to 4000 m/z
and evaluated using, Principal Component Analysis, PCA. Urine peptide
samples that sorted into two groups by PCA were compared by statistical ttest techniques to discern peptides that were present at levels statistically
different between the two groups. Peptides with a t-test probability ⱖ
95% were considered candidates. Candidates underwent peptide
fragmentation with MALDI-TOF-TOF MS. The resulting peptide fragments
were compared to potential parent protein amino acid sequences in the
Swiss-Prot database. Peptides with a total ion score ⱖ20 were considered
homologous. Peptide concentrations were correlated to IC severity using
disease specific and general health questionnaires.
Results: Five urinary peptides were significantly greater in IC subjects; their
presence positively correlated with IC severity. Two of the five peptides
were identified as unique fragments of alpha-2 (IX) collagen and histone
deacetylase 9. Nine peptides were significantly greater in the AC; their
presence negatively correlated with IC severity. Six of the nine peptides
were identified as unique fragments from alpha-2 (IX) collagen, histone
deacetylase 7, MAPK/ERK kinase 3, CUB and Sushi multiple domains 3
isoform 1, a E3 ubiquitin ligase and type-II adenylate cyclase.
Conclusion: Fourteen urinary peptides differentiate IC subjects from
AC. The peptides found in a greater concentration in IC subjects
positively correlated with worsening IC severity which may indicate
break down of protective proteins or up-regulation of inflammationmediated proteins. The dysregulated presentation of alpha-2 (IX)
collagen peptides may reflect altered activity of matrix
metalloproteases. The urinary peptides found in a greater
concentration in AC negatively correlated with worsening IC severity
which may indicate a loss of protective proteins in IC subjects.
Disclosures: M.P. Canter, None; C.A. Graham, None; M.H. Heit,
None; L.S. Blackwell, None; D.W. Wilkey, None; J.B. Klein, None; M.
Merchant, None.
Reduction in Voiding Frequency in a Constant Infusion Rodent
Model Using a Novel Amplitude-Modulated Waveform Through
Transcutaneous Sacral Neuromodulation
A. K. Monga*, S. Wahlgren†, A. R. DiUbaldi†, M. R. Tracey†, M.
Hoffman†, B. Patel†, D. Stoloff†, L. Hodgson†, and R. Toddywala‡
*BUPA Hospital Southampton, Southampton, United Kingdom, †Ethicon,
Inc., Somerville, NJ, ‡Nostrum Pharmaceuticals, Inc., Edison, NJ
Background: Sacral neuromodulation is an effective but invasive
option to treat detrusor overactivity. The Selective Nerve Stimulation
(SNS, known as “Project SyNapSe”) device provides non-invasive,
transcutaneous neurostimulation through a controlled, amplitudemodulated waveform. This carrier waveform is designed to be of
sufficient frequency to overcome tissue impedance. The pulse
envelope contains specific pulse width, amplitude, and shape
information designed to stimulate specific nerves.
Objective: This work aims at demonstrating the feasibility of a
transcutaneous neuromodulation approach to treat bladder overactivity.
Methods: A neurogenic bladder overactivity model was developed in
rodents through constant infusion of a noxious agent (0.25% acetic
acid at 2 mL/h) into the bladder (n ⫽ 8). The experimental design is
schematically represented in Figure 1(a). Baseline hyperactivity was
established by counting the number of voiding contractions every 30
minutes. Commercial Ag/AgCl electrodes (Noraxon Dual Electrode,
Abstracts
Active electrode site ⫽ 1 cm) were applied over the sacral (S1) region.
An amplitude-modulated waveform was applied and voiding
contractions were counted again, every 30 minutes.
Results: 5/8 test animals (63%) responded to the treatment (Defined as
reduction in contractions in test animals ⱖ Mean reduction in contractions in
control animals ⫹ Standard Error). Analysis of the data demonstrated a
statistically significant decrease in the number of contractions after the
application of stimulation (P ⱕ 0.05) (Figure 1(b)).
Conclusion: The novel amplitude-modulated waveform, applied
transcutaneously, was able to reduce the frequency of voiding
contractions in a hyper-reflexive bladder model. The results indicate
the potential utility of this transcutaneous neuromodulation device in
the clinical treatment of urge incontinence.
Disclosures: A.K. Monga, Ethicon, Inc., Consultant; S. Wahlgren,
Employee; Ethicon, Inc., A.R. DiUbaldi, Employee; Ethicon, Inc.; M.R.
Tracey, Employee; Ethicon, Inc., Other; M. Hoffman, Employee;
Ethicon, Inc., Other; B. Patel, Employee; Ethicon, Inc., Other; D.
Stoloff, Employee; Ethicon, Inc., Other; L. Hodgson, Employee;
Ethicon, Inc., Other; R. Toddywala, Employee; Nostrum
Pharamceuticals, Inc., Other.
Pregnancy and Delivery Induced Changes in Rat Vagina Persist
Postpartum
M. Alperin*, A. Feola†, R. Duerr*, S. Abramowitch†, and P. Moalli*
*Magee-Womens Research Institute, University of Pittsburgh,
Pittsburgh, PA, †Musculoskeletal Research Center, University of
Pittsburgh, Pittsburgh, PA
229
Abstracts
Objective: Vaginal birth is considered to be the greatest risk factor for
pelvic organ prolapse. However, the exact impact of pregnancy and delivery
on the vagina and supportive tissues has not been well defined. We sought
to determine the impact of vaginal delivery on the biomechanical behavior of
the vagina using an in vivo testing protocol.
Methods: 25 Long-Evans virgin, pregnant and 4 week postpartum
rats were utilized to measure vaginal distensibility (VD) in vivo. Under
sedation, a custom-made balloon contiguous with a pressure
transducer was inserted into the vagina. The balloon was distended
with water in 0.2 cc increments via an infusion pump. Pressurevolume curves were generated and the slopes were used to
characterize VD (higher slope ⫽ less distensible). Measurements of the
genital hiatus (GH) and total vaginal length (TVL) were recorded
before the experiment. Results are represented as mean ⫾ SD.
Statistical analyses were performed using one-way ANOVA with posthoc testing at a significance of 0.05.
Results: Based on TVL and the volumes required to achieve 10 mmHg,
initial vaginal diameters were not significantly different between the 3 groups
with the mean of 0.78 ⫾ 0.05 cm in virgin, 1.01 ⫾ 0.16 cm in pregnant, and
1.00 ⫾ 0.11 cm in postpartum rats (p ⫽ 0.08). TVL did not differ in virgin
and postpartum animals (p ⫽ 0.14). Virgins generated a mean pressure of
106 mmHg at 1 cc, while pregnant and postpartum rats demonstrated much
lower pressure at the same volume (p ⬍ 0.001 please, click Figure). To
achieve pressures similar to the virgins, postpartum rats required instillation
of 2cc. VD, derived from the slope of the pressure-volume curves, was
increased in pregnant vs. virgin rats as demonstrated by the lower slope
关11.4 ⫾ 7.12 mmHg/mL vs. 195.36 ⫾ 50.22 mmHg/mL (p ⬍ 0.001)兴.
Postpartum rats did not recover to the virgin state and demonstrated
significantly higher distensibility with a much lower slope of 95.5 ⫾ 36.51
mmHg/mL when compared to the slope of virgin rats (p ⫽ 0.01).
Conclusions: This testing protocol affords measurement of VD in
vivo using clinically relevant loading conditions. The continual
increase in VD in the late postpartum period defines a persistent
change in biomechanical behavior of the vagina related to
spontaneous vaginal delivery.
Disclosures: M. Alperin, None; A. Feola, none; R. Duerr, None; S.
Abramowitch, None; P. Moalli, None.
Pelvic Organ Prolapse and Hernias
J. F. Acevedo, D. D. Rahn, S. Roshanravan, and R. A. Word UTSW
MC, Dallas, TX
Objectives: Elastic fiber integrity is maintained by a delicate balance
between synthesis and degradation. Synthesis of elastic fibers in the
230
vaginal wall involves crosslinking of elastin monomers in the
extracellular matrix predominantly by lysyl oxidase (LOX) and LOXL1.
Elastic fibers are degraded by matrix metalloproteases and cysteine
proteases. The goal of this investigation was to determine the
incidence of pelvic organ prolapse, rectal prolapse, and hernia
formation in LOXL1-deficient mice as a function of age. Further, we
sought to test the hypothesis that MMP2 and MMP9 is increased in
pelvic or abdominal fascia from old wild type (WT) or LOXL1-/- mice
with prolapse or hernia formation compared with young WT or agematched knockout mice without evidence of disease.
Methods: Mouse Pelvic Organ Quantification (MOPQ) exams were
used to serially measure the degree of vaginal, perineal, and rectal
prolapse in 176 LOXL1-/- for 22 months. Quantitative gelatin
zymography was conducted in vaginal muscularis from young (n ⫽ 7)
and old (n ⫽ 7) wild type mice and old LOXL1-/- mice with (n ⫽ 7) or
without (n ⫽ 7) prolapse. MMP2 and MMP9 was also assessed in
LOXL1-/- mice with (n ⫽ 4) or without (n ⫽ 4) abdominal hernias.
Statistical analysis was conducted using ␹2 and Student’s t tests.
Results: In this study, young mice (10 –36 wk, n ⫽ 117) were
compared with old (37–52, n ⫽ 29 and 53– 63 wk, n ⫽ 83) and
elderly mice (64 –90 wk, n ⫽ 64). The prevalence of advanced
prolapse (Stage 2–3) in LOXL1-/- increased progressively from 7.7% in
young animals to 14, 16.8, and 20.3% in old and elderly mice
irrespective of parity status. Rectal prolapse increased from 10% in
young mice to 22% in elderly animals. Hernias were absent in young
females but occurred in 6% of old (37– 63 wks) and 16% of elderly
LOXL1-/- mice (p ⬍ 0.01). Hernia formation occurred through fascial
defects at the myopectineal line independent of pelvic organ prolapse.
Pro- and active MMP2 and MMP9 were readily identified in vaginal
muscularis. In contrast, MMP2 and MMP9 were not detectable in
abdominal fascia from WT or LOXL1-/- animals with or without
hernias. Active MMP2 and MMP9 were increased 8- and 6.8-fold in
vaginal muscularis from LOXL1-/- with prolapse compared with agematched WT mice (both p ⬍ 0.02), but were not altered during aging
in WT animals. MMP2 fluorimetric assays confirmed significant
increases in MMP2 activity in tissues from knockouts (p ⫽ 0.004).
Conclusions: This is the first report of abdominal hernias in LOXL1-/mice. Hernia formation was similar to that observed in fibulin-3
deficiency, another mouse model of pelvic organ prolapse. Thus,
pelvic organ prolapse and hernia formation are linked in certain
genetic defects involving defects in elastic fiber assembly. Although
increased MMP2 and MMP9 activity was associated with prolapse of
the pelvic organs, herniation through the abdominal fascia was not.
Taken together, the results suggest that fibulin-3 or LOXL1 function
may be impaired in women with co-morbidities of pelvic organ
prolapse and hernias during aging.
Disclosures: J.F. Acevedo, None; D.D. Rahn, None; S. Roshanravan,
Inherited Pelvic Organ Prolapse in the Mouse: Preliminary
Evaluation of a New Murine Model
A. R. McNanley, A. M. Johnson, M. K. Flynn, R. W. Wood, S. D.
Kennedy, and J. E. Reeder University of Rochester, Rochester, NY
Objective: To describe preliminary anatomic, radiographic, and
genetic observations in a population of mice with inherited,
spontaneous pelvic organ prolapse (S-POP).
Methods: University Committee on Animal Resources protocols were
followed. While monitoring bladder tumor growth in UPII-SV40T
transgenic mice for studies on bladder cancer, S-POP was observed
in males and nulliparous females. Additional S-POP mice were
identified by visible phenotype and euthanized using carbon
dioxide. Necropsies were performed which confirmed prolapsed
pelvic organs. To assess extent of POP without disrupting in vivo
anatomic relationships, specimens were studied using magnetic
resonance imaging (MRI) microscopy. Mice were immersed in 10%
formalin containing MRI gadolinium contrast agent prior to
imaging. Voxel dimensions of 117 ⫻ 58 ⫻ 117 ı̀m were obtained
from the upper thorax to the lower extremities. Images were
reconstructed using Image J and Amira software. Breeding records
between affected mice and wild type mice were analyzed to
determine inheritance patterns.
Results: CT in a male with a profoundly enlarged scrotum showed the
bladder prolapsed into the scrotum (Fig 1). Additional affected mice were
identified. Subsequent necropsy and MRI microscopy in these mice
showed bowel and bladder prolapsed through the pelvic floor. In
females, the uterus was displaced distally and compressed by bladder and
bowel. The appearance of the POP appears similar to that seen in the
human female phenotype. Analysis of breeding colony records suggested
that S-POP was inherited independent of the UPII-SV40T transgene in
both males and females and appeared to be a dominant trait.
Conclusions: This mouse model is distinct from previously
described models, in that POP does not require parturition as a
precipitating event. This suggests a different, perhaps more severe,
form of S-POP than has been previously described, making this a
potentially robust animal model for further study. Identification of
the gene(s) responsible for this phenotype may offer greater
insight into the pathophysiology of POP in humans.
Abstracts
Regional Heterogeneity in the Expression Pattern of the
Sphingosine-1-Phosphate (S1P) Signaling Pathway in the Rat
Lower Urinary Tract (LUT)
K. S. Sandhu, R. G. Chua, S. Collins, N. Kanika, M. Mikhail, A.
Melman, and M. E. DiSanto Albert Einstein College of Medicine,
Bronx, NY
Objective: Proper storing and emptying of the bladder requires
coordinated contractility of the bladder and urethral smooth muscle
(SM). Alteration in SM contractility is associated with urinary
dysfunction such as overactive bladder and incontinence. The
bioactive lipid S1P is a master regulator of SM phenotype, and is
present in serum at levels (⬃1 ␮M) which is consistent with SM
contraction. S1P interacts with three G-protein-coupled receptors
termed S1P1, S1P2, and S1P3 that activate many signal transduction
pathways including the RhoA/Rho-kinase pathway. The goal of this
study was to investigate the existence and relative expression of the
S1P receptors, as well as the major enzymes that regulate the
metabolism of S1P throughout the LUT.
Methods: Four female middle-aged Sprague-Dawley rats were
sacrificed. Serum was obtained and bladder tissue was divided into
bladder dome (BD), mid-bladder (MB), trigone (TRI), and urethra
(URE). Total RNA was extracted and quantitated via nanodrop
absorbance. Real-Time RT-PCR was performed with primers specific to
the S1P receptors (S1P1, S1P2, and S1P3), the S1P synthesizing
enzymes, sphingosine kinases 1 and 2 (SK-1 and SK-2), and the S1P
degrading enzymes, S1P phosphatases 1 and 2 (SPP1 and SPP2).
Expression levels were normalized to ␤-actin and GAPDH. The S1P
serum levels were determined by HPLC.
Results: Chloroform extraction of serum followed by derivatization
of sphingolipids with 9-fluorenylmethyl chloroformiate (FMOC-Cl) and
subsequent HPLC separation on a reverse-phase C-18 column revealed
significant levels of S1P in the low micromolar range. All three S1P
receptors and both isoforms of SK and SPP were expressed
throughout the LUT. However, S1P receptor expression varied
between bladder regions and URE. Most notably, S1P1 expression was
significantly higher (⬃2-fold) in the URE compared to each bladder
region (BD, MB, and TRI) while the expression of S1P2 was 2-fold
greater in the BD compared to the TRI and URE. While there were no
significant differences in the expression of SPPs throughout the LUT,
the expression of SK-2 was 2-fold higher in the URE compared to the
MB and TRI, and SK-1 expression was highest in the BD.
Conclusions: We demonstrate for the first time that the major
components of the S1P signaling pathway exist throughout the rat
LUT. The higher expression of the S1P1 receptor in the URE
compared to the bladder may be functionally relevant as the S1P1
receptor can activate nitric oxide synthase (NOS), which is known to
play a distinct role in urethral SM relaxation. Enhanced relative
expression of the S1P2 receptor in the BD may be important for
sustained force generation necessary for bladder emptying. Higher
relative expression of SK isoforms in the BD and URE suggests
increased local S1P production in these areas of high contractility and
tone, respectively. In summary, our study suggests an important role
of S1P signaling in the LUT and identifies this pathway as a possible
therapeutic target for voiding dysfunction.
Disclosures: A.R. McNanley, None; A.M. Johnson, None; M.K. Flynn,
None; R.W. Wood, None; S.D. Kennedy, None; J.E. Reeder, None.
Disclosures: K.S. Sandhu, None; R.G. Chua, None; S. Collins, None;
N. Kanika, None; M. Mikhail, None; A. Melman, None; M.E. DiSanto,
None.
231
Abstracts
Visibility of the Perineal Membrane Structure in Living Women
on Mr Imaging
C. Brandon, C. Lewicky-Gaupp, K. Larson, and J. L. DeLancey
University of Michigan Hospital, Ann Arbor, MI
Objective: The perineal membrane (PM) is an often discussed, yet
rarely studied, pelvic organ support structure. Recent cadaver
resear1ch1 demonstrates the different ventral and dorsal portions of
the perineal membrane (PM) and its close relationship to the levator
ani muscle. This study seeks to evaluate MR imaging’s ability to
visualize these relationships in living women.
Methods: MR images from 20 nulliparous women were examined.
All subjects (aged 23 to 55 years) denied incontinence or prolapse
symptoms and had pelvic organ prolapse quantification (POP-Q)
exams. Proton density MR images were acquired with a combination
of Philips 1.5T and 3T scanners (4 mm slice, 1 mm gap). The location
of known attachment points, structural connections and anatomical
relationships from previous cadaver studies were examined in each
scan plane. 3-D models were made of selected exemplars to assist
with anatomical relationships.
Results: In the coronal plane (Figure; top row) at the level of the
urethra (U), the PM’s ventral portion is part of a densely grouped and
interconnected series of structures including the compressor urethrae
(CU), vestibular bulb (VB), and pubic portion of the levator ani (LA-p).
This complex is immediately adjacent to the ischiopubic ramus (IPR)
with no visible interposing space or structures. In contrast, the
membrane’s dorsal part at the level of the vagina (V) has a clear,
membranous, lateral portion between vagina and IPR. At this level, the
PM connects medially with the levator ani, lying cephalad to the
vestibular bulb. The close relationship with the LA-p is seen dorsally.
The iliococcygeal portion of the levators (LA-i) is also seen. In the
sagittal plane (Figure; bottom row), the medial section shows the
parallel course and adjacent positions of the PM and LA-p. Lateral
sections show the more dorsal membranous portion. Note the clitoral
crus (CC) can also be seen.
Conclusion: MR images of nulliparous volunteers reveal that the
anatomical features of both the ventral and dorsal perineal membrane
can be seen in living women. The close relationship between the
perineal membrane and levator ani is evident.
1
Stein TA, DeLancey JOL. Structure of the perineal membrane in females: gross and microscopic anatomy. Obstet Gynecol 2008;
111(3):686 –93.
Disclosures: C. Brandon, None; C. Lewicky-Gaupp, None; K. Larson,
None; J.L. DeLancey, Johnson & Johnson, Consultant.
Quantifying the Accuracy of ICD-9 Codes in Identifying
Perioperative Complications as Compared to Chart Review
C. A. Heisler, A. L. Weaver, L. J. Melton, III, and J. B. Gebhart Mayo
Clinic, Rochester, MN
Objective: To quantify the ability of ICD-9 codes to identify
perioperative complications as compared to chart review.
Methods: Medical records of women who underwent vaginal
hysterectomy were reviewed from index surgery through 9-weeks
post-operation for the following perioperative complications: cardiac
or respiratory arrest, congestive heart failure (CHF), pulmonary
embolism, pulmonary edema, urinary tract infection, ureteral
obstruction, hemorrhage, delirium. Documentation reviewed included
surgical consultation, operative note, inpatient and anesthesia records,
direct patient communications and postoperative evaluation. Billing
records were utilized to identify ICD-9 codes corresponding to the
specific complications. Chart review served as the gold standard for
TABLE. Sensitivity, Specificity, PPV and NPV of ICD Code Identification of Perioperative
Complications As Compared to Chart Review (Gold Standard)
Complication
Cardiac Arrest
Respiratory Arrest
CHF
Pulmonary Embolism
Pulmonary Edema
Urinary Tract Infection
Ureteral Obstruction
Hemorrhage
Delirium
232
Sensitivity
PPV
Specificity
NPV
1/1 ⫽ 100%
1/1 ⫽ 100%
0/2 ⫽ 0%
2/2 ⫽ 100%
1/5 ⫽ 20%
24/108 ⫽ 22%
9/12 ⫽ 75%
6/25 ⫽ 24%
1/2 ⫽ 50%
1/1 ⫽ 100%
1/1 ⫽ 100%
0/0
2/2 ⫽ 100%
1/1 ⫽ 100%
24/26 ⫽ 92%
9/9 ⫽ 100%
6/7 ⫽ 86%
1/1 ⫽ 100%
711/711 ⫽ 100%
711/711 ⫽ 100%
710/710 ⫽ 100%
710/710 ⫽ 100%
707/707 ⫽ 100%
602/604 ⫽ 99.7%
700/700 ⫽ 100%
686/687 ⫽ 99.9%
710/710 ⫽ 100%
711/711 ⫽ 100%
711/711 ⫽ 100%
710/712 ⫽ 99.7%
710/710 ⫽ 100%
707/711 ⫽ 99.4%
602/688 ⫽ 87.5%
700/703 ⫽ 99.6%
686/705 ⫽ 97.3%
710/711 ⫽ 99.9%
determination of perioperative complications. Records that were
identified as having a complication through chart review or ICD-9
codes were re-abstracted to verify clinical information. Sensitivity,
specificity, positive predictive values (PPV) and negative predictive
values (NPV) were calculated for ICD code identification of
perioperative complications.
Results: 712 women were evaluated for perioperative complications
after vaginal hysterectomy. For cardiac arrest, respiratory arrest and
pulmonary embolism, ICD codes identified all instances and failed to
identify none (see table). However, ICD codes missed other types of
complications, which caused sensitivity to vary from 0% to 75%. ICD
codes were least likely to identify congestive heart failure and
pulmonary edema, and only slightly more likely to detect postoperative hemorrhage and urinary tract infections.
Conclusion: ICD codes accurately and completely captured major
complications such as cardiac arrest, respiratory arrest and pulmonary
embolism. However, some complications would have been underestimated
or missed entirely if ICD codes were the only means of assessment.
Therefore, depending on the definition of morbidity, chart review is
imperative for accurate ascertainment of complications.
Disclosures: C.A. Heisler, None; A.L. Weaver, None; L.J. Melton, III,
None; J.B. Gebhart, Bard, Grant/Research Support.
A Comparison of Costs for Abdominal, Laparoscopic and
Robot-Assisted Sacral Colpopexy
M. Patel*, D. O. Sullivan†, and P. Tulikangas* *University of
Connecticut, Hartford Hospital, Hartford, CT, †Hartford Hospital,
Department of Research Administration, Hartford, CT
Objective: To review the hospital based costs associated with
abdominal, laparoscopic and robot-assisted sacral colpopexy.
Methods: Cases with the following three procedures were identified
for further analysis: open abdominal sacral colpopexy, laparoscopic
sacral colpopexy or robot-assisted sacral colpopexy. We excluded
those with a concurrent hysterectomy. The estimated total charges,
estimated total costs, estimated direct and indirect costs were
computed based on International Statistical Classification of Diseases
and Related Health Problems 9 codes and adjusted for inflation using
the Consumer Price Index from the US Department of Labor Bureau
of Labor statistics. The operating room time, surgical time, estimated
blood loss and demographics were also reviewed. Results yielding p ⬍
0.05 were considered statistically significant.
Results: There were no difference in age, BMI, stage of prolapse,
estimated blood loss, operating room time and length of procedure
among the three groups. Comparing the inflation-adjusted estimated
hospital charges, the robot-assisted and laparoscopic approaches were
more expensive than the open abdominal sacral colpopexy,
$24,161.48, $19,308.94 and $13,149.99 respectively (p ⫽ 0.0004).
There was no difference between mean adjusted estimated total
charges for the laparoscopic approach and the robot-assisted
approach. The estimated direct costs were significantly higher for
robot-assisted as compared to open sacral colpopexy, but not different
between robot-assisted and laparoscopic sacral colpopexy. All charges
and cost comparisons are in Figure 1.
Conclusion: Robot-assisted sacral colpopexy produces the highest
estimated hospital charges and is more expensive than open sacral
colpopexy. The least expensive surgical approach from the hospital
perspective is the open abdominal sacral colpopexy. Economic gains
from reduced recovery time and loss of productivity may be higher
Abstracts
for laparoscopic and robot-assisted sacral colpopexy, thus off-setting
the higher initial costs. A more comprehensive cost-analysis from a
prospective comparison of these three modalities including these
other factors is warranted.
Disclosures: M. Patel, None; D. O’Sullivan, None; P. Tulikangas,
None.
Comparison
of
Short-Term
Outcomes
of
Robotic
Sacrocolpopexy Versus Abdominal Sacrocolpopexy
E. J. Geller*, N. Y. Siddiqui†, J. M. Wu†, and A. G. Visco† *UNCChapel Hill, Chapel Hill, NC, †Duke University, Durham, NC
Objective: To compare short-term outcomes in patients undergoing
robotic sacrocolpopexy versus abdominal sacrocolpopexy for
advanced pelvic organ prolapse.
Methods: We conducted a retrospective cohort study comparing
robotic sacrocolpopexy to abdominal sacrocolpopexy with placement
of permanent mesh. Data were collected between January 2004 and
March 2008 from two university hospitals regarding demographics and
peri-operative outcomes. The primary outcome was apical support on
6-week post-operative POP-Q examination. Secondary outcomes
included estimated blood loss, operative time, length of stay, blood
transfusion, bowel or bladder injury, urinary retention, post-operative
fever, wound infection, pneumonia, pulmonary embolus, ileus, bowel
obstruction, and mesh erosion.
Results: The analysis included 178 patients (73 robotic and 105
abdominal sacrocolpopexy). There were no differences in age, race or
BMI between groups. Women in the robotic group had more
significant prolapse than the abdominal group on preoperative POP-Q
examination: C (⫹3 vs. ⫹1, p ⫽ 0.002), Ba (⫹4 vs. ⫹3, p ⬍ 0.001)
and Bp (⫹2.5 vs. 0, p ⫽ 0.005). They were also more likely to
undergo hysterectomy (47.9% vs. 29.5%, p ⫽ 0.02) and less likely to
undergo other concomitant procedures for prolapse (5.5% vs. 65.7%,
p ⬍ 0.001) than women in the abdominal group. There was no
difference in the rate of anti-incontinence surgery (50.7% vs. 40.0%,
p ⫽ 0.17). Postoperatively, robotic sacrocolpopexy was associated
with a slight improvement in C point (⫺9 vs. ⫺8, p ⫽ 0.008), but no
difference in Ba or Bp when compared to abdominal sacrocolpopexy.
233
Abstracts
Robotic sacrocolpopexy was also associated with less blood loss (103
⫾ 96 mL vs. 255 ⫾ 155 mL, p⬍0.001), longer total operative time
(328 ⫾ 55 min vs. 225 ⫾ 61 min, p ⬍ 0.001), shorter length of stay
(1.3 ⫾ 0.8 days vs. 2.7 ⫾ 1.4 days, p ⬍ 0.001) and a higher incidence
of postoperative fever (4.1% vs. 0.0%, p ⫽ 0.04). There were no
significant differences in the other secondary outcome measures.
Operative time remained significantly greater in the robotic group
(p ⬍ 0.001) when controlling for BMI, hysterectomy, other
concomitant prolapse surgery, anti-incontinence surgery and lysis
of adhesions. Estimated blood loss remained significantly lower in
the robotic group (p ⬍ 0.001) when controlling for the same
variables.
Conclusions: Robotic sacrocolpopexy demonstrated similar apical
support at 6 weeks compared to abdominal sacrocolpopexy, with less
blood loss and shorter length of stay. Operative time was longer but
may decrease as the learning curve for this new procedure improves.
There were similar outcomes between the two groups in terms of
peri-operative complications. Long-term data are needed in order to
assess the durability of this new minimally invasive approach to
prolapse repair.
Disclosures: E.J. Geller, None; N.Y. Siddiqui, None; J.M. Wu, None;
A.G. Visco, Intuitive Surgical, Consultant; Intuitive Surgical, Paid
Instructor.
Stress Incontinence and Pelvic Muscle Dysfunction after Total
Vaginal Mesh
M. Aungst*, E. Friedman†, W. von. Pechmann‡, N. Horbach‡, and J.
Welgoss‡ *Walter Reed Army Medical Center, Washington, DC,
†George Washington University, Washington, DC, ‡Northern
Virginia Pelvic Surgery Associates, Annandale, VA
Objective: To determine the post operative rates of stress urinary
incontinence, pelvic muscle dysfunction, recurrent prolapse, and
mesh exposure after vaginal mesh reconstructive surgery using the
PROLIFT System (Gynecare, Somerville, N.J).
Methods: This was a retrospective review of women who underwent
vaginal reconstruction with polypropylene mesh using the PROLIFT
system between July 7, 2005 and Jan 31, 2008. Utilizing billing
records (CPT codes), 337 consecutive cases were identified from a
single practice. Complete office records for 335 women were
available and comprise this series. Surgical procedures were
performed by three fellowship trained urogynecologists, generally
assisted by urogynecology fellows and residents.
Results: Follow-up ranged from 1–32 months with a mean follow-up
of 8 months. Patient age ranged from 33– 87; average was 62.
Maximum prolapse stage ranged from II-IV, with 35% having stage II,
63% stage III, and 2% stage IV. Two-hundred forty-four women
underwent combined anterior and posterior PROLIFT (71%), 66
underwent anterior PROLIFT (20%), and 23 (8%) underwent posterior
PROLIFT. Two planned PROLIFT surgeries did not undergo mesh
placement. One case was converted to a uterosacral ligament
suspension, Burch, and anterior repair after ureter injury passing the
deep anterior trocar, and the second was converted to a LeFort after
cystotomy during dissection for anterior mesh placement. Various
concomitant procedures were performed including 160 mid-urethral
slings, 16 vaginal hysterectomies, 3 laparoscopic supracervical
hysterectomies, 37 posterior colporrhaphies, and 23 perineorrhaphies.
Eleven women underwent concomitant cervical conization to shorten
234
an elongated cervix. Intra-operative complications included 18
cystotomies (5%), 3 ureteral injuries (1%), and 1 rectal injury for an
overall visceral injury rate of 6.6%.
Out of 112 women who did not report stress urinary incontinence
(SUI) or demonstrate SUI during preoperative urodynamics, 27
reported it post-operatively for a de novo SUI rate of 24%. Of these
patients 3 underwent interval mid-urethral sling and 2 underwent
periurethral bulking. Fifty-three women (16%) complained of pelvic
muscle dysfunction (new onset dyspareunia or vaginal pain) postoperatively. In 39 (74%) of these women the symptoms largely
resolved within 6 months with medications and physical therapy. One
woman with continued vaginal pain underwent surgery to revise the
mesh. Five (1.4%) women had recurrent symptomatic prolapse, all in
the apical compartment. Fourteen (4%) cases of mesh exposure where
identified; 3 were asymptomatic and managed expectantly and 11
were excised with complete resolution of mesh exposure symptoms.
Conclusions: Over a 2.7 year period of performing vaginal
reconstruction utilizing the PROLIFT System, surgeons can expect a
low rate of recurrent prolapse and mesh exposure. However, pelvic
muscle dysfunction and de novo SUI will be encountered
postoperatively in some women.
Disclosures: M. Aungst, None; E. Friedman, None; W. von
Pechmann, None; N. Horbach, None; J. Welgoss, Ethicon, Consultant;
Medtronics, Consultant.
Complication and Reoperation Rates Following Surgical Repair
for Apical Vaginal Prolapse: A Meta-Analysis
G. B. Diwadkar*, M. D. Barber*, B. Feiner†, C. Maher†, and J. E.
Jelovsek*, *Cleveland Clinic, Cleveland, OH, †Wesley Hospital,
Brisbane, QLD, Australia
Objective: To compare postoperative complication and reoperation
rates for surgical procedures correcting apical vaginal prolapse,
including traditional procedures, sacral colpopexy, and vaginal mesh
kits.
Methods: A literature search was conducted for original articles
published or presented between 1985 and January 2008 addressing
apical prolapse repair and associated complication, recurrence, or
reoperation rates. Exclusion criteria included: ⬍50 subjects, nonEnglish articles, case reports, and follow-up ⬍3 months. Procedures
were separated into 3 groups: Traditional vaginal procedures
(uterosacral ligament, sacrospinous ligament, and iliococcygeus fascial
suspension, and McCalls culdoplasty), sacral colpopexy (open or
laparoscopic), and vaginal mesh kits. Complications were classified
using the Dindo Grading System. Weighted averages and confidence
intervals were calculated for each Dindo grade, specific complications,
reoperations for recurrence, and total reoperations (Dindo IIIb and
prolapse recurrence).
Results: 111 studies including 16,891 subjects met criteria for
inclusion. Dindo grade I (antiemetic, antipyretic, or analgesic use)
and II (other pharmacological treatment or blood transfusion) rates
were greatest in the traditional procedure group. The mesh
complication rate in the traditional group represented erosions
from concomitant procedures. Visceral injury and wound
complication rates were greatest in the sacral colpopexy group.
Dindo grade IIIa (surgery not requiring general anesthesia) and
Dindo IIIb (requiring general anesthesia) rates were highest in the
vaginal mesh kit group, likely due to higher rates of mesh erosion
and fistulas. Reoperation rates for prolapse recurrence were
highest in the traditional group. The total reoperation rate was
greatest in the mesh kit group (8.5%) despite the shortest mean
follow-up of 17.1 months.
Conclusions: Overall complication rates are similar for traditional
surgeries, sacral colpopexies, and vaginal mesh kits for treatment of
apical prolapse. However, the rate of reoperations due to
complications and total reoperation rate are highest for vaginal mesh
kits, in spite of fewer reoperations for prolapse recurrence and
shorter overall follow-up.
Disclosures: G.B. Diwadkar, None; M.D. Barber, American Medical
Systems, Grant/Research Support; B. Feiner, None; C. Maher, None;
J.E. Jelovsek, None.
Long-Term Histological Response to Synthetic and Biologic
Graft Materials Implanted in the Vagina and Abdomen of a
Rabbit Model
L. M. Pierce, A. Rao, S. S. Baumann, J. E. Glassberg, T. J. Kuehl, and
T. W. Muir Scott and White Hospital, Temple, TX
Objective: To evaluate the effects of graft type (synthetic versus
biologic), site of implantation (vagina versus abdomen), and
ovariectomy on the histological response to graft materials used in
pelvic reconstructive surgery.
Methods: Forty-five female New Zealand White rabbits were
randomly assigned to undergo ovariectomy or sham laparotomy and
were surgically implanted with polypropylene mesh (PP; Gynemesh,
Ethicon; n ⫽ 23) or porcine dermis (PS; PelviSoft, C.R. Bard; n ⫽ 22)
into the posterior vaginal wall and abdomen. The same graft type was
implanted at both sites in each animal. Grafts with surrounding host
tissues were harvested 9 months after implantation. Serial full
thickness sections were processed with routine histological stains to
evaluate the host inflammatory response and degree of tissue
incorporation within the grafts. Inflammation, neovascularization, and
fibroblastic proliferation were scored by a pathologist on a scale of 0
to 4 (0 ⫽ none, 1 ⫽ minimal, 2 ⫽ mild, 3 ⫽ moderate, 4 ⫽ severe).
Results: Erosion occurred in the vagina of 8/45 rabbits 关5/23 (22%)
rabbits implanted with Gynemesh (2 with and 3 without ovaries) and
3/22 (14%) rabbits implanted with PelviSoft (2 with and 1 without
ovaries)兴. Erosion did not occur at abdominal sites. Grafts available for
histological analysis included 37 PP samples 关15 vaginal (9 with and 6
without ovaries); 22 abdominal (12 with and 10 without ovaries)兴 and
33 PS samples 关14 vaginal (8 with and 6 without ovaries); 19
abdominal (10 with and 9 without ovaries)兴. Overall, PP induced a
Abstracts
milder and more uniform response than PS, with lower scores for
inflammation (p ⫽ 0.007, Mann-Whitney Rank Sum test) and good
host tissue incorporation between PP fibers. PS induced a more
variable response, with PS grafts missing in 6/20 vaginal sites (but in
no abdominal sites) at 9 months. Some PS grafts in the vagina and
abdomen appeared intact with minimal inflammation and poor host
tissue infiltration, while a severe foreign body reaction was observed
in other animals in which the grafts appeared to be undergoing
digestion. Paired analysis (n ⫽ 28) revealed that vaginal grafts had
higher scores for inflammation (p ⫽ 0.005) and neovascularization
(p ⬍ 0.001), and had lower scores for fibroblastic proliferation (p ⬍
0.001) than abdominal grafts. Vaginal grafts from ovariectomized
rabbits (n ⫽ 12) and those with intact ovaries (n ⫽ 17) had similar
scores for inflammation (p ⫽ 0.32), neovascularization (p ⫽ 0.51), and
fibroblastic proliferation (p ⫽ 0.83).
Conclusions: Synthetic and biologic grafts evoke different foreign
body reactions that may have implications for surgical outcomes in
women. Polypropylene mesh induces a milder, more uniform
response than porcine dermis, whereas porcine dermis elicits a more
variable response and may degrade in the vagina by 9 months.
Because vaginal implantation elicits a different tissue response than
abdominal implantation, vaginal models are most appropriate for
investigations of host responses to graft materials used in vaginal
surgery.
Disclosures: L.M. Pierce, None; A. Rao, None; S.S. Baumann, None;
J.E. Glassberg, None; T.J. Kuehl, None; T.W. Muir, None.
Biomechanical Properties of Synthetic and Biologic Graft
Materials Following Long-Term Implantation in the Rabbit
Abdomen and Vagina
L. M. Pierce*, M. A. Grunlan†, Y. Hou†, S. S. Baumann*, T. J. Kuehl*,
and T. W. Muir* *Scott and White Hospital, Temple, TX, †Texas A&M
University, College Station, TX
Objective: To evaluate the effects of anatomical location and
ovariectomy on biomechanical properties of synthetic and biologic
grafts following long-term implantation in a rabbit model.
Methods: Thirty-five New Zealand White rabbits were randomly
assigned to undergo ovariectomy or sham laparotomy and were
surgically implanted with polypropylene mesh (PP; Gynemesh,
Ethicon; n ⫽ 17) or porcine dermis (PS; PelviSoft, C.R. Bard;
n ⫽ 18) into the posterior vaginal wall and abdomen. Grafts were
harvested 9 months after implantation and measured with
electronic calipers. Static mechanical properties of grafts were
determined with an RSAIII mechanical analyzer by investigators
blinded to treatment. Results were compared to baseline (before
implantation) values (n ⫽ 5). For PS grafts, testing was performed
on abdominal sites only.
Results: Thirty-four PP samples (17 vaginal and 17 abdominal grafts
from 9 rabbits without and 8 with ovaries) and 18 PS samples (18
abdominal grafts from 9 without and 9 with ovaries) were tested. At
baseline, PP grafts were weaker (force required for rupture ⫽ 8.3 N ⫾
1.1SE PP; 16.3N ⫾ 0.5 PS; p ⬍ 0.001) and less resistant to tensile
forces (i.e., less stiff; 3.0 N/mm ⫾ 0.1 PP; 6.8 N/mm ⫾ 0.4 PS;
p ⫽ 0.008) than PS. At 9 months after implantation, PP grafts
increased in elasticity indicated by increased maximal elongation
before rupture (41% ⫾ 4 baseline; 87% ⫾ 7 vagina, p ⫽ 0.003; 73% ⫾
7 abdomen, p ⫽ 0.02) and decreased stiffness (baseline 3.0 N/mm ⫾
0.1; 1.6 N/mm ⫾ 0.2 vagina, p ⫽ 0.003; 2.4 N/mm ⫾ 0.3 abdomen,
235
Abstracts
p ⫽ 0.03). PP grafts tended to increase in strength after implantation
(8.3 N ⫾ 1.1 baseline; 12.2 N ⫾ 1.8 vagina, p ⫽ 0.28; 15.7 N ⫾ 2.0
abdomen, p ⫽ 0.06) although statistical significance was not achieved.
In contrast, PS grafts decreased in maximal elongation (55% ⫾ 4
baseline; 36% ⫾ 4 abdomen, p ⫽ 0.02) and did not change
significantly in strength (16.3 N ⫾ 0.5 baseline; 13.6 N ⫾ 2.5
abdomen, p ⫽ 0.28) or stiffness (baseline 6.8 N/mm ⫾ 0.4; 5.3 N/mm
⫾ 1.2 abdomen, p ⫽ 0.15) from baseline. At abdominal sites, PS grafts
were more resistant to tensile forces than PP (5.3 N/mm ⫾ 1.2 PS vs.
2.4 N/mm ⫾ 0.3 PP; p ⫽ 0.04) and maximal elongation was half that
of PP (36% ⫾ 4 PS vs. 73% ⫾ 7 PP; p ⬍ 0.001), but PS and PP were
similar in strength (p ⫽ 0.52). Vaginal PP grafts showed significant (p
⬍ 0.001) shrinkage from baseline (20% mean decrease in surface
area), while the surface area of abdominal grafts did not change
(p ⫽ 0.16). Abdominal PP grafts were stiffer than vaginal PP grafts
(p ⫽ 0.049) but were not significantly different in strength (p ⫽ 0.19)
or maximal elongation (p ⫽ 0.15). Ovariectomy had no effect on the
mechanical properties of PP or PS grafts compared to grafts from
rabbits with intact ovaries (p ⬎ 0.05 for all comparisons).
Conclusions: Changes in biomechanical properties of synthetic and
biologic graft materials occur following long-term implantation.
Vaginal PP grafts shrink more and are less stiff than abdominal grafts.
At 9 months, PS is similar in strength but is twice as stiff as PP and
has a maximal elongation only half that of PP.
Disclosures: L.M. Pierce, None; M.A. Grunlan, None; Y. Hou, None;
S.S. Baumann, None; T.J. Kuehl, None; T.W. Muir, None.
was more pronounced at larger diameter probes. Women with most
severe injury of PRM (⬎75%) had significantly lower rest and squeeze
pressures at higher probe sizes (10, 20, 30 mm). Only 4/45 (9%) were
in “injured” EAS and IAS group and their anal pressures at rest and
squeeze were lower compared to women with no defects, but not
statistically significant (fANOVA p ⫽ 0.45).
Conclusion: In asymptomatic parous women PRM defects are more
common than EAS and IAS defects. Women with PRM defects have
lower vaginal pressure and abnormal length tension muscle
characteristics.
Disclosures: M.M. Weinstein, None; D.H. Pretorius, Equipment Loan,
Grant/Research Support; S. Jung, None; J.J. Wan, None; C.W. Nager,
None; R.K. Mittal, None.
Anal Sphincter Complex Muscle Anatomy and Function in
Asymptomatic Parous Women
M. M. Weinstein, D. H. Pretorius, S. Jung, J. J. Wan, C. W. Nager,
and R. K. Mittal University of California, San Diego; Pelvic Floor
Function and Disorder Group, San Diego, CA
Objective: To assess the anatomy and function of the anal sphincter
complex muscles: the puborectalis muscle (PRM), external anal
sphincter (EAS) and internal anal sphincter (IAS) with threedimensional ultrasound (3DUS), vaginal and anal manometry in
asymptomatic parous women (APW).
We hypothesized: 1) APW have a high prevalence of the PRM
injury and those with the PRM injury have impaired vaginal pressure
compared to uninjured women. 2) APW with the IAS and EAS defects
have impaired resting and squeeze pressures, respectively.
Methods: Women with one prior vaginal delivery and no anal or
urinary incontinence were studied with 3DUS to assess the PRM, EAS
and IAS. The muscles were assessed with a semi-quantitative scoring
system and grouped into “injured” and “uninjured” groups. Women in
“uninjured” PRM group had ⬍ 25% defect and “injured” group had ⬎
25% defect. The EAS and IAS were assessed for defects along the
sphincters length; “uninjured” EAS and IAS group had ⬍ 25% defect
and “injured” ⫺ ⬎ 25% defect along the sphincter length. Vaginal and
anal pressures were measured at rest and during a pelvic floor
contraction with a sleeve sensor mounted on different diameter
probes. We analyzed data with Student t-test, chi-square and factorial
ANOVA (fANOVA) tests.
Results: 45 women, mean age 50 (range 24 – 68) were assessed; 44
had adequate PRM images. In the uninjured group of 30, 22 had no
PRM defects and 8 had ⬍25% PRM defects. The 14 women (32%) in
the PRM “injured” group had significantly lower vaginal pressures
than “uninjured” group (fANOVA p ⫽ 0.001) 关Figure 1兴; this difference
236
Findings by MRI of Injury and Recovery of the Levator ANI
Muscle and Surrounding Structures After High Risk Vaginal
Birth
J. Miller, C. Brandon, L. Kane Low, J. Ashton-Miller, and J. DeLancey
University of Michigan, Ann Arbor, MI
Objective: To use serial magnetic resonance (MR) imaging and
established criteria from musculoskeletal radiology to classify severity,
type, and resolution of birth related injury to the levator ani muscle
(LA) and surrounding structures.
Methods: We studied 21 women with factors associated with an
increased risk of LA injury: first vaginal delivery, long 2nd stage,
forceps delivery, or anal sphincter laceration (Kearney, 2006). MR was
obtained at 2– 6 weeks and 6 months post vaginal birth using
multiplanar 3T proton density. In the last 11 women a fluid sensitive
sequence was added to increase sensitivity to signal intensity changes
indicative of edema. MR injury features noted were: 1) High signal
intensity reflecting trauma-related edema. 2) Signal intensity pattern
reflecting injury as diffuse or focal. 3) Muscle fiber discontinuity
graded as partial or full tear. The figure shows an early and late scan
example. PB ⫽ pubic bone, R ⫽ Rectum, U ⫽ urethra. Note on early
scan, high signal (lighter color) in the (R) LA’s pubic portion (LA-p)
but normal signal (dark) in adjacent obturator internus (OI). On the
left (L) no LA-p is seen in the expected location (arrow) between the
vagina and OI. At 6 months LA signal intensity has improved on the
right, muscle absence persists on the left.
Results: In 21/21 women high signal intensity was seen in the LA
but not in the OI on early scan. Reduction of the signal intensity
occurred in all late scans though in women with fluid-sensitive images
there remained mildly increased signal in the LA compared to the
unaffected OI. Partial or full LA tears were seen at the location of the
pubic bone attachment point in 6/21 women on early scan; none
showed reattachment on late scan. (One woman with tear dropped
before f/u). None of the women showed a pattern of muscle atrophy
from early to late scans, which would be expected if there were overt
denervation. Of the 11 women with fluid sensitive scans 4 with LA
tears and 4 without showed focal bone marrow edema (high signal).
Conclusion: Results show feasibility of using MR to study birth
related tissue injury and recovery. LA tears and focal bone marrow
edema were seen. None of the LA tears observed in early scans
resolved. Comment: Edema in the LA but not the OI is more
consistent with stretch than compression injury.
Abstracts
One-Year
Anatomic
and
Functional
Outcomes
After
Reconstructive Surgery with Prolift® Pelvic Floor Repair System
M. Alperin,* R. Ellison,* E. A. Frankman,* L. Meyn,† and H. M.
Zyczynski* *Magee-Womens Hospital, University of Pittsburgh,
Pittsburgh, PA, †Magee-Womens Research Institute and Foundation,
Objective: To prospectively assess anatomic and functional outcomes 1
year after prolapse repair using Prolift® (Gynecare/Ethicon, Somerville,
NJ) pelvic floor repair system.
Methods: Baseline and 1 year postoperative data were analyzed in 40
consecutive women enrolled in this IRB approved, prospective study
assessing objective and subjective outcomes after prolapse repair
using Prolift® systems. Objective outcomes were measured by
standardized Pelvic Organ Prolapse Quantification (POPQ)
examination. Subjective analysis included assessment of symptoms,
quality of life, and sexual function using validated Pelvic Floor Distress
Inventory (PFDI), Pelvic Floor Impact Questionnaire (PFIQ), and
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire
(PISQ) self-questionnaires. Global satisfaction with the procedure was
assessed using a Visual Analog Scale from 1 to 10, with the boundaries
of very unsatisfied and very satisfied. Subjects were also asked if they
would recommend the procedure to a friend. Paired Student’s t-tests
were used to analyze pre- versus postoperative data.
Results: Mean age at surgery was 65.8 ⫾ 9.7 (mean ⫾ SD) years,
body mass index was 26.7 ⫾ 3.9 kg/m2 and median parity was 3 (range
1– 8). Six (15%) had previous prolapse surgery and 24 (60%) had a prior
hysterectomy. Total Prolift® was performed in 22 (55%), anterior Prolift®
with apical modification in 14 (35%), and posterior Prolift® in 4 (10%).
Concomitant procedures included 3 hysterectomies and 6 midurethral
Disclosures: J. Miller, None; C. Brandon, None; L. Kane Low, None;
J. Ashton-Miller, None; J. DeLancey, None.
TABLE.
Anatomic Outcomes (POPQ)
Stage†
Stage 0
Stage 1
Stage 2
Stage 3
Stage 4
Ba (cm)
Bp (cm)
C (cm)
Genital Hiatus (cm)
TVL
Functional Outcomes
PFDI (0-1000)
UDI (0-300)
CRADI (0-400)
POPDI (0-300)
PFIQ(0-1200)
UIQ (0-400)
CRAIQ (0-400)
POPIQ (0-400)
PSIQ (0-125)
†
Preoperative
(mean ⴞ SD)
Postoperative
(mean ⴞ SD)
0
0
6
32
2
3
17
20
0
0
p-value
⫹2.7 ⫾ 2.3
⫹0.5 ⫾ 3.2
⫺1.2 ⫾ 4.4
5.0 ⫾ 1.3
8.8 ⫾ 1.2
⫺1.7 ⫾ 1.0
⫺1.8 ⫾ 1.2
⫺6.4 ⫾ 1.2
3.1 ⫾ 0.9
7.5 ⫾ 2.8
⬍0.001
⬍0.001
⬍0.001
⬍0.001
0.008
255.4 ⫾ 151.9
71.1 ⫾ 46.3
82.9 ⫾ 73.8
101.4 ⫾ 58.6
203.6 ⫾ 188.9
71.7 ⫾ 64.2
57.8 ⫾ 85.4
74.1 ⫾ 86.9
82.5 ⫾ 17.9
109.2 ⫾ 148.7
30.6 ⫾ 38.7
43.6 ⫾ 56.2
35.0 ⫾ 51.2
53.1 ⫾ 83.5
23.4 ⫾ 32.8
16.6 ⫾ 34.3
13.1 ⫾ 35.5
100.2 ⫾ 16.1
⬍0.001
⬍0.001
⬍0.001
⬍0.001
⬍0.001
⬍0.001
0.004
⬍0.001
⬍0.001
Frequency.
237
Abstracts
slings. At 1 year, POPQ measures of the anterior, apical, and posterior
compartments were significantly improved from baseline as were quality
of life and sexual function scores (see Table). All 22 women who were
sexually active at baseline were sexually active at 1 year. Dyspareunia
was similar at baseline and at 1 year follow up affecting 9 (41%) and 8
(36%) subjects respectively. Mesh exposure occurred in 2 (5%) subjects.
The median patient global satisfaction with the procedure was 9.2 (range
2.3–10.0) and 95% would recommend it to a friend.
Conclusion: Anatomic support and functional outcomes 1 year after
transvaginal prolapse surgery with Prolift® repair systems are promising
with high patient satisfaction and an acceptable complication rate.
Disclosures: M. Alperin, None; R. Ellison, None; E.A. Frankman,
None; L. Meyn, None; H.M. Zyczynski, Contract researcher, Ethicon
Women’s Health and Urology, Other.
Anatomy and Visceral Function After Anterior Vaginal Prolapse
Repair: A Randomized Controlled Trial
J. N. Nguyen,* and R. J. Burchette† *Southern California
Permanente Medical Group, Downey, CA, †Kaiser Permanente
Research and Evaluation, Pasadena, CA
Objectives: To report 2-year outcomes of a randomized controlled
trial comparing polypropylene mesh reinforced anterior vaginal
prolapse repair to anterior colporrhaphy.
Methods: Seventy-six patients, mean age 60 years and BMI 28 kg/m2,
with stage II or greater anterior vaginal prolapse were recruited from
the urogynecology clinic and randomly assigned to either anterior
colporrhaphy (AC) or Perigee polypropylene mesh repair. Other
surgical procedures were performed as indicated. The primary
outcome was recurrent stage II anterior vaginal prolapse, and
secondary outcomes were effects on quality of life and sexual
symptom scores, surgical time, blood loss, length of hospitalization,
and adverse events. Vaginal support was considered “optimal” when
both points Aa and Ba were at stage 0 (⫺3 cm), and “satisfactory”
when both points Aa and Ba were at stage I (⫺2 cm) and improved
from preoperative staging. Anatomic cure was defined as an optimal
or satisfactory outcome, and “unsatisfactory” (failure) if either point
Aa or Ba was at stage II or beyond (⫺1 cm or lower). A research
nurse and medical assistant, both blinded to the subject’s group
assignment, performed the annual POPQ staging exam administered
the PFDI-20, PFIQ-7 and PISQ-12 questionnaires respectively.
Results: Thirty-eight women had anterior colporrhaphy and 37 had
polypropylene mesh repair. One patient allocated to mesh repair
withdrew from the study prior to surgery. Clinical and demographic
data did not differ significantly between the two treatment groups.
Recurrent stage II anterior vaginal prolapse (primary outcome) at two
years occurred in 20/38 (53%) of anterior colporrhaphy and 5/38
(14%) of the mesh group (p ⫽ .004). Operative time and length of
hospitalization were similar in both groups. Postoperative day one
hemoglobin change was higher in the mesh group (2.4 vs 1.8 g/dl,
p ⫽ .02) but there was no difference in transfusion rates (3%). Quality
of life (PFDI-20, PFIQ-7) symptom scores improved in both the AC
(109 ⫾ 58 vs. 45 ⫾ 32, 82 ⫾ 54 vs. 23 ⫾ 34) and mesh (108 ⫾ 45 vs.
34 ⫾ 31, 82 ⫾ 54 vs. 14 ⫾ 23) groups two years after surgery (p ⬍
.0001). Sexual symptom (PISQ-12) scores were similar between
groups at baseline and did not change significantly after surgery. The
rates of de novo dyspareunia were 4/26 (16%) and 2/22 (9%) in the
colporrhaphy and mesh groups respectively. Two of 37 women (5%)
had vaginal mesh extrusions and were treated without recurrence.
Neither serious adverse events nor deaths occurred in either group.
238
Conclusions: Anterior vaginal prolapse repair with polypropylene
mesh reinforcement offers lower anatomic recurrence than anterior
colporrhaphy at two years. However, quality of life and sexual
symptoms scores improved in both groups.
Disclosures:
J.N.
Nguyen,
American
Medical
Systems,
Grant/Research Support; American Medical Systems, Consultant;
R.J. Burchette, None.
A Cost-Effectiveness Analysis of Botulinum Toxin a Injection
Versus Anticholinergic Medications for the Primary Treatment
of Idiopathic Urge Incontinence
J. Wu, N. Y. Siddiqui, C. L. Amundsen, E. R. Myers, and A. G. Visco
Duke University, Durham, NC
Background: Anticholinergic medications are primary therapy for
urge incontinence. Although anticholinergics are effective, these
medications have bothersome side effects resulting in poor patient
compliance. Botulinum toxin A injection has emerged as an effective
treatment for refractory urge incontinence but it is associated with
higher costs and limited duration of effect.
Objective: To assess the cost-effectiveness of intradetrusor botulinum
toxin A injection compared to anticholinergic medications for the
primary treatment of idiopathic urge incontinence.
Methods: A Markov decision analysis model was developed to
compare the costs, in 2008 US dollars, and effectiveness, measured
in quality-adjusted life-years (QALYs), of botulinum toxin A
injection (BoNT-A) and anticholinergic medications. The
probabilities of improvement and adverse events for each therapy
and the quality of life (utility values) associated with continence
and urge incontinence were derived from published studies. Costs
were based on Medicare reimbursements and national physician fee
schedules. Costs and QALYs were discounted at rate of 3% per
year. The analysis was conducted from a societal cost perspective
with a time period of two years using 3-month cycles. The primary
outcome was the incremental cost-effectiveness ratio (ICER), which
is defined as (BoNT-A cost-Medication cost)/(BoNT-A QALY Medication QALY). Sensitivity analyses were performed to assess
the effect of varying estimates through their ranges.
Results: While the botulinum treatment strategy was more
expensive ($4,392 vs $2,563), it was also more effective (1.63 vs
1.50 QALYs) compared to the anticholinergic regimen. The
calculated ICER was $14,377/QALY. Given a well-accepted
definition for cost-effectiveness of an ICER ⬍ $50,000/QALY,
BoNT-A is cost-effective compared to anticholinergics. We also
performed extensive one-way sensitivity analyses to determine
whether varying estimates through their low and high values would
impact the results. The probability of compliance with
anticholinergics was 33% for the base-case. When compliance
exceeded 75%, anticholinergic medications became cost-effective.
Anticholinergics also became cost-effective if the cost of the
botulinum procedure ($1690 in the base-case) exceeded $3875. For
the remainder of the sensitivity analyses, BoNT-A remained costeffective. Changes in anticholinergic cost over 3 months ($110 to
$570) and changes in efficacy (initial failure after BoNT-A: 8% to
40%; BoNT-A failure at 9 months: 25% to 75%; BoNT-A retention:
4% to 43%; and improvement with medications: 43% to 89%) did
not change the cost-effectiveness of BoNT-A.
Conclusions: Over a two-year period, botulinum toxin A injection
was cost-effective compared to anticholinergic medications for the
primary treatment of urge incontinence. Anticholinergics become
cost-effective if patients are highly compliant with medications or
if the botulinum procedure costs increase substantially.
Disclosures: J. Wu, None; N.Y. Siddiqui, None; C.L. Amundsen,
None; E.R. Myers, Merck, Precision Diagnostics, Grant/Research
Support; Merck, Precision Diagnostics, Consultant; A.G. Visco,
Intuitive Surgical, Consultant; Intuitive Surgical, Paid Instructor.
Preemptive Local Analgesia in Vaginal Surgery
J. B. Long, R. J. Eiland, J. G. Hentz, P. A. Mergens, P. M. Magtibay, R.
M. Kho, and J. L. Cornella Mayo Clinic Arizona, Phoenix, AZ
Objective: To assess the efficacy of preemptive paracervical block
with long-acting local anesthestics on postoperative pain for patients
undergoing vaginal hysterectomy with McCall culdoplasty.
Methods: A prospective, randomized, double blinded trial of
preemptive local analgesia (PLA) in 90 women undergoing vaginal
hysterectomy (with and without concomitant vaginal procedures)
was conducted. PLA consisted of a 10cc paracervical injection of
0.5% bupivicaine with 1:200,000 epinephrine at the start of the
case, and an additional 10cc injected into the more proximal
uterosacral ligaments just prior to placement of McCall culdoplasty
sutures. Pain was recorded using a visual analog score (VAS) at 30
minutes, 3, 12, and 24 hours post-operatively. Additionally, total
narcotic use was recorded at the same time points. All adverse
events were tracked over a 6-week post-operative time period.
Results: The mean pain VAS 30 minutes and 3 hours post-operatively was
43% (P ⫽ 0.003) and 33% (P ⫽ 0.02) lower, respectively, in the PLA group
versus the placebo group. Mean pain VAS for the PLA treatment at 12 and 24
hours after surgery were equivalent to placebo treatment. Additionally, the
mean total dose of narcotic at every time point post-operatively was
significantly less in the PLA group versus the placebo group.
Conclusion: PLA with bupivicaine prior to vaginal hysterectomy is
associated with significantly lower pain scores and a reduction in
narcotic use post-operatively.
Disclosures: J.B. Long, None; R.J. Eiland, None; J.G. Hentz, None; P.A.
Mergens, None; P.M. Magtibay, None; R.M. Kho, None; J.L. Cornella, None.
The 3-D Relationship Between Superior Attachment Points for
Anterior Wall Mesh Operations and the Upper Vagina in
Women with Normal Support
K. Larson, Y. Hsu, and J. O. DeLancey University of Michigan, Ann
Arbor, MI
Objective: Some patients experience apical prolapse after anterior
vaginal wall mesh kit operations. To understand why this may occur,
we examined the 3-D structural relationships between the suspension
points and normal anterior vaginal wall location.
Methods: 11 Asymptomatic women with a uterus and normal support
were identified from subjects recruited as controls for an ongoing study
(all portions of the vagina ⱖ1cm above the hymen during Valsalva).
Multi-planar MR imaging of the pelvis was performed in the supine
position at rest and maximal Valsalva. 3-D reconstructions of the pelvic
bones, uterus, and vagina at rest and maximal Valsalva were created using
3-D Slicer (Slicer2). Reconstructions were imported into IDEA-S®
modeling software. On each side of the pelvis, the line of the arcus
tendineus fascia pelvis (ATFP) was constructed from its visible insertion
in the pubis to the ischial spine (“*” on Fig. 1). Figure 1 shows a 3-D
Abstracts
model of a resting vagina (A) and its’ 2-D representation (B).
Manufacturer-specified anchoring points were reviewed for anterior wall
mesh kits (Anterior Prolift ®, Anterior Avaulta®, and Perigee®) allowing
identification of superior and inferior points along the ATFP. Axes
(cranio-caudal and ventro-dorsal) were constructed through the superior
suspension points and the percentage of anterior vaginal wall length
superior and posterior to these axes were measured.
Results: Vaginal position at rest and Valsalva varies among our 11
women. A portion of anterior vagina is above superior mesh
attachment points in 100% (11/11) at rest and in 73% (8/11) during
Valsalva. A portion of anterior vagina is posterior to superior mesh
attachment points in 82% (9/11) at rest and in 100% (11/11) during
Valsalva. Mean vaginal lengths at rest and maximal Valsalva were 9.3
⫾ 0.7 cm (SD) and 8.6 ⫾ 1.2 cm respectively. The mean percentage
of vaginal length above superior anchoring sites was 40 ⫾ 14% in
the 11/11 at rest and 29 ⫾ 12% in the 8/11 at maximal Valsalva. The
percentage of vaginal length posterior to or behind superior
anchoring sites varied from 3% to 70% (mean percentage at rest
(9/11) 15 ⫾ 6%, and Valsalva (11/11) 24 ⫾ 24%).
Conclusion: The upper vagina lies above and behind superior
suspension points in the majority of women with normal support.
Disclosures: K. Larson, None; Y. Hsu, None; J.O. DeLancey, Johnson
& Johnson, Consultant.
Elastin Metabolism is Increased in the Vagina of Women With
Prolapse Relative to Controls
W. Zong,* S. E. Stein,* B. Starcher,† and P. A. Moalli* *University of
Pittsburgh, Pittsburgh, PA, †University of Texas Health Center, Tyler, TX
Objective: Clinically, prolapse progression is associated with
mechanical stretching of the vaginal wall. Stretch has been shown to
alter the synthesis of extracellular matrix components including
elastin (Am J Physiol 1997; 272: L452). The aim of this study was to
compare elastin metabolism in the vagina of women with and without
prolapse and to define the regulation of this process by hormones.
Methods: Following IRB approval and patient consent, 87 histologically
confirmed full-thickness vaginal biopsies were procured from patients at
time of surgery. Vaginal tissue from premenopausal women with ⬍ stage
II prolapse and no self-reported incontinence served as controls (N ⫽ 20).
Women with prolapse were divided into 3 groups - premenopausal (pre,
N ⫽ 20), postmenopausal not on hormone therapy (post no HT, N ⫽ 29),
and postmenopausal on HT (post HT, N ⫽ 18). The epithelium was
excised leaving the subepithelium, muscularis and adventitia for
biochemical analysis. The elastin degrading matrix metalloproteinase -9
(MMP-9) was detected by gelatin zymography and the elastin precursor,
tropoelastin, by immunoblotting. Tropoelastin was quantified by
densitometry and expressed as units relative to an internal control while
MMP-9 values were arbitrary densitometry units. Mature elastin was
measured via a desmosine crosslink radioimmunoassay (crosslinks/total
239
Abstracts
TABLE.
Median (Interquartile
Range)
Tropoelastin (units)
N
Control
Prolapse
a
Preb
Post-, no HT
c
Post-, HT
Desmosine (pmol/mg)
Control
Prolapse
a
Preb
Post-, no HT
c
Post-, HT
ProMMP-9 (units)
Control
Prolapse
a
Preb
Post-, no HT
c
Post-, HT
Active MMP-9 (units)
Control
Prolapse
a
Preb
Post-, no HT
c
Post-, HT
15
0.8 (0.7, 1.4)
⬍ 0.001*
14
14
15
1.7 (1.1, 2.3)
7.2 (5.4, 13.8)
4.5 (3.0, 7.8)
⬍ 0.001 (a vs b)§
⬍ 0.001 (a vs c)§
0.013 (b vs c)§
15
386 (319, 609)
0.019*
18
28
17
533 (319, 1160)
635 (464, 898)
511 (412, 972)
⬎ 0.99 (a vs b)§
⬎ 0.99 (a vs c)§
⬎ 0.99 (b vs c)§
16
108511 (71716, 162138)
0.003*
15
16
16
172148 (145340, 190155)
143005 (116047, 200158)
145612 (130673, 227104)
⬎ 0.99 (a vs b)§
⬎ 0.99 (a vs c)§
⬎ 0.99 (b vs c)§
16
136971 (112787, 220212)
⬍ 0.001*
15
16
16
228557 (191745, 337239)
264108 (163303, 434441)
254731 (186555, 354290)
⬎ 0.99 (a vs b§
⬎ 0.99 (a vs c)§
⬎ 0.99 (b vs c)§
* Overall P-value comparing control vs prolapse regardless of hormonal status;
protein). Data were analyzed using Kruskal-Wallis test and post hoc
analysis using the Mann-Whitney U test.
Results: Premenopausal women with and without prolapse had
similar age, parity and BMI. Subjects with prolapse had similar parity
and BMI with a median stage of prolapse of III. Proenzyme and active
forms of MMP-9, tropoelastin and mature elastin were uniformly
increased in women with prolapse relative to controls (see Table).
Only tropoelastin was significantly regulated by hormones with the
highest amount in postmenopausal not on HT. Tropoelastin was
suppressed by HT but not to premenopausal levels.
Conclusion: Elastin and MMP-9 are increased in the vagina of women
with prolapse relative to controls suggesting that this tissue is rapidly
remodeling with mechanical stretch. Further studies are needed to provide
insight into the increase in tropoelastin in menopausal women not on HT.
Disclosures: W. Zong, None; S.E. Stein, None; B. Starcher, None;
P.A. Moalli, R01HD045590, Grant/Research Support.
Women’s Perspective on Important Surgeon Attributes and Aids
to Improve Informed Surgical Consent
H. Abed, P. Perera, and R. G. Rogers University of New Mexico,
Albuquerque, NM
Objective: To describe what patients consider important surgeon
attributes and what improves their understanding when giving informed
surgical consent.
Methods: We surveyed women presenting for care to a woman’s
health clinic. Data collected included patient age, race and
education. Women were asked to rank the importance of a variety
240
§
P-value
Post-hoc P-value adjusted to a significance level of 0.017.
of surgeon characteristics including age, gender, experience,
medical school attended, physical appearance and reputation on a
10 point scale ranging “0 ⫽ not at all important” to
“10 ⫽ completely important” when making a decision to have
surgery. Aids used to improve surgical consent understanding were
similarly rated on a three point scale ranging from “1 ⫽ not
helpful” to “3 ⫽ very helpful” as well as their preferred level of
detail regarding a proposed surgical procedure on a three point
scale ranging from “1 ⫽ simple overview with no details” to
“3 ⫽ very detailed”. Women also reported on a 10-point scale their
comfort with surgeons-in-training participation their surgical
procedure. Data were analyzed using frequency tables and repeated
measures Multivariate Analysis of Variance (MANOVA).
Results: 198 women completed surveys. Mean age was 49 ⫾ 17
years. The majority of women were Caucasian (47%), completed
high school (29%), and had undergone at least one prior surgery
(89%). Women ranked the following surgeon’s attributes in
descending order of importance (difference of 1.00 point reflect a
significant difference with p ⬍ 0.05); surgeon experience (9.14 ⫾
1.73), reputation (8.15 ⫾ 2.53), medical school (5.18 ⫾ 3.27),
physical appearance (4.84 ⫾ 3.32), age (4.49 ⫾ 3.05), and gender
(2.90 ⫾ 3.42). Women ranked the following consent aids in
descending order of helpfulness (difference of 0.11 points reflect a
significant difference with p ⬍ 0.05); pamphlets and brochures
(2.74 ⫾ 0.49), easy access to a clinic nurse for questions about
surgery (2.71 ⫾ 0.55), diagrams (2.69 ⫾ 0.54), and pictures (2.68
⫾ 0.56). Women ranked their preferred level of detail provided
regarding surgery in descending order (difference of 0.05 point
reflect a significant difference with p ⬍ 0.05); very detailed
description of functional changes following surgery (2.92 ⫾ 0.32),
risks (2.87 ⫾ 0.41), the course of recovery following surgery (2.87
⫾ 0.37), anatomic changes (2.86 ⫾ 0.39), alternatives to surgery
(2.82 ⫾ 0.45), surgery benefits (2.82 ⫾ 0.45), who actually
operates (attending surgeon or trainee) (2.72 ⫾ 0.54) and details
about anesthesia (2.65 ⫾ 0.63). Women reported that they were
somewhat comfortable with trainees being supervised while
performing surgery (5.76 ⫾ 3.08), and not at all comfortable if
trainees were not supervised throughout the entire surgical
procedure (2.28 ⫾ 2.96).
Conclusions: Women ranked surgeon experience and reputation
as important in their decision making to have surgery. Patients
prefer detailed information about functional and anatomic changes
after surgery, as well as detailed description of risks associated
with surgery.
Disclosures: H. Abed, None; P. Perera, None; R.G. Rogers, Pfizer,
Grant/Research Support; Pfizer, Consultant; Pfizer, Speaker’s Bureau.
Variation in Incontinence and Overactive Bladder
W. F. Stewart,* A. G. Hirsch,* J. G. Blaivas,† D. K. Newman,‡ C.
Payne,§ M. P. Fitzgerald,¶ K. L. Burgio,储 G. Cundiff,** A. Dilley,†† and
V. A. Minassian* *Geisinger Clinic, Danville, PA, †Weill Medical
College, Cornell Medical Center, New York, NY, ‡University of
Pennsylvania Medical Center, Berwyn, PA, §Stanford University
School of Medicine, Stanford, CA, ¶Loyola University Health System,
Maywood, IL, 㛳University of Alabama at Birmingham, Birmingham,
AL, **Providence Health Care, Vancouver, BC, CANADA,
††GlaxoSmithKline, King of Prussia, PA
Introduction: Studies report incidence estimates for overactive
bladder (OAB) and incontinence that are inconsistent with
prevalence estimates. This inconsistency may be explained by how
studies define incidence (e.g. continent at baseline and incontinent
at follow-up). It is possible that a portion of individuals thought to
be non-cases at cross-section (baseline or follow-up) were actually
in an “inactive” (symptom-free) period. We used data from the
General Longitudinal Overactive Bladder Evaluation (GLOBE) to
determine if variation in symptom expression, explains the
inconsistencies between incidence and prevalence estimates.
Methods: A random sample of 15,656 primary care patients, 40⫹
years of age, was mailed the GLOBE Bladder Health Survey (BHS);
44% responded. A sub-sample of baseline respondents received the
same survey 6 months later; 74% responded. The BHS uses a 4week recall period to assess urgency and incontinence. Occurrence
was reported as never/rarely, a few times, about once a week, a
few times a week, or every day. Composite scores for urgency and
incontinence symptoms were derived as indicators of severity and
occurrence. Change in symptom scores were modeled as
categorical and continuous measures using logistic and linear
regression. Covariates included age, BMI, duration, UTI, bladder
problems, pelvic surgeries, BPH, births, hysterectomy, and
symptom patterns. Active urgency and active incontinence were
defined as symptoms at least a few times in the past 4 weeks.
Results: Transition from active to inactive urgency and
incontinence symptoms was higher for males, while females had
higher transition rates from inactive to active (Figure 1). Age and
duration of time with symptoms were associated with persistence
of active symptoms for both genders.
Conclusion: A high proportion of individuals transition between active
and inactive symptom status over six months. Duration of time with
symptoms is an indicator of persistence and possibly progression. The
variation in symptom expression over short periods of time may explain, in
Abstracts
part, the inconsistencies between incidence and prevalence data. These
results suggest that the definition of cases in incidence studies may not fully
account for prior periods of active symptom expression.
Disclosures: W.F. Stewart, GlaxoSmithKline, Grant/Research Support;
AstraZeneca, Grant/Research Support; Roche, Grant/Research Support;
Merck, Grant/Research Support; GlaxoSmithKline, Consultant; A.G.
Hirsch, GlaxoSmithKline, Grant/Research Support; AstraZeneca,
Grant/Research Support; J.G. Blaivas, GlaxoSmithKline, Consultant; D.K.
Newman, Astellas, Grant/Research Support; Contura, Grant/Research
Support; Coloplast, Consultant; P&G, Consultant; Bard, Consultant;
Watson Pharma, Speaker’s Bureau; Novartis, Speaker’s Bureau; Astellas,
Speaker’s Bureau; GlaxoSmithKline, Speaker’s Bureau; Allergan, Speaker’s
Bureau; SCA, Speaker’s Bureau; C. Payne, Roche, Grant/Research
Support; American Medical Systems, Consultant; Allergan, Consultant;
Astellas, Consultant; BL Pharma, Consultant; Glaxo SmithKline,
Consultant; NDI medical, Consultant; Pfizer, Consultant; Roche,
Consultant; Curant, Shareholder; clinical trial Advanced Bionics, Other;
Advisory Board Allergan, Other: clinical trial Celgene, Other; scientific
advisory board Curant, Other; clinical trial Q-Med, Other; M.P. Fitzgerald,
Pfizer, Grant/Research Support; Astellas, Grant/Research Support; Pfizer,
Consultant; Astellas, Consultant; K.L. Burgio, Pfizer, Grant/Research
Support; GlaxoSmithKline, Consultant; Astellas, Consultant; Ortho
McNeil, Consultant; Pfizer, Consultant; G. Cundiff, GlaxoSmithKline,
Consultant; A. Dilley, full time employee GlaxoSmithKline, Other; V.A.
Minassian, GlaxoSmithKline, Grant/Research Support.
Epidemiology of Daytime Urinary Frequency in CommunityDwelling Women
E. S. Lukacz,* E. L. Whitcomb,* J. M. Lawrence,† C. W. Nager,* and
K. M. Luber‡ *UCSD, La Jolla, CA, †Kaiser Permanente Southern
California, Pasadena, CA, ‡Kaiser Permanente San Diego, San
Diego, CA
Objective: The objective of this study was to assess the prevalence
and degree of bother from daytime urinary frequency in a communitybased population of women, and to propose evidence-based
definitions of increased daytime urinary frequency.
Methods: The voiding habits of 4,061 women from a communitybased sample recruited for an epidemiologic study were analyzed. The
241
Abstracts
validated questionnaire to identify pelvic floor disorders included
questions related to daytime urinary frequency and degree of bother
related to daytime frequency using a 100 mm visual analog scale
(VAS). Daytime urinary frequency was assessed with the question:
“During waking hours, how frequently do you need to empty your
bladder?” Responses were categorized into 1) less than every 6 hours,
2) every 5 to 6 hours, 3) every 3 to 4 hours, 4) every 1 to 2 hours,
and 5) more than once per hour. We explored degree of bother for
each interval of frequency of daytime voiding. Degree of bother was
compared using ANOVA and Student’s t-tests. Associations with a twosided p-value of ⬍ 0.05 were considered significant.
Results: Median daytime frequency of voiding was every 3 to 4 hours.
Overall, 6% of women voided less than every 6 hrs, 16% every 5 to 6 hours,
51% every 3 to 4 hours, 24% every 1 to 2 hours and 3% more than every
hour. Each interval increase in daytime frequency was associated with
significantly increased degree of bother as measured by VAS (Figure 1. p ⬍
0.001). The mean degree of bother for frequency of every 2 hours or more
was twice that of the bother for less than every 2 hours (23.6 ⫾ 23.7 vs.
51.7 ⫾ 30.1 mm p ⬍ 0.001).
Conclusions: In this cohort of community-dwelling women, most
reported a daytime urinary frequency of every 3 to 4 hours. Nearly a
third of women (27%) reported daytime urinary frequency of every 2
hours or more. These women were nearly twice as bothered by their
frequency than those who voided less frequently than every 2 hours.
The International Continence Society definition of increased daytime
frequency is “the complaint by the patient who considers that he/she
voids too often by day.” This appears to correlate well with a cutpoint of every 2 hours or more given the marked increase in degree
of bother related to voiding more frequently than every 2 hours.
Disclosures: E.S. Lukacz, Pfizer Inc, Consultant; Medtronic Corp,
Gamble Pharmaceuticals, Speaker’s Bureau; Intuitive Corp, Speaker’s
Bureau; E.L. Whitcomb, None; J.M. Lawrence, None; C.W. Nager,
None; K.M. Luber, Pfizer, Inc, Consultant; Watson Pharmaceuticals,
Consultant; Astellas, Consultant; Pfizer, Inc, Speaker’s Bureau; Watson
Pharmaceuticals, Speaker’s Bureau; Astellas, Speaker’s Bureau.
POPQ Measures do not Predict Incontinence Pessary Size
C. W. Nager for the Pelvic Floor Disorders Network, UCSD, San
Diego, CA
242
Objectives: To determine, in women without advanced pelvic organ
prolapse with or without a uterus, 1) whether successful incontinence
pessary fitting can be predicted by specific POP-Q measurements, and
2) whether POP-Q measures predict pessary size.
Methods: In a multicenter study, 446 women with stress urinary
incontinence (SUI) and POP-Q stage ⱕ 2 were randomized to 1 of 3
treatment arms: 1) incontinence pessary, 2) behavioral therapy, or 3)
combined. This analysis includes 252 women assigned to receive an
incontinence pessary. Pessary fitting was typically performed by
trained nurse practitioners, nurses, or physical therapists. Pessary
fitting was considered unsuccessful if the provider obtained an
inadequate fit after at least 3 attempts, the participant found the
pessary painful, or the participant did not plan to use the pessary after
fitting. The size and type of the pessary was used to obtain measures
of the diameter of the ring or dish including the knob (bolster). Linear
and logistic regression were used.
Results: Mean age and body mass index were 49 years and 29 kg/m2,
respectively. 94% were parous. 3% reported previous prolapse
surgery, 5% previous UI surgery, and 22% previous total hysterectomy.
235 women (93%) were successfully fitted with an incontinence ring
(n ⫽ 122) or incontinence dish (n ⫽ 113); 17 women (7%) were
unsuccessfully fitted. The median number of pessaries attempted was
2. Hysterectomy, genital hiatus (GH, with or without strain) and
GH/TVL (total vaginal length) ratios did not predict unsuccessful
fitting (p ⬎ 0.05). However, mean TVL was greater in women
successfully fitted (9.6 cm compared to 8.8 cm in those unsuccessfully
fitted; p ⫽ 0.007). Neither total vaginal length (for women with and
without a cervix,), point D in women with a cervix, or point C in
women without a cervix, predicted final pessary diameter (p ⬎ 0.05).
Conclusions: The vast majority of women with SUI without
advanced pelvic organ prolapse can be successfully fitted with an
incontinence pessary by trained non-physicians. Women with a
shorter vaginal length were less likely to be successfully fitted, but
specific POP-Q measures were not helpful in determining
incontinence pessary size. Our data suggest that the trial and error
method of incontinence pessary fitting cannot be made more
scientific with specific vaginal measures.
Disclosures: C.W. Nager, None; ...for the Pelvic Floor Disorders
Network, None.
Patient-Centered Goal Attainment for OAB and SUI
E. R. Trowbridge, B. Tomney, V. E. Bovbjerg, K. L. Hullfish, and W.
D. Steers University of Virginia, Charlottesville, VA
Objective: Women with overactive bladder (OAB) and stress urinary
incontinence (SUI) experience significant impairment in their quality of life.
However, current outcome measures for treatment of OAB and SUI often do
not directly identify or measure achievement of patient-centered goals. Our
primary objective was to compare pre-treatment goals for women with OAB
and SUI and quantify their attainment post-treatment. Secondary objective
was comparing both quality of life and satisfaction measures.
Methods: Prospective cohort of 54 women seeking care for OAB
(predominant symptoms: urgency, frequency and urge incontinence)
(n ⫽ 27) and SUI (positive cough stress test, urodynamic SUI) (n ⫽ 27)
responded to open-ended questions about their personal treatment
outcome goals. Women received nonsurgical therapy (bladder training,
anticholinergic, pessary) or surgery (autologous fascia sling, prolapse
surgery, botox). At 12-month follow-up, women reported their level of
agreement that each goal had been met using a 5-point scale
Abstracts
(⫺2 ⫽ strongly disagree to ⫹2 ⫽ strongly agree). In addition, women
completed: Incontinence Impact Questionnaire (IIQ-7), Urogenital
Distress Inventory (UDI-6), Patient Health Questionnaire 关PHQ-9兴, and
physical and mental health scales (SF-12). Overall satisfaction was
measured on a 4-point scale (completely to not satisfied).
Results:
Both groups were similar in age (57.6 vs 54.4 yrs,
p ⫽ 0.27), race (96% Caucasian, p ⫽ .98), parity (2.5 vs 2.3, p ⫽ .78)
and in duration of symptoms (5.2 vs 6.7 yrs, p ⫽ .93). 63% of women
with OAB also reported prolapse symptoms vs 41% with SUI
(p ⫽ 0.18). At 12 months follow-up, women with OAB reported
greater goal attainment (p ⫽ 0.01), despite both groups reporting
similar satisfaction (satisfied/very satisfied) (p ⫽ .89) with treatment.
Types of goals differed significantly between women with OAB vs SUI.
Women with SUI were significantly more likely than OAB women to
report goals related to no longer leaking (48% vs 11%, p ⫽ .006) and
increasing their activity levels (19% vs 0%, p ⫽ .05), whereas OAB
women were more likely to report goals unrelated to pelvic floor
symptoms (ie self-image/relationships) (19% vs 4%, p ⫽ .08). There
was no significant difference in the self-reported severity of urinary
incontinence or the reported amount of urine loss between the two
groups. Initial proportion of women receiving nonsurgical treatment
did not differ between the groups (82% vs 78%, p ⬎ .9) for OAB vs
SUI women respectively. Similarly, there were no significant
differences in the IIQ-7, UDI, SF-12 physical and mental health scores
and depression scores between the two groups at baseline.
Conclusions: Personal treatment goals differed between women
with OAB and SUI but overall attainment of patient-centered goals at 1
year follow-up was similar for both groups. Our findings suggest that
comprehensive treatment of PFD may benefit from identifying and
specifically addressing patient-centered goals especially for women
with outcome goals unrelated to pelvic symptoms.
Disclosures: E.R. Trowbridge, None; B. Tomney, None; V.E.
Bovbjerg, None; K.L. Hullfish, None; W.D. Steers, None.
in medical education. The number of women willing to be
interviewed by a medical student or a resident (77% vs. 78%),
examined in the office (41% vs. 49%) or examined under anesthesia
(42% vs. 54%) were similar. Of the 49% of women willing to be
examined in the office by a resident, 36% would only allow a female
resident. Of the 54% of women willing to be examined under
anesthesia by a resident, 84% would be agreeable to an exam by
either gender. There were no women that agreed to care by a male
resident but not a female resident. Women that were aware of their
physician’s involvement in teaching were significantly more likely to
allow an interview by a medical student or resident regardless of
gender (p ⬍ 0.001). Additionally, being aware of this involvement in
teaching was significantly associated with women allowing male (p ⬍
0.016) and female (p ⬍ 0.002) residents to examine them in office
but had no effect on examinations in the operating room. Women
greater than 40 years old had increased odds of permitting office
interviews by medical students or residents (OR 2.99, 95% CI 1.54,
5.83) in comparison to women younger than 40 years of age. Women
older than 40 years also had increased odds of allowing an exam in
the operating room by a female (OR 1.86, 95% CI 1.02, 3.41) or male
resident (OR 2.52, 95% CI 1.30, 4.90) but not an exam in the office as
compared to women less than 40 years old. The number of years that
the women had been patients in the practice (ⱕ4yrs vs. ⬎4yrs) did
not affect the decision to allow interviews or exams by any group,
except for interviews by male medical students. Women in the
practice ⬎4 years had increased odds of allowing an interview by a
male medical student (OR 1.66, 95% CI 1.03, 2.67).
Conclusion: Prior awareness of a physician’s involvement in teaching
and age greater than 40 years old were associated with a patient’s
decision to be interviewed or examined by a medical student or resident,
regardless of gender.
Disclosures: B.L. Robinson, None; E.K. Saks, None; M. Gopal, None;
H. Harvie, None; W. Ronner, None; L. Arya, None.
Willingness of Gynecologic Patients to be Interviewed and Examined
by Female and Male Medical Students and Resident Physicians
B. L. Robinson,* E. K. Saks,† M. Gopal,† H. Harvie,† W. Ronner,* and
L. Arya† *Pennsylvania Hospital, Philadelphia, PA, †Hospital of the
University of Pennsylvania, Philadelphia, PA
Objective: To assess the willingness of gynecologic patients to allow
female or male medical students and residents to participate in their
care in the office and operating room.
Methods: A 6-item questionnaire was administered to 312 patients
in a single-physician gynecology office. The willingness to be
interviewed and examined in the office and operating room under
anesthesia by female or male medical students and residents was
determined. The following variables were collected: age, number of
years as a patient in the practice and prior knowledge of their
gynecologist’s involvement in medical education. Descriptive
analysis was performed to determine the proportion of women
agreeable to be interviewed and/or examined by gender.
Univariable analysis was performed to determine if awareness of
their physician’s involvement with medical education impacted
their willingness to have medical student and resident
participation.
Results: The mean age of the women was 50.9 ⫾ 15.3 years with a
mean length of time of 6.6 ⫾ 6.4 years in the practice. Seventy-one
percent of the patients were aware that their physician was involved
Prophylactic Antibiotics to Prevent Urinary Tract Infection
(UTI) During Clean Intermittent Self-Catheterization (CISC) for
Management of Voiding Dysfunction After Prolapse/
Incontinence Surgery: A Decision Analysis
G. Sutkin,* J. L. Lowder,* and K. Smith† *Division of Urogynecology,
Department of Obstetrics and Gynecology, University of Pittsburgh,
Pittsburgh, PA, †Section of Decision Sciences and Clinical Systems
Modeling, Department of Internal Medicine, University of
Objective: To date, no randomized controlled trial (RCT) of
prophylactic antibiotic use to prevent UTI during CISC for voiding
dysfunction after prolapse/incontinence surgery has been performed.
Prior to initiating a RCT to study this question, we sought to model
this clinical situation using decision analysis (DA) methods.
Methods: A decision tree model was constructed to evaluate risks
and benefits of prophylactic antibiotic use during selfcatheterization for voiding dysfunction after prolapse/incontinence
surgery in women. In this model, women requiring selfcatheterization were randomized to either prophylactic antibiotics
or not. Probabilities for UTI after CISC with or without
prophylactic antibiotics were obtained from published literature
and from practice quality assurance reviews. Probabilities for
sequelae from antibiotic use or UTI were obtained from published
literature and expert consensus. The main outcome was the
probability of experiencing no UTI or adverse event. Two clinical
scenarios were modeled and were defined as: 1) True UTI - UTI
243
Abstracts
symptoms and positive culture; 2) Bacteriuria - any positive urine
culture with or without symptoms.
Results: Under baseline assumptions, prophylactic antibiotics were
favored in both models. In the True UTI model, prophylactic
antibiotics had an 83.1% probability of no UTI or adverse events,
16.1% better than no prophylactic antibiotics. Prophylactic
antibiotics were favored unless the probability of UTI without
prophylaxis was ⬍ 17% (base 33%) or the probability with
prophylaxis was ⬎32% (base 16%). Using 2-way sensitivity analysis
for these two parameters, prophylaxis was favored unless the
absolute risk of UTI was decreased ⬍ 1% by prophylaxis (Graph 1).
Results were not sensitive to variation of antibiotic adverse events
within clinically plausible ranges. Similar findings were seen in the
Bacteriuria analysis.
Conclusions: Using decision analysis methods to evaluate risks and
benefits, use of prophylactic antibiotics is favored for the prevention
of UTI when CISC is used to manage voiding dysfunction after
prolapsed/incontinence surgery.
were developed to identify risk factors associated with bacteriuria for
each pathogen.
Results: Four hundred women were included in this study. Mean
(⫾ SD) age of this cohort was 53 ⫾ 16 years with a range of
22– 85 years. Urinary symptoms were reported by 77% of women.
Thirty five percent of patients had a history of recurrent UTI. Forty
two percent of women had some type of pelvic organ prolapse.
Bacteruria defined as greater than 105 CFU/ml was noted in 16%
(n ⫽ 63) of women included in this study. The most prevalent
single bacteria in this group was Escherichia coli at 43%. Thirty
nine women had positive cultures with a variety of other
organisms. Nitrites and leukocyte esterace were significantly
associated with E. coli and Citrobacter in the urine (p ⬍ 0.01).
However, a significant association between urine dipstick results
and other urinary pathogens was not seen. The sensitivity of
positive urine nitrites or leukocyte esterase for E. coli was 0.48
(95% CI 0.31, 0.69) while the specificity for these tests were 0.97
(95 % CI 0.95, 0.99) and 0.85 (95% CI 0.81, 0.89), respectively.
Similar results were noted for Citrobacter. Urine nitrites
(AUC ⫽ 0.73, CI 0.63, 0.82) was the most accurate single dipstick
test for E coli but less so for Citrobacter (AUC ⫽ 0.62, CI 0.47,
0.77). The addition of leukocyte esterase to the urine nitrite test
demonstrated a trend towards improved accuracy for both E. coli
(AUC ⫽ 0.80, CI .71, 0.89) and Citrobacter (AUC ⫽ 0.77, CI 0.61,
0.92). Urine leukocyte esterase and nitrites results were not useful
for detecting bacteriuria from other pathogens in this population.
After controlling for clinical factors, leukocyte esterase remained a
significant predictor of bacteriuria for both E. coli (OR ⫽ 2.9, CI
1.1, 7.8) and Citrobacter (OR ⫽ 6.8, CI 1.7, 27.4) while the
presence of urine nitrites was associated only with E. coli
(OR ⫽ 24, CI 8.3, 69.0).
Conclusions: Although urine dipstick tests for nitrites and leukocyte
esterase may be useful for screening women for the presence of E.
coli and Citrobacter in the urine, other pathogens may be missed by
these tests.
Disclosures: G.M. Northington, None; H.S. Harvie, None; H.
Adunuthula, None; L.A. Arya, None.
Disclosures: G. Sutkin, None; J.L. Lowder, None; K. Smith, None.
The Sensitivity and Specificity of Urine Dipstick Results for
Bacterial Pathogens
G. M. Northington, H. S. Harvie, H. Adunuthula, and L. A. Arya
University of Pennsylvania, Philadelphia, PA
Objective: Although urine dipstick results for nitrites and leukocyte
esterase have demonstrated good specificity for bacteriuria, the
discriminatory power of these tests for specific pathogens is
unknown. The primary objective of this study is to identify the
predictive value of urine dipstick results for different types of
pathogens detected in urine from women.
Methods: We performed a retrospective chart review of all new
patients reporting to the urogynecology clinic from April 2003
through May 2005. Charts were reviewed for leukocyte esterase,
nitrites, bacterial counts, and pathogen identity. Demographic and
clinical data were also recorded. Paired urinalysis and urine culture
results were used to calculate the sensitivity and specificity of the
urine dipstick for each pathogen identified. The accuracy of each test
was estimated by calculating the area under its receiver operating
characteristic curve (AUC). Multivariate logistic regression models
244
The Association Between Regional Anesthesia and Acute
Postoperative Urinary Retention in Women Undergoing
Midurethral Slings
K. J. Wohlrab,* N. B. Korbly,* E. A. Erekson,* C. D. Drimbarean,† C.
R. Rardin,* and V. W. Sung* *Division of Urogynecology and
Reconstructive Pelvic Surgery, Department of Obstetrics and
Gynecology; Alpert Medical School at Brown University, Providence,
RI, †Department of Anesthesiology; Women and Infants’ Hospital of
Rhode Island, Providence, RI
Objective: To estimate the association between regional anesthesia
and acute postoperative urinary retention in women undergoing
outpatient midurethral sling procedures.
Methods: We performed a retrospective cohort study. Women
undergoing outpatient midurethral sling procedures between January
2005 and December 2007 were included. Women were excluded if
they underwent any concomitant procedure, or were admitted
overnight following the procedure. All slings were performed under
the supervision of a fellowship-trained urogynecologist at a tertiary
care center. We recorded demographic, perioperative and surgical
data and preoperative urodynamic results. Exposure was defined as
the type of anesthesia, categorized as regional (spinal or combined
spinal/epidural) or non-regional (general endotracheal, monitored
anesthesia care with sedation, or local). Retrograde voiding trials were
routinely performed on all women prior to discharge after anesthetic
effects had clinically resolved and the woman was ambulatory. The
retrograde voiding trial was performed by filling the bladder with 300
mL of normal saline and having the woman void within 20 minutes.
Acute postoperative urinary retention was defined as a failed trial of
void, or voiding less than 200 mL, for which a patient was discharged
home with an indwelling catheter. Statistical analysis included
descriptive statistics, chi-square, Fisher’s exact test, and two sample ttest, as appropriate. Multivariable logistic regression was used to
estimate the effect of regional anesthesia on acute postoperative
urinary retention. Variables with p-values less than 0.1 were retained
in the final model.
Results: A total of 130 women meet our inclusion criteria. Thirtynine (30%) women had regional anesthesia and 91 (70%) women had
non-regional anesthesia. Women receiving regional anesthesia were
older compared to women receiving non-regional anesthesia (57.3 vs.
50.5 years, p ⬍ 0.01), but otherwise were similar in parity, previous
pelvic surgery, preoperative urodynamic findings, and approach to
midurethral sling (p-value greater than 0.05 for all). Overall, 49
(37.7%) women had acute postoperative urinary retention. More
women who received regional anesthesia had acute postoperative
urinary retention compared to women who received non-regional
forms (66.7% vs. 25%, p ⬍ .001). On multivariable analysis, women
receiving regional anesthesia had an increased odds of acute
postoperative urinary retention compared to women receiving nonregional anesthesia (OR ⫽ 5.9, 95% CI 2.4, 14.0), after adjusting for
age and approach to midurethral sling.
Conclusions: Regional anesthesia is a risk factor for acute
postoperative urinary retention following outpatient midurethral slings.
Disclosures: K.J. Wohlrab, None; N.B. Korbly, None; E.A. Erekson,
None; C.D. Drimbarean, None; C.R. Rardin, Boston Scientific,
Consultant; V.W. Sung, None.
Tolterodine Causes Measurable Restoration of Urethral
Sensation in Women with Urge Urinary Incontinence
K. Kenton, L. Lowenstein, and L. Brubaker Loyola University Stritch
School of Medicine, Maywood, IL
Objective: Antimuscarinic agents remain the mainstay of treatment
for urge urinary incontinence (UUI). While the precise mechanism
of benefit with antimuscarinic agents is unclear, it is likely that
alterations in afferent nerve fibers play a role in treatment
response. The aim of this study was to determine if tolterodine for
UUI results in changes in bladder and/or urethral sensation.
Methods: After IRB approval, women with ⱖ 1 UUI episode per
week on 7-day diary, seeking treatment were recruited. Participants
were treated with 4 mg of long-acting tolterodine for 2 months. At
baseline and 2 months after starting drug, all participants had
Current Perception Threshold (CPT) testing and completed the
validated Social Aspects of Aging Incontinence Questionnaire
(MESA). CPT testing was done using a Neurometer® device
(Neurotron Inc, Baltimore, MD) connected to ring electrode on a
14 French catheter. CPTs were obtained in the urethra at 3
frequencies 2000 Hz, 250 Hz and 5 Hz corresponding to A-␤, A-␦,
and C fibers. Baseline and post-treatment measures were compared
using the Wilcoxon Signed Rank Test.
Abstracts
TABLE. Urethral Current Perception Thresholds Before and
After Tolterodine
Baseline
CPT Median
(25th-75th
IQR)
Urethra 2000
2.6 (1.3–5.4)
Hz
Urethra 250 Hz 1.3 (.69–2.1)
Urethra 5 Hz
1.1 (1–1.9)
Posttreatment
CPT Median
(25th-75th
IQR)
1.7 (1.1–2.7)
.75 (.4⬘–1.2)
.84 (.32–1.1)
P
Value
.92
.003
.06
Results: 17 women were enrolled and underwent baseline CPT
testing. 4 of 17 (24%) discontinued medication due to side effects,
did not have repeat testing, and were not included in the analysis.
Participants had a mean ⫾ SD age of 62 ⫾ 14, a median vaginal
parity of 2 (range 0 – 4), and a median of 14 (1– 40) UUI episodes
per week on 7-day diary. Mean MESA urge subscale scores
improved significantly from baseline after treatment (10 ⫾ 3.5 and
6.5 ⫾ 3.7, p ⫽ .007). Table 1 shows baseline and post-treatment
urethral CPTs. Urethral CPT at 250 Hz was significantly lower
(improved sensation) after treatment with tolterodine, and urethral
CPT at 5 Hz trended toward a significant decrease.
Conclusion: Urethral sensitivity improves after 2 months of
treatment with long-acting tolterodine. These findings suggest that this
class of drugs may restore urethral sensory nerves to mediate
uninhibited bladder contractions in addition to their known motor
effects.
Disclosures: K. Kenton, Pfizer, Grant/Research Support; L.
Lowenstein, None; L. Brubaker, Pfizer, Grant/Research Support;
Allergan, Grant/Research Support.
Do Patients Want to be Involved in Treatment Decisions for
Pelvic Floor Disorders?
V. W. Sung,* C. A. Raker,† and M. A. Clark‡ *Alpert Medical School
at Brown University, Providence, RI, †Women and Infants Hospital,
Providence, RI, ‡Brown University, Providence, RI
Objective: There has been an emphasis on patient involvement in
medical decision making; however, patient preferences are not
well studied in pelvic floor disorders (PFDs). Our objective was to
validate the Autonomy Preference Index (API) and Control
Preferences Scale (CPS) in women with PFDs and to identify
variables associated with patient preferences for decision making
and information seeking.
Methods: The API and CPS have been validated in other fields. We
adapted them for PFDs. The API consists of two scales: an 8-item
information-seeking scale and a 6-item decision-making preference
scale. Higher scores (range 0 –100) indicate stronger preferences
for participation. The CPS consists of one item with a 5-point scale
on decision-making preferences. Patients are categorized as active,
collaborative or passive, and lower scores indicate stronger
preferences for involvement. We performed a cross-sectional study
of women seeking care for PFDs at a tertiary care center from
10/06 –10/07. Women completed the API and CPS at enrollment and 2
weeks later. Patient variables were collected. For validation, we used
245
Abstracts
Cronbach’s alpha and the intraclass correlation coefficient (ICC) to
measure internal consistency and test-retest reliability. For construct
validity, we hypothesized that the API decision making scale and CPS
would be negatively correlated. Multiple linear regression was used to
identify correlates of patient preferences in decision making and
information seeking. For sample size, our null hypothesis was that ICC
for the API would be moderate (ICC ⱕ .5) and our alternative was
that it would be good (ICC ⬎ .7). At alpha ⫽ .05 and beta ⫽ .80, a
sample of 63 women would be needed. To account for multiple
comparisons and attrition, we aimed to recruit 110 women.
Results: 110 women were recruited with baseline data, and 93
completed the surveys twice. Mean age was 60 ⫾ 18 years, 35%
had prior surgery, 30% had prolapse symptoms and 70% had
incontinence. The API had good psychometric properties
(Cronbach’s alpha ⫽ .80, ICC ⫽ .70). The CPS had moderate testretest reliability (ICC ⫽ .50). The API and CPS were negatively
correlated (r ⫽ ⫺.3). The mean score for the API information seeking
scale was 70 ⫾ 32, but the mean score for the decision making scale
was 53.3 ⫾ 17, indicating that although women were neutral in their
decision-making preference, they had a strong preference to be well
informed. On the CPS, 44% preferred an active, 47% preferred a
collaborative, and 9% preferred a passive role in their treatment
decision. On multiple linear regression, prior physical therapy was
associated with higher preferences for decision-making participation
(p ⬍ .05). No correlates were identified for information seeking. Age,
race, symptom severity and duration were not associated with
decision making or information seeking preferences.
Conclusions: The API and CPS are valid in women with PFDs.
Although most women prefer a collaborative role in decision-making,
they have a strong preference for being well informed about their
options.
Disclosures: V.W. Sung, None; C.A. Raker, None; M.A. Clark, None.
Clinical Correlates of Anterior Abdominal Wall Neurovascular
Anatomy in Gynecologic Surgery
D. D. Rahn, J. N. Phelan, A. B. White, and M. M. Corton U.Texas
Objective: The purpose of this study was to describe the relationships
of relevant nerves and vessels of the lower anterior abdominal wall to
common laparotomy and laparoscopic trocar incisions.
Methods: Dissections were performed on 10 unembalmed female
cadavers. The course of the ilioinguinal and iliohypogastric nerves
was traced from the posterior abdominal wall to the lower portion
of the anterior abdominal wall and labia majora. The deep inferior
epigastric vessels were traced from the external iliacs to the level
of the umbilicus. Measured relationships of nerves and vessels
were made to a point 5 cm superior to the pubic symphysis (PS)
and 8 cm lateral from midline, a commonly used landmark for
accessory laparoscopic trocar insertion. Nerve and vessel positions
were also measured relative to the midline 2 cm superior to the PS,
a typical site for transverse incisions.
Results: From their origin at L1, the ilioinguinal and
iliohypogastric nerves coursed laterally toward the iliac crest,
pierced the deep surface of transversus abdominus, and coursed in
the plane between the transversus abdominus and internal oblique
muscles. The nerves then passed medially and downward, pierced
the internal oblique muscles, and traveled between the
aponeuroses of the internal and external obliques. The ilioinguinal
246
nerve pierced the superficial surface of the external oblique muscle
关mean (range)兴 2.5 (1.1–5.1) cm medial and 2.4 (0 –5.3) cm inferior
to the anterior superior iliac spine (ASIS). The iliohypogastric nerve
emerged 2.5 (0 – 4.6) cm medial and 2.0 (0 – 4.6) cm inferior to the
ASIS. The line connecting left and right ASIS crossed midline ⱖ9
cm superior to the PS. The closest distance of the ilioinguinal and
iliohypogastric nerves to a point 5 cm superior to PS and 8 cm
from midline was 0.6 (0 –1.6) cm and 1.3 (0 –3.7) cm, respectively.
At a point 2 cm superior to PS, the ilioinguinal and iliohypogastric
nerves were 5.9 (4.0 – 8.3) cm and 3.8 (1.3–5.7) cm lateral from the
midline, respectively. In all specimens, the width of the nerves in
the anterior abdominal wall was ⱕ2 mm. Tracing from the external
iliacs, the inferior epigastric vessels coursed medially toward the
umbilicus. At the point 2 cm superior to the PS, they were 6.1
(4.8 –7.9) cm from the midline. At the level of the ASIS, the vessels
were 3.7 (2.6 –5.5) cm from midline.
Conclusions: Placement of lateral accessory trocars 5 cm superior
to PS and 8 cm lateral to midline, as often recommended, does
minimize the risk of inferior epigastric vessel injury but increases
the likelihood of ilioinguinal and/or iliohypogastric nerve injury as
both commonly course beneath this trocar site. To avoid injury to
both nerves and vessels, lateral ports should be placed cephalad to
the ASIS and ⬎5 cm from midline. Pfannenstiel fascial incisions
over 7 cm in total width may compromise the iliohypogastric
nerves. The ilioinguinal nerve and inferior epigastric vessels, however,
should be spared in fascial incisions narrower than 11 cm.
Disclosures: D.D. Rahn, None; J.N. Phelan, None; A.B. White, None;
M.M. Corton, None.
Episiotomy in the United States: Has Anything Changed?
E. A. Frankman,* L. Wang,† C. H. Bunker,† and J. L. Lowder*
*Magee-Womens Hospital, University of Pittsburgh, Pittsburgh, PA,
†Clinical and Translational Science Institute, University of
Objective: To describe 1) episiotomy rates in the US following
recommended changes in clinical practice; and 2) trends in
cesarean delivery (CD) compared to trends in vaginal delivery
rates, episiotomy usage, and anal sphincter laceration (ASL).
Methods: The National Hospital Discharge Survey (NHDS), a
federal dataset sampling inpatient hospitals, was used to obtain
data based on ICD-9-CM diagnosis and procedure codes from
1979 –2004. Age-adjusted rates (AAR) of term, singleton, vertex,
liveborn spontaneous vaginal delivery (SVD), operative vaginal
delivery (OVD), CD, episiotomy and ASL were calculated using
1990 census data for women 15– 44 years of age.
Results: Estimated annual deliveries (3,140,075 to 3,354,939) and
AAR of SVD per 1000 women (38.1 to 36.7) remained stable from
1979 –2004. AAR of OVD declined from 8.7 in 1979 to 4.6 in 2004
while CD rates increased from 8.3 in 1979 to 17.2 in 2004. Rate of
episiotomy with all vaginal deliveries deceased from 51.6% in 1979
to 17.3% in 2004 with a sharp decline after 1997 from 31.0%
(1998) to 17.3% (2004) (Figure 1). ASL and episiotomy trends are
described in Figure 2.
Conclusions: Routine episiotomy has declined since liberal usage
has been discouraged. ASL rates with SVD have decreased, likely
reflecting decreased usage of episiotomy. Rates of ASL with OVD
have not changed and may reflect continued usage of episiotomy
with OVD. Decline in OVD corresponds to a sharp increase in CD
which may indicate practitioners are favoring cesarean delivery for
difficult births.
Abstracts
to chronic low back pain inquiries showed a trend toward
significance in favor of TAH (p ⫽ 0.052). One participant from the
SCH group ultimately underwent trachelectomy secondary to
recurrent cervical dysplasia.
Conclusion: No statistically significant differences were found with
respect to lower urinary tract symptoms, prolapse or sexual function
in patients undergoing TAH compared with SCH after nearly 10 years
of follow up.
Disclosures: E.A. Frankman, None; L. Wang, None; C.H. Bunker,
None; J.L. Lowder, None.
Total or Supracervical Hysterectomy: Single-Site Long-Term
Outcomes of the Tosh Trial
W. J. Greer, T. L. Wheeler, H. E. Richter, R. E. Varner, and M. L.
Mann University of Alabama at Birmingham, Birmingham, AL
Objective: Two year outcomes from the Total Or Supracervical
Hysterectomy (TOSH) trial were published in 2003, showing no
difference in pelvic floor symptoms between groups. The purpose of
this study was to characterize longer-term differences in outcomes.
Methods: 54 original TOSH participants from one site were mailed
the same questionnaires addressing pelvic symptoms, sexual
function, and quality of life that had been previously completed.
Medical and surgical histories were updated via questionnaire and
medical records review. Further questions addressed any
subsequent treatments for urinary incontinence, pelvic organ
prolapse or other pelvic surgeries. Linear and logistic repeated
measures for continuous and categorical variables were used to
estimate differential improvements over time.
Results: 37 of the 54 original TOSH participants (69%) at one site
responded. Of these, 19 were TAH and 18 were SCH. There were
no differences in baseline demographics, pelvic floor symptoms or
vaginal exam findings between groups (P ⬎ 0.05). Mean (⫾SD)
follow up was 9.12 ⫾ 0.7 years (range 8.1 to 10.1). Within and
between group results for selected outcomes are shown in the
Table. No significant difference was found in any lower urinary
tract or pelvic floor symptom, breast or menopausal symptoms,
weight change, or need for treatment of urinary incontinence
between the two groups. Within group analysis of sexual health
questions showed a significant change in ability to have and enjoy
sex in the TAH group (p ⫽ 0.002). Two of the SCH patients (7.4%)
reported a history of bleeding compared to none in the TAH
group, but this was not statistically significant (p ⬎ 0.05). Answers
Disclosures: W.J. Greer, None; T.L. Wheeler, None; H.E. Richter,
None; R.E. Varner, None; M.L. Mann, None.
Risk Factors that Predict Failure After Vaginal Repair of
Obstetric Vesicovaginal Fistulas
R. Nardos,* C. Chen,† and M. Muletta* *Addis Ababa Fistula
Hospital, Addis Ababa, Ethiopia, †Cleveland Clinic, Cleveland, OH
Objective: To identify fistula and bladder characteristics, and vaginal
closure techniques which predict failures after vesicovaginal fistula
repairs.
Methods: A retrospective analysis of all patients with vesicovaginal
fistulas that underwent vaginal repairs from January of 2006 to
December of 2007.
Results: Of the 1045 patients that underwent vaginal vesicovaginal
fistula repair during the study period, the majority of these fistulas
were mid-vaginal (26%), adjacent to one or both ureteral orifice
(21%), or a combination of different locations (17%).
247
Abstracts
TABLE. Characteristics Associated with Repair Failures
Characteristics
Complete urethral
destruction
Severe vaginal scarring
Small bladder size
Circumferential or
urethral fistulas
One layer closure
Odds Ratio
95% Confidence
Interval
8.37
3.26–20.44
4.58
3.80
2.81
2.92–7.13
2.41–5.95
1.87–4.23
1.61
1.07–2.42
Circumferential fistulas accounted for 6% of cases and 9% of
patients had either an absent urethra or a fistula that compromised
the urethra. Despite the presence of a fistula, most patients still
had a fair or good residual bladder size (84%) and had only minimal
scarring of their vaginas (85%). Forty-eight percent of patients
underwent a one layer closure of their fistulas while 52%
underwent a two or more layer closure. The short-term cure rate
was 74% with a 10% failure rate that required reoperation and a
15% stress incontinence rate. Bladder and fistula characteristics that
were significantly associated with repair failures were bladders
with complete urethral destruction, severe vaginal scarring, small
bladders, and fistulas that were circumferential or involved the
urethra (Table). Additionally, one layer fistula closures were also
associated with fistula repair failures. However, as most small
bladders were only amenable to one layer closure, after excluding
small bladders (16%), one layer bladder closures were not
significantly associated with repair failures.
Conclusions: Risk factors for failure after vaginal repair of vesicovaginal
fistulas include bladders that are small with complete urethral
destruction, fistulas that involve the urethra or are circumferential, severe
vaginal scarring, and one layer repair of fistulas. However, after excluding
small bladders, one layer closures were not associated with repair
failures.
Disclosures: R. Nardos, None; C. Chen, None; M. Muletta, None.
Risk-Adjusted Perioperative Morbidity Model for Women
Undergoing Vaginal Hysterectomy
C. A. Heisler, A. L. Weaver, L. J. Melton, III, and J. B. Gebhart Mayo
Clinic, Rochester, MN
Objective: To develop and evaluate the utility of a risk-adjusted
model for perioperative morbidity following vaginal hysterectomy.
Methods: The medical records of all adult women who had a vaginal
hysterectomy (VH) for benign indication at a single institution during
2004 –2005 were reviewed for demographics, baseline medical status,
peri-operative findings, surgical procedures and complications within 9
weeks post-surgery. Morbidity outcomes included hospital readmission,
reoperation, unplanned ICU admission or any medical problem
requiring intervention. Multivariate logistic regression models were fit,
using stepwise and backward selection, to identify factors significantly
associated with perioperative non-UTI morbidity. Since urinary tract
infection (UTI) was considered to be a relatively minor complication
that did not increase additional morbidity, the regression model was
adjusted for it. Associations were summarized by calculating odds
ratios (OR) and corresponding 95% confidence intervals (CI) using the
parameter estimates from the model. This model was internally
248
validated with 100 women treated at the same institution who were
not utilized in creating the original model. In this way, we could
calculate expected and observed complications rates for validation.
Results: The model was developed using 712 patients, of whom 139
(19.5%) had a non-UTI morbidity within 9 weeks following
hysterectomy. The following variables were found to be significantly
associated with increased morbidity: congestive heart failure (CHF) or
prior myocardial infarction (MI) (OR ⫽ 13.0, 95% CI ⫽ 2.7– 63.5),
change (pre-post) in hemoglobin ⬎ 3.1 g/dL (OR ⫽ 2.4, 95% CI ⫽ 1.63.8), preoperative hemoglobin ⬍12.0 g/dL (OR ⫽ 3.3, 95%
CI ⫽ 1.9 –5.5), and prior thrombosis (OR ⫽ 2.7, 95% CI ⫽ 1.0-6.8).
The c-index, summarizing the overall predictive ability of this model,
was 0.68. The predicted probabilities of having a non-UTI morbidity as
estimated by the model were similar to the observed rates in the
validation sample. For example, among the patients with a decrease in
hemoglobin as their sole risk factor, the predicted probability of a
non-UTI morbidity was 26% (95% CI 20 –32%) compared to an
observed rate of 21% in the validation sample.
Conclusion: We identified variables that predispose women
undergoing benign vaginal hysterectomy to increased perioperative
morbidity. Specifically, CHF or prior MI, change in hemoglobin ⬎ 3.1
g/dL, preoperative hemoglobin ⬍12.0 g/dL and prior thrombosis were
associated with more complications. Determining risk-adjusted rates of
complications allows providers to focus on areas where greater
impact on patient care and quality improvement can be made.
Disclosures: C.A. Heisler, None; A.L. Weaver, None; L.J. Melton, III,
None; J.B. Gebhart, Bard, Grant/Research Support.
Incontinence Surgery is not Indicated as Prophylaxis in All
Women Undergoing Abdominal Sacrocolpopexy
D. M. Elser,* E. J. Stanford,† M. D. Moen,‡ K. Keil,§ and C. A.
Matthews¶ *Illinois Urogynecology, LTD, Oak Lawn, IL, †University
of Tennessee Memphis, Memphis, TN, ‡Illinois Urogynecology, LTD,
Park Ridge, IL, §Keil Urogynecology, Denver, CO, ¶Virginia
Commonwealth University, Richmond, VA
Objective: Based on recent literature, many gynecologists began to
perform an incontinence procedure at the time of all pelvic organ
prolapse (POP) surgery. The more common practice among pelvic
reconstructive surgeons is to rely on urodynamic testing with and
without prolapse reduction to determine if an anti-incontinence
procedure is indicated. Our objective is to evaluate the utility of
urodynamic testing in determining the need for anti-incontinence
surgery in a cohort of women undergoing sacrocolpopexy (ASC).
Methods: Records of 238 women who underwent Abdominal
Sacrocolpopexy (ASC) by 9 surgeons during the time period 2005–2007,
inclusive, in 5 university and private practice Urogynecology centers
were identified through billing records & reviewed. Baseline
demographics, pre-operative (pre-op) history and physical examination,
pre-op urodynamics results, operative procedure, 6 week post op visit,
and the last recorded visit were recorded and analyzed. Responses were
considered positive if patient reported any episodes of incontinence, or
urgency,without attempt to quantify frequency or severity.
Results: Mean age was 60.9 (35– 89). Pre-op urodynamics confirmed
urodynamic stress incontinence (USI) in 106 (44%) women, 25
(10.5%) of whom were diagnosed with occult or potential stress
incontinence. Sixty-eight (29%) women received a midurethral sling,
while 44 (18%) women underwent a Burch procedure. Table I reports
post op bladder function symptoms at 6 weeks & at last visit with a
TABLE.
Baseline N ⴝ 238
6 weeks
N ⴝ 238
Long term visit
(N ⴝ 147)
Any symptoms of
23 (11%)
21 (14%)
incontinence
Any symptoms of urgency/
35 (17%)
26 (18%)
frequency
Urgency/ frequency post op
13 (6%)
10 (7%)
and DO pre op
Urgency frequency both pre
10 (5%)
14 (9.5%)
op and post op
New urgency/ frequency
10 (5%)
14 (9.5%)
post op
No USI/ No occult USI/ No 115/124 (93%) 84/89 (94%)
incontinence surgery & no
incontinence post op
No USI/ No occult USI/ No
9/124 (7%)
5/89 (6%)
incontinence surgery &
any incontinence post op
mean 41.8 weeks (range 8 –96). At the remote visit, 10 patients
requested further intervention for stress incontinence and 1 patient
planned sacral neuromodulation for severe DO. There were 124 (52%)
women who did not demonstrate USI or occult stress incontinence
pre-operatively and who did not receive an incontinence procedure at
the time of ASC. At 6 weeks, 9 (7%) of these women demonstrated
any symptoms of incontinence.
Conclusions: Using urodynamic evaluation of lower urinary tract
function to determine whether or not to perform an incontinence
procedure at the time of ASC appears to be a highly effective approach.
Routinely performing incontinence procedures at the time of all POP
surgeries, as suggested by some authors, is not supported by our data.
Disclosures: D.M. Elser, Novasys Medical, Grant/Research Support;
Ethicon, Consultant; Boston Scientific, Paid Instructor; E.J. Stanford,
Coloplast, Consultant; M.D. Moen, Boston Scientific, Consultant;
Ethicon, Consultant; Allergan, Speaker’s Bureau; Astellas, Speaker’s
Bureau; K. Keil, Intuitive Surgical, Speaker’s Bureau; C.A. Matthews,
Proctor and Gamble, Consultant; Pfizer, Consultant.
Continued Improvement in Overactive Bladder Symptoms and
Quality of Life in Sexually Active Women With Overactive
Bladder And Urgency Urinary Incontinence Treated With
Tolterodine Extended Release for 6 Months
R. Rogers,* G. Bachmann,† F. Sun,‡ and J. D. Morrow‡ *Univ of
New Mexico School of Medicine, Albuquerque, NM, †University of
Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical
School, New Brunswick, NJ, ‡Pfizer Inc, New York, NY
Objective: To assess improvements in overactive bladder (OAB)
symptoms and health-related quality of life (HRQL) during a 24week study of tolterodine extended release (TOL ER) in sexually
active women with OAB and urgency urinary incontinence (UUI).
Methods: This study consisted of a 12-week, double-blind (DB),
randomized, placebo-controlled phase immediately followed by a 12week open-label (OL) phase. Women reported OAB and UUI
symptoms for ⱖ3 months; ⱖ8 micturitions, ⱖ3 micturition-related
urgency episodes, and ⱖ0.6 UUI episodes per 24 hours in 5-day
Abstracts
baseline diaries; at least “some moderate” bladder problems; and
being sexually active and in a heterosexual relationship for ⱖ6
months. Subjects completed 5-day bladder diaries, the validated
Overactive Bladder Questionnaire (OAB-q), Pelvic Organ
Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ), Sexual
Quality of Life-Female questionnaire (SQOL-F), and the Hospital
Anxiety and Depression Scale (HAD) at baseline and weeks 12 and
24. Data from women who received TOL ER during both the DB
and OL phases were assessed.
Results: Among 202 women randomized to TOL ER, 161 received TOL ER
for the entire 24 weeks. Compared with baseline, women reported
significant improvements in all endpoints at week 12 that were maintained
during the OL phase (Table). Improvements in most endpoints became
significantly larger from weeks 12 to 24, except UUI episodes per 24 h;
nocturnal micturitions; and PISQ total, Behavioral/Emotive, and Partnerrelated scores. At week 12, subjects reported a 100% median reduction in
UUI episodes vs baseline, with 57% of subjects reporting no UUI episodes in
5-day diaries at week 12. At week 24, subjects reported an additional 45%
median reduction in UUI episodes, with 70% of subjects reporting no UUI
episodes at week 24.
Conclusion: TOL ER significantly improved OAB symptoms and
HRQL of women within the 12-week DB phase of this study; these
improvements were maintained or became significantly greater
during the subsequent 12-week OL phase. The number of women
reporting no UUI episodes on a 5-day diary also continued to
improve from weeks 12 to week 24. These data suggest that longterm compliance with OAB pharmacotherapy is important for
optimal treatment outcomes.
Disclosures: R. Rogers, Pfizer Inc, Consultant; G. Bachmann, Pfizer
Inc, Consultant; F. Sun, Employee-Pfizer Inc, Other (please specify
type of relationship and company name); J.D. Morrow, EmployeePfizer Inc, Other.
Impact On Variation in Symptoms
V. A. Minassian,* D. Newman,† J. Blaivas,‡ M. P. Fitzgerald,§ C.
Payne,¶ G. Cundiff,储 K. Burgio,** A. Dilley,†† A. G. Hirsch,* and W. F.
249
Abstracts
Stewart* *Geisinger Health System, Danville, PA, †Penn Center for
Continence and Pelvic Health, Berwyn, PA, ‡Weill Medical College at
Cornell University, New York, NY, §Loyola University Medical
Center, Maywood, IL, ¶Stanford University School of Medicine,
Stanford, CA, 㛳Providence Health Care, Vancouver, BC, Canada,
**Director of UAB Continence Program, Birmingham, AL,
†††GlaxoSmithKline, King of Prussia, PA
Objectives: The relative impact of urgency, frequency and
nocturia among overactive bladder (OAB) patients is debated. One
test of the relative importance of urgency, frequency and nocturia
is to determine their ability to predict changes in behaviors used to
adapt to OAB. We used the General Longitudinal Overactive
Bladder Evaluation (GLOBE) to determine the comparative validity
of baseline symptom scores in predicting behavior change between
baseline and six-month scores.
Methods: The GLOBE Bladder Health Survey (BHS) was mailed to
a random sample of 15,656 primary care patients, 40⫹ years of age
(response rate 44%, n ⫽ 6856). A sub-sample of respondents
received the same survey 6 months later, and 74% (n ⫽ 2748)
responded. The BHS used a 4-week recall to assess urgency,
nocturia, frequency, incontinence and adaptive behaviors.
Composite scores were derived for prevalence of urgency,
nocturia, frequency, incontinence, and of general adaptive
behaviors as indicators of severity/occurrence. Symptom specific
behavior scores were derived for nocturia, urgency, and
incontinence.
Change in behavior scores between baseline and 6 months were
modeled using linear regression. The independent variables were change
in symptom scores. Covariates included age and time since onset. We
used the partial r2 for each symptom to compare the relative strength of
the association with change in adaptive behavior score.
Results: The sample included 1537 women and 1182 men. Table 1
describes partial correlation coefficients to indicate the relative
amount of variance in the outcome explained by the independent
symptom variable. Change in symptoms status partially explained
change in behavior, with the partial correlations consistently stronger
in females. Change in urgency score had the strongest correlation
with behavioral change scores.
Conclusion: Among OAB symptoms and features, urgency is
clearly the strongest predictor of change. Moreover, a
comprehensive model that includes urgency, frequency and
nocturia adds relatively little to the predictive validity above and
beyond urgency alone.
250
Disclosures: V.A. Minassian, GlaxoSmithKline, Grant/Research Support;
D. Newman, Astellas, Grant/Research Support; Contura, Grant/Research
Support; Coloplast, Consultant; P&G, Consultant; Bard, Consultant;
Watson Pharma, Speaker’s Bureau; Novartis, Speaker’s Bureau; Astellas,
Speaker’s Bureau; GSK, Speaker’s Bureau; Allergan, Speaker’s Bureau;
SCA, Speaker’s Bureau; J. Blaivas, GlaxoSmithKline, Consultant; M.P.
Fitzgerald, Pfizer, Grant/Research Support; Astellas, Grant/Research
Support; Pfizer, Consultant; Astellas, Consultant; C. Payne, Roche,
Grant/Research Support; American Medical Systems, Consultant; Allergan,
Consultant; Astellas, Consultant; BL Pharma, Consultant; GlaxoSmithKline,
Consultant; NDI medical, Consultant; Pfizer, Consultant; Curant,
Shareholder; clinical trial Advanced Bionics, Other; clinical trial Celgene,
Other; clinical trial Q-Med; Advisory board Allergan, Other; scientific
advisory board Curant, Other ; G. Cundiff, GlaxoSmithKline, Consultant;
K. Burgio, Ortho McNeil, Grant/Research Support; GlaxoSmithKline,
Consultant; Pfizer, Consultant; Astellas, Consultant; Ortho McNeil,
Consultant; advisory board Astellas, Other; A. Dilley, full time employee
GlaxoSmithKline, Other; A.G. Hirsch, GlaxoSmithKline, Grant/Research
Support; AstraZeneca, Grant/Research Support; W.F. Stewart,
GlaxoSmithKline, Grant/Research Support; AstraZeneca, Grant/Research
Support; Roche, Grant/Research Support; Merck, Grant/Research
Support; GlaxoSmithKline, Consultant.
Association Between Urinary Incontinence And Depressive
Symptoms In Overweight And Obese Women
V. W. Sung,* A. L. Hernandez,† T. L. Wheeler II,‡ D. S. West,§ D. L.
Myers,* and L. L. Subak† *Alpert Medical School at Brown
University, Providence, RI, †University of California, San Francisco,
CA, ‡University of Alabama, Birmingham, Birmingham, AL,
§University of Arkansas for Medical Sciences, Little Rock, AR
Objective:
To estimate the association between urinary
incontinence (UI) and depressive symptoms in overweight and
obese women.
Methods: A total of 338 incontinent and overweight women in the
Program to Reduce Incontinence by Diet and Exercise (PRIDE) clinical
trial were randomized to a 6-month lifestyle intervention (weight loss
and exercise) or a structured education program. At baseline, women
completed the Beck’s Depression Index (BDI) and were categorized as
having no depressive symptoms (BDI score ⬍ 9) or as having
depressive symptoms (BDI score ⱖ 10), according to standard BDI
scoring. Number and type of UI episodes were determined by selfreport on a 7-day voiding diary. Effect of UI on quality of life was
measured by the 30-item Incontinence Impact Questionnaire (IIQ).
Multivariable logistic regression analysis was used to identify
independent risk factors for depressive symptoms at baseline.
Variables with p ⱕ 0.1 were retained in the final multivariable
model.
Results: At baseline, the mean age of participants was 53 ⫾ 11
years, body mass index (BMI) was 36 ⫾ 6 kg/m2, weekly number
of UI episodes was 24 ⫾ 18 episodes. Thirty percent (N ⫽ 101) of
women had BDI scores suggestive of some degree of depression.
Compared to women without depressive symptoms, women with
depressive symptoms were younger (mean age 51 vs. 54 years,
p ⫽ .03), less likely to have any college education (81% vs. 89%,
p ⫽ .05) and had minimally higher BMI (mean 37 vs. 36 kg/m2,
p ⫽ .06). In addition, women with depressive symptoms reported a
higher number of UI episodes per week (mean 28 vs. 23 UI
Abstracts
episodes, p ⫽ .005), a higher number of stress incontinence
episodes per week (11 vs. 9, p ⫽ .05), and worse scores on the IIQ
(136 vs. 97, p ⬍ .001) than women without depressive symptoms.
In separate multivariable analyses, we found the risk for having
depressive symptoms increased with each 7-unit increase in UI
episodes per week (OR 1.10, 95% CI 1.01–1.21) and each 50-point
increase in IIQ (OR 1.43, 95% CI 1.20 –1.70).
Conclusions: Urinary incontinence and worse incontinencespecific quality of life measured by the IIQ were independently
associated with depressive symptoms among overweight and obese
women.
Disclosures: V.W. Sung, None; A.L. Hernandez, None; T.L. Wheeler
II, Pfizer, Speaker’s Bureau; D.S. West, None; D.L. Myers, None; L.L.
Subak, Pfizer, Grant/Research Support.
Prevalence And Degree of Bother From Pelvic Floor Disorders
In Obese Women
E. L. Whitcomb,* E. S. Lukacz,* J. M. Lawrence,† C. W. Nager,* and
K. M. Luber‡ *University of California San Diego, La Jolla, CA,
†Kaiser Permanente Southern California, Pasadena, CA, ‡Kaiser
Permanente San Diego Medical Center, San Diego, CA
Objective: To determine the prevalence and degree of bother from
pelvic floor disorders (PFD) in obese women from a managed care
population and to evaluate whether their prevalence is higher among
women with greater degree of obesity. We hypothesized that the
prevalence and degree of bother from PFD would increase among
more obese women.
Methods: A secondary analysis was performed on 1,155 obese (BMI
ⱖ 30 kg/m2) female members of a health maintenance organization
enrolled in a large epidemiologic study of 4,458 women. A validated
questionnaire identified women with pelvic organ prolapse (POP),
stress urinary incontinence (SUI), overactive bladder (OAB), and anal
incontinence (AI). Degree of bother from PFD was assessed using a
100 mm visual analog scale (VAS). The prevalence of PFD and
degree of bother were compared across three categories of obesity
(obese ⱖ 30 kg/m2, super-obese ⱖ 35 kg/m2 and morbidly obese ⱖ
40 kg/m2). Chi-squared and Kruskal-Wallis analyses were used to
compare the prevalence of PFD by degree of obesity. ANOVA was
used to compare mean VAS scores across the three groups.
Associations with a two-sided p-value ⬍ 0.05 were considered
significant.
Results: The mean age ⫾ SD of the obese cohort was 56.4 ⫾ 14.8
years, and the mean BMI 35.4 ⫾ 5.3 kg/m2. The prevalence of PFD
was: POP 9%, SUI 24%, OAB 22%, AI 29%, and any one or more PFD
46%. The prevalence (%, CI) of any PFD was highest in morbidly
obese women (57%, 49%– 64%) compared to super-obese (53%, 47%58%) and obese women (44%, 41%– 48%), p ⬍ 0.05. A significant
increase in the prevalence of POP, SUI, and any PFD was found in
morbidly obese women compared to obese women, and in the
prevalence of SUI in super-obese women compared to obese women.
Although not statistically significant, a trend of increasing prevalence
of OAB and AI was seen with higher degree of obesity. There were no
significant differences in the prevalence of PFD between morbidly and
super-obese women. Degree of bother for PFD did not vary by degree
of obesity.
Conclusions: In this population, there was a consistent trend of
increasing prevalence of PFD with higher degree of obesity, however
degree of bother related to these conditions did not vary with
increasing degree of obesity. Future study should explore PFD as an
indication for weight reduction.
Disclosures: E.L. Whitcomb, None; E.S. Lukacz, Pfizer Inc.,
Medtronic Corp., Consultant; Novartis Pharmaceuticals, Proctor &
Gamble Pharmaceuticals, Intuitive Corp., Speaker’s Bureau; J.M.
Lawrence, None; C.W. Nager, None; K.M. Luber, Pfizer Inc., Watson
Pharmaceuticals,
Astellas,
Consultant;
Pfizer
Inc.,
Watson
Pharmaceuticals, Astellas, Speaker’s Bureau.
Optimism, Pessimism, And Female Sexual Function
M. GOPAL,* T. Chua,† and L. Arya* *University of Pennsylvania,
Philadelphia, PA, †Boston Univeristy School of Medicine, boston, MA
Objective: Optimism and pessimism are two opposing outlooks on
life that can affect all aspects of a woman’s life including her sexual
function. The primary aim of this study was to determine the
association between optimism and female sexual function. The
secondary aim was to determine if there is an association between a
woman’s perception of her partner’s sexual function and her own
sexual function.
Methods: 222 consecutive women reporting to a suburban
gynecology clinic for their annual gynecologic examination
participated in this cross-sectional study. Self-reported questionnaires
were administered to the study participants. Female sexual
dysfunction was measured by the Female Sexual Function Index (FSFI)
and defined as an FSFI score of 27 or greater. The Life Orientation
Test-Revised (LOT-R) was used to measure optimism and pessimism.
The Center for Epidemiologic Studies Depression scale was used to
determine depression. Other covariates of interest included: stress and
urge incontinence, exercise, difficulty with sleep, BMI, age and
number of prescribed medications. Questions measuring a woman’s
perception of her partner’s sexual drive and recent sexual interaction
were also administered. Associations predictive of female sexual
dysfunction were determined by univariate analysis and multivariable
logistic regression.
Results: Seventy-six women with sexual dysfunction were compared
to 146 women without sexual dysfunction. On univariate analysis,
significant risk factors for female sexual dysfunction were age (OR
1.02, 95%CI: 1.00; 1.05), exercise (OR 0.34, 95%CI: 0.16; 0.74), and
251
Abstracts
use of two or more prescription medications (OR 3.06, 95%CI: 1.30;
7.16). Women who perceived their partner as having a low sexual
drive (OR 4.50, 95%CI: 2.04; 9.91) or those with partner’s that
initiated sexual activity less than half the time (OR 6.63, 95%CI 2.01;
21.9) had increase odds of sexual dysfunction. Women in the sexual
dysfunction group had lower optimism scores in comparison to
women without sexual dysfunction (8.1 ⫾ 2.5 vs. 8.7 ⫾ 2.5,
p ⫽ 0.12). On multivariable regression, independent risk factors for
female sexual dysfunction were age (OR 1.06, 95%CI 1.02; 1.10),
intake of anxiety or depression medication (OR 5.41, 95%CI: 1.68;
17.43) and perception of her partner’s sexual function as being low
(OR 6.67, 95%CI: 1.30; 33.33). Women who exercised (OR 0.18,
95%CI: 0.04; 0.75) and were optimistic (OR 0.73, 95%CI: 0.53; 0.99)
had significantly decreased odds of sexual dysfunction.
Conclusions: Optimistic women have decreased odds of sexual
dysfunction. A woman’s perception of her partner’s sexual function is
associated with her own sexual function.
Disclosures: M. Gopal, None; T. Chua, None; L. Arya, None.
Modification of the PISQ-12, the short form of the Pelvic Organ
Prolapse/Urinary Incontinence Sexual Questionnaire, to Assess
Sexual Activity and Sexual Preferences
S. O. Aschkenazi, T. Gamble, A. Nguyen, R. Kuo, S. M. Botros, P. K.
Sand, and R. P. Goldberg Northwestern University, Feinberg School
of Medicine, Evanston, IL
Objective: The short version of the PISQ questionnaire containing 12
selected questions from the long form was previously validated and
found to predict long-form scores. It has good validity, reliability and
is responsive to change in sexually active women. It is easily
understood and rapidly completed. However, it does not assess the
base-line sexual-activity status and sexual-preference of respondents.
In view of its many attributes and familiarity among physicians
treating pelvic-floor disorders, we aimed to test whether a modified
version of the PISQ-12, which includes two preliminary questions
regarding sexual-activity in the past 6 months and sexual preference
(heterosexual/same-sex partner/both) would be as reliable, and could
be used interchangeably, or complement the original PISQ-12.
Methods: As part of a cross-sectional, multi-item, epidemiologic
survey, 154 women volunteers completed a modified PISQ-12
questionnaire, which included the addition of two preliminary
questions addressing sexual activity in the past six months and sexual
preferences (heterosexual vs. same-sex partner). In addition,
participants completed the un-modified PISQ-12 questionnaire, which
included the12 questions assessing sexual function. In half the cases,
the modified PISQ-12 was presented at the beginning of survey with
the unaltered PISQ-12 at the end. This order was reversed for the
remaining of the surveys. Mean PISQ-12 and individual PISQ-12 scores
were compared between the modified PISQ-12 assessing sexual
activity and sexual preference, and the unmodified questionnaire. The
mean total and individual PISQ-12 item-scores, standard deviations
(SD), range and P-values were calculated and compared using a nonparametric test (signed-rank test) for non-continuous variables graded
by a Likert scale (0 – 4). Intraclass correlation coefficient between
total/individual scores of the 2 questionnaires was calculated via oneway ANOVA, to assess the reliability/agreement between the two
times measurements. An ICC ⱖ 0.9 is considered as excellent
reliability.
Results: There were 148 pairs of modified and unaltered PISQ-12
questionnaires, which were complete and eligible for analysis. The
252
mean difference in total scores of the assessments was 0.1, SD ⫽ 3.28,
p-value ⫽ 0.7094, indicating no statistical differences between scores
of the modified vs. the unchanged PISQ-12. The correlation coefficient
was 0.9217. Of note, there were no significant differences in PISQ-12
scores between women with different sexual preferences.
Conclusions: This study showed a very strong significant correlation
between the previously validated PISQ-12 and the modified PISQ-12,
which includes a preliminary assessment of sexual activity and sexual
preference. Based on these results the modified PISQ-12 can be
reliably used in comparative studies assessing sexual function
providing crucial information on baseline sexual-activity status and
sexual preference of the participants.
Disclosures: S.O. Aschkenazi, None; T. Gamble, None; A. Nguyen,
None; R. Kuo, None; S.M. Botros, None; P.K. Sand, Indevus
Pharmaceuticals, AMS, Astellas, Consultant; R.P. Goldberg, Boston
Scientific., Consultant; Boston Scientific., Paid Instructor.
Urinary Incontinence, Depression and PTSD in Women
Veterans
C. S. Bradley,* I. E. Nygaard,† M. A. Mengeling,‡ C. M. Kennedy,* J.
C. Torner,§ and A. G. Sadler‡ *University of Iowa, Dept. of Ob/Gyn,
Iowa City, IA, †University of Utah, Dept. of Ob/Gyn, Salt Lake City,
UT, ‡Veterans Affairs Medical Center, Iowa City, IA, §University of
Iowa, Department of Epidemiology, Iowa City, IA
Objective: To measure associations between urinary incontinence
(UI) symptoms, depression and post-traumatic stress disorder (PTSD)
in women veterans.
Methods: This cross-sectional study included women veterans ⱕ 50
years of age who sought care at 2 Midwestern VA Hospitals and
clinics in the preceding 5 years. Participants completed a computerassisted telephone interview assessing urogynecologic, medical and
mental health disorders. We defined depression and PTSD using the
short form Composite International Diagnostic Interview and
Posttraumatic Diagnostic Scale, respectively, and used standardized
epidemiologic items to identify UI type and frequency. Bi- and
multivariable analyses compared characteristics and associated
conditions between women with urge/mixed UI and no UI and
between women with stress UI only and no UI.
Results: 925 (62%) of 1493 eligible women enrolled and completed
data collection. After excluding 32 with current/recent pregnancy,
893 were included in this study. Mean (SD) age and body mass index
were 39.0 (8.6) years and 28.2 (6.2) kg/m2. Median parity was 2. 81%
were Caucasian. 60% served in the regular military, 11% in the
Reserves/National Guard, and 28% in both. 181 (20.3%) reported urge
UI a few times monthly or more (Urge/Mixed UI). 140 (15.7%)
reported stress (only) UI symptoms a few times monthly or more
(Stress UI). 305 (34.2%) had no UI symptoms (No UI). Compared to
those with no UI, women with any type of UI were older, more
parous, heavier and had more chronic medical problems (pⱕ0.001
each). Brain injury and sexual assault were more common in those
with Urge/Mixed UI compared to no UI (p ⬍ 0.001 for both). Women
with Urge/Mixed UI had higher rates of depression and PTSD
(p ⬍ 0.0001 for both) and lower SF-12 mental component scores
(p ⫽ 0.0005) compared to women with no UI. Women with stress UI
were similar to those with no UI in these parameters. After controlling
for other factors, depression and PTSD remained significantly
associated with Urge/Mixed UI (adjusted OR 关95%CI兴 ⫽ 1.7 关1.1, 2.7兴
and 2.0 关1.2, 3.3兴, respectively).
Abstracts
Conclusions: Unlike women veterans with stress UI only, those with
urge/mixed UI symptoms are more likely to have depression, PTSD
and poorer mental health-related QOL than those with no UI.
Disclosures: C.S. Bradley, Pfizer, Speaker’s Bureau; Merck,
Shareholder; I.E. Nygaard, None; M.A. Mengeling, None; C.M.
Kennedy, Glaxo Smith Kline, Grant/Research Support; Merck,
Grant/Research Support; Takeda, Grant/Research Support; J.C. Torner,
None; A.G. Sadler, None.
Results: The most commonly used treatments were LAX and FS:
42.1% and 38.9% respectively at baseline, and 37.8% and 38.8% at 6
months. Among subjects who used LAX or FS at baseline, 68.7% and
67.8% continued with LAX or FS at 6 months. Significant predictors of
LAX use at 6 months were baseline LAX use (p ⫽ 0.008, OR ⫽
3.17) and CSI at 6 months (p ⫽ 0.04, OR ⫽ 1.09). Total variance
explained was 12.8%. Baseline perceived effectiveness, SE severity and
satisfaction with LAX did not predict whether subjects would use LAX
at 6 months follow-up. None of the examined variables were
identified by the regression analysis as predictors of LAX persistent
use. Logistic regression analysis identified baseline FS use (p ⬍ 0.003,
OR ⫽ 2.79) as the significant predictor of using FS at 6 months
follow-up. Total variance explained was 11.3%. None of the examined
variables were predictors of FS persistent use.
Conclusions: LAX and FS are the most commonly and most
persistently used treatments for CC. Approximately 2/3 of subjects
persist in their use of these treatments for at least 6 months. Baseline
LAX or FS treatment predicts the use of these treatments in 6 months.
In addition, CSI at 6 months influences LAX use on follow-up.
Surprisingly, baseline perceived effectiveness, SEs and satisfaction with
LAX or FS are not predictors of use of these treatments at 6 months.
No variable is identified as a predictor of persistent use of either LAX
or FS.
Disclosures: T. Nguyen, None; O. Palsson, None; M. Von Korff,
None; A. Feld, None; R. Levy, None; M. Turner, None; W. Whitehead,
Novartis Pharmaceuticals, Grant/Research Support; R24 DK67674,
Treatment Use In Patients With Chronic Constipation
T. Nguyen,* O. Palsson,* M. Von Korff,† A. Feld,‡ R. Levy,‡ M.
Turner,* and W. Whitehead* *University of North Carolina, Chapel
Hill, NC, †Group Health of Puget Sound, Seattle, WA, ‡University of
Washington, Seattle, WA
Objective: To determine a) which treatments are used most
commonly and most persistently in patients with chronic constipation
(CC) by Rome III criteria, b) what influences the use of these
treatments at 6 month follow-up and c) what influences the persistent
use of these treatments.
Methods: HMO patients with a clinical diagnosis of CC (ICD-9CM
code 564.0X) in the last year and subjects (matched by age and sex)
without a CC diagnosis for the previous 5 years were invited to
complete a postal survey. Participation rate was 66.2% (n ⫽ 1707).
Subjects from either sampling group meeting Rome III criteria for CC
at baseline (n ⫽ 936) were invited to complete a 6 month follow-up
survey, and 789 of them (84.3%) did so. The analysis sample for the
current study was 789 subjects with CC who completed the followup. The baseline and follow-up questionnaires included demographics,
the Constipation History Questionnaire, Rome III Diagnostic
Questionnaires, constipation treatments for the past three months,
and ratings of treatment effectiveness, side-effect (SE) severity and
satisfaction. Persistent use was defined as use of a treatment at
baseline plus the 6-month follow up. Statistical analysis involved
logistic regression using SPSS. Dependent variables in separate
regression analyses were laxative (LAX) or fiber supplement (FS) use
at 6 months, and persistence of LAX or FS use. Independent variables
were demographics, the validated Constipation Severity Index (CSI) at
baseline and at 6 months, baseline Rome III IBS diagnosis, baseline
treatment use, and baseline perceived treatment effectiveness, SEs,
and satisfaction.
Patient-Centered Treatment Goals for Pelvic Floor Disorders:
Association With PFD-Specific And General Quality of Life
V. E. Bovbjerg,* E. R. Trowbridge,* M. D. Barber,† T. E. Martirosian,*
W. D. Steers,* and K. L. Hullfish* *University of Virginia School of
Medicine, Charlottesville, VA, †Cleveland Clinic, Cleveland, OH
Objective: To determine the relationship of PFD patient-centered
goals to PFD-specific and general quality of life and health status
measures; patient-centered goals should be related to, but not
identical to, PFD-specific and general measures of quality of life and
well being, with stronger associations to PFD-specific measures.
Methods: As part of a one year cohort study of patient-centered
outcomes of PFD treatment, 143 women with PFD identified up to
five goals for PFD treatment, and reported their level of goal
attainment (⫺2 关worst possible outcome兴 to ⫹2 关best possible
outcome兴) at 1.5, 3, 6, and 12 months. Mean goal attainment was
calculated by summing individual goal attainment for each participant
at each interval, and dividing by the number of goals, so that positive
values indicated greater goal attainment and negative values relative
lack of goal attainment (range ⫺2 to ⫹2). At those same intervals,
participants completed brief measures of PFD-specific quality of life
(Incontinence Impact Questionnaire 关IIQ-7兴, Urogenital Distress
Inventory 关UDI-6兴, Incontinence Quality of Life 关I-QOL兴), as well as
general measures of depression (nine item Patient Health
Questionnaire 关PHQ-9兴), and emotional and physical functional status
(SF-12 physical 关PCS兴and mental health 关MCS兴 scales). The associations
of goal attainment to quality of life and health status were estimated
using Pearson product moment correlation coefficients, such that
positive coefficients indicated that greater goal attainment was
associated with higher quality of life, better health status, and fewer
depressive symptoms.
TABLE.
Age (y)
SF-12 Mental
Component
History head/
brain injury
History sexual
assault
Depression
PTSD
No UI
(n ⴝ 305)
Urge/Mixed UI
(n ⴝ 181)
Stress UI
(n ⴝ 140)
35.6 ⫾ 9.2
47.6 ⫾ 7.8
42.6 ⫾ 6.6
44.8 ⫾ 8.9
40.1 ⫾ 7.4
47.1 ⫾ 8.1
29.2%
44.2%
30.7%
41.3%
63.5%
47.1%
23.6%
23.9%
42.5%
42.5%
28.6%
24.3%
(Data not presented from women with infrequent UI (few times
yearly)).
253
Abstracts
Results: At 12 months, goal attainment was moderately correlated
with IIQ-7 (r ⫽ 0.32, p ⬍ 0.01), UDI-6 (r ⫽ 0.40, p ⬍ 0.01), and I-QOL
total (r ⫽ 0.46, p ⬍ 0.01), and avoidance (r ⫽ 0.40, p ⬍ 0.01),
psychological (r ⫽ 0.37, p ⬍ 0.01), and social (r ⫽ 0.55, p ⬍ 0.01)
subscales. Goal attainment was weakly correlated with PHQ-9 (r ⫽ 0.27, p ⫽ 0.02) and SF-12 mental health (r ⫽ 0.28, p ⫽ 0.02) scales,
and not significantly associated with SF-12 physical (r ⫽ ⫺0.19,
p ⫽ 0.11) scale scores. Correlation patterns for follow-up visits at 1.5,
3, and 6 months showed similar associations, with no significant
associations of goal attainment and PHQ-9 to SF-12 scores at either 1.5
or 3 months.
Conclusion: Achievement of patient-identified goals for PFD
treatment was consistently but moderately associated with PFDspecific measures of quality of life, suggesting that goal attainment is
related to but not synonymous with condition-specific quality of life.
The association of goal attainment to general QOL measures has not
been previously reported: the lack of consistent associations suggests
that goal attainment is not merely a reflection of the general health
status of patients with PFD.
Disclosures: V.E. Bovbjerg, None; E.R. Trowbridge, None; M.D.
Barber, American Medical Systems, Grant/Research Support; T.E.
Martirosian, None; W.D. Steers, Investigator, Astellis and Allergan,
Grant/Research Support; K.L. Hullfish, None.
Patient-Centered Treatment Goals for Pelvic Floor Disorders:
Association With Patient Satisfaction
V. E. Bovbjerg,* E. R. Trowbridge,* M. D. Barber,† T. E. Martirosian,*
W. D. Steers,* and K. L. Hullfish* *University of Virginia School of
Medicine, Charlottesville, VA, †Cleveland Clinic, Cleveland, OH
Objective: To assess the association of patient-identified goals for
pelvic floor disorder (PFD) treatment with measures of patient
satisfaction with care.
Methods: As part of a one year cohort study of patient-centered
outcomes of PFD treatment, 143 women with PFD identified up to
five goals for PFD surgical and non-surgical treatment, and reported
their level of goal attainment (⫺2 关worst possible outcome兴 to ⫹2
关best possible outcome兴) at 1.5, 3, 6, and 12 months. Mean goal
attainment was calculated by summing individual goal attainment for
each participant at each interval, and dividing by the number of goals,
so that positive values indicated greater goal attainment and negative
values relative lack of goal attainment (range ⫺2 to ⫹2). At those
same intervals, participants completed three survey items assessing
their satisfaction with care: their overall level of satisfaction
(completely satisfied, very satisfied, satisfied, not satisfied), whether
they would “have the same treatment again” given the outcomes (yes,
not sure, no), and whether they would recommend the treatment
they had undergone to others (yes, not sure, no). The associations of
goal attainment to satisfaction were assessed using oneway analysis of
variance, treating satisfaction responses as categories which were
compared on levels of goal attainment.
Results: At 12 months, mean goal attainment differed significantly by
satisfaction (F ⫽ 24.2, p ⬍ 0.01): participants who reported being
completely (mean attainment ⫽ 1.6 ⫾ 0.5) or very satisfied
(attainment ⫽ 1.2 ⫾ 0.6) with treatment reported higher goal
attainment than those who were satisfied (attainment ⫽ 0.4 ⫾ 1.0) or
not satisfied (attainment ⫽ ⫺0.5 ⫾ 0.9). Those who reported they
would undergo the same treatment again had significantly higher
levels of goal attainment (attainment ⫽ 1.1 ⫾ 0.9) than those who
254
were unsure (attainment ⫽ ⫺0.3 ⫾ 1.1) or said they would not
undergo the same treatment again (attainment ⫽ ⫺0.4 ⫾ 0.8;
F ⫽ 18.6, p ⬍ 0.01). Similarly, those who reported they would
recommend the treatment to others had significantly higher levels of
goal attainment (attainment ⫽ 0.9 ⫾ 1.0) than those who were unsure
(attainment ⫽ ⫺0.1 ⫾ 1.3) or said they would not recommend the
treatment (attainment ⫽ 0.1 ⫾ 0.5; F ⫽ 7.1, p ⬍ 0.01). Results for
follow-up visits at 1.5, 3, and 6 months showed similar associations.
Conclusion: Attainment of patient-identified treatment goals was
highly associated with patient satisfaction. Future work should
determine whether treatment plans that explicitly address patientidentified goals result in greater patient satisfaction.
Disclosures: V.E. Bovbjerg, None; E.R. Trowbridge, None; M.D.
Barber, American Medical Systems, Grant/Research Support; T.E.
Martirosian, None; W.D. Steers, Investigator, Astellis and Allergan,
Grant/Research Support; K.L. Hullfish, None.
Urinary Incontinence-Related Costs Decrease With Improved
Incontinence Following Treatment
L. L. Subak,* R. R. Wing,† A. M. Pinto,‡ S. Nakagawa,* J. Creasman,* J.
W. Kusek,§ M. Kuppermann,* and W. H. Herman¶ *University of
California, San Francisco, San Francisco, CA, †The Miriam Hospital,
Providence, RI, ‡Baruch College/CUNY, New York, NY, §NIDDK,
Bethesda, MD, ¶University of Michigan, Ann Arbor, MI
Objective: To estimate the effect of a lifestyle intervention for
urinary incontinence (UI) on UI management costs and health-related
quality of life (QOL) and to identify predictors of these outcomes
among overweight women with UI participating in a weight loss trial.
Methods: A total of 338 incontinent and overweight women in the
Program to Reduce Incontinence by Diet and Exercise (PRIDE) clinical
trial were randomized to a 6-month lifestyle intervention (weight loss
and exercise) or a structured education program. At baseline and 6
months, women quantified the number of supplies used for UI and
additional laundry and dry cleaning required each week specifically
due to UI. UI management costs (“cost”) were calculated by
multiplying resources used by national resource costs ($2005). Healthrelated QOL was estimated with the Health Utilities Index (HUI3) and
other QOL measured by the SF36, Incontinence Impact Questionnaire
(IIQ) and Urogenital Distress Inventory (UDI). Potential predictors of
changes in these outcomes were examined using generalized
estimating equations controlling for age, ethnicity, parity,
hysterectomy, baseline weight, change in weight and clinical site for
change in cost and age, ethnicity, clinical site and change in UI
frequency for change in HUI3.
Results: The mean (⫾SD) age of participants was 53 ⫾ 10 years, BMI
was 36 ⫾ 6 kg/m2, with reported annual household incomes of
⬍$40,000 (26%), $40,000 –$99,999 (51%) and ⱖ$100,000 (23%). Selfreported mean UI frequency was 24 ⫾ 18 episodes with 18% of
women classified as stress only/predominant, 49% urge
only/predominant and 34% mixed UI. At 6 months, the mean weight
loss was 6 kg and weekly UI episodes decreased by 37%. Mean weekly
cost was $7.76 ⫾ $14 (median $3.79) at baseline and decreased to
$4.61 ⫾ $9.69 (median $1.97) at 6 months (p ⬍ 0.001). In
multivariable analyses, cost decreased by $1 per week for each
decrease of 7 UI episodes per week (p ⫽ 0.03) and was strongly
associated with greater improvement in UDI and IIQ scores
(p ⬍ 0.006 for trend). Change in weekly cost was not associated with
annual income, type of UI or change in weight. Mean HUI3 score was
0.81 ⫾ 0.18 (median 0.85) at baseline and decreased to at 0.78 ⫾ 0.23
(median 0.85) at 6 months (p ⫽ 0.02). In multivariable analyses, the
HUI3 score increased by 0.04 for each 5 kg decrease in weight
(p ⬍ 0.001) and was strongly associated with greater improvement in
SF36 Physical Component and Mental Component Summary scores
(p ⬍ 0.01 for trend). Change in HUI3 score was not independently
associated with change in UI frequency.
Conclusion: This is the first report of the change in UI management
cost over time associated with change in UI frequency. At 6 months
in PRIDE, cost decreased by over 55% and was strongly and
independently associated with decreasing UI frequency. Improved
health-related quality of life was strongly associated with weight loss
but not with improved UI. A lifestyle intervention weight loss that
improved UI frequency decreased UI management costs and improved
health-related quality of life.
Disclosures: L.L. Subak, Pfizer Pharmaceutical, Inc. (Subak),
Grant/Research Support; R.R. Wing, None; A.M. Pinto, None; S.
Nakagawa, None; J. Creasman, Pfizer, Inc., Grant/Research Support;
J.W. Kusek, None; M. Kuppermann, Boehringer-Ingelheim
Pharmaceuticals, Inc., Grant/Research Support; W.H. Herman, None.
Collagen Scaffold Improves Healing After Simulated Maternal
Birth Injury
M. Alperin,* A. Feola,† R. Duerr,* L. Meyn,* S. F. Badylak,‡ S.
Abramowitch,† and P. Moalli* *Magee-Womens Research Institute,
University of Pittsburgh, Pittsburgh, PA, †Musculoskeletal Research
Center, University of Pittsburgh, Pittsburgh, PA, ‡McGowan Institute
for Regenerative Medicine, University of Pittsburgh, Pittsburgh, PA
Objective: Damage to the vagina and its supportive tissues during
childbirth contributes to significant morbidity later in life. Short of
recommending a cesarean section prior to the onset of labor, little has
been done to develop strategies to prevent or treat maternal birth
injury. Our aim was to determine whether the use of an acellular
collagen scaffold following traumatic vaginal delivery mitigates the
impact of maternal birth injury in a rodent model.
Methods: 58 Long-Evans virgin, immediate postpartum (0 –2 hrs), and
4-week postpartum rats were utilized. Virgin rats served to account
for factors associated with delivery that may impact recovery. 38
animals underwent simulated birth injury via balloon distension and
recovered for 4 weeks. In 20 rats, either a strip or a liquid suspension
of porcine small intestinal submucosa (SIS) was placed over the site of
vaginal injury prior to closure, while the 18 remaining injured animals
underwent a standard suture repair. 10 uninjured virgin and 10
uninjured 4-week postpartum rats served as controls. After sacrifice,
the amount of fibrillar collagens I, III and V present in the
subepithelium and muscularis of the mid vagina were assessed via
quantitative fluorescence microscopy using a scanning laser confocal
microscope and analyzed using custom software (MatlabTM). The ratio
of collagen I/V and I/III was used as an indication of tissue
biomechanical properties (higher ratio ⫽ improved biomechanical
properties) later to be confirmed by mechanical testing. Results are
represented as mean pixel intensity ratios. Statistical analyses were
performed using one-way analysis of variance with Sidak’s multiple
comparison post-hoc tests at the 0.05 significance level.
Results: Immunofluorescent analyses demonstrated that the ratio of
collagen I/V decreased 44% in virgin rats after simulated birth injury
relative to virgin controls (p ⫽ 0.001), indicating persistent injury after
4 weeks of recovery. After treatment with SIS, the ratio of collagen
Abstracts
I/V was 28% higher than the ratio of the non-treated group and similar
to that of uninjured controls (p ⫽ 0.11). Examination of the ratio of
collagen I/III revealed no significant differences in virgins after
simulated birth injury when compared to virgin controls (p ⫽ 0.98).
This ratio, however, was significantly higher in injured animals after
treatment with SIS, even when compared to the uninjured controls,
(p ⬍ 0.001). For the postpartum animals, ratios of both collagen I/V
and I/III were significantly lower (65% for I/V and 42% for I/III) after
simulated birth injury followed by 4 weeks recovery than 4 week
postpartum controls (p ⬍ 0.001). SIS treatment increased these ratios
by 59% and 35%, respectively, to levels which were similar to the
postpartum controls (p ⫽ 0.29 for I/V; p ⫽ 0.57 for I/III).
Conclusion: Collagen scaffold improves collagen ratios in the
fibromuscular layer of the vagina following simulated birth injury. The
data indicate that SIS treatment enhances the quality of tissue when
applied at the time of injury.
Disclosures: M. Alperin, None; A. Feola, None; R. Duerr, None; L.
Meyn, None; S.F. Badylak, None; S. Abramowitch, None; P. Moalli,
None.
Co-Morbidities and Incontinence in an Elderly Long-Term Care
Population
B. Ridgeway, L. Chacko, M. D. Barber, and B. J. Messinger-Rapport
Cleveland Clinic, Cleveland, OH
Objective: Identify co-morbidities and medicines associated with
urinary (UI) and fecal incontinence (FI) in a female, elderly long-term
care population.
Methods: Medical records of all female residents were reviewed in a
privately-owned inner-city long-term care facility. Data were extracted
from the in-patient physician and nursing notes, the most recent
Minimum Data Set (MDS), and the Medication Administration Record.
Demographics, medical conditions, and co-morbidities that may be
associated with UI or FI, including age, diabetes (DM), congestive
heart failure (CHF), dementia, depression, gait impairment, neurologic
conditions, constipation, and number of daily medicines were
recorded. Medications reported to be associated with UI including
cholinesterase inhibitors, diuretics, glitizones, anti-hypertensives, antipsychotics, hormonal therapies and sedative-hypnotics were
documented. Presence and severity of UI and FI was determined by
the latest MDS evaluation. The relationships between incontinence
and co-morbidities, medical conditions, and medications were
evaluated using the Chi-square, Student’s t, and Wilcoxon signed-rank
tests as appropriate. Multivariable logistic regression was used to
evaluate the independent associations of co-morbidities and
medications with UI and FI. This study was approved by the
Cleveland Clinic IRB and the Fairfax Healthcare Center.
Results: Sixty-seven (100%) female residents were evaluated during
the 10 week study period. The mean ⫾ SD (range) age was 86.4 ⫾
8.6 (62–101) years and the rates of incontinence were: UI 66%, FI
46%, and dual incontinence 42%. The following percentage of
residents had the following diagnoses: DM 31%, CHF 30%, dementia
79%, depression 36%, and gait disorders 85%. On univariate analysis,
the co-morbidities dementia (p ⫽ .04), depression (p ⫽ .02), and gait
disorders (p ⫽ .01) were significantly associated with UI while only
dementia (p ⫽ .01) was associated with FI. In multivariable analysis,
dementia maintained independent relationships with UI and FI with
odds ratios (95% confidence intervals) of 4.3 (1.3, 17.4) and 6.8 (1.6,
47.2) respectively while gait disorders maintained its relationship with
255
Abstracts
UI with an odds ratio of 9.1 (2.0, 54.7). Dementia was the only comorbidity associated with severity of both UI (p ⫽ .01) and FI
(p ⫽ .006). The total number of medicines and all medications
individually were not associated with UI or FI except second
generation anti-psychotics (ziprasidone, aripiprazole) which were
associated with decreased UI (p ⫽ 0.03). Of the 44 residents with UI,
only 1 (2%) was treated with medicines approved for overactive
bladder.
Conclusions: UI and FI affect the majority of female long term care
residents. Dementia and gait disorders are significantly associated with
incontinence in this population. Medication treatment targeting
incontinence type and therapeutic interventions for associated comorbidities such as gait disorders may decrease incontinence.
Disclosures: B. Ridgeway, None; L. Chacko, None; M.D. Barber,
American Medical Systems, Grant/Research Support; B.J. MessingerRapport, Novartis, Consultant; Pfizer, Speaker’s Bureau; Forest,
Speaker’s Bureau.
Estrogen Regulates LOXL1 And Elastogenesis in The Vaginal
Wall
S. M. Roshanravan,* P. G. Drewes,* P. Keller,* J. F. Acevedo,* B.
Starcher,† and R. A. Word* *UT Southwestern Medical Center,
Dallas, TX, †UT Health Science Center, Tyler, Tyler, TX
Objective: Although it is well established that estrogen improves the
atrophic effects of menopause on vaginal epithelium, little is known
regarding its effect on the supportive fibromuscular layer of the
vaginal wall. Lysyl oxidase-like 1 (LOXL1) is a copper-dependent
amine oxidase produced by smooth muscle and fibroblasts that,
together with other family members, plays a vital role in cross-linking
and stabilization of collagen and elastic fibers. LOXL1 knockout mice
develop pelvic organ prolapse suggesting that this enzyme plays an
important role in maintenance of pelvic organ support. The goal of
this investigation was to determine the role of estrogen in regulation
of LOXL1 and elastic fiber synthesis in the vaginal muscularis.
Methods: Mice (6 – 8wks) were ovariectomized, and after 14 d,
treated with vehicle, estradiol (E2) (physiologic dose, 15 ug/kg/d), or
E2 (pharmacologic dose, 50 ␮g/kg/d) for 3 or 14 d (n ⫽ 16 for each
group at each time point). Real time PCR and immunoblot analysis
were used to assess LOXL1 mRNA and protein. N-glycosidase F, ␣23,6,8,9-neuraminidase, and endo-␣-N-acetylgalactosaminidase were
used to assess the glycosylation status of LOXL1. Desmosine content
and elastic fiber staining were used as indices of mature cross-linked
elastic fibers.
Results: LOXL1 mRNA was decreased significantly (9-fold) in vaginal
tissues from ovariectomized mice compared with nonpregnant cycling
controls. Treatment of ovariectomized mice with E2 resulted in
significant upregulation of LOXL1 mRNA and protein (5-fold increase
at 14 days, p ⬍ 0.05). Interestingly, however, the molecular mass of
pro-LOXL1 was decreased ⬃8 kDa in vaginal tissues from E2-treated
mice. Real time PCR studies using LOXL1-specific oligonucleotide
primers to carboxy-teminal or first exons of LOXL1, together with
deglycosylation experiments, indicated that E2 treatment induced
expression of an alternatively spliced isoform of LOXL1 in the vaginal
muscularis. E2-induced increased expression of LOXL1 was
accompanied by significant increases in vaginal weight (from 14 ⫾ 1
to 134 ⫾ 10 mg, p ⬍ 0.01) and protein content (364 ⫾ 40 compared
with 3271 ⫾ 233 ug/vagina, p ⬍ 0.001). Elastic fiber staining and
desmosine assays revealed a marked increase in elastic fibers in the
256
vaginal wall from estrogen-treated animals (141 ⫾24 to 374 ⫾ 48
pmol des/vagina).
Conclusions: Estradiol replacement results in robust increases in a
novel isoform of LOXL1 in the ovariectomized mouse vaginal
muscularis. Perhaps the most interesting finding is the dramatic
increase in mature elastic fibers in vaginal tissues from adult animals
treated with E2 suggesting that the vaginal wall is unique from other
adult organs in which elastogenesis is limited to developmental time
periods. Overall, these findings indicate that the beneficial effects of
E2 extend beyond its effect on the epithelial layer of the vagina given
that E2 enhances both elastogenesis and protein synthesis in the
muscularis layer.
Disclosures: S.M. Roshanravan, None; P.G. Drewes, None; P. Keller,
None; J.F. Acevedo, None; B. Starcher, None; R.A. Word, None.
Incidence of Extrusion in Patients Treated with Type I
Polypropylene Mesh “KITS” in Pelvic Organ Prolapse Repair
J. C. Lukban* and R. Moore† *Eastern Virginia Medical School,
Norfolk, VA, †Atlanta Urogynecology Associates, Alpharetta, GA
Objective: To determine rate of mesh extrusion in patients receiving
type I, polypropylene mesh in the repair of anterior, posterior, and/or
apical or uterine descent.
Methods: Data were pooled from two ongoing, multi-center, singlearm, prospective trials evaluating the efficacy and safety of the
Perigee® and Apogee® Systems (American Medical Systems, Inc.,
Minnetonka, MN, USA) as part of the Perigee with IntePro Trial and
the PROPEL Trial, respectively. The primary endpoint of each was
anatomic “cure” (Stage ⱕ I). A secondary endpoint was incidence of
extrusion (vaginal exposure of mesh). Patients were followed
postoperatively at 6 weeks, 3 months, 6 months and 12 months, and
will be followed prospectively through 2 years. Nineteen academic
and community urogynecologic, urologic or gynecologic practices in
the United States contributed patients. Each patient underwent
transvaginal placement of type I polypropylene mesh (IntePro™,
American Medical Systems, Inc., Minnetonka, MN, USA) by means of
bilateral double transoburator trocars for anterior wall repair (Perigee)
or bilateral transgluteal trocars for posterior wall repair with or
without apical or uterine descent (Apogee). Reporting also includes
patients who received Apogee or Perigee as a non-study
(concomitant) repair in either of the two trials.
Results: 262 women were enrolled for the surgical repair of prolapse
(ⱖStage II) in the anterior (AC), posterior (PC), and/or apical
compartments. Mesh was placed in AC and PC in 173 and 195
patients, respectively. Menopausal status of patients in the two
subgroups was 87.8% for AC and 77.4% for PC. Prior hysterectomy
was present in 49.1% of AC and 48.2% of PC. Rate of extrusion
(vaginal exposure) was 6.9% (12/173) in the AC and 13.3% (26/195)
in the PC. Of the anterior extrusions, 4.6% (8/173) required trimming
of mesh (ⱕ2 cm) with primary closure in the operating room while
2.3% (4/173) received non-invasive intervention in the form of inoffice trimming (0.6%, 1/173) or estrogen cream (1.7%, 3/173). Of the
posterior extrusions, 7.7% (15/195) required trimming of mesh (ⱕ2
cm) in the operating room while 6.2% (12/195) received non-invasive
intervention in the form of in-office trimming (4.6%, 9/195) or
estrogen cream (2/195, 1.0%). Patients experiencing extrusion had a
mean follow-up time of 13.9 months (range 6.0 –22.9) in the AC
group and 12.6 months (range 5.1–23.8) in the PC group. Anatomic
cure for patients experiencing extrusion was 91.7% for AC and for PC
88.0% (posterior) and 92% (apical) at stated mean follow-up.
Conclusion: One must consider the risks and benefits of employing
type I polypropylene mesh in the anterior and posterior compartments.
Extrusions in our study required revision in the operating room in less
than 5% and 8% of cases following Perigee and Apogee, respectively.
Patients exhibiting vaginal exposure of mesh maintained a high rate of
anatomic “cure.”
Disclosures: J.C. Lukban, Pfizer, Glaxo-Smith-Kline, and AMS,
Consultant; R. Moore, AMS, Allergan, Consultant.
Racial Differences in the Prevalence of and Bother from Pelvic
Organ Prolapse (POP)
E. L. Whitcomb,* G. Rortveit,† J. S. Brown,‡ J. M. Creasman,‡ D. H.
Thom,‡ S. K. Van Den Eeden,§ and L. L. Subak‡ *University of
California San Diego, La Jolla, CA, †University of Bergen, Bergen,
Norway, ‡University of California San Francisco, San Francisco, CA,
§Kaiser Permanente Division of Research, Oakland, CA
Objective: To compare the prevalence of, risk factors for and level of
bother associated with subjectively reported and objectively measured
POP in a racially diverse cohort of women.
Methods: The Reproductive Risks for Incontinence Study at Kaiser II
(RRISKII) is a population-based cohort study of 2,270 randomly
selected middle-aged and older women. Symptomatic POP was selfreported as a feeling of a bulge, pressure or protrusion or a visible
bulge from the vagina in the past 3 months. Women also reported if a
healthcare provider ever told them that they have prolapse. Degree of
prolapse was measured using the POP-Quantification System (POP-Q)
in a subset of 1,137 women. Bother was quantified on a 5-point selfreported scale and we defined “bother” as moderate or great bother.
Multivariable logistic regression analysis was used to identify independent
association of POP and race while controlling for common risk factors for
POP (age, BMI, parity, education, urinary tract infection, urinary
incontinence and constipation, all p ⬍ 0.2 after adjustment).
Results: Mean (⫾SD) age was 52 ⫾ 10 years and 47% were white,
18% African-American, 17% Latina and 17% Asian. Symptomatic POP
was reported by 74 (3%) women. In multivariable analysis, the risk of
symptomatic POP was significantly higher in Latinas (OR 3.3, 95% CI
1.2– 8.9) and white women (OR 3.2, CI 1.3– 8.3) compared to AfricanAmerican women. Almost three times as many women with
symptomatic POP reported moderate or great bother compared to
women without symptoms but who had been told by a healthcare
provider that they have prolapse (36% vs. 13%, respectively;
p ⫽ 0.001). After controlling for symptomatic POP, Latina women
remained 3.4-times more likely to report bother compared to white
women (p ⫽ 0.02). Degree of prolapse by POP-Q Stage was similar
across all racial groups (Stage 0: 6 – 8%, Stage 1: 24 –29%, Stage 2:
64 – 69%, and ⱖ Stage 3: 0 –1%; p ⫽ 0.80). Report of moderate or great
bother increased with POP-Q Stage, and was reported by 10% of
women with Stage 0 –1, 26% Stage 2, 75% Stage 3 and 100% of
women with Stage 4. POP-Q Stage was associated with degree of
bother (Spearman correlation coefficient ⫽ 0.36; p ⫽ 0.001). Women
with Stage ⱖ 2 prolapse and self-reported POP symptoms were 4.6times more likely to report moderate or great bother than women
with Stage 2 prolapse without self-reported symptoms (p ⫽ 0.03).
Conclusion: The prevalence of self-reported symptomatic POP was
3-fold greater for Latina and white women compared to other racial
groups. Latina women were 3-fold more likely to be bothered by their
POP than white women. Level of bother increased with self-report of
POP symptoms and increasing POP-Q Stage. Of note, report of
Abstracts
significant bother was markedly increased 4 –5 fold among women
with a POP-Q Stage ⱖ 2 and self-reported POP symptoms. This finding
suggests that the addition of self-reported measures may provide more
clinically relevant outcomes in studies using the POP-Q system.
Disclosures: E.L. Whitcomb, None; G. Rortveit, None; J.S. Brown,
NIDDK Cooperative Agreement DK 57136, DK 48489-08 NIDDK
5U01, K24 NIDDK, P50 DK 64538 ORWH NIDDK, Grant/Research
Support; J.M. Creasman, None; D.H. Thom, None; S.K. Van Den
Eeden, None; L.L. Subak, None.
Environmental Factors Play a Dominant Role Over Genetics in
Women with Stress Urinary Incontinence: A Large PopulationBased Classical Twin Study
A. Nguyen, S. Aschkenazi, T. Gamble, R. Goldberg, P. Sand, A. Ching,
P. Stibbe and S. Botros Evanston Incontinence Center, Northwestern
University, Feinberg School of Medicine, Evanston, IL
Objective: Both genetic and environmental factors are believed to
impact the development of stress urinary incontinence (SUI) however,
their relative contribution is unknown. The aim of this study is to use
a classical twin analyses to explore the extent to which genetic and
environmental factors influence the development of stress urinary
incontinence in a large community based sample of monozygotic (MZ)
and dizygotic (DZ) twins.
Methods: This is a population-based classical twin study of 751
female MZ and DZ twin pairs. Structural equation models were fitted
to data from anonymous surveys obtained from female twin pairs who
attended the annual Twins Days Festival held in Twinsburg, Ohio
from 2003–2007. Stress urinary incontinence was identified by an
affirmative answer to the question, “Do you leak urine with coughing,
straining, laughing, physical activity or exercise?” Concordance and
correlation rates were calculated and structural equation models were
used to estimate the contribution of genetic effects versus common
and unique environmental factors on stress urinary incontinence.
Results: Out of 751 twin pairs consisting of 652 MZ and 99 DZ pairs
who volunteered to participate in the survey, there were 638 MZ and 99
DZ twin sister pairs with complete data pertaining to stress urinary
incontinence. Mean age was 41.7 ⫾ 16.1 years (range 18 – 85), mean
body mass index (BMI) was 26.1 ⫾ 6.4 (range 13.5–55.8), with race
comprised of 89.5% white, 6.0% Black, 2.0% Hispanic, and 2% other
ethnicities. There was no difference in general demographics: age, race,
parity, BMI, menopausal status, mode of delivery or prior surgery
between MZ and DZ twins. The overall prevalence was 42.3% and 49% in
MZ and DZ twins, respectively. Concordance rates for SUI were 32% and
37.3% amongst MZ and DZ twins, respectively. The tetrachoric
correlations were 0.789 in MZ, and 0.748 in DZ twins with largely
overlapping 95% confidence intervals (MZ: 0.721– 0.845; DZ:
0.536 – 0.882). The concordance rates and tetrachoric correlations were
in agreement both indicating that genetic effects were not contributory.
Sequential structural equation modelling of the categorical data revealed
that the best fitting model of twin resemblance included the common
and unique environmental factors with the common environment
contributing 70.63% (95%CI: 27.95– 83.50) of the variance and unique
environmental factors contributing 21.1% (95%CI: 15.5–27.84) of the
variance. Using this statistical model, the impact of genetics was not
statistically significant 8.26% (95%CI: 0%–52%).
Conclusions: The results of this study indicate that environmental
factors play a dominant role over genetics in women with stress
urinary incontinence. Further longitudinal studies are warranted to
257
Abstracts
confirm these findings in a more racially diverse sample and evaluate
the impact of individual environmental factors on the development of
SUI.
Disclosures: A. Nguyen, None; S. Aschkenazi, None; T. Gamble,
None; R. Goldberg, Boston Scientific, Consultant; P. Sand, Astellas,
Indevus, Watson, Boston Scietntific, American Medical Systems, Pfizer,
Ortho-McNeil and Allergan, Consultant; A. Ching, None; P. Stibbe,
None; S. Botros, None.
Are Pessary Related Ulcers In Post Menopausal Women
Associated With Bacterial Vaginosis (BV)?
M. To*, D. M. Elser†, and B. Hanna‡ *University of Illinois at
Chicago, Chicago, IL, †Illinois Urogynecology, LTD, Oak Lawn, IL,
‡Womens Health, Carol Stream, IL
Objective: Women with advanced pelvic organ prolapse (POP) who
opt for pessary use to manage symptoms often develop a vaginal
discharge that is clinically similar to bacterial vaginosis (BV). Our
objective was to determine if BV predisposes to development of
vaginal ulcers in postmenopausal pessary users.
Methods: Women with stage 3 or 4 POP opting for pessary use,
were recruited between January–November 2005. Each was followed
for 1 year, or less if pessary use ceased. Power analysis prior to
initiation of the study, using 10% as a clinically significant difference
in ulcer formation determined that to achieve power of 80% and alpha
of 0.05, 100 women needed to be enrolled. Patients were consented
at time of pessary placement. Women were seen initially at 2 weeks
and then every 3 months. At each visit, the pessary was removed and
cleaned; vaginal speculum exam was performed; & the absence or
presence of ulceration was noted. For all patients, a rapid test for
presence of BV using the Proline Imino Peptidase (PIP) Activity Test
(Quidel Corp., San Diego, CA) was performed. The physician &
patient were blinded to the results.If an ulcer developed, pessary was
removed and treatment was randomized to either metrogel or estrace.
Re-examination was performed every 2 weeks until ulcer resolution.
Results: One hundred fifteen patients were enrolled. Types of
pessary used were ring: 68; donut: 28; gellhorn:37; gehrung: 4; cube:4
and incontinence ring:1. During this time, 5 patients changed pessary
size & 19 changed pessary style. Sixteen patients opted for surgical
management of prolapse during the study period. Of the 35 ulcer
patients, 10 (29%) opted for surgery versus 8/80 (10%) who did not
develop ulcers.
Thirty-four patients developed 53 ulcerations requiring temporary
pessary removal. Some patients developed vaginal ulceration on more
than one occasion. Using chi-square analysis, there was a significant
association between incidence of ulceration and type of pessary used
(p ⫽ 0.032). Ulcers occurred with the following frequencies: Donuts:
11; Gellhorn: 12, and Ring: 13. Most ulcers were resolved by the 2
week exam with a mode of 15 days (Range 7-106). One-way ANOVA
found association between ulcer size and type of pessary worn
(p ⫽ 0.031). None of the BV tests were positive.
There was no significant difference between time to ulcer
resolution in women treated with topical estrogen cream vs. topical
metronidazole vaginal gel (p ⬎ 0.05).
Conclusions: The majority of postmenopausal women with stage 3
or stage 4 prolapse can be managed safely and successfully long-term
with a vaginal pessary. The discharge associated with pessary use does
not appear to be due to BV. It is plausable that vaginal ulcers
associated with pessary use are due to atrophy, pressure from a
foreign object, or a combination of the two.
258
Disclosures: M. To, None; D.M. Elser, Novasys Medical, Grant/
Research Support; Ethicon, Consultant; Boston Scientific, Paid Instructor;
B. Hanna, None.
Video Presentations
Presentation Number: Video 1
The Transobturator Sling Procedure For Stress Urinary
Incontinence
S. B. Tate, anb R. D. Acland University of Louisville, Louisville, KY
Clinical Problem: Stress Urinary Incontinence.
Surgical Solution: Transobturator Sling.
Methodology: Utilizing three dimensional videography of predissected specimens, this video demonstrates the clinical anatomy of
the transobturator sling procedure. Excerpts of an educational video
of the procedure being performed in an unembalmed cadaver
illustrate the surgical techniques and correlation to previously
mentioned surgical anatomy.
Outcome: By watching this video describing the relevant clinical
anatomy and transobturator sling procedure, the viewer will gain an
understanding of the important anatomic considerations and the
surgical procedure.
Disclosures: S.B. Tate, Honoraria Bard, Other; R.D. Acland, None.
The Michigan 4-Wall Sacrospinous Ligament Supsension for
Vaginal Vault Prolapse
K. Larson, D. M. Morgan, and J. O. DeLancey University of
Michigan, Ann Arbor, MI
Clinical Problem: Vaginal vault prolapse.
Surgical Solution: The Four-Wall Sacrospinous Ligament Suspension
is a novel approach to sacrospinous suspension for treatment of
vaginal vault prolapse. The procedure incorporates components
critical to successful re-suspension of the vaginal apex in a minimally
invasive, effective manner. It suspends all four vaginal walls to a single
ligament through an apical incision, allowing direct healing between
vagina and ligament.
Methodology: The first step in the operation is to identify a point on
each of the 4 vaginal walls that will reach the sacrospinous ligament
without either undue tension or sagging. The intervening vaginal wall
is then excised. Utilizing both sharp and blunt dissection, a pathway is
developed along the peritoneum to the ligament. Two passes of
looped, PDS suture in a Deschamps ligature carrier result in 4 strands
of suture anchored in the ligament. These are sewn to the edges of
the vaginal cuff and tied to bring the cut edge of the cuff into direct
contact with the ligament. This allows the vagina to heal to the
ligament directly, thus eliminating the need for permanent suture. If
deemed necessary, an anterior repair would be performed prior to
bringing the sutures through the vaginal cuff. A posterior repair, on
the other hand, would be performed at the completion of the
ligament suspension.
Outcome: Our published results from 100 consecutive patients
(almost 1/2 of whom had failed prior operations) reveal a 90%
satisfactory treatment rate in a population consisting exclusively of
stage III and IV post-hysterectomy prolapse.1 Subsequent, unpublished
experience in over 1,000 cases reveals that introduction of PDS suture
(to replace previously used chromic and Vicryl®), results in apical
failure rates less than our previously reported 4%. Attaching the
anterior wall to the ligament minimizes both anterior enterocele and
symptomatic cystocele formation (6% in published series). By
attaching the left and right walls to one ligament, contralateral vaginal
wall descent has been avoided; thus, there is no need for bilateral
suspension which can increase complications associated with
accessing both ligaments. This approach is also minimally invasive and
avoids abdominal incisions and their complications including
incisional hernias and infections), allowing for quicker recovery. In
this surgery, there is minimal bowel manipulation, no foreign body to
cause erosion or infection and no port site or port placement
complications. Lastly, we have found this procedure is not
significantly more difficult in obese patients.
Disclosures: K. Larson, None; D.M. Morgan, None; J.O. DeLancey,
Johnson & Johnson, Consultant.
1
Am J Obstet Gynecol, Vol 158: 872-881. 1988.
Trans-Obturator Post Anal Sling (TOPAS) for Fecal Incontinence
P. L. Rosenblatt Boston Urogynecology Associates, Cambridge, MA
Clinical Problem: Fecal incontinence is a significant medical
problem, as well as a socially debilitating issue. Several surgical
procedures have been utilized in the past to treat this condition,
including anal sphincteroplasty and the artificial anal sphincter, but
none has borne out to be clearly superior.
Surgical Solution: The Trans-Obturator Post Anal Sling (TOPAS) is a
minimally invasive procedure that places a synthetic sling behind the
anorectum to provide posterior support, in a manner similar to the
natural support provided by the puborectalis muscle. The TOPAS
procedure is performed as follows: local anesthetic is injected into the
post anal area and medial thighs through the obturator foramen. Two
small incisions 2 cm lateral and 3 cm posterior to the anus are made
and a tunnel beneath the anorectum is developed. The 2 cm wide
synthetic sling belly is passed from one side to the other and
positioned under the anorectum. A curved introducer needle is placed
through medial thigh incisions, around the ischiopubic ramus, and is
directed posteriorly into the ischiorectal fossa. After the needle is
passed through the ipsilateral buttock incision, the mesh is connected
to the needle and brought up through the medial thigh incisions.
Tension on the arms of the sling is then adjusted by gently elevating
the sling arms while the surgeon’s index finger is placed in the
rectum. The plastic sleeves are then removed from the sling. The post
anal incisions are vigorously irrigated and closed with delayed
absorbable suture.
Methodology: A retrospective, IRB-approved analysis designed to
assess the efficacy of TOPAS for the treatment of Fecal Incontinence
was performed. For the evaluation of fecal incontinence, patients
were asked to fill out intake questionnaires, bowel diaries and Fecal
Incontinence Quality of Life Questionnaires (FIQOL) pre-operatively
and post-operatively.
Outcome: Fecal incontinence diary data were available from 8
patients, although a baseline diary was not submitted by 1 of these
patients. The number of incontinent episodes and incontinent days
decreased after surgery. At 6 weeks post-op, 2 patients reported
complete continence and 1 additional patient reported a ⬎ 50%
decrease in incontinent episodes. One postoperative complication, a
wound infection with separation of the postanal incision and mesh
Abstracts
exposure, resulted in sling removal. FIQOL data indicates an
improvement in symptoms for all four categories addressed.
Disclosures: P.L. Rosenblatt, American Medical Systems, Grant/Research
Support; American Medical Systems, Consultant; Licensing agreement,
American Medical Systems.
Endoscopic Fibrin Sealant For the Treatment of Urogenital
Injury and Fistula
C. R. Rardin, D. L. Myers, K. J. Wohlrab, and R. Moore Alpert
Medical School at Brown University, Providence, RI
Clinical Problem: Urogenital injuries and fistulae can be distressing
problems with a wide variety of sequellae; traditional surgical
management carries significant risks of its own.
Surgical Solution: Endoscopic use of two-component fibrin sealant.
Methodology: cystoscopic application of fibrin sealant to the area of
injury is described and demonstrated.
Outcome: In one case of recurrent vesicovaginal fistula, and another
case of non-healing iatrogenic vesicovaginal injury, successful resolution is
demonstrated.
Disclosures: C.R. Rardin, None; D.L. Myers, None; K.J. Wohlrab,
None; R. Moore, None.
Posterior Vaginal Wall Support: How Does It Fail?
C. Lewicky-Gaupp, R. U. Margulies, D. E. Fenner, and J. O. DeLancey
University of Michigan Hospital, Ann Arbor, MI
Clinical Problem: Support failures of the posterior vaginal wall,
including rectocele and enterocele, are a distressing problem for many
women. The specific mechanisms of posterior vaginal wall failure
remain elusive. The objectives of this video are threefold. We plan to:
(1) review the posterior compartment anatomy, (2) describe three
proposed structural mechanisms of posterior wall failure including
failure of the perineal body, the levator ani muscles and the vaginal
portion of the uterosacral ligaments, and (3) show the relationship
between failure mechanisms and surgical repair.
Methodology: Using animation as well as conceptual anatomic
drawings, the video begins by showing the normal posterior
compartment anatomy. Normal anatomy is then compared to posterior
vaginal wall support failure, specifically in the areas noted above.
Individuals with posterior vaginal wall prolapse who have undergone
static and dynamic MRI are shown as examples for this video. The
video displays their clinical pelvic exams including Kegel and Valsalva
maneuvers. While these individuals may have some degree of failure
in multiple regions, each has a dominant site of failure which serves
as an exemplar of one of the proposed mechanisms. Their dynamic
(Valsalva and/or Kegel) and static MR images show the specific
location and nature of the anatomic defects responsible for their type
and extent of prolapse. Finally, we propose that, because each type of
failure is associated with a specific anatomic defect, various surgical
techniques can be employed to correct these defects. We present
examples of three surgical techniques including distal repair of the
perineal body, a more proximal repair of a gaping genital hiatus, and
lastly a four-wall sacrospinous ligament suspension to address the
most proximal site of failure.
259
Abstracts
Outcome: This video will demonstrate examples of three specific
mechanisms of posterior vaginal wall support failure (separation of the
perineal body, levator ani muscle failure, and failure of the vaginal
portion of the uterosacral ligaments) using both clinical and MRI
examples. As clinicians, we know that these three types of failure can
occur in varying combinations. The aim of this video, which focuses
on the unique structural elements of each of these three areas of
support, is to impart a better understanding of the basic structural
failures leading to posterior wall prolapse as well as some of the
surgical techniques that can be used to address these specific
structural failures.
We gratefully acknowledge the support of the Office for Research
on Women’s Health and NICHD’s SCOR on Sex and Gender Factors
Affecting Women’s Health (1 P50 HD44406).
Disclosures: C. Lewicky-Gaupp, None; R.U. Margulies, None; D.E.
Fenner, None; J.O. DeLancey, Johnson & Johnson, Consultant.
Posterior Wall Prolapse Repair; Apical Fascial Defects
P. A. Castillo*, M. Jean Michel*, L. M. Espaillat†, and G. W. Davila*
*Cleveland Clinic Florida, Weston, FL, †Temple University Hospital,
Philadelphia, PA
Clinical Problem: To illustrate how restoring integrity of the
endopelvic fascia in the posterior vaginal wall can resolve most posterior
compartment prolapse.
Surgical Solution: Rectocele repair represents a commonly performed
procedure by pelvic surgeons. A rectocele is a herniation of the posterior
vaginal wall resulting from a defect in the rectovaginal septum, not the
vagina or rectum. It can be caused by either a discrete tear in the septum
or by attenuation of these tissues. Rectovaginal defects vary considerably
and discrete tears can occur in any location or direction along the
rectovaginal septum. With careful surgical dissection defined tears can
often be found. Specifically, transverse apical fascial defects often times
may be the underlying cause for most posterior wall prolapse. Restoring
continuity of the endopelvic fascia from the vaginal apex to the perineal
body will restore anatomy and function as well as resolve symptoms
often associated with a rectocele.
Methodology: The posterior colporrhaphy and discrete fascial defect
repair may be combined. Following careful dissection of the vaginal
mucosa off of the closely adherent underlying rectovaginal fascia, an
apical fascial tear is identified. The detached fascial edge is
reapproximated to its apical attachment site at the cervical ring or
cardinal-uterosacral ligament complex with interrupted permanent
sutures thus restoring continuity of the endopelvic fascia. The fascia
overlying the levator ani muscles can then be plicated in the midline,
anterior to the rectovaginal fascia in an interrupted fashion using
delayed absorbable suture. A perineorrhaphy is then performed to
normalize the genital hiatus and provide vertical support to the lower
vagina. Minimal if any vaginal mucosa is then resected and closed in a
traditional fashion.
Outcome: Correction of the discrete fascial defect at the time of
posterior colporrhaphy re-establishes endopelvic fascial integrity from
apex to perineum, levator plate integrity, anterior rectal wall support,
normal vaginal caliber and length, and integrity of perineal body.
Disclosures: P.A. Castillo, None; M. Jean Michel, None; L.M.
Espaillat, None; G.W. Davila, AMS, Adamed, Synovis Astellas Watson
Zuidex Protein Polymer Technologies Duramed, Grant/Research
Support; AMS, Watson, Adamed, Consultant; Watson, AMS, Synovis,
USSurgical, Pfizer, Astellas, Adamed, Other.
260
Surgical Principles in Obstetric Vesicovaginal Fistula Repair
C. Chen*, R. Nardos&dagger, and A. Browning‡ *Cleveland Clinic,
Cleveland, OH, †Addis Ababa Fistula Hospital, Addis Ababa,
Ethiopia, ‡Barhirdar Hamlin Fistula Centre, Barhirdar, Ethiopia
Clinical Problem: Vesicovaginal fistulas from obstructed labor are a
health crisis of epidemic proportions in non-industrialized nations
with an estimated prevalence of 3.5 million. Fistulas that result from
obstructed labor are often complex with evidence of diffuse tissue
necrosis, which is very different from the fistulas encountered in
industrialized countries. The objective of our video is to demonstrate
basic surgical techniques in vaginal repair of circumferential
vesicovaginal fistulas that result from obstructed labor.
Surgical Solution: Vaginal repair of a circumferential vesicovaginal
fistula with placement of a pubococcygeus sling.
Methodology: For the vesicovaginal fistula repair, the vaginal
epithelium is dissected off the proximal urethra. Both ureteral orifices
are identified and ureteral stents placed. The bladder is mobilized
circumferentially by dissecting the posterior bladder and fistula edge
from the proximal anterior vaginal epithelium and anterior bladder
and fistula edge from the paravesical attachments and the underside of
the pubis. As the distal bladder defect is much larger than the
proximal urethra opening, the anterior portion of the distal bladder is
wrapped around the proximal urethra and sutures are placed at 12:00,
03:00 and 09:00. This will reconnect the anterior and lateral urethra
to the anterior bladder. The posterior urethra is reattached to the
posterior bladder with a purse-string suture. The remainder of the
poster bladder defect is reapproximated vertically. A dye test is
performed to check the integrity of the closure. The vaginal
epithelium is reapproximated over the repaired bladder. For the
pubococcygeus sling, the pubococcygeus muscle/ perineal membrane
complex under the pubic rami is detached proximally and sutured in
the midline under the mid-urethra.
Outcome: In a published series addressing the short term outcomes
of circumferential vesicovaginal fistula repairs, in 72 cases, 97% of
patients had successful repair with 2 patients experiencing wound
breakdowns requiring reoperations. The urinary retention rate was 8%
with an incontinence rate of 47%, mostly secondary to stress
provocations. In a published series addressing the short term outcome
after pubococcygeus slings, in 27 cases, the continence rate was 81%
with a retention rate of 15%.
Disclosures: C. Chen, None; R. Nardos, None; A. Browning, None.
Tips & Tricks Presentations
Presentation Number: Tip and Trick 1
Modification of the Anterior Prolift® Mesh for Reconstruction
of Anterior and Apical Vaginal Prolapse
J. A. Daucher*, M. Alperin†, R. E. Ellison†, L. A. Meyn†, and H. M.
Zyczynski† *Reston Hospital Center, McLean, VA, †Magee-Womens
Hospital / University of Pittsburgh School of Medicine, Pittsburgh,
PA
Objective: To describe a modification to the shape and anchoring
points of an anterior Prolift® mesh (Gynecare/Ethicon, Somerville, NJ)
that provides apical support in women with anterior and apical
prolapse who do not require posterior wall graft reinforcement.
Description: As much as 55% of the presentation of anterior vaginal
prolapse can be attributed to loss of apical support 关1兴. Concurrent
apical suspension during anterior vaginal prolapse repair is critical for
durable outcomes while maintaining vaginal length. Currently, the
three Prolift® systems do not provide anterior and apical support
without implanting posterior mesh. Total and posterior Prolift® kits
provide apical support with bilateral fixation to sacrospinous
ligaments. The proximal anchoring points of the anterior Prolift®
mesh are the arcus tendineous at the ischial spine. This lateral support
is insufficient for a prolapsing cervix or vaginal apex. We have
devised a modification to the anterior Prolift® mesh that provides
simultaneous anterior and apical support with a reduced mesh load in
the case of a well-supported posterior compartment.
Experience: Mesh modification starts with the for 5–6 cm incision of the
midline proximal tab of the anterior Prolift® mesh. A suture is then secured
to the end of each newly created mesh arm to extend its length. After
cystoscopy confirms the absence of injury to the bladder, the surgeon
removes the distal anterior cannulas and reuses them for the insertion
through each sacrospinous ligament via the transgluteal, infracoccyeal
approach typically employed with the posterior and total Prolift® kits. Newly
created mesh arms with attached sutures are then pulled through the
sacrospinous ligaments. The sutures are removed leaving the mesh arms
deep to the skin. The end result is a six point anchoring of the anterior
mesh. To determine the safety and early anatomic support of our
modification, we performed an IRB approved retrospective study.
Demographic and anatomic measures (Pelvic Organ Prolapse Quantification
(POPQ)) were recorded at baseline and 3 months as were peri-operative
complications.
Analysis: A total of 19 women with a mean age of 63 ⫾ 9 and BMI
of 27 ⫾ 4 kg/m2 underwent an anterior Prolift® with apical
modification. Subjects were predominantly postmenopausal (86%) and
Caucasian (100%). There were 2 trocar perforations of the bladder, no
cystotomies and no rectal injuries. No women had an EBL ⬎500 ml
and there were no infections. Two mesh exposures were recorded.
Preoperative and postoperative POP-Q measures were as follows: Ba:
pre ⴙ2.2 ⫾ 1.6, post ⴚ2.3 ⫾ 0.8, (p ⬍ 0.001); Bp: pre ⴚ1.7 ⫾ 1.2,
post ⴚ1.8 ⫾, 1.0 (p ⫽ 0.728); C: pre ⫺3.3 ⫾ 2.3, post ⴚ7.0 ⫾ 1.1 (p
⬍ 0.001), TVL: pre 8.8 ⫾ 1.2, post 8.3 ⫾ 1.4 (p ⫽ 0.37).
Conclusions: The proposed modification to the anterior Prolift®
mesh provides for apical support in women with an apical component
to their anterior predominant prolapse without additional posterior
mesh load.
Disclosures: J.A. Daucher, None; M. Alperin, None; R.E. Ellison,
None; L.A. Meyn, None; H.M. Zyczynski, Johnson & Johnson,
Nasal Speculum Retraction to Excise Urethral Mesh Erosion
Following A TVT
K. Strohbehn*, and B. C. Young† *Dartmouth-Hitchcock Medical
Center, Lebanon, NH, †Beth Israel, Boston, MA
Objective: To describe a technique to excise eroded mesh from the
urethra without compromising the integrity of the urethra wall,
utilizing a nasal speculum.
Description: A 46 year old woman was referred from an outside
hospital with continued problems of voiding dysfunction. She was
ultimately diagnosed with intraurethral mesh erosion two months
following a TVT procedure. Erosion of blue mesh in a mid-urethral
posterior location was visualized on pre- and intraoperative
cystourethroscopy. Following cystourethroscopy, a nasal speculum
was introduced into the urethral meatus to gently retract the distal
urethral walls. This facilitated excellent visualization of the mesh. The
mesh was grasped and traction applied to it. It was then trimmed just
Abstracts
deep to the mucosa on each side where it exited the urethra.
Urethrotomy was unnecessary.
Experience and Analysis: Traditional treatment of intraurethral
mesh has been described, with urethral wall incision in order to
remove the mesh followed by urethral closure. Others have described
urethroscopy with attempted mesh excision using cystoscopic
equipment. This approach proved difficult in one other case of
urethral mesh erosion seen by the senior author, due to the distance
of the instrumentation from the mesh with a poor fulcrum effect and
lack of good visualization. In this case, we describe the use of a nasal
speculum that assisted in visualization and excision of eroded mesh
from within the urethra, thereby keeping the urethra intact and
avoiding potential complications from urethral wall disruption. The
patient returned to normal voiding but did have recurrent stress
urinary incontinence.
Disclosures: K. Strohbehn, DuraMed, Grant/Research Support; B.C.
Young, None.
Surgical Reconstitution of Unilaterally Detached Puborectalis
Muscle
A. Allen*, M. Nihira†, and S. A. Shobeiri† *OUHSC, Tulsa, OK,
†OUHSC, Oklahoma City, OK
Objective: To present a novel surgical technique for repair of
symptomatic detachment of the puborectalis muscle.
Description: An avulsed puborectalis muscle is a known complication
of vaginal delivery. This problem is most often asymptomatic. To develop
a surgical approach, six fresh frozen pelves and 12 embalmed cadavers
were dissected via a paramedian three cm incision, two cm lateral to the
anococcygeal line into the ischioanal fossa. The following average
measurements were obtained in fresh frozen pelves: anococcygeal body
3.6 cm, puborectalis arm 4.4 cm. The inferior rectal nerve was
encountered in all specimens traveling lateral and caudad to the area of
dissection. Deep transverse perineal muscle was seen more anteriorly in
the same plane. Further dissection was performed to follow the
puborectalis insertion into the pubic bone. A 3 ⫻ 5 cm autologous fascia
lata graft was sutured to the levator raphe posteriorly and the ischiopubic
rami anteriorly as a conduit to stabilize the contralateral arm of the
puborectalis muscle.
Experience and Analysis: We present the case of a 32 year old
patient with dyspareunia and fecal incontinence since the vaginal birth of
her child two years prior to presentation. The diagnosis of an avulsed
right puborectalis was made by physical examination, and confirmed by
MRI and 3-D ultrasound. The patient underwent reconstitution of the
puborectalis muscle as described. Intraoperatively, no puborectalis
remnant was identified. To our knowledge, no published report of
surgical management of disrupted puborectalis muscle exists. The goals
of this procedure were to alleviate the patient’s complaints of
dyspareunia and fecal incontinence. The three month follow-up MRI
confirmed stabilization of the puborectalis sling and return of the anus to
a more anatomic position. At nine months, the patient was continent of
stool and did not experience dyspareunia. The best time to repair a torn
muscle would be immediately after the incident. In the case of the
puborectalis muscle, the injury goes unrecognized, and may remain
asymptomatic until later in life. We have described a novel technique that
will benefit patients with symptomatic puborectalis injury. The dilemma
remains on what to do with asymptomatic patients with known
puborectalis injury.
Disclosures: A. Allen, None; M. Nihira, None; S.A. Shobeiri, None.
261
Abstracts
Making Pelvic Floor Ultrasound Images Clearer; Top Ten
Instrumentation Tips for Improving Pelvic Floor Imaging
Quality
R. Hall, T. Omotosho, H. Abed, and R. Rogers University of New
Mexico, Albuquerque, NM
Objective: We present a clear demonstration of the top ten
instrumentation tools that will enhance pelvic floor imaging using
transperineal 2D and 3D diagnostic ultrasound.
Description: Diagnostic imaging of the pelvic floor musculature and
anal sphincter complex can be done using a wide variety of
ultrasound transducers. One cannot assume that the ultrasound system
obtains a high quality image by merely turning it on. Optimization of
the ultrasound instrumentation makes a marked difference in image
quality, but is operator dependent. The endovaginal transducer is the
most commonly available transducer for practitioners; therefore,
examples of all technique tips will be given using this mode. Using a
Philips IU22 ultrasound system, images of the anal sphincter complex
and pelvic floor will be altered by instrumentation options to compare
differences in focal zone(See Figure 1), gain, TGC, read zoom, write
zoom, sector width, mapping/post processing, color power angio,
chroma, and 3D manipulation. A definition of each of the top ten
“knobs” and comparative images of correct and incorrect use will be
provided.
Experience and Analysis: Refining instrumentation techniques
improves ultrasound imaging of the pelvic floor, and are simple
changes that are easy to incorporate into practice.
Disclosures: R. Hall, None; T. Omotosho, None; H. Abed, None; R.
Rogers, Pfizer, NIH, Grant/Research Support; Pfizer, Consultant; Pfizer,
Speaker’s Bureau.
Gynecologic Problems Following Abdominoperineal Resection
of the Anus and Rectum
M. B. Berger, R. U. Margulies, and D. E. Fenner University of
Objective: To describe the presenting gynecologic symptoms and
treatment options for women who have previously undergone
abdominoperineal resection of the anus and rectum for benign and
malignant conditions.
Methods: Since it was first described by Miles in 1908, the
abdominoperineal resection has been a standard treatment for low
rectal cancers and is also used as a surgical treatment for inflammatory
bowel disease. In women, in order to “close” the vacant pelvic cavity,
the levator ani muscles are plicated in the midline. Multiple studies
have demonstrated sexual dysfunction, decreased subjective measures
of body image, and decreased quality of life measures following
abdominoperineal resection. However, there is a paucity of literature
262
describing the specific gynecologic symptoms and management
following this type of surgical procedure. We have treated a number
of women following abdominoperineal resection and have identified a
cluster of gynecologic signs and symptoms, including a posterior
vaginal “shelf,” with steep posterior angulation of the vaginal apex
toward the sacrum, copious foul vaginal discharge, which is
frequently “trapped” at the apex of the vagina, and dyspareunia.
Results: We have evaluated four patients who presented with
copious vaginal (n ⫽ 3) discharge and dyspareunia (n ⫽ 2) following
abdominoperineal resection (3 for ulcerative colitis, 1 for anorectal
cancer). Median age was 52 (range 40 – 61). Median follow up time
was 2 months (range 1–12 months). All of these women were found
on exam to have steep posterior vaginal angulation and “shelf” likely
caused by levator ani muscle plication at the time of their colorectal
surgery. One was being followed for abnormal pap smears, and her
primary gynecologist was having difficulty accessing the cervix due to
the vaginal angle. We treated the two patients with dyspareunia
surgically with a midline levator ani muscle transection (relaxing
incision) and transverse pull down of the vaginal wall. Of those
treated surgically, one had complete resolution of her dyspareunia,
and the other is not sexually active because of partner issues but is
using a vaginal dilator painlessly. The other two patients have been
managed conservatively with vaginal clindamycin cream as well as
douching assisted by manual retraction of the vaginal “shelf” to allow
for drainage of secretions while showering. Of those treated
conservatively, one remains sexually active without dyspareunia, and
the other is not sexually active due to lack of a partner. Both have
noted a significant decrease in their vaginal discharge. In short-term
follow-up, both the conservative and surgical management strategies
have resulted in decreased vaginal discharge and increased patient
satisfaction.
Conclusions: Excessive levator plication in the setting of anorectal
resection may result in gynecologic complaints that can be effectively
managed conservatively, with vaginal clindamycin and douching, or
surgically with levator transaction and vaginal reconstruction.
Disclosures: M.B. Berger, None; R.U. Margulies, None; D.E. Fenner,
None.
Surgical Approach to Vaginal Ulcers in the Setting of Advanced
Pelvic Organ Prolapse
C. A. Brincat, R. U. Margulies, and J. O. DeLancey University of
Objective: When a vaginal ulcer is present on a large prolapse, a
decision must be made about delaying surgery until healing occurs
versus excising the ulcer at the time of operation. This report
concerns our operative technique and treatment outcomes with
excising unhealed but not infected ulcers in a cohort of women with
advanced pelvic organ prolapse at a Midwestern tertiary care facility.
Description of the Technique: Ulcers are first evaluated for gross
infection and atypical appearance suggesting malignancy. Infection is
treated if present and the ulcer is biopsied if it has an unusual
appearance. In this series all clean vaginal ulcers were excised at the
time of surgery. A full thickness circumscribing incision is made
through the epithelium and fascia at the junction between the
indurated tissue and the normal vaginal mucosa. This situation
occurred most often at the vaginal apex and the ulcer was included in
that portion of the vagina excised during 4-wall sacrospinous ligament
suspension. In the more severe cases, where mucosa is directly on the
peritoneum, the area is excised including the attached peritoneum,
using the knife to scrape the epithelium off of the fascia where no
cleavage plane can be dissected. Once excised, the tissue is sent for
histologic examination.
Experience and Analysis: We reviewed the surgical billing records of a
senior urogynecologic surgeon at our facility over a 10 year period
(1997–2007) and identified 1605 cases. We then reviewed the 692 operative
reports of transvaginal apical prolapse repairs, and included cases where the
word “vaginal ulcer” appeared in the operative findings. Twenty-five patients
with vaginal ulcers at the time of their prolapse repair were identified and
their postoperative medical records were reviewed. None of these patients
had postoperative wound infections or cuff dehiscence. None of the
pathology reports described malignancy in the specimen.
Conclusion: Excising vaginal ulcers at the time of surgical treatment
for pelvic organ prolapse is an acceptable alternative to delaying
surgery when infection is not present.
Abstracts
Disclosures: C.A. Brincat, None; R.U. Margulies, None; J.O.
DeLancey, Johnson & Johnson, Consultant.
Poster Presentations
Presentation Number: Poster 1
Clinical Outcome after Lefort Colpocleisis Combined with Two
Different Midurethral Slings in the Elderly Patients
S. S. Badalian, St. Joseph’s Hospital Health Center, SUNY Upstate
Medical University, Syracuse, NY
Category: Surgery SUI.
Objective: To compare the clinical outcome and the effectiveness of
Lefort colpocleisis combined with two different midurethral slings
(TVT-GYNECARE, and TOT-MONARC) for the treatment of complete
prolapse with occult stress urinary incontinence in elderly patients.
Methods: A retrospective chart review was performed from January
of 2002 to December of 2007 on 27 elderly women (mean age 81
years, range: 76 – 88 years) who underwent a Lefort colpocleisis
combined with midurethral sling procedure. All patients had multiple
medical co-morbidities. Of the patients, 82% had prior Gelhorn
pessaries for a few years, and 74% had a prior hysterectomy. Only one
surgeon performed all the procedures. All the procedures were
performed under spinal anesthesia.
Results: Fourteen patients had a Lefort colpocleisis with a TVT
procedure (mean age 80.7 years) and 13 patients had the Lefort with
a TOT procedure (mean age 81.1 years). There were no differences in
the mean blood loss and the mean hospital stay days. All the patients
were discharged home after 24 – 48 hours. The mean operating time
was 90 (⫾23) minutes for the TVT group and 76 (⫾12) minutes for
the TOT group (p ⬍ 0.05). There were no intraoperative or early
postoperative complications. Preoperative complications of urinary
retention, frequent urinary tract infections and intermittent urinary
flow were resolved in all patients. No stress urinary incontinence was
demonstrated after the surgery. De novo urge incontinence was seen
in two patients in the TVT group. There were no cases of erosion or
extrusion of the sling. All the patients were satisfied or extremely
satisfied after the repair and did not feel regret for the loss of sexual
function.
Conclusion: In our patient population, both the TVT and TOTMONARC combined with the Lefort colpocleisis appears to be an
effective treatment option for correcting a complete prolapse and
occult stress urinary incontinence in elderly patients who desire to
have an obliterative procedure and a quick recovery. We are in the
process of collecting long-term data to assess the objective and
subjective cure rates along with patient satisfaction rates after the
combined procedures. Considering the similar results of the
procedures, we favor the combination of Lefort colpocleisis with TOTMONARC because of its simpler technique of placement and shorter
operating time for elderly patients with multiple co-morbidities.
Disclosures: S.S. Badalian, Novartis, Algeran, P&G, AMS, Speaker’s
Bureau.
Is Burch or Mid-Urethral Sling Better With Abdominal Sacral
Colpopexy?
M. Patel*, D. O’Sullivan†, and P. Tulikangas* *University of
Connecticut, Hartford Hospital, Hartford, CT, †Hartford Hospital,
Department of Research Administration, Hartford, CT
263
Abstracts
Objective: To compare the post-operative rates of stress urinary
incontinence (SUI), urgency and additional treatment for either stress
or urge urinary incontinence after abdominal sacral colpopexy (ASC)
with and without a concomitant anti-incontinence procedure.
Methods: A cohort of women who had undergone ASC (n ⫽ 150)
either alone (27%) or with an anti-continence procedure (73%), were
analyzed to determine the rates of post-operative SUI and urinary
urgency symptoms. Review included demographics, preoperative
symptoms of urgency, SUI, standard questionnaires, pelvic organ
prolapse quantification exam, multichannel urodynamics (MUDS),
post-operative complaints of SUI, urgency and treatment for either
condition. Post-operative SUI, urgency and repeat treatment for SUI
was compared between subjects who had either Burch, midurethral
sling (tension-free vaginal tape 关TVT兴) or no anti-incontinence
procedure, stratified based on whether they had demonstrable
preoperative SUI, potential SUI or no SUI. Odds ratios (OR) and 95%
confidence intervals (CI) were generated with SPSS v. 14, with p ⬍
0.05 deemed significant.
Results: A total of 110 women had SUI preoperatively (81 with
genuine SUI and 29 with potential SUI). Median length of follow up
was 8 months (range 1– 61 months). Eighty-six subjects underwent a
Burch, 24 had a TVT and 40 had no anti-incontinence procedure at
the time of ASC. Post-operatively, 13% (20/150) of all subjects had
SUI, 20% (4/20) with potential SUI, 45% (9/20) with genuine SUI and
35% (7/20) without preoperative SUI. Subjects with preoperative SUI
who had a Burch were more likely to have post-operative SUI than
those who had a TVT (13 versus 0, p ⫽ 0.007). Of the subjects with
post-operative SUI, 35% (7/20) had another operation. Among those
who underwent a subsequent operation for SUI, the initial operation
was a Burch in 85% (6/7) of the cases and 15% (1/7) had no prior
anti-incontinence procedure. Pre-operatively, complaints of urinary
urgency or detrusor overactivity on MUDS were noted in 56%
(84/150) of subjects. Post-operatively 24% (36/150) of subjects had
persistent symptoms of urinary urgency. Post-operative de novo
urgency was seen in 18% (27/150) of patients. Subjects were more
likely to have post-operative urgency if they had pre-operative SUI 关OR
3.90 (95% CI, 1.63–9.29)兴. Preoperative urgency was not associated
with higher rates of post-operative urgency, regardless of type of antiincontinence procedure.
Conclusions: Both Burch and TVT procedures improve SUI
symptoms in patients undergoing ASC. Midurethral slings performed
with ASC have lower rates of post-operative SUI. Urge symptoms are
common in women both before and after surgery. Post-operative
urinary urgency symptoms are not worsened by either Burch or TVT.
Disclosures: M. Patel, None; D. O’Sullivan, None; P. Tulikangas,
None.
Factors Related with Failure and Complication after Retropubic
Tension-Free Vaginal Tape and Transobturator Tension-Free
Vaginal Tape
Y. Kim, H. Ahn, Y. Jeon, B. Jee, and C. Suh Department of Ob&Gyn,
Seoul National University Bundang Hospital, Seongnam, Republic
Of Korea
Objective: The aim of the present study was to evaluate the factors
predicting failure and complications in the surgical management of
stress urinary incontinence.
264
Methods: This is a retrospective study of 76 patients with stress
urinary incontinence who had received retropubic tension-free vaginal
tape (TVT) or transobturator tension-free vaginal tape (TOT) from
January 2005 to December 2006. Medical records were reviewed and
clinical characteristics were compared according to operation
procedures.
Results: Twenty-four patients underwent TVT and 52 patients
underwent TOT. There was no significant difference in the patients’
demographics and preoperative urodynamic study between the two
groups. Mean operative time was significantly shorter in the TOT
group (34 min and 17 min, p ⬍ 0.05). The subjective cure rates (very
satisfied, satisfied) were 91.7% in TVT and 98.1% in TOT. The age of 3
patients (1 TVT and 2 TOT) who showed incontinence after
procedure ranged from 48 to 52 and all of them were
perimenopausal. In the TOT group, 2 patients suffered from leg pain
more than 1 week and 1 patient more than 4 weeks and there was no
such complication in TVT group. Two cases of vaginal erosion were
developed only in patients received TOT, and they had mild to
moderate degree of cystocele. De novo urgency (frequency and
urgency) was more frequent in the TVT group than in the TOT group
(p ⬍ 0.05, Fisher’s Exact test). In addition, 3 patients (1 TVT and 2
TOT) presented with voiding difficulty that was treated with an alpha1 adrenergic blocker; their ages were 40, 41, and 42, respectively.
Conclusions: TVT and TOT are both effective and safe surgical
managements for stress urinary incontinence. Perimenopausal women
could be considered as having a risk factor of surgical failure after
TVT or TOT. Physicians should be aware of possible leg pain after the
TOT procedure. In a patient with cytocele who is scheduled for TOT,
helical passer should be introduced carefully being cautious of
possible vaginal erosion or perforation at lateral angle of vagina during
the procedure.
Disclosures: Y. Kim, None; H. Ahn, None; Y. Jeon, None; B. Jee,
None; C. Suh, None.
Outcomes of Mid-Urethral Synthetic Slings When Performed by
Urogynecologists, Urologists, and General Gynecologists
T. V. Deniseiko Sanses*, C. L. Grimes†, K. A. Hoskey*, M. L. Russo†,
C. Melick‡, J. Blomquist*, and M. Ellerkmann* *Greater Baltimore
Medical Center, Baltimore, MD, †The Johns Hopkins Hospital,
Baltimore, MD, ‡Johns Hopkins Bloomberg School of Public Health,
Baltimore, MD
Objective: To describe the patient demographics, perioperative
outcomes, surgeon’s experience and preferences in performing synthetic
midurethral sling procedures at a private community hospital setting.
Methods: This is a retrospective cohort study of mid-urethral
synthetic slings performed at a community hospital between 2001 and
2007. Non-synthetic slings and slings performed with concurrent
surgeries were excluded from analysis. All variables were stratified by
surgeon’s specialty: urogynecology (URO-GYN), urology (URO), and
general gynecology (GYN). Nominal variables were assessed with
Pearson ␹2 test. ANOVA and Scheffe multiple comparison tests were
used to compare continuous variables. The Pearson product-moment
correlation coefficient was used to examine the relationship between
years of surgeon’s experience and sling operating room (OR) time.
Results: 639 out of 1324 mid-urethral slings were analyzed. 17
different types of synthetic sling procedures were performed. TVT
(Gynecare) was the most prevalent type: 279 cases or 43.7% of all
procedures.
Compared to URO-GYN and URO, GYN less frequently operated on
patients with a history of voiding dysfunction and/or prior
incontinence surgery (19.1% vs 20.1% vs 12.3%, p ⫽ 0.041 and 15.6%
vs 15.8% vs 5.8%, p ⬍ 0.001, respectively).
Mean sling OR time in minutes was 38.9 ⫾ 9.1 for URO-GYN, 34.9
⫾ 13.4 for URO, and 33.4 ⫾ 20 for GYN, p ⫽ 0.003. Estimated blood
loss and intra-operative complications (bladder, urethral, vaginal
perforations) were similar among all specialties. In the postoperative
period, readmission to hospital was more common by URO-GYN 4.3%
than by URO 0.5% and GYN 1.0%, p ⫽ 0.012. There was no difference
in return to OR cases: 4.9% for URO-GYN, 2.2% for URO, and 4.1% for
GYN, p ⫽ 0.369. The tape release/removal frequency was similar 1.2%
URO-GYN, 0.5% URO, and 2.4% GYN, p ⫽ 0.265.
URO-GYN was most likely to have a fellow present in 75.9% vs
2.7% vs 0.3% of cases (p ⬍ 0.001). GYN attendings were in practice
longer than URO-GYN and URO (19.7 ⫾ 8.6 vs 13.2 ⫾ 6.8 vs 10.5 ⫾
4.9 years of experience; p ⬍ 0.001). A slight inverse correlation
(r ⫽ –.164, p ⬍ 0.001) was found between surgeon’s years of
experience and sling OR time.
URO-GYN utilized the retropubic approach in 82.7% of cases vs
URO 16.3% vs GYN 42%, p ⬍ 0.001; URO preferred the suprapubic
approach in 44.6% vs URO-GYN 3% vs GYN 0%, p ⬍ 0.001; and GYN
used the transobturator approach in 53.6% vs URO-GYN 14.8% vs
URO 38.6%, p ⬍ 0.001.
Conclusions: Many types of minimally invasive synthetic mid-urethral
slings are available. Although population demographic and surgical
approaches vary, all three surgical specialties (urogynecologists, urologists,
and general gynecologists) have similar major perioperative outcomes.
Disclosures: T.V. Deniseiko Sanses, None; C.L. Grimes, None; K.A.
Hoskey, None; M.L. Russo, None; C. Melick, None; J. Blomquist,
None; M. Ellerkmann, None.
Preliminary Results of Peri-Operative and 3-Month Outcomes
from a World-Wide Observational Registry of Tension-Free
Vaginal Tapes in Women With Stress Urinary Incontinence
S. Khandwala*, V. Lucente†, R. Kalbfleisch‡, K. Lee§, D. Tincello¶,
T. Botha储, G. Buchsbaum**, and D. Grier††
*Advanced
Urogynecology of Michgan, Dearborn, MI, †The Institute for Female
Pelvic Medicine & Reconstructive Surgery, Allentown, PA, ‡McMaster
University, Hamilton, ON, Canada, §Samsung Medical Centre, Seoul,
Republic of Korea, ¶Leicester General Hospital, Leicester, United
Kingdom, 㛳Arwyp Medical Centre, Arwyp, South Africa, **University
of Rochester, Rochester, NY, ††Sound Urological Associates,
Edmonds, WA
Objective: To obtain long-term clinical and patient reported
outcomes on the use of GYNECARE TVT*, TVT*-Obturator and TVTSECUR* Systems in a worldwide prospective registry.
Methods: 563 women from 24 sites in 7 countries, with confirmed SUI ⫾
mixed incontinence, have been enrolled under IRB guidelines. Assessments
are done at baseline, peri-operatively, and at up to 3, 6 & 12 months and
then annually to 5 years. Peri-operative data are collected. Effectiveness
evaluations include objective assessment by standing stress test at 12 months,
subjective assessment using the Incontinence Quality of Life instrument (IQOL). Complications are collected.
Results: 352 (62.5%) women have been TVT SECUR patients; 90
(16.0%) TVT-O and 121 (21.5%) TVT. In TVT SECUR patients,
“Hammock” placement was used in 247 women (70.2%), and “U”
placement in 105 women (29.8%).
Abstracts
Demographics and medical history of patients in the 3 groups
appeared to be well balanced for age, weight, menopausal status, and
previous gynecological surgeries. There were similar proportions of
SUI (66.8%, 65.3%) to mixed incontinence (33.2%, 34.7%) in TVT
SECUR and TVT groups, respectively. For TVT-O, the proportion was
55.6% with SUI and 44.4% with mixed.
The proportion of patients with concurrent surgery was higher in
the TVT-O group (44.4%) compared to TVT SECUR (17.9%) and TVT
(21.5%). Here we report peri operative data excluding patients with
concurrent surgeries. Median surgical duration was 15.5, 27 and 22
minutes for TVT SECUR, TVT and TVT-O, respectively. Use of local
anaesthesia with sedation was higher in TVT SECUR group (73.5%)
compared to 41.8% TVT and 45.5% TVT-O. Discharge from hospital on
the day of surgery occurred in 85.5% TVT SECUR patients compared
with 74.2% for TVT and 72.0% for TVT-O. Normal voiding at discharge
was reported in 92.4% for TVT SECUR, 89.0% TVT and 96.0% TVT-O.
Improvements in I-QOL mean changes from baseline were reported in
all 3 groups. The proportion of patients with improvement greater
than the minimal clinically important difference of 6.3 points at the 3
month visit were 86.3% TVT SECUR, 85.7% TVT-O and 90.0% TVT.
Complications included: 1 bladder perforation (0.8%) during a TVT
procedure; 1 vaginal laceration during a TVT SECUR procedure
(0.3%); bleeding in excess of 200 ml was reported in 1 (0.3%) TVT
SECUR patient; mesh exposure in 4 TVT SECUR (1.1%) and 3 TVT
patients (2.5%); voiding dysfunction in 3 TVT SECUR (0.9%) and 1
TVT patient (0.8%); haematoma in 3 TVT SECUR (0.9%) and 1 TVT-O
(1.1%); de novo urgency in 2 (0.6%) TVT SECUR patients; worsening
urge incontinence in 1 (0.8%) TVT patient.
Conclusions: These early results suggest that TVT SECUR is well
tolerated and safe to use. Follow up continues to assess the long-term
effectiveness of this novel single-incision sling.
Dislcosures: S. Khandwala, Ethicon, Novartis, Astellas, Consultant; V.
Lucente, Ethicon, Pfizer, Novartis, Astellas, Indevus, Bard, Consultant;
R. Kalbfleisch, None; K. Lee, None; D. Tincello, Ethicon, Eli Lilly,
Pfizer, Consultant; T. Botha, None; G. Buchsbaum, Ethicon,
Consultant; D. Grier, None.
Comparison of Surgical Outcome of TVT and TOT for SUI
with POP
S. Bai, H. Yang, H. Jung, M. Jeon, and S. Kim Department of
Obstetrics and Gynecology, Seoul, Republic of Korea
Objectives: To compare tension-free vaginal tape and transobturator
tape for surgical treatment of stress urinary incontinence associated
with pelvic organ prolapse for postoperative complications and
success rate.
Methods: Two hundred ten women who underwent surgery for pelvic
organ prolapse (stage ⱖ II) and tension-free vaginal tape or transobturator
tape for stress urinary incontinence were included in this study from March
2000 to May 2006 at Division of Female Pelvic Medicine and Reconstructive
Surgery, Yonsei University Health System in Seoul. The patients were divided
into two groups; 145 patients underwent tension-free vaginal tape and 133
patients underwent transobturator tape. Patients were examined in a supine
and a 45° upright position using the Pelvic Organ Prolapse-Quantification
system. Postoperative complications such as hemoglobin loss after surgery,
hematoma, bladder and bowel injury, mesh erosion, urinary retention, de
novo urgency, urinary tract infection were analyzed. Cure of stress urinary
incontinence was defined as an absent subjective complaint of leakage and
absent objective leakage on a cough stress test. This study was approved by
265
Abstracts
the Institutional Review Board of Yonsei University Health System Center.
The Student’s t-test and chi-square test were used for statistical analysis by
using SPSS, version 12.0 (SPSS Inc., Chicago, IL, U.S.A.). p ⬍ 0.05 was
determined to be significant.
Results: All patients were evaluated at the 12-month follow-up. The
characteristics of patients showed no significant difference between
the two groups. Postoperative complications were significantly less
common after the transobturator tape than tension-free vaginal tape.
(hemoglobin loss after surgery; tension-free vaginal tape (2.9 ⫾ 0.93
g/dL), transobturator tape (1.5 ⫾ 0.77 g/dL), p ⫽ 0.04, urinary
retention; tension-free vaginal tape (35.17%), transobturator tape
(21.05%), p ⫽ 0.0002, urinary tract infection; tension-free vaginal tape
(11.72%), transobturator tape (3.75%), p ⫽ 0.02) The groups did not
differ significantly in cure rates.
Conclusions: All techniques appear to be equally effective in the
surgical treatment of stress urinary incontinence associated with
pelvic organ prolapse. However, transobturator tape seems to be a
safer procedure in postoperative complications.
Disclosures: S. Bai, None; H. Yang, None; H. Jung, None; M. Jeon,
None; S. Kim, None.
Foreign Body Reaction in Vaginally Eroded and Non Eroded
Polypropylene Tension Free Sub-Urethral Tapes in the Human
Female: A Case Series
T. Kavvadias*, D. Kaemmer†, U. Klinge†, S. Kuschel*, and B.
Schuessler* *Cantonal Hospital of Lucerne, Lucerne, Switzerland,
†University Hospital Aachen, Aachen, Germany
Objective: The aim of this study was to establish the pattern of tissue
reaction induced by macroporous polypropylene mesh (MPPM) at the
vaginal wall and to compare this pattern in eroded and non eroded material.
Methods: Ten women (mean age: 57 years, min. 43 max. 73) who
were primarily treated for SUI with sub-urethral tapes (7 TOT-Safyre, 2
TVTs and 1 TOT-Monarc), were seen in our outpatient clinic between
May 2004 and December 2006 with the following diagnoses: tapeerosion in five patients; voiding disorders with residual urine volume
in three patients; dislocation of the tape with recurrent SUI in two
patients. In all patients the tapes were removed. Mean time between
surgical treatment and revision was 20 months (min. 1 max. 30).
Explanted tissue and tape material was stained with 1%
Hematoxylin/Eosin solution and foreign body reaction was tested by
immunohistochemistry aiming at accumulation of macrophages (CD68), expression of matrix metalloproteinase (MMP) 2 and 13, cellular
proliferation (Ki-67) and apoptosis (TUNEL) using a standard avidinbiotin complex and counterstaining with diaminobenzidine. Two
investigators, blinded to the clinical data, scored the findings with a
visual semi-quantitative scoring system; discrepancies were resolved
under discussion. The collagen I/III quotient was also evaluated using
cross-polarization microscopy after staining in picrosirius solution.
Results: The inflammatory reaction consisted of fibrotic ingrowth
between the pores following the length of the tape; eight out of ten
explanted tapes were ‘rolled up’. The collagen I/III quotient was 7,05.
Conclusions: Microscopic findings resemble results found in
abdominal wall surgery and meshes explanted from animal models.
The collagen I/III quotient was typical of fibrotic tissue. There were
no major differences between the five eroded and the five non eroded
tapes, indicating that the origin of erosion is not based on a different
pattern of tissue reaction in the individual patient. Limitation of this
266
study is the small sample size. However this is to our knowledge the
first study which examines tissue reaction of the vaginal wall initiated
by explanted MPPM in the human female. Although the results are
derived from tension-free vaginal tapes, in which erosion is rare and
easy to control, future focus of this study may be in prolapse meshes,
in which erosion of MPPM is a major problem, not yet resolved.
Disclosures: T. Kavvadias, None; D. Kaemmer, None; U. Klinge,
None; S. Kuschel, None; B. Schuessler, None.
Impact of Body Mass Index on Outcome Of Transobturator
Tape For The Treatment Of Stress Urinary Incontinence
P. A. Castillo, V. C. Aguilar, and G. Davila Cleveland Clinic Florida,
Weston, FL
Objective: To identify the impact of body mass index (BMI) on the
efficacy of transobturator slings for stress urinary incontinence in
women.
Methods: 442 patients who underwent Monarc (AMS) trans-obturator
tape for SUI at a tertiary care center. Patients with a minimum of 6
months postoperative follow-up were analyzed retrospectively.
Postoperative outcomes among obese women, defined as BMI ⬎27, were
compared to non-obese women (BMI ⬍ 27). Selection criteria for
patients with stress urinary incontinence included positive cough stress
test during filling cystometry, positive valsalva leak point pressure ⬎60
cm H20 and maximal urethral closure pressure ⬎20 cm H2O. Failure was
defined as report of any leakage events, any pad usage, a positive empty
supine stress test (ESST) or patient self assessment other than cured or
greatly improved at last post-operative visit.
Results: A total of 442 patients underwent a Monarc TOT procedure
from March 2003 to Feb 2008. Records of 179 patients with a
minimum of 6 months follow-up data were analyzed. Outcomes from
63 (35.2%) patients in the obese group were compared to 116 (64.8%)
patients in the non-obese group.
Conclusion: When correcting for disparity of group size, there was
no significant difference in failure rate between groups. Preoperative
obesity does not appear to be a risk factor for failure of transobturator
sling.
Disclosures: P.A. Castillo, None; V.C. Aguilar, None; G. Davila, AMS,
Adamed, Synovis Astellas Watson Zuidex Protein Polymer Technologies
Duramed, Grant/Research Support; AMS, Watson, Adamed, Consultant;
Talks/honorarium:Watson, AMS, Synovis, USSurgical, Pfizer, Astellas,
Adamed, Other
TABLE.
OBESE
(n ⴝ 63)
Failure
Fail
Rate
Self assess
Leak
Pads
ESST
16
19
14
6
25.40%
30.20%
22.20%
9.50%
NON-OBESE
(n ⴝ 116)
Failure
Fail
Rate
29
23
29
3
25%
19.80%
25%
2.60%
p Value
0.545
0.141
0.718
0.068
Body Mass Index as a Risk Factor for Cystotomy During MidUrethral Sling Placement
G. C. Dunivan, A. Connolly, M. L. Jannelli, E. C. Wells, and E. J.
Geller University of Noth Carolina, Chapel Hill, Chapel Hill, NC
Objective: To determine if body mass index (BMI) is a risk factor for
cystotomy in women undergoing mid-urethral sling for stress urinary
incontinence via the suprapubic approach.
Methods: After IRB approval, a retrospective chart review was
performed at an academic institution for all women undergoing a midurethral sling for stress urinary incontinence between June 2005 and
October 2007 by the division of Urogynecology/Reconstructive Pelvic
Surgery. All patients had a system placed which utilizes a suprapubic
approach. Data collected included demographics, BMI, history of prior
surgeries and preoperative POP-Q through electronic and paper
medical records. There were no exclusions for clinical history, such as
presence of mixed incontinence or prior pelvic surgery, nor for
concomitant surgeries. The primary outcome was cystotomy at the
time of sling placement. Data were analyzed with SPSS 15.0 (SPSS
Inc., Chicago, IL). Student’s t-test, Chi-square, Wilcoxon rank sum and
logistic regression were performed.
Results: 198 women were identified through the operating room
database: 69 women with a BMI ⱖ 30 kg/m2 and 129 women with a
BMI ⬍ 30 kg/m2. Demographics were similar except for prior
hysterectomy (58.0% vs 38.0%, p ⫽ 0.007) and preoperative C point
(⫺6.0 vs ⫺5.0, p ⫽ 0.011), in the BMI ⱖ 30 kg/m2 group versus the
BMI ⬍ 30 kg/m2 group. The overall cystotomy rate was 10.6%. The
cystotomy rate was lower in the BMI ⱖ 30 kg/m2 group with 3
perforations (4.3%) versus 18 perforations (14.0%) in the BMI ⬍ 30
kg/m2 group (p ⫽ 0.04). In a logistic regression model controlling for
BMI, age, race, prior anti-incontinence surgery, prior paravaginal
repair, prior hysterectomy and prior cesarean delivery, a BMI ⬍ 30
kg/m2 retained its association with an increased risk of cystotomy
(OR ⫽ 4.7, 95% CI 1.2–18.5) as did prior anti-incontinence surgery
(OR ⫽ 3.6, 95% CI 1.1–13.3).
Conclusions: Women with a BMI ⬍ 30 kg/m2 and those with a
history of anti-incontinence surgery are at a higher risk of cystotomy
during the placement of a mid-urethral sling utilizing the suprapubic
approach. These data add to the existing literature which predominately
reports on the transvaginal route and may aid the clinician in counseling
patients on this minimally invasive procedure.
Disclosures: G.C. Dunivan, None; A. Connolly, None; M.L. Jannelli,
None; E.C. Wells, None; E.J. Geller, None.
Intra-Operative Complications of Mid-Urethral Slings in the
Obese and Non-Obese
J. L. Woelk, C. S. Claydon, P. Brezina, S. M. Atkinson, Jr., and C.
Hodson East Carolina University, Brody School of Medicine,
Greenville, NC
Objective: To determine the effect of obesity on intra-operative
complication rates during mid-urethral sling procedures.
Materials and Methods: After IRB approval, pre-operative, operative,
and anesthesia records were reviewed on all mid-urethral sling
procedures performed at our institution between January 2001 and April
Abstracts
2007. Operative notes and anesthesia records were reviewed for body
mass index in kg/m2 (BMI), cystotomy, bowel injury, ureteral injury,
estimated blood loss (EBL), retropubic hematoma, operative time (ORT),
concurrent procedures, and product used. Obesity was defined as BMI ⱖ
30. Data were divided into those with BMI ⱖ 30 and ⬍30. All cases
without cystoscopy were excluded for intra-operative injury rate
calculation. Intra-operative injury was determined by cystoscopy at time
of procedure and repeat operation within one year. EBL and ORT were
calculated from cases limited to mid-urethral sling alone. The data were
subdivided into two groups consisting of those receiving a trans-obturator
(TO) and those receiving a retropubic (RP) approach. NCSS system
software (Kaysville, Utah) was used for statistical analysis. Means were
compared using the Neuman-Keuls method for one-way analysis of
variance with significance defined as p ⬍ 0.05.
Results: A total of 675 mid-urethral sling procedures were identified.
All groups were similar in terms of age, race, and parity. Cystoscopy
was not performed in 138 cases, leaving 537 for injury analysis.
Additional procedures were performed in 394 cases leaving 281 for
EBL and operative time analysis. Difference in cystotomy rate between
BMI ⱖ 30 and ⬍30 of 1.6% and 4.8% (p ⫽ 0.044) respectively, was
statistically significant. Relative risk was 1.37 关95% CI 0.96 –1.57兴. No
bowel or ureteral injuries were identified. One retropubic hematoma
occurred requiring re-operation in the BMI ⬍ 30 group. Mean EBL
was 53.0cc and 54.0cc and operative time was 65.2 minutes and 68.4
minutes for BMI ⱖ 30 and ⬍30 respectively. Neither difference was
statistically significant. There was no significant difference between
the BMI ⱖ 30 and BMI⬍30 in the RP and TO sub-group analysis in
regards to intra-operative injury, ORT, and EBL. In the TO group, no
cystotomies occurred in those with BMI ⱖ 30 and two occurred in
those with BMI ⬍30 (3.13%). Mean EBL for these two groups were
38.8cc and 45.4cc respectively. Mean ORT was 46.1 minutes and 49.8
minutes. There were no injuries in the RP group with BMI ⱖ 30 and
there were 14 cystotomies (5.4%) and one retropubic hematoma
(0.24%) with BMI ⬍30. Mean EBL was 69.2cc and 59.6cc respectively
and mean operative time was 72.0 minutes and 71.3 minutes in this
group.
Conclusion: BMI ⱖ 30 does not affect EBL or ORT and is associated
with decreased risk of cystotomy in patients undergoing mid-urethral
sling procedures.
Disclosures: J.L. Woelk, None; C.S. Claydon, GlaxoSmithKline,
Speaker’s Bureau; P. Brezina, None; S.M. Atkinson, Jr., Gynecare,
Consultant; C. Hodson, None.
Early Versus Late Sling Lysis Results in Greater Improvement in
Voiding Symptoms
M. M. South,* J. M. Wu,* G. D. Webster,† A. C. Weidner,* J. J.
Roelands,* and C. L. Amundsen* *Duke University Urogynecology
and Pelvic Reconstructive Surgery, Durham, NC, †Duke University
Urology, Durham, NC
Objective: Voiding dysfunction occurs anywhere from 5% to 20%
after anti-incontinence procedures. The symptoms include urinary
retention and obstructive and irritative voiding symptoms. The goal of
this study was to determine if the time from sling placement to
midline sling lysis affected overall improvement in patient symptoms.
Methods: After IRB approval, we conducted a retrospective cohort
analysis of 112 subjects undergoing midline sling lysis from January
1997 through September 2007. The inclusion criteria were subjects
267
Abstracts
with a vaginal midline sling lysis for irritative and/or obstructive
symptoms following a prior pubovaginal or midurethral sling. We
excluded any subject with sling erosion without voiding symptoms
and those who underwent a repeat sling at the time of lysis. We
compared subjects who had an early sling lysis (⬍1 year from sling to
lysis) to a late sling lysis (⬎1 year). The primary outcome was based
on the subject’s report of overall improvement in symptoms. We
abstracted data on demographics, presenting symptoms, physical
examination findings, date of anti-incontinence procedure, date of
midline sling lysis, and post-operative symptoms. Statistical analysis
consisted of Student’s t-test, chi-square, Fisher’s exact test and
multivariate logistic regression.
Results: Of 112 subjects, 74 (66%) had an early sling lysis and 38
(34%) had a late sling lysis. These two groups were similar in age,
menopausal status, presence of preoperative irritative and obstructive
symptoms, anterior colporrhaphy at the time of lysis and presence of
an eroded sling. The early lysis group had a higher percentage of
midurethral slings (36% vs. 8%, p ⫽ .001), a lower rate of preoperative complete retention (70% vs. 89%, p ⫽ .001), and a lower
rate of prior urethrolysis (16% vs. 45%, p ⫽ .003). No significant
difference in follow-up time was found between early lysis compared
to late lysis (49 months vs. 43 months, p ⫽ .729). 10 (8.9%) subjects
developed recurrent stress urinary incontinence after sling lysis which
was independent of time to lysis. 94 (84%) subjects had improvement
in their voiding dysfunction symptoms after midline sling lysis. Overall
improvement occurred more often in the early sling lysis group
compared to the late sling lysis group (91% vs. 71%, p ⫽ 0.01). This
finding retained significance in a multivariate logistic regression model
that included age, prior urethrolysis, pre-operative complete retention
and type of sling (OR 3.9, 95% CI 1.4 –11.1).
Conclusions: Based on this large cohort, we conclude that patients
will benefit from earlier (within one year) midline sling lysis for
voiding symptoms after a pubovaginal or midurethral sling procedure.
The development of recurrent stress urinary incontinence after
midline sling lysis is low and independent of time to lysis.
Disclosures: M.M. South, None; J.M. Wu, None; G.D. Webster,
None; A.C. Weidner, None; J.J. Roelands, None; C.L. Amundsen,
None.
Vaginal Sling for Stress Urinary Incontinence Under Local
Anesthetic in the Office Setting
M. P. Woods Bellevue Obstetrics and Gynecology Associates, PC,
Bellevue, NE
Objective: To assess feasibility of in office placement of a new
vaginal sling procedure under local anesthetic, including patient
comfort using a visual analog scale, resource utilization, and patient
satisfaction. Secondary assessment on the patient’s life using UDI- 6
preoperatively and at 3 months postoperatively was also performed.
Methods: 20 patients found on multichannel urodynamics to have
genuine stress incontinence were recruited for an IRB approved study
to assess tolerability and short term efficacy of TVT-Secur in the office
setting. All procedures were placed in the “hammock” fashion, a
standardized protocol for local anesthetic infiltration without sedation
was utilized, all patients had intraoperative cystoscopy performed and
received Ciprofloxin 500 mg by mouth 1 hour prior to procedure. A
visual analog scale (1–10) was utilized on all patients at the time of
local anesthetic injection, placement of device, over all procedure,
268
and at 1,4 and 8 hours postoperatively. Estimated blood loss, total
office time, and return to normal activities were recorded. UDI-6 was
filled out by patients preoperatively and collected at three months
postoperatively.
Results: VAS for the various aspects of the procedure : infiltration of
local anesthetic(mean ⫽ 0.8, range ⫽ 1– 4), incision (mean ⫽ 0.05,
range ⫽ 0 –1), dissection (mean ⫽ 0.1, range ⫽ 0 –1), Device placement
(mean ⫽ 1.9, range ⫽ 1– 8), overall (1.55, range ⫽ 1–3)., 1 hour
(mean ⫽ 1.9, range ⫽ 0 – 8), 4 hour (mean ⫽ 2.8, range ⫽ 0 –9), 8 hour
(mean ⫽ 2.5, range ⫽ 0 – 8). Return to normal activities (mean ⫽ 3.64
days, range ⫽ 1–13 days. EBL (mean ⫽ 18.6cc’s, range ⫽ 10 – 40cc’s).
Total Office Time (mean⫽52.95 minutes, range ⫽ 27–90 minutes).Return
to normal activities (mean ⫽ 3.64 days, range ⫽ 0 –13 days). UDI-6 results
are pending at this time and will be available at time of presentation.
Conclusions: It appears that single incision vaginal sling (TVT-Secur)
is well tolerated in the office setting with the use of local anesthetic
only. Long term results for this new technology are not yet available
and we are unable to determine if there is a change in efficacy at
different sites of service and this warrants further study.
Disclosures: M.P. Woods, Ethicon Women’s Health and Urology,
Grant/Research Support; Ethicon Women’s Health and Urology,
Consultant.
Efficacy and Safety of Secur Tension Free Vaginal Tape 关Tvt兴
Surgery in Stress Urinary Incontinence— a Short Term FollowUp Study
H. Yasmin, and M. L. Mokrzycki Saint Peters University Hospital,
New Brunswick, NJ
Objective: SECUR TVT system is a new minimally invasive treatment
for female urinary incontinence. The objective was to establish the
safety and efficacy of Secur TVT.
Methods: The Secur TVT features a small compact design that does
not require exit incisions and uses the prolene polypropylene mesh.
The mesh tape is inserted through the vagina and positioned without
tension under the midurethra, creating the supportive sling. The study
was done at Obstetrics & Gynecology Department, Saint Peters
University Hospital, Drexel University, NJ, USA. A group of 60 patients
with Stress urinary Incontinence 关SUI兴, i.e pure SUI in 57/60 women ;
3/60 women with mixed urinary incontinence from October 2006December 2007 were recruited to undergo SECUR TVT operation.
The primary outcome was bladder perforation and secondary
outcomes were cure rate of SUI symptoms, blood loss, voiding
difficulty, and de-novo urgency. Preoperative evaluation consisted of
complete clinical examination with urodynamic assessment.
Results: The mean age was 60years 关range 34 – 88兴, the median parity
was 2.3关1– 4兴 and the mean duration of urinary incontinence
symptoms was 8weeks. The average BMI in this group of women was
27.1 关range17.5– 43.8兴. The mean surgery time was 45 mins and mean
estimated intraoperative blood loss was 100 ml. There were no cases
of bladder perforation in all of the 60 cases, and no other major
perioperative complications. The mean duration of hospital stay was
only 1.5 days. 3/60 关5%兴 women with mixed incontinence had
persistent urgency urinary incontinence; 3/60 关5%兴 women developed
de-novo urgency. The mean follow up of these 60 patients to the
office after the procedure was 8 weeks (range 2–20 wks). 3/60 (5%)
women had voiding difficulties. There were no immediate post-operative
complications like retropubic haematoma, vaginal haematoma or bowel
obstruction. The cure rate of Secur TVT in stress urinary incontinence
was reported to be 90% 关54/60 women兴 at short term followup. These 54
women reported complete resolution of stress urinary incontinence
symptoms at their follow-up visits. There were five 关5/60兴 reported
failures and improvement of symptoms in one patient 关1/60兴.
Conclusions: The Secur TVT shows a significant cure rate (90%) and
appears to be simple, safe and effective sling procedure for SUI. It
avoids major complication like bladder, vascular and intestinal injuries.
Further follow-up is required to evaluate long-term complications and
patient satisfaction.
Disclosures: H. Yasmin, None; M. L. Mokrzycki, None.
An Early Clinical Evaluation of the Miniarc™ Performed Under
General or Local Anesthesia for the Treatment of Stress Urinary
Incontinence
M. J. Kennelly,* S. Pringle,† C. Klingele,‡ and K. Keil§ *McKay
Urology, Charlotte, NC, †Southern General Hospital, Glasgow, United
Kingdom, ‡Mayo Clinic and Medical College, Rochester, MN, §Keil
Urogynecology, Denver, CO
Objective: To report intra and peri-operative data comparing general
vs. local anesthesia from a single arm, multicenter, prospective trial
utilizing the MiniArc sling system for the treatment of Stress Urinary
Incontinence.
Methods: The MiniArc procedure was performed on 103 femles with
documented stress urinary incontinence. No other concomitant
procedures were performed. Mean age of cohort was 50.8 years
(range 32–79 years), mean BMI was 27.9 kg/m2 (range 20 – 40 kg/m2),
and parity 2 (⫾1.1). 28.1% (29/103) were implanted under general
anesthesia and 71.8% (74/103) under local (with or without sedation).
A single incision (1.5 cm) was made at the mid-urethral level and the
8.5cm sling was placed with a single 3mm diameter needle along the
transobturator trajectory into the obturator internus muscles. Intraoperative parameters included length of stay (LOS) defined as time
from administration of first procedural medication to discharge,
estimated blood loss (EBL), length of catheter placement, pain scores
per Wong-Baker Faces Pain Scale 0 –10 range at discharge, and
complications. Data on voiding function and pain level were collected
via phone interview at 7 days post-procedure.
Results: LOS was 12.81 (⫾26.06) hours with general anesthesia and
2.96 (⫾4.59) hours with local. EBL under general anesthesia was
26.72 mL (⫾27.65) and 29.86 mL (⫾29.04) under local. At discharge,
subjects reported a mean pain score of 0.86 (⫾1.48) after general
anesthesia and 0.59 (⫾1.07) after local. 80/103 subjects (77.7%) were
sent home without a catheter. 58.6% (17/29) subjects who went
home with catheter were in the general group and 8.1% (6/74) were
in the local group. 21/23 (91.3%) of subjects had a catheter placed for
24 hours or less. Two subjects delayed normal voiding until day 2 and
day 3 post-procedure (local group). Post-procedure data were
collected on 102 subjects at 7 days. 100% (102/102) of subjects
reported voiding normally. Mean pain scores were 0.57 (⫾1.07) for
the general anesthesia group and 0.34 (⫾1.01) for the local group.
The median durations reported for taking prescription pain
medications were 2 days and 1 day for the general and local
anesthesia groups respectively. There were four device or procedure
related adverse events reported: 1 intra-operative vaginal wall
perforation (local group), 1 broncho spasm with bradycardia post
procedure (general anesthesia), 1 mesh extrusion at 3 weeks postprocedure (local anesthesia), and 1 UTI (local anesthesia).
Abstracts
Conclusions: Early data suggest that MiniArc™ can be performed
under local anesthesia. Results of subjects under local anesthesia in
comparison to those under general anesthesia showed shorter facility
stay with minimal complications and little post-operative pain.
Subjects in the MiniArc™ study continue to be followed for 24
months.
Disclosures : M.J. Kennelly, American Medical Systems, Coloplast,
Pfizer, NDI Medical, Allergan, Grant/Research Support; Bard, AMS,
Ethicon Women’s Health, Coloplast, Consultant; Pfizer, Watson,
Astellas, GSK, Novartis, Allergan, Speaker’s Bureau; S. Pringle,
American Medical Systems, Grant/Research Support; C. Klingele,
American Medical Systems, Grant/Research Support; K. Keil, American
Medical Systems, Grant/Research Support; AMS, Astellas, Consultant.
The Short-Term Efficacy and Safety of the Miniarc; A Single
Incision Sling System VS. the Tension-Free Vaginal Tape Secure
System Procedure (TVT-S) in Women with Urodynamic Stress
Incontinence
Y. Asulin, E. Kulwa, and B. Hines Stamford Hospital, Department of
Ob/Gyn, Stamford, CT
Objective: The purpose of this study is to compare the short-term
efficacy and safety of the Tension Free Vaginal Tape Secur System
(TVT-S) procedure with the MiniArc; a single incision Sling system in
women with urinary stress incontinence. This study will compare the
two procedures in regards to peri-operative morbidity such as rate of
bladder injury, EBL, operative time and rate of return to normal
bladder function. In addition, we will compare outcome
symptomatology, quality of life as well as urodynamic outcome.
Study design: IRB approved pilot Retrospective study.
Methods: Sixteen women with urinary stress incontinence were
treated surgically with either the TVT Secur (n ⫽ 8) or with the
MiniArc (n ⫽8), Single-Incision Slings. Data was extracted from preoperative records, operative records, PACU records and progress
notes from follow up visits. This study compared the two procedures
in regards to the intraoperative and postoperative course and
complications, rate of bladder injury, estimated blood loss, operative
time and rate of return to normal bladder function. In addition, we
compared outcome symptomatology and urodynamic outcome.
Results: The mean age for the TVT S group was 66.25 years old and
for the MiniArc group it was 46.4 years old. The mean BMI for the
TVT S group was 23.07 and for the MiniArc group it was 25.5. Mean
Parity for the TVT S was 2 and for the MiniArc it was 3. The mean
preoperative post void residual for the TVT S was 25cc and for the
MiniArc it was 29.4cc. The mean operative time for the TVT S was
21.6 minutes and for the MiniArc it was 29.1 minutes. EBL as well as
recovery time in the PACU was minimal for both procedures.
Intraoperative cystoscopy was done for all procedures and no bladder
or vaginal wall injuries were noted. One patient in the TVT S group
had urinary retention and eventually was able to void spontaneously
after the cutting of the sling. Another patient in the TVT S group had
persistent urinary incontinence in the six week follow up visit. The
rest of patients in the TVT S group were dry in the six week post
operative checkup. All patients in the MiniArc group were dry post
operatively and no complications were recorded.
Conclusions: Both the TVT S and the MiniArc single incision sling
procedures appeared to be equally effective as surgical treatment of
stress urinary incontinence in women. There appeared to be minimal
269
Abstracts
complications as these procedures were proven to be relatively safe
with good short term efficacy. The operating time was slightly longer
in the MiniArc group than in the TVT S group; however, both
procedures took longer to complete than the traditional Sling
procedures. In addition, these single incision sling procedures were
found to be technically more difficult to perform. Issues that require
further investigation include whether or not these single incision sling
procedures result in higher rates of urinary retention than traditional
sling procedures, as well as the long term efficacy of these
interventions.
Disclosures: Y. Asulin, None; E. Kulwa, None; B. Hines, None.
Medium-Term Outcome Results and Surgical Complications of
ⴖInside-Outⴖ Transobturator TVT (TVT-O): A Prospective Study of
119 Consecutive Patients
R. S. Gold, A. Groutz, and J. Hasson Lis Maternity Hospital, Tel Aviv,
Israel
Objective: A prospective study to examine the surgical complications
and medium-term outcome results of the transobturator Tension-free
Vaginal Tape (TVT-O) procedure. Results were compared to a
previous series of 313 consecutive retropubic TVT procedures carried
out by our group.
Methods: A total of 119 consecutive women who underwent TVT-O
for urodynamically-proven stress urinary incontinence (SUI) were
prospectively enrolled. Postoperatively the patients were scheduled
for evaluation at 1, 3, 6 and 12 months, and annually thereafter. All
underwent urodynamics at 3 months postoperatively. Main outcome
measures were perioperative morbidity, postoperative urodynamicallyconfirmed persistent SUI (symptomatic,asymptomatic), persistent, or
de novo overactive bladder (OAB) and bladder outlet obstruction
(BOO).
Results: The mean follow-up was 19.9 ⫾ 5.7 months (12–30
months). Ten (8%) patients had postoperative voiding difficulties
necessitating catheterization for 7–14 days. No loosening procedure of
the tape was required. Twelve (10%) patients had protracted
postoperative thigh pain, with spontaneous resolution within 3– 6
months. Vaginal erosion of the tape was diagnosed in 2 (1.7%)
patients. Ten (8%) patients developed recurrent urinary tract
infections. Iatrogenic lower urinary tract injury was excluded by
urethrocystoscopy. Subjectively, 8 (7%) patients had persistent
postoperative SUI. However, urodynamic evaluation revealed
asymptomatic sphincteric incontinence in 7 (6%) additional patients.
Of the 65 patients who had preoperative OAB, 55 (85%) still had
persisting symptoms after operation. Four other patients (7%)
developed de-novo OAB symptoms, one of whom was found to have
BOO by pressure-flow studies. Comparison of the TVT-O and
retropubic TVT series is presented in Table.
Conclusions: Medium-term outcome results of TVT-O procedure are
comparable with TVT. The TVT-O procedure is associated with a
short operation time and bladder injury is unlikely to occur. However,
postoperative protracted thigh pain is a troublesome complication and
patients should be informed accordingly. Longer follow up and further
anatomical research are required before the TVT-O can be considered
a valid alternative to the retropubic TVT procedure.
Disclosures: R.S. Gold, None; A. Groutz, None; J. Hasson, None.
270
Preincision Lidocaine Versus Placebo for Prevention of
Postoperative Groin Pain in Women Undergoing Midurethral
Sling Placement Via the Obturator Space
A. Mendenhall, and I. B. Addis University of Arizona College of
Medicine, Tucson, AZ
Objective: To compare the effectiveness of lidocaine versus saline in
relieving postoperative groin pain in patients who receive a
midurethral sling via the obturator space (TOT).
Methods: We conducted a randomized double blind placebo
controlled trial at the University Medical Center from December 3rd
2007 until April 15, 2008. Patients were used as their own controls
and were randomized to have lidocaine injected into the obturator
space on either the right or left groin with saline injected into the
opposing side during the sling procedure. Pain assessments were
carried out using both a verbal and visual analog scale at the 1 and 2
hour marks as well as at 2 and 6 weeks post operatively. Univariate
analysis was performed using t test and chi square where appropriate.
Multivariate analysis was performed using linear regression with our
primary outcome being results from the verbal and visual pain scale.
Variables found to be significant in univariate analysis were included
in the multivariate analysis. Stata 9.0 was used for all analysis.
Results: 22 total patients have been enrolled in this study, which is
ongoing. The mean age at the time of surgery was 52.2 years of age
with a mean BMI of 33.2. 68% of enrolled patients had an additional
operation at time of TOT placement. In general patients had relatively
little pain post operatively from the TOT procedure on either the
right or left groin. On a verbal scale from 0-10, average pain levels at
1 hour, 2 hours, 2 weeks and 6 weeks were 2.42, 2.38, 1.31 and 0.27
respectively. In multivariate analysis no statistically significant
difference was found between lidocaine and saline in post operative
groin pain levels. At one hour there was a significant association
between pain and pre-op narcotic use, PACU pain meds and estimated
blood loss.
Conclusion: In patients undergoing the TOT procedure post
operative groin pain is minimal. Of those patients who do have pain,
there is no difference in pain levels with lidocaine or sterile saline. It
is possible that any injection may have an effect in relieving groin
pain during this procedure and further study may be beneficial.
Disclosures: A. Mendenhall, None; I.B. Addis, None.
Three-Year Clinical Trial of Nonsurgical, In-Office Transurethral
Radiofrequency Collagen Denaturation for Treatment of Stress
Urinary Incontinence: Interim Efficacy Results
D. M. Elser,* G. K. Mitchell,† J. R. Miklos,† K. G. Mitchell,‡ K. Cline,§
and W. Wells,¶ *Illinois Urogynecology, LTD, Oak Lawn, IL,
†Atlanta Urogynecology Associates, Alpharetta, GA, ‡SOGA, Houston,
TX, §Regional Urology, LLC, Shreveport, LA, ¶Alabama Research
Center, LLC, Birmingham, AL
Background: Transurethral radiofrequency collagen denaturation, a
one-time treatment for women with stress urinary incontinence (SUI)
due to bladder outlet hypermobility, is performed in an office setting
in about 30 minutes using local anesthesia. This clinical trial aims to
demonstrate its long-term effectiveness.
Methods: A 3-year prospective study is conducting patient
evaluations at baseline and at 3, 6, 12, 18, 24, and 36 months
following treatment at 13 physician offices or ambulatory surgery
centers in the US. This study includes women with SUI due to bladder
outlet hypermobility for ⱖ12 months who failed prior conventional
nonsurgical treatment. Women with urge or mixed urinary
incontinence or who had prior incontinence surgery or bulking agent
injections were excluded. Patients received pretreatment oral
antibiotic, oral sedative if requested, and local periurethral lidocaine
injection. Device was positioned in the bladder and radiofrequency
energy was delivered in nine 1-minute increments, resulting in
collagen denaturation of 36 circumferential sites from the bladder
neck to the proximal urethral submucosa. Patients completed the
Incontinence Quality of Life (I-QOL), Patient Global Impression of
Improvement (PGI-I), and Urogenital Distress Inventory (UDI-6)
instruments, and underwent a 1-h in-office stress pad weight test.
Adverse events and responses to satisfaction questions were noted.
Interim efficacy results are reported.
Results:
One hundred thirty-six women underwent transurethral
collagen denaturation treatment. Most returned to normal daily activities
within 1-2 days. At baseline, mean number of leaks due to activity was
2.9/d. Mean I-QOL and UDI scores were 51.3 and 52.7. At 12 months, 73
patients were evaluated. Mean number of leaks due to activity was 1.9/d.
Additionally, 69% had ⱖ50% reduction in leaked volume (median
reduction, 15.2g) on the stress pad weight test (P ⬍. 0001), which
revealed that 45% of women evaluated were dry (29%, no leaks; 16%, ⬍1
g leakage). Mean change in I-QOL scores from baseline was 19.6 points
(P ⫽ .0001), and 75.0% had improved UDI-6 scores. Mean UDI-6
improvement was ⫺17.6 points (P ⫽ .0001). On the PGI-I scale, 42.3% of
patients reported their incontinence was “very much” or “much” better
vs baseline. Additionally, 35.1% reported they would definitely or
probably recommend transurethral collagen denaturation to a friend with
SUI vs 14.2% who probably or definitely would not. No serious adverse
events have been reported at any time point following treatment. Of
note, intent-to-treat analysis showed no characteristic differences between
patients lost to follow-up and those evaluable at 12 months. Eighteenmonth results will be presented.
Conclusions: Transurethral collagen denaturation shows measurable
durable improvement at least 12 months posttreatment. This
treatment may allow SUI patients to avoid burdensome treatment and
compliance requirements of other nonsurgical therapies.
Disclosures: D.M. Elser, Novasys Medical, Grant/Research Support;
G.K. Mitchell, Novasys Medical, Consultant; J.R. Miklos, Novasys
Medical, Grant/Research Support; AMS, Paid Instructor; K.G. Mitchell,
Novasys Medical, Grant/Research Support; K. Cline, Novasys Medical,
Inc., Grant/Research Support; W. Wells, Novasys Medical, Inc.,
The Adjustable Continence Therapy (Act®) System: One Year
Results of The North America Act® Clinical Study Group
S. E. Sutherland MD,* S. R. Aboseif MD,† S. D. Nash MD,‡ J. Slutsky
MD,§ N. Baum MD,¶ L. Tu MD,储 N. Galloway MD,** and P.
Pommerville MD,†† *Metro Urology, Center for Continence Care and
Female Urology, Mpls/St Paul, MN, †Kaiser Permanente, Los Angeles,
CA, ‡Kansas City Urology Care, Leawood, KS, §Urological Surgeons,
Kankakee, IL, ¶Neil Baum Urology, New Orleans, LA, 㛳CHUSFleurimont, Fleurimont, QC, CANADA, **Emory University School of
Medicine, Atlanta, GA, ††Can-Med Clinical Research, Victoria, BC,
Canada
Abstracts
Objectives: Management of stress urinary incontinence (SUI)
associated with intrinsic sphincter deficiency is challenging after prior
failed therapies. The Uromedica Adjustable Continence Therapy
(ACT®) system is a novel device under FDA investigation that provides
bulk at the bladder neck with adjustable silicone balloons for urethral
coaptation and bladder neck support. We present preliminary results
about the efficacy, safety, adjustability, and technical feasibility of the
ACT® system for treatment of recurrent female SUI.
Materials/Methods: The study population involves female patients
with recurrent SUI with or without urethral hypermobility. Baseline
and follow-up tests were performed at 6 weeks, 3 months, 6 months,
9 months, 12 months and annually thereafter including urinalysis, a 3day voiding diary, provocative pad weight test, direct visual stress test,
Stamey score and validated questionnaires to assess the degree of
stress incontinence, voiding dysfunction, sexual function and quality
of life. The surgical technique involves a small incision between the
labia majora and minora at the level of the urethral meatus. A trocar is
passed under fluoroscopic guidance to the urethrovesical junction.
The device is delivered and the balloon filled with contrast. The
injection port for balloon adjustment is placed into a subcutaneous
pouch in the labia majora. Device adjustments were permissible when
necessary beginning 6 weeks post-operatively.
Results: There have been 161 patients implanted to date, with 107
subjects completing at least 12 months of follow-up. Mean age is 67.8
years (31–94 years). 83.9% (N ⫽ 115) had a previous anti-incontinence
procedure, with 42.5%, 31.3%, 7.5% and 1.5% experiencing 1,2,3 and
4 prior failed procedures, respectively. Difficulty of ACT® surgery was
mild, moderate, or severe in 62%, 29%, and 9% of procedures,
respectively. Improvement in Stamey score of at least 1 grade was
achieved in 82 patients (76.6%). Mean provocative pad weight
decreased from 49.7 grams at baseline to 11.9 grams at 1 year (p ⬍
0.001). Quality of life was assessed by the IQol, UDI and IIQ
questionnaires and the results suggest improvements at 12 months (p
⬍ 0.001); baseline score was 36.0 (SD 23.6) compared to 70.5 (SD
26.5) at 12 months for IQoL, 61.3 (SD 16.3) compared to 32.7 (SD
22.2) for UDI, and 54.2 (SD 27.6) compared to 23.4 (SD 27.3) for IIQ.
The mean number of balloon adjustments through 1 year to achieve
maximum continence was 2 (0 – 8). Device or procedure related
adverse events (bladder perforation, intermittent retention, port or
balloon erosion, migration, discomfort) were reported in 56.2% of
subjects. Of these, 81% were considered mild in severity.
Conclusion: Preliminary data suggest the Uromedica ACT® system
is an effective, simple, safe and minimally invasive treatment for
recurrent female SUI. The balloons are easily adjusted percutaneously
to enhance efficacy. Complications are usually of mild severity.
Additional follow-up will determine the long-term durability of this
device.
Disclosures: S.E. Sutherland, MD, None; S.R. Aboseif, MD, None;
S.D. Nash, MD, None; J. Slutsky, MD, None; N. Baum, MD, None; L.
Tu, MD, None; N. Galloway, MD, None; P. Pommerville, MD, None.
A Prospective Multi-Center Clinical Trial Evaluating the Apogee
System for The Treatment of Posterior Vaginal Wall and Apical
Prolapse: A Sub-Analysis of Apical Extrusions with or without
Concomitant Hysterectomy
J. C. Lukban,* M. Patel,† D. Van Drie,‡ S. Weprin,§ S. Zylstra,¶ R.
Vera,储 J. Nguyen,** T. Erickson,†† M. Virelles,‡‡ J. Flaherty,§§ R.
271
Abstracts
Beyer,¶¶ R. Moore,储储 M. Hodroff,*** *Eastern Virginia Medical
School, Norfolk, VA, †Piedmont Urology Associates, Gastonia, NC,
‡Grand Valley Gynecologists, PC, Grand Rapids, MI, §Huey &
Weprin Obstetrics & Gynecology, Englewood, OH, ¶Milford Regional
Medical Center, Milford, MA, 㛳Texas Tech University Health Science
Center OB/GYN Department, El Paso, TX, **Southern California
Permanente Medical Group, Downey, CA, ††Rosemark Womencare
Specialists, Idaho Falls, ID, ‡‡Institute for Women’s Health & Body,
Wellington, FL, §§Intermed, Portland, ME, ¶¶Women’s Health Care
Specialists, Paw Paw, MI, 㛳㛳Atlanta Urogynecology Associates,
Alpharetta, GA, ***Fore River Urology, Portland, ME
Category: Vaginal Prolapse Repairs with Grafts.
Objective: To describe the incidence of apical extrusion (vaginal
exposure of mesh) in patients receiving the Apogee® System (AMS,
Minnetonka, MN, USA) for pelvic organ prolapse repair with or
without concomitant hysterectomy.
Methods: In an ongoing, prospective, multi-center study involving
13 U.S. sites, women with posterior vaginal prolapse (ⱖ Stage II)
and/or apical or uterine descent (ⱖ Stage II) were enrolled for
primary posterior and/or apical mesh implant. Concomitant
hysterectomy was performed at the discretion of the operating
TABLE.
Mean Age (range)*
Menopause, n (%)*
Estrogen Replacement
ⱖ 4 weeks preop., n (%)
Prior Hysterectomy, n
(%)
Posterior Prolapse, %
(n)
Baseline (⫾Stage II)
6-mo (⫾Stage I)
12-mo (⫾Stage I)
Apical Prolapse, % (n)
Baseline (⫾Stage
II)*0
6-mo. (⫾Stage I)
12-mo. (⫾Stage I)
Extrusion Rate, %
(n)
Surgical Mgmt.
Conservative
Mgmt.⫾
Extrusion Site, % (n)
Midline Incision/
Apex
Distal Vagina
Apogee without
Hysterectomy
(n ⴝ 97)
Apogee with
Hysterectomy
(n ⴝ 36)
61.0 (33.0–90.0)
92 (95.8)
47 (48.5)
53.2 (34.0–87.0)
19 (54.3)
13 (37.1)
66 (68.0)
–
99.0 (96/97)
90.8 (79/87)
93.3 (56/60)
94.1 (32/34)
96.9 (31/32)
93.3 (28/30)
23.7 (23/97)
50.0 (17/34)
94.3 (82/87)
91.7 (55/60)
9.3 (9/97)
96.9 (31/32)
90.0 (27/30)
8.3 (3/36)
3.1 (3/97)
6.2 (6/97)
5.6 (2/36)
2.8 (1/36)
4.1 (4/97)
1.0 (1/97)
4.1 (4/97)
2.8 (1/36)
2.8 (1/36)
2.8 (1/36)
*Statistical difference between treatment groups (p ⬍ 0.05).
⫾Includes those who received local estrogen and/or trimming in the
office or observed.
Overall extrusion rates were similar in both groups, with 9 (9.3%)
and 3 (8.3%) subjects exhibiting vaginal exposure of mesh in the Apogee
only and concomitant hysterectomy groups, respectively (p ⫽ 1.0). Apical extrusions were seen in 1 (1.0 %) patient receiving Apogee alone and
in 1 (2.8%) receiving concomitant hysterectomy (p ⫽ 0.47).
272
surgeon. A sub-analysis was performed to determine extrusion rates in
patients who received a concomitant hysterectomy versus those who
did not receive hysterectomy at the time of transvaginal Intepro™
(type I polypropylene mesh) insertion employing bilateral transgluteal
trocars. Primary endpoint for the parent study was the percent of
patients with Stage ⬎ I (“cure”) at follow-up, with clinical evaluations
performed by an unblinded practitioner. Patients were seen
postoperatively at 6 weeks, 3 months, 6 months and 12 months, and
will be followed prospectively through 2 years. Continuous
measurements were compared using a two sample t-test for difference
of means. Frequency measurements were compared by Fisher’s exact
test.
Results: 133 women underwent the procedure with a mean followup of 10.0 months (range 2.3–14.6). Ninety-seven (73%) had Apogee
alone and 36 (27%) had concomitant hysterectomy. Demographic data
and outcomes are presented in the table below.
Conclusions: Incidence of apical extrusion seems to be infrequent
and independent of concomitant hysterectomy after repair with
Apogee at a mean follow-up of 10.0 months. Page 1 of 2.
Disclosures:
J.C. Lukban, Pfizer, Glaxo-Smith-Kline, and AMS,
Consultant; M. Patel, Medtronic, AMS, Consultant; D. Van Drie,
Ethicon, AMS, Consultant; S. Weprin, None; S. Zylstra, Medtronic,
AMS, Consultant; R. Vera, Encision, Shareholder; J. Nguyen, AMS,
Grant/Research Support; AMS, Consultant; T. Erickson, AMS,
Consultant; M. Virelles, None; J. Flaherty, None; R. Beyer, AMS,
Consultant; R. Moore, AMS, Allergan, Consultant; M. Hodroff, AMS,
Medtronic, Consultant.
A Tertiary Referral Center’s Experience with Complications
Arising from Transvaginal MESH KIT Procedures
E. A. Hurtado, and R. A. Appell Baylor College of Medicine,
Houston, TX
Objective: Due to the supposed high rate of failure associated with
traditional vaginal prolapse repairs, many surgeons have turned to the
use of transvaginal polypropylene mesh kits. Several case series
describe excellent anatomic cure rates with few complications outside
of minor mesh exposure. However as with any new procedure,
further unexpected complications may arise. The purpose of this case
series is to review a referral center’s experience with complications
from transvaginal mesh kits.
Methods: In this case series, 12 patients presented to the senior
author’s practice with complications associated with transvaginal
mesh kit procedures. All patients underwent complete surgical
removal of the mesh to the level where the mesh arms attached to
the body of the mesh for treatment of mesh exposure, pain, or vaginal
bleeding/discharge followed by an anterior or posterior colporrhaphy
of the remaining scar tissue. A chart review was performed to collect
demographic data, operative notes, pathology, and post-operative
follow-up. IRB approval was obtained.
Results: All 12 patients underwent surgical removal of mesh with a
mean follow-up time of 3.4 months. See table 1 for patient
demographics. In surgery, 8 of 12 patients had mesh that had
bunched together creating a fibrotic band which occurred in all
groups listed in table 1. Six of 12 patients had complete resolution of
pain. The other 6 patients had improvement of their pain though 3
patients described it as still bothersome. Of the 9 patients with mesh
exposure, all required significant resection of the vaginal wall due to
Abstracts
TABLE.
Number
Age (years)
Prior prolapse surgery
Prior hysterectomy
New onset pelvic/vaginal pain
Vaginal bleeding/ discharge
Mesh Exposure
Prior exposure treatment
Time to referral (months)
All
PerigeeTM
Perigee and
ApogeeTM
Anterior
ProliftTM
Total ProliftTM
12
60.7
0
10
12
4
9
4
11.9
4
51.0
0
2
4
0
2
1
18.0
1
77
0
1
1
1
1
0
23.0
2
59.0
0
2
2
1
2
1
13.0
5
65.8
0
5
5
2
4
2
5.4
mesh present within 1 mm of the epithelial layer. One patient
required resection of a 5 ⫻ 5 cm area. After resection, no further
mesh exposure occurred. Of 8 pieces of mesh sent for microscopic
analysis, 2 had chronic inflammatory changes, 2 had giant cells
present, and 3 had both giant cells with chronic inflammation.
Conclusion: The use of transvaginal mesh kits may cause previously
undescribed complications such as pelvic/vaginal pain or large
extrusions requiring complete removal. Removal of all mesh except
the arms may cure or significantly improve these complications.
Additionally, these patients may have chronic inflammation and
foreign body reaction to the mesh.
Disclosures: E.A. Hurtado, None; R.A. Appell, None.
Anterior Colporrhaphy and/or Sling at the Time of Vaginal
Vault Suspension: Can Recurrence of Anterior Vaginal Wall
Prolapse be Prevented?
R. Lefevre,* L. M. Espaillat,† V. C. Aguilar,* and G. W. Davila,*
*Cleveland Clinic Florida, Weston, FL, †Temple University Hospital,
Philadelphia, PA
Objective: To evaluate the rate of recurrent cystocele following
Apogee vault suspension performed with or without anterior
colporraphy. Our secondary aim was to assess any additional effect of
suburethral slings on cystocele recurrence.
Background: Vaginal vault suspension may alter the vaginal axis and
place excessive strain on the anterior vaginal wall predisposing it to
prolapse recurrence. Performing an anterior colporrhaphy (AR) and/or
suburethral sling at the time of vault suspension even in those with
no significant anterior wall prolapse may prevent such cystocele
recurrence.
TABLE.
Groups
AR
Sling
N
No
Yes
No
Yes
36
24
48
71
No
No
Yes
Yes
Cystocele
recurrence (%)
6 (16.7%)
6 (25%)
12 (25%)
11 (15.5)
p ⴝ 0.51
Recurrence
RR
p-value
关1.00兴
1.86
1.94
0.9
0.37
0.27
0.86
Methods: Data was gathered on 179 patients who underwent an
Apogee vault suspension. Demographic information, pre and postoperative pelvic examination, and surgical procedures performed
were recorded. Cystocele recurrence was defined as a ⱖGrade 2
Baden-Walker and this was assessed at the last post-operative visit.
Patients were grouped based on whether they had AR or sling at the
time of Apogee vault suspension. The groups were adjusted for
availability of follow-up week’s data. The cystocele recurrence rate
was compared between the different groups and the corresponding
impact of each procedure was analyzed using the SAS software
version 9.1. A significance level of 0.05 was assumed for all tests.
Results: Follow-up was available for a mean of 34.65 weeks (2 to 211
weeks). 95 (53.1%) patients underwent AR along with the vault
suspension while 84 (46.9%) did not. Of those 95 patients from the
former group, 71 (39.6%) had a concomitant sub-urethral sling while
24 (13.4%) did not. 48 (26.8%) patients out the group of 84 without
an anterior repair had a concomitant sling while 37 (20.6%) did not.
The overall cystocele recurrence rate was 19.5% (35/179) amongst the
studied population. This was further subdivided for each of the above
groups and comparisons were made. In those with a ⱕGrade 1 preoperative cystocele, similar lack of recurrence prevention was noted.
Conclusion: Anterior colporrhaphy and/or performance of a
suburethral sling at the time of vault suspension does not seem to
affect the recurrence rate of cystoceles in our patient population. A
well-designed randomized controlled trial would be helpful in proving
or disproving this surgical concept.
Disclosures: R. Lefevre, None; L.M. Espaillat, None; V.C. Aguilar,
None; G.W. Davila, AMS, Adamed, Synovis Astellas Watson Zuidex
Protein Polymer Technologies Duramed, Grant/Research Support;
AMS, Watson, Adamed, Consultant; Talks/honorarium: Watson, AMS,
Synovis, USSurgical, Pfizer, Astellas, Adamed, Other.
Pelvic Organ Proplapse Repair Using Perigee and Apogee
System: A Retrospective Review of Complications and Efficacy
J. A. Califano, G. Slobodov, and D. J. Culkin University of
Oklahoma HSC, Oklahoma City, OK
Objective: It is estimated that half of women who have children will
experience some form of prolapse in later life. Ideal intervention for
pelvic organ prolapse would be minimally invasive, safe, and
efficacious. We report the results of using Perigee and Apogee systems
by AMS for cystocele and rectocele repair via a transvaginal approach.
273
Abstracts
Methods: A retrospective chart review of patients undergoing
treatment of pelvic organ prolapse with placement of the Perigee and
Apogee system from January 2005 to July 2007. The data analyzed
outcomes and complications.
Results: A total of forty-one patients with a mean age of 61 (41–79)
underwent the procedure. Twenty-two patients had placement of
Perigee with Apogee repair, eighteen had Perigee alone, and one
patient has Apogee performed. Follow-up ranged from 1 month to 15
months (mean ⫽ 5). The presenting symptoms were stress urinary
incontinence (SUI) 34(83%), urge urinary incontinence (UUI) 4(10%),
and mixed urinary incontinence (MUI) 3(7%). Four patients (10%) had
intraoperative bladder perforations from passage of the trocar and
were treated with primary repair and extended foley catheter
placement. Four patients (10%) experienced urinary retention
immediately following the procedure requiring clean intermittent
catheterization. Denovo detrusor instability at two weeks follow-up
was seen in eight patients (20%) all were treated with
anticholinergics. Dyspareunia was noted in three patients (7%) postoperatively. Pudendal neuropathy, was seen in three patients (7%) at 2
months follow-up, however at 9 months only one patient had
occasional symptoms of pudendal neuropathy with the other two
cases completely resolving. Two patients required excision of mesh,
one patient had exposed mesh, the second patient had pain due to an
Apogee web causing dyspareunia and postcoital bleeding. Symptoms
resolved in both patients after excision. Two patients had interstim
sacral nerve stimulators placed for severe frequency and urgency.
Conclusion: The use of the Perigee and Apogee systems for anterior and
posterior repair is a safe, minimally invasive technique and is well tolerated.
Detrussor instability, pudendal neuropathy, and dyspareunia were the most
frequent post-operative complaints. Long-term results are needed to assess
durability and efficacy, but initial findings are promising.
Disclosures: J.A. Califano, None; G. Slobodov, None; D.J. Culkin,
None.
Two Year Anatomical Outcome after Pelvic Organ Prolapse
Repair with Prolift Transvaginal Mesh
E. Kulwa, B. Hines, and A. Yitzhack Stamford Hospital, Stamford, CT
Objective: To investigate long term (two year) anatomical outcomes
after pelvic organ prolapse repair with prolift.
Methods: A retrospective chart review of 50 patients who underwent
Prolift for repair of anterior and posterior compartments pelvic organ
prolapse at one instituition between May 2005 and April 2006 with 2
years of follow up was done. Pre- op and post-op POP Q scores were
obtained for each patient at 6 week, 6 month, 1 year and 2 year follow
up periods. The Pre op and 2 yr post-op POPQ scores were analyzed.
Wilcoxon matched pairs signed rank test was used to compare the pre
and 2 year post-op POP Q scores at points Aa, Ba, C, Ap, Bp and D.
Results: Prolift use was associated with statistically significant
improvement in POP Q scores 2 years post-op at points Aa, Ba, Ap
and Bp (Wilcoxon matched pair signed rank test p value ⬍0.05).
There was no difference in pre and post op POP Q scores at 2 year
follow up at points C and D (Wilcoxon matched pair signed rank test
p value ⬎ 0.05).
Conclusions: Prolift leads to good control of anterior and posterior
prolapse in the long term but does not seem to have any effect on
apical or uterine prolapse in the long term.
Disclosures: E. Kulwa, None; B. Hines, None; A. Yitzhack, None.
274
Bilateral, Graft-Augmented Sacrospinous Hysteropexy: 1-Year
Anatomical and Functional Outcomes Following Surgery for
Uterine Preservation
T. L. Gamble,* S. O. Aschkenazi,* A. Nguyen,* Y. A. Liu,† J.
Beaumont,‡ S. M. Botros,* P. K. Sand,* and R. P. Goldberg* *Evanston
Northwestern Healthcare/Northwestern University Feinberg School
of Medicine, Evanston, IL, †Northwestern University, Evanston, IL,
‡Center for Outcomes Research and Education/ Evanston
Northwestern Healthcare, Evanston, IL
Objective: To evaluate the 1 year anatomic and functional outcomes
of a bilateral “anterior approach” sacrospinous hysteropexy with
allograft-reinforcement for uterovaginal prolapse.
Methods: 39 consecutive women with Stage ⱖ2 uterine prolapse
underwent a bilateral ⬘anterior approach’ sacrospinous hysteropexy
with acellular dermal graft reinforcement to the anterior and apical
compartments. Subjects self-selected uterine preservation as an
alternative to vaginal hysterectomy. Surgical technique: Through a
vertical anterior vaginal incision, and limited dissection within the
paravaginal space, the ischial spine and sacrospinous ligament were
identified by palpation. Single permanent 00 Gore Tex sutures were
placed 1.5 cm medial to the ischial spines on both the right and left
sacrospinous ligament (SSL), using a push and catch suturing device
(Capio, Boston Scientific Corporation, Marlborough MA). Each SSL
suture was secured to an acellular allograft (4 –5 cm ⫻ 7–10 cm) sized
to patients’ dimensions. ‘Arcus to arcus’ paravaginal support and
reinforcement of the anterior colporraphy was obtained by securing
the graft at three levels along the arcus tendineus fascia pelvis. These
sutures were then secured to a fixation point on the ipsilateral vaginal
apex located 1 cm lateral to the cervix on both sides. Once tied, these
SSL sutures establish apical fixation of the graft and both vaginal
apices. Anterior and posterior colporrhaphy repairs were performed
in the usual fashion. Changes in pre- and post-operative POPQ staging
were assessed using McNemar’s test. Paired t-tests were used to
compare pre and post surgery PFDI and PISQ.
Results: Mean age was 57(range) years (36 –78), BMI 27 (18 –39), and
mean parity 3.0 (1– 8). Mean operative time and estimated blood loss
were 146 minutes and 203 ml (range: 75– 400) respectively. All 39
women had anterior colporrhaphy, 97% had posterior repair and 85%
had concurrent midurethral slings. Mean interval of 13.8 (5–25)
months was obtained in 33/39 (83%) of subjects. No erosions or
significant complications were observed. POPQ staging was improved
for all compartments (p ⬍ 0.05) : Aa ⫺3.1, Ba ⫺3.1, C ⫺4.1, Ap
⫺1.8, Bp ⫺1.7, D ⫺3.0. The risk of recurrent uterine prolapse as
defined as Baden-Walker stage 3– 4 after one year was: uterine
prolapse 2.6%, cystocele 4% and, rectocele 4.3%. Post-operative mean
total PFDI scores were significantly improved (25.9 vs. 77.1,
p ⫽ 0.043). Dyspareunia as measured by Likert scale {21% vs. 22%
(p ⫽ 0.706)} and mean total PISQ scores {27.9 vs 29.1 (p ⫽ 0.732)}
were not statistically different before and after surgery.
Conclusion: Bilateral sacrospinous hysteropexy with anterior graftaugmentation provides effective support and improved self-reported
QOL without adverse effects on female sexual function at one year
among women who desire uterine preservation.
Disclosures: T.L. Gamble, None; S.O. Aschkenazi, None; A. Nguyen,
None; Y.A. Liu, None; J. Beaumont, None; S.M. Botros, None; P.K.
Sand, Watson Pharmaceuticals,Inc;Indevus; Ortho-McNeil; Allergan,
Grant/Research
Support;
Watson
Pharmaceuticals,Inc;Indevus;
Ortho-McNeil; Allergan, Consultant; Indevus; Ortho-McNeil;, Speaker’s
Bureau; R.P. Goldberg, Boston Scientific, Consultant.
Abstracts
Mesh Augmented Repair of Cystocele with Anterior Approach
to Bilateral Sacrospinous Ligament Fixation
Endofast Reliant™ System-A Novel Technique for Pelvic Organ
Prolapse Repair
P. Dramitinos, T. R. Ferzandi, K. J. Hanaway, and P. L. Rosenblatt
Mount Auburn Hospital/Harvard Medical School, Cambridge, MA
M. Alcalay,* M. Livneh,† M. Cosson,‡ J. Lucot,§ and P. Von
Theobald¶ *Department of Obstetrics & Gynecology, Chaim Sheba
Medical Center, Ramat Gan, Israel, †Endogun Medical Systems Ltd.,
Kibutz Haogen, Israel, ‡Departments of Obstetrics and Gynecology,
CHRU de Lille, Lille, France, §Departments of Obstetrics and
Gynecology, CHRU de Lille, Lille, France, ¶Departments of Obstetrics
and Gynecology, CHU de Caen, Caen, France
Objective: To determine the safety and efficacy of bilateral sacrospinous
ligament (SSL) fixation with mesh interposition via the anterior approach
for anterior vaginal wall prolapse.
Methods: The records of 18 patients who underwent prolapse repair
utilizing mesh to augment bilateral SSL fixation through the anterior
approach from June, 2004 to January, 2008 were reviewed. Preoperatively, all women had symptomatic anterior vaginal wall
prolapse. The procedure involved a midline incision in the anterior
vaginal wall from the bladder neck to the cervix (or vaginal cuff). The
endopelvic fascia was dissected off the full thickness vaginal wall
bilaterally until the ischial spines were identified. Any overlying tissue
was dissected off the SSLs. Gore-Tex™ sutures were placed through
the SSLs, bilaterally, approximately 3 cm medial to the ischial spine
using the Capio™ needle driver. This suture was then passed through
the corners of the wide part of a modified trapezoid-shaped piece of
Gynemesh™ prolene mesh or through the proximal corners of the
mesh from the Gynecare Prolift™ Anterior Pelvic Floor Repair System
(where the proximal arms had been excised). The proximal portion of
the mesh was sutured to the proximal pubocervical fascia. The distal
portion of the mesh was affixed using several different methods:
passage of permanent suture through the arcus tendineous fascia
pelvis with the Capio needle driver, transobturator passage of the
distal arms of the Prolift™ system, or suturing the mesh to the
lateral/distal portion of the pubococcygeus. The sutures that had gone
through the SSL were then tied down using pulley stitches, effectively
elevating the apex of the vagina/cervix to the SSL, providing support
to the bladder. The epithelium was reapproximated and the vagina
was packed overnight.
Results: All 18 patients underwent a successful procedure. Mean age
was 63 years (46 –78y). Mean follow-up was 6.5 months (1.25–22
months). At last follow-up, 16 women (89%) had no recurrence of
anterior vaginal wall prolapse (Ba ⱕ 002d2). Preoperatively, the mean
value for leading edge of the anterior wall with respect to the hymen
(Ba) was ⫹1.2 (⫺1.5 to ⫹5). The mean Ba at most recent postoperative follow-up was ⫺2.4 (⫺3 to ⫺1). There were no significant
intraoperative complications. Mean estimated blood loss was 147 ml
(50 – 450 ml). Post-operatively, 5 patients required prolonged bladder
catheterization (maximum 13 days). Post-operative complications
included: 3 patients (17%) with pain/dyspareunia, 3 patients (17%)
with urinary tract infection, 1 patient (6%) with mesh exposure, 3
patients (17%) with worse or de novo stress incontinence, 4
patients (22%) with worse or de novo symptoms of overactive
bladder.
Objective: To evaluate the efficacy of EndoFast Reliant™ system, a
novel transvaginal technique for Pelvic Organ Prolapse (POP) repair,
reinforcing the prolapsed organ with polypropylene mesh with softtissue fasteners.
Methods: Between March and November 2007, a prospective
multicenter study was carried out in 15 women with anterior and/or
posterior POP, who underwent vaginal repairs with mesh reinforcement.
The fasteners anchored the mesh into the soft tissue adjacent to the
ischial spines and posterior symphysis for the anterior compartment, and
at the ischial spines and puborectalis for the posterior compartment.
Eleven patients (79%) underwent double compartment corrections. We
excluded patients who needed hysterectomy or correction of stress
urinary incontinence. All patients had preoperative evaluation including
physical examination (using the POP-Q system), pelvic floor symptom
evaluation using the PFDI questionnaire, and sexual function assessment
using the FSFI questionnaire. Following surgery the physician’s
satisfaction with the system was documented, and the patients were
followed at 2 weeks, 3 and 6 months post operatively, using the same
measures that were evaluated at the preoperative visit. To follow possible
migration of the fasteners, the patients had an X-ray examination of the
bony pelvis immediately after the procedure and 3 months
postoperatively. For statistical analysis we used SAS software.
Results: The surgical procedure was performed under general or
regional anesthesia. At time of writing, 15 patients had reached 3
month follow up, and 12 had reached 6-month follow up. Mean age
was 63.6 years (range 34.2–79.2) and the mean BMI was 24.9 (range:
21.6 –28.7). No intra-operative complications were observed. During
follow up no mesh erosions were noted. No detachment or migration
of fasteners have been observed. One case of misplacement of a single
fastener was observed leading to dyspareunia; the fastener was duly
removed under local anesthesia with no clinical consequences. Two
cases of de - novo SUI occurred (14%), of which one was treated
surgically. Prolapse was resolved in 100% of our patients at 3 months
(Grade 0 or 1) and in 83.3% at 6 months (2 patients of 12 had grade 2
prolapse) as noted by physical examination. Consistent significant
improvement in PFDI score related to prolapse, bladder and rectal
symptoms were observed 3 and 6 months follow up. Sexual function
did not change significantly during 6 months in the domains of
satisfaction, arousal, lubrication, orgasm and satisfaction. Pain during
intercourse improved significantly after surgery from a mean score of
0.6 at screening to a mean score of 2.7 (p ⫽ 0.038) at 6 month.
Conclusions: This series demonstrates that mesh augmented repair
of cystocele with anterior approach to bilateral SSL fixation is a safe
procedure without significant intra- or post-operative complications, as
well as an effective procedure, providing long-term support to the
anterior vaginal wall.
Conclusions: The low morbidity and the reduced dyspareunia of the
EndoFast Reliant™ system make this procedure an attractive option
for mesh use during prolapse repair. Longer follow up data is needed
to strengthen these conclusions.
Disclosures: P. Dramitinos, None; T.R. Ferzandi, None; K.J.
Hanaway, None; P.L. Rosenblatt, Ethicon Women’s Health and
Urology, Consultant; Bard Urological, Consultant; Boston Scientific
Corporation, Consultant.
Disclosures: M. Alcalay, Acting as a consultant to Endogun Medical
Systems, Consultant; M. Livneh, Endogun VP Executive Clinical and
Medical Affairs, Other; M. Cosson, None; J. Lucot, None; P. Von
Theobald, None.
275
Abstracts
Anterior Repair With Mesh: with or without Prior Anterior
Repair
Safety and Efficacy of Vaginal Hysterectomy at the Time of
Transvaginal Mesh Placement for Utero-Vaginal Prolapse
R. D. Moore,* R. Beyer,† K. Jacoby,‡ S. Freedman,§ K. McCammon,¶
and M. Gambla储 *Atlanta Medical Research Institute, Alpharetta, GA,
†Women’s Health Care Specialists, Paw Paw, MI, ‡Integrity Medical
Research, MountLake Terrace, WA, §Sheldon J Freedman MD, Las
Vegas, NV, ¶Eastern Virginia Medical School, Norfolk, VA, 㛳Central
Ohio Urolgy Group/Riverside Methodist Hospital, Columbus, OH
M. Murphy,* R. Shrestha,† R. Haff,‡ H. van Raalte,§ S. Molden,§ and
V. R. Lucente§ *Institute for Female Pelvic Medicine, North Wales,
PA, †Abington Memorial Hospital, Abington, PA, ‡St. Luke’s Hospital,
Bethlehem, PA, §Institute for Female Pelvic Medicine, Allentown, PA
Objective: To compare outcomes of patients with primary versus
recurrent cystoceles undergoing anterior repair with mesh via a
transobturator route.
Methods: In an ongoing, prospective, multi-center trial, 8 U.S. Sites
implanted women with anterior vaginal wall prolapse (ⱖ Stage II). All
sites received IRB approval prior to enrollment. Each patient underwent
placement of Type I, polypropylene mesh (Perigee System with
IntePro™, American Medical Systems, Inc., Minnetonka, MN, USA)
employing a transobturator approach. At the time of implant, the
cystocele was not reduced nor repaired under the mesh. Additional
reconstructive and incontinence procedures were completed as
indicated. Exclusion criteria included concomitant hysterectomy or
history of anterior wall graft. Intra- and post-operative data and
complications were evaluated as well as QOL questionnaires (PFDI, PFIQ7, PISQ-12). Patients are being followed through 24 months. Surgical
success was defined as ⱕ Stage 1 anterior wall prolapse. Continuous
measurements were compared using the two sample t-test for difference
of means. Frequency measurements were compared by Fisher’s exact test
or Chi-Square test.
Results: 110 subjects were implanted; 25 had previous anterior repair
关PAR兴 with recurrent cystocele and 85 had no previous anterior repair
关NPAR兴. There was no significant difference in demographics (age, bmi,
gravidity, parity), but prior hysterectomy was significantly greater in the
NPAR (p ⫽ 0.0001). Average follow-up was 16.7 ⫾ 7.8 mos. Two intraoperative complications only occurred in NPAR_hematoma and bladder
perforation. There was no significant difference on the 12 mo anterior
staging success rates between the two groups (PAR: 95.2%; NPAR: 88.6%,
p ⫽ 0.253). Overall, 12 extrusions were seen for an overall extrusion rate
of 10.9%. There was no significant difference in extrusions between the
two groups (PAR: 20%; NPAR: 8.2%, p ⫽ 0.097). Average onset of
extrusions was 240.8 days (PAR, 38 –124) and 177.6 days (NPAR,
48 – 426). There was no significant difference between other
complication rates such as de novo urge with incontinence or pain.
Objective: Previous investigations have shown an increased risk of mesh
exposure when vaginal hysterectomy is performed at the time of transvaginal
reconstruction with mesh to treat uterovaginal prolapse. However, there may
be times when concomitant hysterectomy is indicated. We therefore sought
to assess the safety and efficacy of vaginal hysterectomy in this situation.
Methods: This was a retrospective, repeated measures study of women
with uterovaginal prolapse who underwent vaginal hysterectomy and
pelvic reconstruction with the transvaginal mesh (TVM) technique
between January 2005 and December 2007. Care was taken to keep the
TVM incision(s) separate from the vaginal cuff, and mesh was never
placed under the cuff closure. Patient demographics and perioperative
outcomes were collected in a retrospective chart review. Preoperative
values of the Urogenital Distress Inventory (UDI-6), Incontinence Impact
Questionnaire (IIQ-7), and Pelvic Organ Prolapse Quantitation (POPQ)
were compared to postoperative values.
Results: Of the 39 women meeting the study criteria, 16 underwent an
anterior, 6 a posterior, and 17 a total TVM procedure at the time of vaginal
hysterectomy. Midurethral slings were placed in 35 (89.7%). There were 2
(5.1%) operative complications; both cystotomies which were immediately
recognized and repaired. All patients had at least 2 months of follow-up but 2
(5.1%) did not have postoperative POPQ measures. Median length of followup was 12 (range 2–38) months for the quality of life measures and 10
(2–38) months for the POPQ measures. Vaginal length was an average of 0.9
cm shorter postoperatively, but otherwise significant improvements were
seen in all other measures (Table 1). Of the 37 patients with postoperative
POPQ measures, there was 1 (2.7%) failure in a treated compartment and 5
(13.5%) in an untreated compartment. There were no apical failures and no
mesh exposures.
Conclusions: Incisions for transvaginal mesh placement should be kept
separate from the vaginal cuff and mesh should not be tunneled behind the
cuff. When these surgical principles were followed in this series of patients
with close to one year of follow-up, transvaginal mesh reconstruction was
safely and effectively performed with concomitant hysterectomy.
Conclusions: Anterior repair of cystocele with mesh graft via
transobturator approach seems to be a safe and effective procedure
both in patients with primary cystoceles and those with recurrent
cystoceles that have had previous attempt at repair. In the current
study there was no significant difference in the extrusion rate or the
anterior success rate between these groups of patients. Patients with
recurrent cystoceles are thought to be at a higher risk of
complications and failure, however in the current study with the use
of the Perigee procedure this was not found to be the case through
medium term follow up.
Disclosures: R.D. Moore, AMS, Allergan, Consultant; R. Beyer, AMS,
Consultant; K. Jacoby, AMS, Grant/Research Support; AMS, Consultant;
AMS, Shareholder; S. Freedman, AMS, Consultant; K. McCammon,
AMS, Allergan, Astellas, Grant/Research Support; Honoraria: AMS,
Allergan, Astellas, Other; M. Gambla, Lilly, AMS, GTX Inc, Pfizer,
Bayer, Grant/Research Support; AMS, Boston Scientific, Lilly,
Consultant.
276
Disclosures: M. Murphy, Ethicon Women’s Health and Urology,
Consultant; Boston Scientific, Consultant; R. Shrestha, None; R. Haff,
None; H. van Raalte, Ethicon Women’s Health and Urology,
Consultant; S. Molden, Ethicon Women’s Health and Urology,
Consultant; V.R. Lucente, Ethicon Women’s Health and Urology,
Consultant.
Efficacy, Functional Outcomes and Adverse Effects of LowWeight Polypropylene Mesh for Pelvic Prolapse Repair
N. Kohli,* and R. Zipper† *Brigham and Women’s Hospital, Boston,
MA, †Zipper Urogynecology, Melbourne, FL
Objective: To analyze the efficacy, functional outcomes, and adverse
effects utilizing low weight polypropylene mesh in the surgical
treatment of advanced pelvic prolapse (cystocele and rectocele) using
a sacrospinous/arcus apical attachment.
Methods: A retrospective chart review was conducted in order to
identify patients undergoing low-density mesh augmentation of the
anterior and/or posterior segment with or without concurrent vaginal
hysterectomy. Preoperative information including demographic data,
POP-Q exam, and pelvic floor dysfunction/functional assessment was
collected. Patients were seen on a routine basis at 1 week, 6 weeks,
and 6 months postop. They were also seen intermittently as needed.
Postoperative
data
including
POP-Q
exam,
pelvic
floor
dysfunction/functional assessment, and adverse effects was collected
on follow-up.
Results: 100 patients were included in the retrospective analysis
with six-month follow-up. Average age of the patients was 67.3 ⫾ 13.5
yrs and parity was 3.2 ⫾ 1.2. Nineteen patients had grade 2 prolapse
of at least 1 vaginal segment and the remaining patients had grade 3
or greater prolapse of either the anterior or posterior segment.
Approximately 50% (55/100) of the patients had undergone previous
hysterectomy and presented with post hysterectomy prolapse. 50
patients underwent anterior mesh placement, 37 underwent posterior
mesh placement, and 13 patients underwent total vaginal mesh in both
segments. 11 patients underwent concurrent vaginal hysterectomy.
Average surgical time was 55.4 ⫾ 17.2 mins and EBL was 30.6 ⫾ 15.4 cc.
Average length of stay was 1.5 ⫾ 0.6 days. There were no significant
intraoperative complications reported. Using point Aa or Ap of ⫺0.5 or
greater to define surgical failure, cure rates for the mesh augmented
segment were 100% (100/100) on 6 month follow-up. On 6 month
follow-up, 19/42 (45%) patients with preoperative defecatory dysfunction
reported improvement after surgery. 3 patients reported new onset
defecatory dysfunction. The remainders were unchanged. For 6 (6%)
patients, exposure of mesh was reported. The mesh exposure occurred
between the 1 week post-op and the at the 6 week postop visit. Three
patients underwent successful mesh revision and the remaining three
patients were not sexually active and declined treatment. Of the 6
patients with mesh exposure 3 (50%) underwent concurrent vaginal
hysterectomy. In sexually active women, sexual function improved in 4
patients while 4 patients reported on new onset dyspareunia.
Conclusions: Surgical treatment of advanced prolapsed with lowweight polypropylene mesh is effective and associated with few
complications. Surgical cure rates are significantly greater compared
to previously reported traditional plication techniques. Functional
outcomes for pelvic floor dysfunction improve in some patients
following surgery. Mesh erosion is infrequent and may be higher in
cases of concurrent hysterectomy.
Abstracts
Disclosures: N. Kohli, Coloplast, Consultant; Coloplast, Paid
Instructor; R. Zipper, Coloplast, Grant/Research Support.
Erosion Rates of Transverse Vaginal Incisions for Pelvic Organ
Prolapse Repairs Utilizing Various Types of Synthetic Mesh
B. K. Jarnagin, L. Knoepp, and M. Adelman Vanderbilt University
School of Medicine, Nashville, TN
Objective: To determine if using an initial transverse incision during
a vaginal, mesh-utilizing approach for surgical correction of pelvic
organ prolapse improves general healing and decreases typical meshrelated complications.
Method: We performed a retrospective chart review of 65 patients
who underwent surgical correction of pelvic organ prolapse with
different mesh kits. All subjects who had a transverse incision rather
than standard vertical incision for entry into the vagina were included.
Data collected from the preoperative visit, operative report, and 6week and 3-month postoperative visits were used to provide general
descriptive statistics of the study population, to evaluate the presence
or absence of mesh erosion at postoperative visits, to and compare
subjective and objective prolapse-related symptoms and exam findings
pre- and postoperatively.
Results: The average age of our study population was 65 years old,
and the average BMI was 30. Of the 65 cases reviewed, there were
124 incisions (anterior and/or posterior vaginal). Evidence of erosion
was noted at either the 6-week or 3-month post-operative visit for 6
(4.8%) patients. Four (3.2%) of these 6 mesh erosions/extrusions were
identified and classified as minor, with resolution noted by the 3month postoperative exam. This left a total of 2 (1.6%) erosions that
persisted and required surgical intervention after the 3-month visit.
Both cases resolved after this intervention without further sequelae.
No cystotomies, enterotomies, or rectal perforations were reported.
The average preoperative POP-Q stage of the study population was 34, with objective improvement to an average POP-Q stage of 0 by the
time of the final postoperative visit.
Conclusion: The use of transverse vaginal entry incision results in a
low rate of persistent mesh erosion/extrusion and potentially decreases
the rate of other major surgical complications. Therefore, this incision
type may be useful as an alternative to the standard, currently-used
vertical vaginal incision, as current studies often imply significant erosion
and surgical complication rates using these current techniques.
Disclosures: B.K. Jarnagin, Bard, Inc.; Gynecare, Consultant; Bard,
Inc.; Gynecare, Speaker’s Bureau; Bard, Inc., Paid Instructor; L.
Knoepp, None; M. Adelman, None.
Complications Associated with the Use of Transvaginal Mesh in
Pelvic Organ Prolapse Repair
F. A. Ganj,* R. R. Chesson,† O. A. Ibeanu,† and A. Bedestani†
*Louisiana State University, Metairie, LA, †Louisiana State
University, New orleans, LA
Objective: To determine the intraoperative and postoperative
complications associated with the use of transvaginal polypropelene
mesh in the repair of pelvic organ prolapse.
277
Abstracts
Materials and Methods: Retrospective study of 127 cases of
transvaginal repair of pelvic organ prolapse using synthetic mesh,
performed from September 2005 to July 2007 in the Louisiana State
University Medical system. The surgeries were performed by the same
primary urogynecologist and involved synthetic mesh interposition
between the sacrospinous ligament complex, arcus tendineus fascia
pelvis, and vaginal apex, extending to the anterior and/or posterior
vaginal wall for the repair of cystocele and/or rectocele and vaginal
vault prolapse. The operative reports and patients charts were
reviewed for intraoperative and postoperative complications, along
with the type of intervention for the complications. Institutional
Review Board approved the study. Statistical analysis was performed
using SPSS version 11.5 for windows.
Results: Mean age (⫾SD) was 63.5 ⫾ 10.16 years (range 26 to 79),
mean body mass index ( ⫾ SD) was 28.0 ⫾ 5.0, and median parity was
3 (range 0 to 8). Mean follow up period was 18.7 ⫾ 6.1 months
(range 7 to 31). Mean post operative values ( ⫾ SD) for POP-Q
measurements Aa, Ap, and C were: ⫺2.4 ⫾ 1.1 (cm), ⫺2.4 ⫾ 0.9
(cm), and ⫺7.7 ⫾ 1.2 (cm), respectively. The difference between preoperative and post-operative values of these points were statistically
significant (p ⬍ 0.0001). Mesh erosion rate was 10.2%, and significant
correlation was observed between mesh erosion and concurrent
vaginal hysterectomy (p ⫽ 0.008, OR:5.65). There was also correlation
between intraoperative bladder perforation and mesh erosion
(p ⫽ 0.028, OR:20.54). Parity and anterior vaginal mesh were risk
factors for postoperative de novo urinary incontinence (p ⬍ 0.05).
Posterior vaginal mesh and parity were risk factors for the
development of prolapse in the hitherto uninvolved pelvic
compartment (p ⬍ 0.05). Post-operative de novo urinary incontinence
was seen less in patients with posterior vaginal mesh and patients
with previous pelvic organ prolapse repair (p ⬍ 0.05). Combined
anterior and posterior vaginal mesh surgery increased the risk of
intraoperative bleeding and need for blood transfusion (p ⬍ 0.05).
Conclusion: Surgical repair of pelvic organ prolapse using
polypropylene mesh interposition with apical fixation is an effective
procedure. Concurrent vaginal hysterectomy is associated with
increased risk of vaginal mesh erosion. The performance of a
combined anterior and posterior vaginal mesh repair is a risk factor
for intraoperative bleeding and blood transfusion. Prolapse in another
compartment and de novo urinary stress incontinence are a
complication of the use of repair with use of mesh. Most mesh
erosions were easy to resolve but there are occasional major
complications.
Disclosures: F.A. Ganj, None; R.R. Chesson, None; O.A. Ibeanu,
None; A. Bedestani, None.
Anatomic and Functional Outcomes of a New Rectocele Repair
Technique Incorporating the Transvaginal Plication of the
Rectal Muscularis Layer
H. van Raalte,* M. Murphy,† S. Molden,* E. Rogerson,‡ R. Haff,‡ and
V. Lucente* *Institute for Female Pelvic Medicine, Allentown, PA,
†Institute for Female Pelvic Medicine, North Wales, PA, ‡St. Luke’s
Hospital and Health Network, Bethlehem, PA
Category: Other Surgery.
Objective: To evaluate anatomic and quality of life outcomes following
rectocele repair using a rectal plication technique compared a standard
posterior colporrhaphy technique.
Methods: A retrospective repeated measures study was used to evaluate
patients that underwent surgery to treat posterior compartment prolapse
from May 2004 to October 2007. Two techniques for repair were used, a
standard posterior colporrhaphy and a rectal plication technique. The
rectal plication technique was performed through a standard
colporrhaphy incision extended to the level of the rectovaginal space. A
running plication suture was placed through the rectal muscularis, and
following rectal plication, the vaginal wall was closed with a routine
posterior colporrhaphy closure. The techniques were compared using
pre- and postoperative outcomes including colorectal symptoms, POP-Q
measurements and CRADI-8 scores. Patients with posterior compartment
graft use, concomitant abdominal surgery or incomplete pre-operative
data were excluded.
Results: 75 patients were included. Of these patients, 56 underwent
a rectal plication repair and 19 underwent a posterior colporrhaphy.
Median follow-up was 3.3 months (range 1–35 months). Baseline
demographic data and time to follow-up were not significantly
different between groups. Preoperative functional complaints were
higher in the plication group, including manual stenting (55.4% versus
15.8%, p ⫽ 0.004), incomplete emptying (66.1% versus 52.6%,
p ⫽ 0.42), fecal urgency (17.9% versus 10.5%, p ⫽ 0.49) and fecal
incontinence (39.3% versus 26.3%, p ⫽ 0.38). Post-operative
anatomical measures demonstrated a 97% cure (stage ⬍2) with greater
improvement in POP-Q measurements seen in the plication group
compared to the colporrhaphy group (Table 1). Postoperative CRADI8 questionnaires were completed by 66 (88%) of patients. CRADI-8
scores were significantly improved in both groups, with the greatest
change in CRADI-8 scores seen in the plication group.
Conclusions: Our results suggest the rectal plication technique is
anatomically as effective as a standard posterior colporrhaphy and may
result in improved functional outcomes, particularly among patients
with greater preoperative colorectal functional complaints.
TABLE. Anatomic and Functional Outcome Data
POP-Q Points
Change in Point Ap
Change in Point Bp
p-value (within groups)
CRADI-8 Scores
Pre-operative CRADI
Post-operative CRADI
Change in CRADI scores
p-value (within groups)
278
p value
(Between
Groups)
Rectal Plication
N ⴝ 56
Posterior
Colporrhaphy N ⴝ 19
⫺1.6 (⫾1.5)
⫺2.2 (⫾1.98)
⬍0.001
⫺0.25 (⫾0.87)
⫺1.2 (⫾2.3)
⬍0.001
0.11
0.42
36.0 (⫾22.4)
18.3 (⫾16.10)
⫺17.5 (⫾19.9)
⬍0.001
31.8 (⫾22.8)
21.2 (⫾13.0)
⫺13.6 (⫾24.5)
⬍0.001
0.48
0.49
0.52
Disclosures: H. van Raalte, Ethicon, Consultant; M. Murphy, Boston
Scientific, Ethicon, Consultant; S. Molden, Ethicon, Consultant; E.
Rogerson, None; R. Haff, Ethicon, Consultant; V. Lucente, Ethicon,
Bard, Cook, AMS, Consultant.
Which Layers are Plicated at the Time of Colporrhaphy?
M. J. Wong, R. Urwitz-Lane, J. C. Felix, and B. Ozel University of
Southern California Keck School of Medicine, Los Angeles, CA
Objective: To determine which of the four layers of the vagina
(epithelium, subepithelium, muscularis, adventitia) are plicated at the
time of anterior and posterior colporrhaphy.
Methods: We retrospectively reviewed the excised vaginal tissue from
23 women who had vaginal colporrhaphies; 14 anterior colporrhaphy
and 19 posterior colporrhaphy specimens were collected. Each specimen
was examined histologically with a pathologist to determine which layers
were present. The surgical technique used in both the anterior
colporrhaphy and the posterior colporrhaphy consisted of incising the
vaginal epithelium in a sagittal fashion and dissecting the epithelium away
from the underlying tissues using sharp dissection with scissors. The
tissues that were left on the bladder or rectum were then plicated using
delayed absorbable suture.
Results: The median age of the subjects was 56. Median Ba and Bp
were ⫹1 and 0, respectively. The epithelium and subepithelium were
present in all specimens. The muscularis layer was present in 7 (50%)
of 14 specimens collected from the anterior vagina and 4 (21%) of 19
specimens collected from the posterior vagina. However, the
muscularis was not present the entire length of the specimen in most
cases.
Conclusion: During anterior colporrhaphy and posterior colporrhaphy
the tissues plicated at the time of repair consists of the adventitia and the
muscularis in more than half the cases.
Disclosures: M.J. Wong, None; R. Urwitz-Lane, None; J.C. Felix,
None; B. Ozel, None.
Colpocleisis as Pelvic Reconstructive Surgery: Our Surgical
Experience and Patient Satisfaction
C. I. Marrero, A. Aponte, R. Torres, F. Santos, and J. Rivera Obstetric
and Gynecology Department, Medical Sciences Campus University of
Puerto Rico, San Juan, PR
Objective: Describe the experience performing colpocleisis, evaluating
surgical characteristics, patient co-morbidities, and patient satisfaction
after the surgical procedure.
Methods: A retrospective study was conducted using a departamental
database to identify patients that had undergone total colpocleisis in the
University Hospital at the Medical Center, Puerto Rico from 2001 to
2007. Data includes demographics such as age, parity, and body mass
index, indications for surgery. Comorbidities were also evaluated such as
history of systemic illnesses, toxic habits and number of previous pelvic
related surgeries. Pelvic organ prolapse evaluation was recorded using the
POP-Q system. Additional surgical procedures performed at the time of
colpocleisis and surgical outcomes were described. Surgical related data
description such as estimated blood loss, type of anesthesia, recovery
Abstracts
period, and intra-operative and post-operative complications were also
recorded. Patients were contacted by the investigator and were
interviewed using a modified version of two previously validated and
frequently used questionnaires; the Incontinence Impact Questionnaire,
and the bowel function questionnaire. Patients were asked about
recurrent urinary or bowel symptoms, patient satisfaction after the
procedure, and the rate of surgical failure due to recurrent prolapse.
Results: From January 2001 to December 2007, a total of 31
colpocleisis were performed. Among 31 patients evaluated, the mean
age of the population was 71.5; with a mean BMI of 28.1. Comorbidities were: 61% with multiple medical disorders; 58% reported
previous surgeries due to related pelvic disorders. Sixty one percent
of the patients were multiparas and grand multiparas. Most of the
patients (96%) had stage IV pelvic prolapse. Mean estimated blood
loss was 278 ml; the mean operative time was 150 minutes with
83.8% percent of patients receiving spinal anesthesia. Mean hospital
stay was 2.2 days. Only one readmission was reported due to an
infected hematoma. Twenty patients (65%) were interviewed, there
were 4 deaths non-related to the surgical procedure, and 7 patients
could not be located. Ninety five percent of the patients interviewed,
reported that their previous condition interfered with their usual
activities and 100% report complete improvement after surgery
(p ⬍ 0.001). Nine patients referred having abdominal pain before the
procedure and only 3 reported this symptoms after the procedure
(p ⬍ 0.05). All of the patients reported being satisfied with the
surgery.
Conclusions: Colpocleisis is a surgical procedure that can be offered to
the non-sexually active elderly women, with medical comorbidities as a
safe procedure. Our experience has shown that it can be performed with
a short operative time, low rate surgical complications under regional
anesthesia, and with a small amount of blood loss. It has also been shown
to be associated with high rate patient satisfaction, marked improvement
in their symptoms, thus improving quality of life.
Disclosures: C.I. Marrero, None; A. Aponte, None; R. Torres, None;
F. Santos, None; J. Rivera, None.
Uterosacral Ligament Vaginal Vault Suspension in the
Correction of Anterior and Apical Prolapse
K. Y. Dyer,* K. M. Luber,† and S. A. Menefee* *UCSD, La Jolla, CA,
†Kaiser Permanente, San Diego, CA
Objective: Many surgeons have observed that stabilization of apical
prolapse often corrects anterior vaginal wall descent. However, the
efficacy of correcting apical support, without a procedure to
TABLE.
Point Ba
⫺3
⫺2
⫺1
0
⫹1
⫹2
⫹3
⫹4
Pre-op
(n ⴝ 17)
10 (58.8%)
5 (29.4%)
2 (11.8%)
0 (0%)
0 (0%)
Post-op
(n ⴝ 17)
1 (5.9%)
6 (35.3%)
4 (23.5%)
5 (29.4%)
1 (5.9%)
279
Abstracts
specifically repair the anterior vaginal wall in women with combined
apical and anterior prolapse is unknown. The objective of this study is
to determine whether uterosacral ligament suspension (USLS)
adequately addresses coexisting anterior vaginal wall descent in
women with combined apical and anterior prolapse.
Methods: We performed a retrospective observational study of women
undergoing USLS for apical prolapse, who also had preoperative anterior
vaginal wall descent and did not undergo a procedure to specifically
address the anterior vaginal defect. In all subjects, intraoperative
replacement of the apex corrected both the anterior and apical prolapse.
Inclusion criteria were C ⱖ ⫺3, Ba ⱖ 0 and eligible for vaginal support
of the apex, with at least 6 months of follow-up. Objective failure was
defined as Ba ⱖ 0.
Results: Seventeen women met our inclusion criteria. The mean
patient age was 56 .3 (⫾10.9) years, median parity 3 (range 1– 6), and
the median follow-up was 19.0 months (range 6 –54). All patients
underwent a concomitant vaginal hysterectomy and 59% had a
posterior repair. Post operative Ba measurements demonstrated that 6
of the 17 patients met our objective criteria for failure. None of the
patients with anterior vaginal wall failures were noted to have apical
recurrence as defined by a point C value of ⱖ ⫺3.
Conclusions: With an objective anterior vaginal wall failure rate of
35.2%, the use of USLS as a stand alone procedure for women with
combined apical and anterior vaginal wall prolapse should be
reconsidered. Further studies are needed to define the optimal
anterior vaginal wall procedure for women meeting these criteria.
Disclosures: K.Y. Dyer, None; K.M. Luber, None; S.A. Menefee,
None.
Combined Abdominal Sacral Colpopexy and Rectopexy for
Prolapse: A Functional and Anatomical Outcome Surgical Series
C. K. Olivera,* A. D. Garely,† J. Garbus,† D. P. Pappas,† S. Bajaj,† P.
Yadlapalli,† J. David,† S. Bajaj,† D. Yadlapalli,† M. Feuerman,† C.
Mondesir,† A. Shahryarinejad,* T. Samuels,* S. Ginath,* C. AscherWalsh,* and M. D. Vardy* *Mount Sinai School of Medicine, New
York, NY, †Winthrop University Hospital, Mineola, NY
Objective: To evaluate the anatomical and functional outcomes of
patients with pelvic organ and internal rectal prolapse, when surgical
correction was performed concomitantly.
Methods: Retrospective study evaluating 29 consecutive subjects
undergoing a combined abdominal sacral colpopexy (ASC) and a
rectopexy (Ripsteins’, suture, or low anterior resection). Subjects
were included if they were diagnosed with both uterovaginal prolapse
by a Urogynecologist and internal rectal prolapse by a Colorectal
surgeon. Surgical characteristics, and concomitant surgeries, subjective
symptoms of frequency and urgency, diagnosis of urge and stress
incontinence, abdominal pain, constipation, and pelvic organ prolapse
quantification (POPQ) point C scores. Data was analyzed with SAS.
McNemar’s test, stepwise multivariable analysis (linear and logistic),
and generalized estimated equations were utilized with type I error set
at 0.05.
Results: All genitourinary symptoms significantly improved over time
except stress incontinence at 1, 3, and 6 months and urge
incontinence at 6 months (Table 1). The gastrointestinal symptoms of
abdominal pain and constipation also significantly improved at 1, 3,
and 6 months. The median POPQ C point was ⫺4 at baseline and ⫺7
at 3 and 6 months respectively, and significantly improved at 3 and 6
months compared to baseline (p ⬍ 0.0001). Mean POPQ C point was
higher (⫺6.75) without concomitant paravaginal repair than with
(⫺5.075) concomitant paravaginal repair at 3 and 6 months
(p ⬍ 0.0001).
Conclusions: The symptoms of frequency, urgency, urge incontinence
in the first 3 months, abdominal pain and constipation all improved
significantly with the combined ASC/Rectopexy when we controlled for
the type of rectopexy performed (Ripsteins’ vs. Suture vs. Low anterior
resection). The POPQ C points improved significantly at 3 months and 6
months compared to baseline with the combined ASC/Rectopexy. The
addition of a paravaginal repair reduced support of the POPQ C point
adjusting for the changes at 3 and 6 months compared to baseline.
Disclosures: C.K. Olivera, None; A.D. Garely, pfizer, Grant/Research
Support; AMS, Grant/Research Support; covidian, Consultant; AMS,
Consultant; Tri-anim, Consultant; Pfizer, Speaker’s Bureau; Astellas,
Speaker’s Bureau; Allergan, Speaker’s Bureau; Medtronics, Speaker’s
Bureau; Covidian, Speaker’s Bureau; Tri-anim, Speaker’s Bureau; J.
Garbus, None; D.P. Pappas, None; S. Bajaj, None; P. Yadlapalli, None;
J. David, None; S. Bajaj, None; D. Yadlapalli, None; M. Feuerman,
None; C. Mondesir, None; A. Shahryarinejad, None; T. Samuels, None;
S. Ginath, None; C. Ascher-Walsh, None; M.D. Vardy, GSK, Speaker’s
Bureau; Wyeth, Speaker’s Bureau; Astellas, Speaker’s Bureau; Tyco,
Grant/Research Support; Astellas, Grant/Research Support; Tyco,
Consultant; Astellas, Consultant.
TABLE 1. Symptoms
Baseline
N ⴝ 29
1 month
N ⴝ 29
3 month
N ⴝ 25
6 month
N ⴝ 21
Frequency
62.1%
Urgency
44.8%
Urge Incontinence
34.5%
Stress Incontinence
48.30%
Abdominal pain
57.10%
Constipation
75.0%
20.7%
p ⫽ 0.0017
20.7%
p ⫽ 0.0184
6.9%
p ⫽ 0.0043
27.6%
p ⫽ 0.0755
17.9%
p ⫽ 0.0007%
28.6%
p ⫽ 0.0002
16.0%
p ⫽ 0.0020
20.0%
p ⫽ 0.0272
8.0%
p ⫽ 0.0253
25.0%
p ⫽ 0.0817
0.0%
p ⫽ 0.0001
16.0%
p ⬍ 0.0001
28.6%
p ⫽ 0.0318
9.5%
p ⫽ 0.0032
9.5%
p ⫽ 0.0714
28.6%
p ⫽ 0.1456
10.0%
p ⫽ 0.0029
5.0%
p ⫽ 0.0001
Parameters
280
Robotic Versus Vaginal Colpopexy for Apical Prolapse A CaseControl Study
D. Shveiky, A. I. Sokol, B. I. Kudish, and C. B. Iglesia, Washington
Hospital Center, Washington, DC
Category: Robotic/Laparoscopic/ASC.
Objective: The aim of this retrospective case-control study was to
compare objective and subjective outcomes of robotic-assisted
laparoscopic versus vaginal colpopexy procedures for apical prolapse.
Methods: IRB approval was obtained for this study. Over the period
of 12 months, 15 patients who had robotic-assisted laparoscopic
colpopexies were compared to 30 controls who had vaginal
colpopexy procedures and were matched for age, POP-Q stage and
procedure type. Main outcome measures included short-term objective
cure rate (POP-Q stage ⬍2), validated quality-of-life measures (PFDI
and PFIQ short forms) at 3 months postoperatively and perioperative
complications. Descriptive and univariate analyses were used to
examine statistical significance.
Results: During the study period, 45 patients with stage 2–3 apical
prolapse underwent apical suspension procedures. Patients’ mean age
was 53.5 with 67% of them had stage 3 prolapse. Parity, BMI,
ethnicity and menopausal status were similar between the two
groups. No intraoperative complications occurred. Mean operating
time was 338.13 (⫾55.3) minutes for the robotic cases and 198.8
(⫾46.8) minutes for the vaginal controls (p ⬍ .001). Estimated blood
loss was significantly lower for the robotic than vaginal cases (78.6 vs.
148.6cc, p ⫽ 0.02). Mean hospital stay was similar in both groups.
Two weeks postoperatively, visual analog pain scale scores were
similar between groups. One patient from the robotic group
presented with symptoms of peritonitis and underwent diagnostic
laparoscopy on postoperative day 10, with a final diagnosis of vaginal
cuff cellulitis. The cure rate was 93.3% for the robotic group and
86.6% for the vaginal controls (p ⫽ 0.51). Vaginal mesh erosion
occurred in 2 of the 16 controls (12.5%) and in none of the robotic
cases (p ⫽ 0.3). Both groups showed significant improvement in PFDI
and PFIQ scores (p ⬍ 0.01) compared to baseline. However, the
improvement in these scores did not differ significantly between the
two groups.
Conclusions: Robotic-assisted apical suspension is a valid treatment
option for apical prolapse with short-term results comparable to the
vaginal approach and a low rate of perioperative complications.
Disclosures: D. Shveiky, None; A.I. Sokol, None; B.I. Kudish, None;
C.B. Iglesia, None.
An Evaluation of Conventionally Versus Robotically-Tied Suture
Knot Integrity
T. M. Muffly,* T. C. McCormick,* J. Dean,† A. Bonham,* and R. Hill,‡
*University of Missouri at Kansas City, Kansas City, MO, †Arizona
College of Osteopathic Medicine, Glendale, AZ, ‡St. Luke’s Hospital of
Kansas City, Kansas City, MO
Objective: To evaluate the knot integrity of three commonly used
sutures in sacrocolpopexy tied conventionally and robotically.
Methods: Knots were tied with polyglactin 910, polypropylene, and
polyester, both conventionally and robotically. The number of strandto-strand square throws varied from four to six knots tied dependent
Abstracts
on the suture used. We compared the knots when subjected to tensile
force until the suture broke or untied.
Results: Average peak force required to break suture was 94.4 N
(SD ⫽ 14.6) for conventional and 85.8 N (SD ⫽ 32.3) for robotically
tied knots (p ⫽ 0.20). The average force required for suture to untie
was 47.7 N (SD ⫽ 18.8) and was seen only among the robotically tied
polyglactin 910 knots. Robotically tied polyglactin 910 knots were
significantly weaker than all other robotic and conventional knots
tested (p ⬍ 0.05). The robotically tied polypropylene knots were
significantly stronger than the conventionally tied polyester and
polypropylene knots (p 0.05). The tying modality and material
interaction was significant, (p ⬍0.001), suggesting that the effect of
suture material varied depending on the tying modality.
Conclusion: Knot failure rates for conventional or robotically tied
suture varied based on the suture material utilized.
Disclosures: T.M. Muffly, None; T.C. McCormick, None; J. Dean,
None; A. Bonham, None; R. Hill, None.
Laparoscopic Sacral Colpopexy May be a Cost Effective Option
Compared to Abdominal Sacral Colpopexy for the Surgical
Management of Apical Prolapse: A Cost Minimization Analysis
B. A. Suozzi,* J. L. Klauschie,* M. O’ Brien,† and A. W. McBride‡
*Exempla Saint Joseph Hospital Department of Obstetrics and
Gynecology, Denver, CO, †Biometrics/Clinical Science Department
University of Colorado Health Sciences Center, Denver, CO,
‡Mountain States Urogynecology, Exempla Saint Joseph Hospital,
Denver, CO
Objective: Sacral colpopexy is a well established surgical
treatment of apical prolapse which can be performed abdominally
or as a minimally invasive laparoscopic procedure. Our group has
shown comparable anatomic outcomes between these procedures;
however, there is little information comparing the cost of the two
procedures. The objective of this study was to perform a cost
minimization analysis of the two procedures with analysis of
hospital charges.
Methods: This study is a single-centered, retrospective chart review
of all patients undergoing abdominal sacral colpopexy (ASC) or
laparoscopic sacral colpopexy (LSC) at a community teaching hospital
during the 2005 calendar year. Groups were compared with regards
to total operating room (OR) time and OR level of complexity. Total
hospital charges were broken down into the following groups: OR
charge (derived from total OR time and level of complexity), general
equipment, suture, mesh/grafts, laparoscopic specific equipment,
pharmacy, laboratory, post-anesthesia care unit (PACU), hospital floor and
services, pathology, and additional work-ups. Statistical significance was
established at the 5% level for all analyses.
Results: Hospital charges for a total of thirty patients were reviewed.
Eleven patients underwent ASC and 19 underwent LSC. The mean
number of concurrent procedures was slightly higher for the LSC group
(ASC ⫽ 3.45 vs. LSC ⫽ 3.95). There was no statistical difference between
the mean and median total hospital charges for the two groups (ASC
mean ⫽ 29723, median ⫽ 25480 vs. LSC mean ⫽ 27604, median ⫽
28110). The OR charges accounted for a substantial percentage of the
total charges (ASC mean ⫽ 40.1%, median ⫽ 40.0% vs. LSC mean ⫽
44.1%, median ⫽ 43.7%). No significant difference existed between OR
charges for both groups (ASC mean ⫽ 11966, median ⫽ 9630 vs. LSC
281
Abstracts
mean ⫽ 12190, median ⫽ 12603). There were identical mean total OR
times (235minutes) and the median varied by 14 minutes (ASC ⫽ 208 vs.
LSC ⫽ 222), which was not statistically significant. No statistical
differences were noted for total equipment charges, total laboratory
charges, or PACU charges. The ASC group had lower suture charges (ASC
mean ⫽ 509, median ⫽ 525 vs. LSC mean ⫽ 1136, median ⫽ 791, p ⫽
0.04). The mean and median laparoscopic specific charges were 3128
and 2793, respectively. The LSC group incurred less total pharmacy
expenses (ASC mean ⫽ 3090, median ⫽ 2543 vs. LSC mean ⫽ 1863,
median ⫽ 1840, p ⫽ 0.006) and less charges for oral pain medications
(ASC mean ⫽ 80, median ⫽ 80 vs. LSC ⫽ 47, median ⫽ 42, p ⫽ 0.014).
The LSC group had lower floor charges (ASC mean ⫽ 3971, median
3547 vs. LSC ⫽ 2468, median ⫽ 2286, p ⫽ 0.002) and a shorter length
of stay (ASC mean ⫽ 2.5 days, median ⫽ 2.0 vs. LSC mean ⫽ 1.4,
median ⫽ 1.0, p ⫽ 0.003).
Conclusions: Patients undergoing LSC are likely to incur lower
pharmacy and floor related charges and are likely to have a shorter
length of stay. LSC may be a cost effective option compared to ASC
for the surgical management of apical prolapse.
Disclosures: B.A. Suozzi, None; J.L. Klauschie, None; M. O’Brien,
None; A.W. McBride, None.
A Comparison of Anterior Compartment Outcomes in Patients
Undergoing Sacral Colpopexy with and Without Concurrent
Anterior Colporrhaphy
J. Klauschie,* B. Suozzi,* M. O’ Brien,† and A. W. McBride‡
*Exempla Saint Josesph Hospital, Department of Obstetrics and
Gynecology, Denver, CO, †Biometrics/Clinical Science Department,
University of Colorado Health Sciences Center, Denver, CO,
‡Mountain States Urogynecology, Exempla Saint Josesph Hospital,
Denver, CO
Objective: Sacral colpopexy is commonly used for the correction of
apical vaginal prolapse, but also may help correct prolapse of the
anterior compartment. When sacral colpopexy alone, does not address
these anterior wall defects, additional procedures may be needed. In
this study, anatomic outcomes of the anterior compartment were
examined after sacral colpopexy in patients with and without
concurrent anterior colporrhaphy (AC).
Methods: This is a retrospective study of 84 patients who underwent
either laparoscopic (n ⫽ 43), or abdominal sacral colpopexy (n ⫽ 41);
patients were included if they had one postoperative exam. The
patients were from a single urogynecological practice at a community
teaching hospital. Patients were stratified into two groups: those who
underwent concurrent anterior colporrhaphy (AC ⫹) and those who
did not (AC ⫺). POP-Q points Aa and Ba were compared
preoperatively and postoperatively (6 weeks, 6months, and 1yr).
Anatomical failures in the anterior compartment were defined as POPQ Stage 2 or greater after the 6 week postoperative exam, symptoms
of anterior wall prolapse (AWP), or additional treatment such as
pessary or surgery. Patients with AWP of Stage 2 or greater present at
the 6 week exam were classified as persistent prolapse.
Results: Twenty-five percent (21/84) of the patients undergoing
sacral colpopexy had concurrent AC. The AC (⫹) group had more
advanced preoperative AWP (AC (⫹) Aa/Ba ⫽ 1/1.8 vs. AC (⫺)
⫺0.1/1.3 p ⫽ 0.02). Both groups had significant postoperative
improvements in the anterior compartment. There were no significant
282
differences in postoperative Aa/Ba values between the two groups at
any postoperative visit. Mean Aa/Ba at 6 months for AC (⫹) was
⫺1.8/⫺1.5, and ⫺2.1/⫺2.1 (p ⫽ NS), for AC (⫺). At one year the
mean Aa/Ba measurements for AC (⫹) were ⫺1.5/⫺1.9 and for AC
(⫺) were ⫺2.3/⫺2.3 (p ⫽ NS).
Anatomic failures occurred in both groups. None of the AC (⫹)
patients had persistent prolapse at the 6 week exam with the mean
Aa/Ba ⫽ ⫺2.6/⫺2.6. There were 4 failures (25%, n ⫽ 16) in the AC
(⫹) group at the 6 month exam and one new failure at one year
(11%, n ⫽ 9). Two patients in this group underwent additional
treatment for their AWP. In the AC (⫺) group, mean Aa/Ba values at 6
weeks were: ⫺2.4/⫺2.4; however, there were ten patients with
persistent AWP. These patients had a mean preoperative Aa
value ⫽ 1.5 which was significantly higher than the mean
preoperative values of the AC(⫹) group (1.0) and of the AC (⫺)
group (⫺0.4), p ⫽ 0.001. There were 5 patients with failures (13%,
n ⫽ 40) in the AC (⫺) group at 6 months, and 2 new cases at one
year (8%, n ⫽ 24). One patient underwent additional surgery for AWP,
and one other requested reoperation for symptoms, but did not fit
criteria for anatomic failure.
Conclusions: In many cases sacral colpopexy alone does reduce
anterior compartment defects, primarily with less advanced AWP.
Persistent prolapse of the anterior compartment is a risk when no
concurrent repair is performed especially in patients with more
advanced AWP.
Disclosures: J. Klauschie, None; B. Suozzi, None; M. O’Brien, None;
A.W. McBride, None.
Dynamic Magnetic Resonance Imaging And Clinical Staging of
Pelvic Organ Descent: Comparison of Pubococcygeal Versus
Midpubic Reference Lines With Clinical Correlation
B. S. Hampton,* C. A. Woodfield,† V. W. Sung,* and J. A. Brody†
*Brown Alpert Medical School/Women and Infants’ Hospital,
Providence, RI, †Women and Infants’ Hospital, Providence, RI
Category: Imagining.
Objective: Currently, there is no consensus regarding which
magnetic resonance imaging (MRI) reference line for staging pelvic
organ descent, pubococcygeal line (PCL) (inferior symphysis pubis to
last coccygeal joint) vs midpubic line (MPL) (midsagittal long axis of
symphysis pubis), correlates best with clinical staging. The primary
study objective is to determine which MRI reference line (PCL vs
MPL) agrees best with clinical staging.
Methods: An IRB approved retrospective study of all patients with
pelvic floor complaints and clinical records at our institution who
underwent dynamic pelvic floor MRI examinations on a 1.0 or 1.5
T MRI magnet from January 2004 through April 2007 was
performed. All MRIs were read by two experienced body MRI
radiologists blinded to clinical data. The degree of descent on MRI
for each pelvic compartment (anterior, vault, posterior) was staged
by consensus, first using the PCL and then the MPL reference line.
Readings for each reference line were temporally spaced by 4
weeks. Clinical records were reviewed by a fellowship trained
Urogynecologist blinded to MRI results. Demographic and clinical
data, including symptoms of pelvic floor dysfunction and pelvic organ
prolapse staging using the pelvic organ prolapse quantification (POPQ),
were recorded. Agreement between MRI staging and clinical staging was
estimated using weighted kappas. All statistical analyses were performed
using STATA 9.0.
Abstracts
Results: Twenty two patients were included in this study with mean
age of 54.9 years (SD 11.7) and median parity of 2 (range 0 –3).
Clinical patient characteristics included prior pelvic surgery 71.4%,
urinary incontinence 61.9%, pelvic organ prolapse 85%, pelvic pain
23.8%, constipation 27.8%, and fecal incontinence 14.3%. POPQ and
MRI staging (median, range) by vaginal compartment were as follows:
1) anterior: POPQ 1 (0 –3), MPL 2 (1–3), PCL 0.5 (0 –2); 2) posterior:
POPQ 2 (0 –3), MPL 2 (1–2), PCL 2 (1–3); 3) vault: POPQ 1 (1–3),
MPL 1 (0 –2), PCL 0 (0 –2). Agreement between clinical and MR
staging using the PCL was fair in the anterior compartment
(␬ ⫽ 0.29), and poor in the vault (␬ ⫽ 0.03) and posterior (␬ ⫽ 0.08)
compartments. Agreement between clinical and MR staging using the
MPL was fair in the anterior (␬ ⫽ 0.37), vault (␬ ⫽ 0.31), and
posterior (␬ ⫽ 0.25) compartments.
Conclusions: The MPL reference line shows better agreement with
clinical staging than the PCL reference line for this population of
women with pelvic floor complaints. Agreement for the PCL reference
line and clinical staging in this population is particularly poor in the
posterior compartment and vault.
Disclosures: B.S. Hampton, Ethicon Women’s Health and Urology,
Consultant; C.A. Woodfield, None; V.W. Sung, None; J.A. Brody,
None.
Magnetic Resonance Imaging of Abdominal Versus Vaginal
Prolapse Surgery With Mesh
S. Ginath,* M. Vardy,† J. S. Luchs,‡ A. Shahryarinejad,† C. Olivera,† S.
Zhou,† C. Ascher-Walsh,† M. Brodman,† A. Condrea,* and A. Garely,‡
*Wolfson Medical Center & Sackler School of Medicine, Holon & TelAviv, ISRAEL, †Mount Sinai School of Medicine, New York, NY,
‡Winthrop University Hospital, Mineola, NY
Category: Imaging.
Objective: Compare 2 surgeries for symptomatic apical vaginal
prolapse with normal controls, by analyzing MRI measured landmarks
and quality of life (QOL) measures, before and after surgery.
Methods: Prospective multicenter pilot study (n ⫽ 16). Nuliparous
controls (N ⫽ 6) were compared to 10 parous (3.0 ⫾ 1.0) women
with a uterus and apical prolapse ⱖ stage 2. Group A (N ⫽ 5)
underwent ASCP with monofilament polypropylene mesh (MPM), and
Group B (N ⫽ 5) vaginal MPM kit repair (total ProLift). Subtotal
hysterectomy was performed in all Group A and none in B. All study
patients underwent pre-op and 3 months post operative POPQ,
dynamic MRI, validated health status, quality of life (QOL) and sexual
function questionnaires (SF-36, PFIQ-7, PISQ-12, PFDI-20).
Comparison of MRI pelvic angles, and distances (Figure 1) was
performed and analyzed by Mann-Whitney Rank Sum test and chisquare test.
Results: Group B were older than A patients (67.2 ⫾ 8.4 years versus
53.6 ⫾ 8.3 years, p ⫽ 0.03). There were no significant differences in
parity, menopausal status, BMI, general health and QOL scores
between study groups postoperatively. No differences were seen in
MRI landmarks postoperatively (Table 1).
Conclusions: ASCP compared to Prolift for vaginal apical support
are similar at 3 months by POPQ, QOL, and MRI analysis. Both
treatments returned POPQc and QOL measures to values comparable
to nulliperous controls by 3 months. Changes in g angle may reflect
levator atrophy. Longer follow-up with larger numbers seems
warranted.
Disclosures: S. Ginath, None; M. Vardy, Tyco, Grant/Research
Support; Astellas, Grant/Research Support; AMS, Consultant; Astellas,
Consultant; Wyeth, Speaker’s Bureau; GSK, Speaker’s Bureau; Astellas,
Speaker’s Bureau; J.S. Luchs, None; A. Shahryarinejad, None; C.
Olivera, None; S. Zhou, None; C. Ascher-Walsh, None; M. Brodman,
None; A. Condrea, None; A. Garely, Pfizer, Grant/Research Support;
AMS, Grant/Research Support; Covidian, Consultant; Tri-Anim,
Consultant; AMS, Consultant; Pfizer, Speaker’s Bureau; Allergen,
Speaker’s Bureau; Covidian, Speaker’s Bureau; Astellas, Speaker’s
Bureau; Medtronics, Speaker’s Bureau; Tri-Anim, Speaker’s Bureau.
Two Valsalva or not Two Valsalva: Do Repetitive Valsalva
Maneuvers Help Women Obtain their Maximum Prolapse on
Dynamic MRI?
J. A. Tumbarello, Y. Hsu, S. Rohrer, and J. O. DeLancey University
of Michigan, Ann Arbor, MI
Category: Imaging.
Objective: Dynamic magnetic resonance imaging (MRI) is increasingly
used to study pelvic organ prolapse. During clinical examination several
attempts are often needed to achieve a maximally developed prolapse for
quantification. This study seeks to quantify differences in anterior vaginal
wall prolapse during sequential Valsalva attempts.
Methods: Subjects were taken from an ongoing case-control study
evaluating anterior vaginal wall prolapse. Women with a prolapse whose
leading edge extends ⱖ1 cm beyond the hymenal ring and who were
enrolled after February 1, 2007 were included (n ⫽ 45). Prior to the MRI
portion of the study all women underwent clinic pelvic floor testing,
including POP-Q, at which time they were given instructions and asked to
283
Abstracts
practice pushing their prolapse out to its maximal extent. During the MRI,
women were again instructed to push their prolapse to the maximum
extent. All subjects performed 2 maximal Valsalvas during mid-sagittal
dynamic MRI scans. The most dependent bladder point was marked in each
MR image and its vertical distance to a horizontal reference line placed at the
inferior pubic bone was measured (Figure 1). The amount of bladder descent
between the first and second maximal Valsalva efforts were compared.
Results: Of the 45 subjects included, 91% (n ⫽ 41) had a significant
(p ⬍ .001) increase in bladder descent from the first Valsalva attempt
to the second with a mean change of 1.38 ⫾ 1.54 cm. Of the patients
that had a significant increase in bladder descent, 44% (n ⫽ 18) had
more than a centimeter of difference (mean 2.58 ⫾ 1.66 cm) and 20%
(n ⫽ 8) had more than 2 cm difference (mean 3.96 ⫾ 1.6 cm)
between their first and second attempt.
Conclusion: As is true during clinical examination, several attempts
may be required to have anterior compartment prolapse present at its
maximal size during dynamic MR imaging of the pelvic floor.
Disclosures: J.A. Tumbarello, None; Y. Hsu, None; S. Rohrer, None;
J.O. DeLancey, Johnson & Johnson, Consultant.
Accuracy of the Midpubic Line in Estimating the Location of the
Vaginal Hymen with the Midpubic Line Measurement on
Dynamic Magnetic Resonance Imaging in Women with Pelvic
Organ Prolapse
K. J. Wohlrab,* B. S. Hampton,* C. A. Woodfield,† V. W. Sung,* C. R.
Rardin,* and J. M. Brody† *Division of Urogynecology and
Reconstructive Pelvic Surgery, Department of Obstetrics and
Gynecology; Alpert Medical School at Brown University, Providence,
RI, †Department of Radiology; Alpert Medical School at Brown
University, Providence, RI
Category: Imaging.
Objective: The midpubic line (MPL) is defined as the line along the
midsaggital axis of the symphysis pubis, and is used as an
approximation of the vaginal hymen (VH) for MRI assessment of
pelvic organ prolapse. The primary aim of this study is to test the
accuracy of the MPL in locating the VH in women with complaints of
pelvic organ prolapse who undergo dynamic MRI. The secondary aim
of this study is to estimate the agreement between radiologic staging
using both the MPL and VH as references points to clinical Pelvic
Organ Prolapse Quantification (POPQ) staging.
284
Methods: We performed an IRB-approved prospective cohort study.
Women undergoing dynamic MRI for complaints of pelvic organ prolapse
were consented. Demographic and POPQ measurements were collected
from patient charts. Prior pelvic surgeries, complaints of a vaginal bulge,
pain, urinary or fecal incontinence were recorded at the time of the MRI.
A MRI surface marker (Beekley MR Spot®; Bristol, CT) was placed at the
level of the posterior vaginal hymen immediately prior to MRI
examination. All images were viewed by a radiologist with expertise in
pelvic floor imaging. Images were obtained during rest, Kegel, and
Valsalva maneuvers, and the distance between the MPL and VH was
measured with each. The radiologic measurements of the leading edge of
prolapse for the anterior, apical and posterior compartments during
Valsalva were also measured, with reference to both the MPL and VH.
These measurements were then staged based on POPQ definitions.
Descriptive statistics were performed. Weighted kappas were used to
estimate the agreement between both methods of radiologic assessments
and clinical measures.
Results: Thirteen women were recruited into the study; POPQ measures
were available in 8. The mean age was 49.2 years (SD 12.0), median parity
was 2 (range 1–4), and the median POPQ stage was 2 (range 1–3); 81.8%
had prior pelvic surgery, 75% complained of a vaginal bulge, 66.7% had
pelvic pain, 16.7% had urinary incontinence and 8.3% had fecal
incontinence. The MPL accurately located the VH in 12 out of 13 patients at
rest and with Kegel; however, during Valsalva, the MPL correctly located VH
in only 2 patients. The median difference between the MPL and VH marker
during Valsalva was 1 cm (range 0–2.5 cm). Agreement in staging between
clinical and MR techniques using the MPL reference line was fair in the
anterior (␬ ⫽ 0.31) and poor in the posterior (␬ ⫽ 0.04) compartments.
Agreement between clinical and MR staging using the VH reference line was
fair in the anterior (␬ ⫽ 0.23) and very good in the posterior (␬ ⫽ 0.86)
compartment. Data were not sufficient to estimate agreement in the apical
compartment.
Conclusions: This study demonstrates that the MPL approximates
the vaginal hymen at rest, but with Valsalva, excursion of the
hymen reduces this accuracy. Staging of pelvic organ prolapse
using MR measurements showed only fair agreement to clinical
staging in the anterior compartment, but very good agreement in
the posterior compartment when VH was used as the reference
point.
Disclosures: K.J. Wohlrab, None; B.S. Hampton, Ethicon, Consultant;
C.A. Woodfield, None; V.W. Sung, None; C.R. Rardin, Boston
Scientific, Consultant; J.M. Brody, None.
A New Technology to Measure the Biomechanical Properties of
the Vaginal Wall
H. van Raalte,* V. Lucente,* L. Lipetskaia,† and V. Egorov‡ *Institute
for Female Pelvic Medicine, Allentown, PA, †St. Luke’s Hospital and
Health Network, Bethlehem, PA, ‡Artann Laboratories, Trenton, NJ
Category: Imaging.
Objective: The objective of this study is to demonstrate the potential
use of mechanical imaging technology to measure and compare
biomechanical properties of the vaginal wall in women with and
without pelvic organ prolapse.
Methods: Thirteen women were enrolled in the study and
underwent transvaginal MI evaluation. The women enrolled included
5 women with normal pelvic support, 3 of which had had prior
reconstructive pelvic surgery, and 8 women with current pelvic organ
prolapse. MI was performed utilizing a vaginal probe, similar in
dimensions to a transvaginal ultrasound probe, which was comprised
of two separate pressure sensor arrays and orientation sensors. The
images were obtained in an office setting at the time of routine
vaginal examination. Imaging results were electronically recorded and
then analyzed at Artann Laboratories.
Results: Among women with and without prolapse, the elasticity
coefficient is calculated as the slope (Es) of scanhead applied force
versus elevation angle of the probe and is used to characterize the
elasticity of the vaginal wall against which the scanhead has been
pressed. Comparison of a woman with normal pelvic support to a
woman with pelvic organ prolapse revealed a measurable difference
in elasticity coefficient (Es) values. Es values were 0.18 ⫾ 0.01 in a
patient with normal support compared to 0.025 ⫾ 0.01 in a patient
with Stage 3 prolapse for the anterior compartment. Similarly, Es
values were 0.11 ⫾ 0.01 in a patient with normal support compared
to 0.035 ⫾ 0.01 in a patient with Stage 2 prolapse for the posterior
compartment. Using these values, the ratio of normal-to-prolapse
vaginal wall elasticity as detected by the MI device was found to be
7.2 for the anterior compartment and 3.1 for the posterior
compartment. For patients with prior reconstructive surgery, areas
of previous scar tissue and graft placement could be easily seen on
mechanical imaging with a measurable increase in tissue rigidity.
Even within the vaginal site of graft placement, areas of increased
rigidity, such as mesh arms used in graft kits, could be visually
discerned.
Conclusions: Our findings suggest that MI offers a non-invasive,
quantitative evaluation of vaginal elasticity with the potential for a more
comprehensive evaluation of overall vaginal support structures. In a
transvaginal scanning application, MI can reproduce a real-time,
circumferential evaluation of the vaginal walls. The potential gynecologic
application of the MI could impact our further understanding of risk
factors for the development of prolapse, individual variations in
biomechanical properties and provide insight into optimal approaches for
surgical repair. This last application is particularly important with the
increasing use of graft materials for pelvic reconstructive surgery and the
need to more extensively evaluate the functional properties of the vaginal
walls following these repairs.
Disclosures: H. van Raalte, Ethicon, Consultant; V. Lucente, Ethicon,
Bard, AMS, Cook, Consultant; L. Lipetskaia, None; V. Egorov,
Employee at Artann Labs, Other.
3-D Ultrasound Characterization of Mid-Urethral Slings: A
Comparison of Three Different Sling Types
B. J. Vassallo,* C. D. Harris,† D. E. Pesch,‡ M. D. Moen,* and M. B.
Noone* *Illinois Urogynecology, Park Ridge, IL, †Knoxville Urology
Clinic, Knoxville, TN, ‡Advocate Lutheran General Hospital, Park
Ridge, IL
Category: Imaging.
Objective: To describe the changes in suburethral sling width and
the degree of migration from the mid-urethra which occur after
sling placement and to compare the differences in these
characteristics across three of the leading mid-urethral sling
products.
Methods: Forty-two women were studied by transvaginal 3-dimensional
ultrasound after undergoing placement of American Medical System,
Abstracts
Boston Scientific or Ethicon mid-urethral slings. The primary outcomes of
suburethral sling shrinkage and migration from the mid-urethra were
compared by One-way ANOVA test.
Results: Eighteen women with AMS slings (transobturator), ten with
Boston Scientific slings (8 retropubic, 2 transobturator) and fourteen
with Ethicon (8 retropubic, 6 transobturator) were statistically similar
across the demographics of age, race, weight, parity, menopausal
status, previous pelvic surgery, and concomitant surgery.
Cure/improved rates were 88.9, 100 and 92.9, respectively. Mean
percent sling shrinkage was 49.8 ⫾ 21.3, 50.1 ⫾ 32.6 and 39.1 ⫾
23.7 (p ⫽ 0.43) and mean percent sling migration was 4.11 ⫾ 25.0,
12.4 ⫾ 13.5 and 9.9 ⫾ 31.3 (p ⫽ 0.67), respectively.
Conclusions: All three types of slings showed similar degrees of
shrinkage and migration away from the mid-urethra. Such alteration
from the intended sling width and implanted location does not seem
to have a significant effect on cure rate.
Disclosures: B.J. Vassallo, Unrestricted grant from Boston Scientific,
Grant/Research Support; Boston Scientific, Consultant; Novartis, OrthoMcNeil, Speaker’s Bureau; C.D. Harris, Boston Scientific, Consultant; D.E.
Pesch, None; M.D. Moen, Ethicon, Consultant; Astellas, Allergan, Speaker’s
Bureau; M.B. Noone, Boston Scientific, Ethicon, Consultant; Ortho-McNeil,
Astellas, Allergan, Speaker’s Bureau.
Translabial Ultrasound (TLU) Accurately Depicts Anal Sphincter
and Pubovisceralis (PV) Anatomy
T. B. Omotosho, R. J. Hall, H. Abed, L. L. Leeman, and R. G. Rogers
University of New Mexico Hospital, Albuquerque, NM
Category: Imaging.
Objective: To describe and compare anal sphincter and PV anatomy
using 2D and 3D TLU and endoanal ultrasound (EAU) images.
Methods: We compared TLU and EAU of 31 primiparous women with
a mean age of 25 ⫽ 5 years. All women were examined in the dorsal
lithotomy position after voiding, using a Philips IU22 3-9 MHz 3D
endovaginal and a B & K 16 MHz 3D endoanal transducer. 2D axial
images of the internal anal sphincter (IAS) were measured at 3 levels
(proximal, mid and distal) at 12, 3, 6 and 9 o’clock. External anal
sphincter (EAS) images were measured at the distal level. 2D and 3D
transverse width measurements of the PV were taken at the mid level.
Sphincter and PV integrity were qualitatively assessed. Pearson’s
correlations were performed for paired measurements of IAS, EAS and
PV.
Results: 31 women underwent both TLU and EAU. No sphincter
defects or disruptions or asymmetries in the PV were identified
with either modality. Figure 1a compares TLU and EAU 3D images
obtained at the mid level and figure 1b compares TLU to EAU at
the distal level. Both TLU and EAU images accurately depict the PV
and anal sphincters. No correlations were found between TLU and
EAU measurements; qualitative agreement was a 100% between
modalities.
Conclusion: TLU 2D and 3D ultrasound accurately image pelvic
floor anatomy. Sphincter and PV measurements do not correlate
between modalities. Further study is needed to determine if the
detection of sphincter and levator ani disruption is equivalent
between methods.
285
Abstracts
including BMI, type of past or recent surgery, presenting complaint,
and diagnosis were recorded for all patients. The main outcome was
the mean difference of the two PVR volume measurements (catheterultrasound).
Results: Bladder ultrasound and catheter postvoid residual volume
were measured for each of 112 subjects. The mean difference
between the two measurements was 48.2ml with a standard deviation
(sd) of 105.6 ml. A paired t-test of the null hypothesis that the
difference between bladder ultrasound and catheter volume was zero
was statistically significant (p ⬍ 0.0001). When stratifying the results
by patient weight, the mean difference within the extremely obese
group (BMI ⬎ 40 kg/m2) was ⫺55.7 ml (sd ⫽ 253.6) compared with
59.4 ml (sd ⫽ 121.7) among the overweight group (BMI 25–29.9
kg/m2). This difference in measurement between the weight groups
was statistically significant (F test p-value 0.05). There was also a
difference in measurement between the mean inpatient (62.3ml (sd ⫽
119.5)) and mean outpatient (19.7 ml (sd ⫽ 61.6)) groups (p ⫽ 0.01).
The difference in measurement between PVR and ultrasound
increased as PVR increased. Comparing patients with ⬍50 ml PVR to
those with 50 –200 ml and greater than 200 yielded an F test p-value
of 0.0001.
Conclusions: Although the mean difference between the catheter
and ultrasound PVR measurements was 48.2 ml, the standard
deviation was large (105.6 ml). As a normal PVR measurement in the
outpatient setting is ⬍50 ml, one can see that a PVR ultrasound
measurement that differs by greater than 50ml from the gold standard
straight catheterization could be problematic in the clinical setting.
This difference in PVR between ultrasound and straight catheter
measurement is more pronounced as BMI increases and as the
catheterized PVR increases. In addition, bladder ultrasound seems to
be much less accurate in the immediate postoperative period. This
study does not support the replacement of straight catheter
measurement of PVR by ultrasound.
Disclosures: M.E. Tarr, None; S. Valaitis, None.
Disclosures: T.B. Omotosho, Pfizer, Grant/Research Support; R.J.
Hall, None; H. Abed, None; L.L. Leeman, None; R.G. Rogers, Pfizer,
Is Bladder Ultrasound Measurement of Postvoid Residual
Volume Accurate When Used in The Evaluation of Post Surgical
and Clinic Urogynecology Patients?
M. E. Tarr, and S. Valaitis University of Chicago, Department of
OBGYN, Chicago, IL
Category: Imaging.
Objective: To determine if the measurement of postvoid residual
volume (PVR) with the use of a bladder ultrasound accurately reflects
the true PVR as determined by the gold standard, straight
catheterization of the urethra, in postoperative and ambulatory
urogynecology patients.
Methods: After receiving Institutional Review Board approval, 112
subjects were recruited from both the urogynecology clinic and
following urogynecologic operative procedures. After written consent
was obtained, subjects who had recently voided underwent an
ultrasound measurement of PVR using the Bladder Scan (Diagnostic
Ultrasound) followed by immediate straight catheterization of the
urethra to reveal the true PVR measurement. Demographic data
286
Trends in Stress Urinary Incontinence Inpatient Procedures in
The United States, 1979 –2004
S. S. Oliphant,* L. Wang,† C. H. Bunker,† and J. L. Lowder*
*University of Pittsburgh, Pittsburgh, PA, †Clinical and
Translational Science Institute, University of Pittsburgh, Pittsburgh,
PA
Category: Epidemiology.
Objective: To describe national trends in surgery for female stress
urinary incontinence (SUI).
Methods: The National Hospital Discharge Survey (NHDS), a federal
dataset sampling U.S. inpatient hospitals, was analyzed for patient and
hospital demographics and ICD-9-CM diagnostic and procedures codes
from 1979 to 2004. Age-adjusted rates (AARs) per 1000 women were
created using 1990 U.S. Census population data.
Results: The number of women undergoing SUI surgery has increased
from 48,345 in 1979 to 103,467 in 2004. In women ⱖ52 years of age the
AAR more than doubled from 0.64 to 1.6, while in women ⬍ 52 the AAR
fell from 0.57 to 0.47. AARs for Retropubic urethral suspensions (ICD-9
59.5) fell from 0.37 in 1979 to 0.14 in 2004. Suprapubic sling (59.4)
AARs rose from 0.02 in 1979 to a peak of 0.10 in 1997, and then fell to
0.03 in 2004. AARs for Other repair of SUI (59.79) rose from 0.06 in
1979 to 0.64 in 2004. No specific code for midurethral sling exists.
Abstracts
Conclusion: The number of women undergoing SUI surgery has
increased significantly from 1979 to 2004. NHDS data does not
include ambulatory procedures, so accurate information on same-day
surgeries is unavailable. Missed sampling, coding changes, and
imprecise codes may explain the decline in Suprapubic sling
procedures as well as rising numbers of Other repair of SUI. To
obtain accurate national estimates of female incontinence procedures
a specific ICD-9-CM code for midurethral sling needs to be created
and the National Survey of Ambulatory Surgery needs to be
reinstituted.
Methods:
Women presenting to a midwestern tertiary care
urogynecology clinic for POP were included. Comprehensive initial
evaluation of new patients included a standardized questionnaire
addressing onset and progression of prolapse symptoms, as well as a
complete urogynecologic examination with the Pelvic Organ Prolapse
Quantification system (POP-Q). Patients’ perception of (1) initial
prolapse discovery, (2) timeframe from symptom onset to worsening,
(3) symptoms perceived as most bothersome, and (4) factors that
drove treatment seeking were assessed. Descriptive statistics were
used for baseline data and differences in means were compared with
Student’s t-tests. Responses were correlated with clinical data. The
study was IRB approved (HUM00010718).
Results: One hundred and seven women participated. The mean
participant age was 57.5 ⫾ 14.0 years and mean BMI was 26.9 ⫾ 4.2
kg/m2. Ninety-four percent were vaginally parous (median parity 3.0,
range 0 to 8); only 6 were nulliparous. Almost fifty percent (47.4%) of
women sought medical attention “immediately” after discovering a
bulge, irrespective of whether or not they had symptoms of pelvic
floor dysfunction. The median time to seek care was 4 months (range
1 month to 45 years). Care was sought by 80.0% of women within
one year of discovering their prolapse; the most common reason cited
was “worsening of the bulge.” Twenty-six percent of the women
associated their prolapse with a sentinel event (moving furniture,
pushing a car). These women were significantly younger than those
that reported a gradual onset of prolapse (52.0⫾ 3.0 vs. 58.4 ⫾ 1.6
years, p ⫽0.05). The prolapse was self discovered by 75.7% (81/107)
of women, with the remainder being discovered by health care
providers. The anterior wall (mean point Ba) of the self-discovery
group was 1.3 cm beyond the hymen; this was significantly greater
than that of women diagnosed by their physicians (mean Ba 0.1,
p ⫽0.03). The most common bothersome symptom reported was
“bulge/pressure” (84.1%) followed by urinary incontinence (24.3%).
Other symptoms that patients attributed to their prolapse included:
back pain (15.9%), a feeling of incomplete bladder emptying (15.9%),
and constipation (11.2%).
Conclusions: Most women describe a gradual development of their
pelvic organ prolapse, yet seek medical advice soon after they initially
discover it. Self-discovery of prolapse is associated with a higher stage
of prolapse than prolapse diagnosed by health care providers.
Disclosures: C. Lewicky-Gaupp, None; R.U. Margulies, None; K.
Larson, None; D.E. Fenner, None; D.M. Morgan, None; J.O. DeLancey,
Johnson & Johnson, Consultant.
Disclosures: S.S. Oliphant, None; L. Wang, National Institutes of
Health, Grant/Research Support; C.H. Bunker, National Institutes of
Health, Grant/Research Support; J.L. Lowder, None.
Current Trends in Help Seeking Behavior Amongst Women
with Socially Bothersome Urinary Incontinence
A. Nguyen, S. Aschkenazi, T. Gamble, P. Sand, R. Goldberg, J.
Beaumont, P. Stibbe, A. Ching, and S. Botros Evanston Incontinence
Center, Northwestern University, Feinberg School of Medicine,
Evanston, IL
Objective: Many prior studies have published rates regarding help
seeking among women with UI however, few have reported rates in
women who specifically report socially bothersome UI. We sought to
determine the current rates of help seeking among women with
socially bothersome urinary incontinence (UI), the reasons cited for
not seeking care and the factors promoting help seeking behavior.
Methods: A multi-item survey was administered to 1287 twin sisters
at the annual Twinsday Festival held in Twinsburg, Ohio during the
Self-Reported Natural History of Pelvic Organ Prolapse as
Described by Women Seeking Treatment
C. Lewicky-Gaupp, R. U. Margulies, K. Larson, D. E. Fenner, D. M.
Morgan, and J. O. DeLancey University of Michigan Hospital, Ann
Arbor, MI
Category: Epidemiology
Objective: To describe the self-perceived natural history of pelvic
organ prolapse (POP) in women presenting to a tertiary-care center.
287
Abstracts
years 2003–2006. Women were questioned about whether they felt
socially bothered by their incontinence, whether they sought care
from their physician, whether the physician brought up the issue with
them, and their reasons/perceptions for not seeking care. Logistic
regression for repeated binary measures was used to evaluate risk
factors accounting for shared genetics within pairs. Generalized
estimating equation (GEE) methodology was used for comparisons
between women who did and did not successfully seek medical
attention for bladder, bowel, or other pelvic symptoms.
Results: Of 1287 twin sisters, 21% had stress incontinence, 4% had
urge incontinence, and 27% had mixed incontinence. More women
with mixed UI reported socially bothersome symptoms than women
with pure stress or urge incontinence- 45% (N ⫽ 155), 21% (n ⫽ 270)
vs. 16% (N ⫽ 9), respectively. Over 60 – 80% of women with socially
bothersome UI failed to seek help from their physician- 63% versus
80% and 87% respectively for mixed, stress and urge incontinence. A
dramatically lower percentage of physicians brought up the issue with
their patient-9% and 2% for stress and urge UI respectively. Women’s
reports of socially bothersome symptoms were associated with help
seeking for all three types of urinary incontinence. Prior hysterectomy
(OR 2.95, 95% CI 1.11–7.80), severity of stress incontinence (OR 2.94,
95% CI 1.13–7.68) and Urinary Distress Inventory score (OR 1.03 95%
CI 1.01–1.06) predicted help seeking for mixed UI after multiple
regression. The most common reasons cited for not seeking help for
UI included the misconceptions that UI is a normal part of aging
(40 – 47%), a normal part of childbirth (19 –34%), that their physician
never asked (20 –27%), personal embarrassment (19 –25%) and
unawareness of treatment options (8 –21%).
Conclusions: This study indicates that the majority of women with
socially bothersome urinary incontinence do not seek help from their
physicians and very few are screened by their physicians. There is still
the common misconception that urinary incontinence is a normal part
of aging or childbirth. Educational efforts are desperately needed to
dispel the misconceptions associated with urinary incontinence and
increase physician involvement in screening in order to improve help
seeking behavior over the next decade.
Disclosures: A. Nguyen, None; S. Aschkenazi, None; T. Gamble,
None; P. Sand, Astellas, Indevus, Watson, Boston Scietntific, American
Medical Systems, Pfizer, Ortho-McNeil and Allergan, Consultant; R.
Goldberg, Boston Scientific, Consultant; J. Beaumont, None; P. Stibbe,
None; A. Ching, None; S. Botros, None.
Regional Variation in Pelvic Floor Surgery In Northern New
England
J. L. Whiteside,* M. A. McCutcheon,† K. Strohbehn,* E. A. Gormley,*
and P. D. Hanissian* *Dartmouth Medical School, Lebanon, NH,
†Dartmouth-Hitchcock Medical Systems, Lebanon, NH
Objective: To investigate regional variations in pelvic floor surgery
rates across northern New England.
Methods: Using state discharge data from the Uniform Hospital
Discharge Data Set (UHDDS), utilization rates in NH, MA, ME, and VT
for inpatient pelvic floor surgeries by ICD-9 procedures codes for
women 18 years and older from 2002 to 2005 were examined. These
rates were age and sex normalized to the NH/VT region using Claritas
demographic data establishing expected utilization rates. Observed
surgical utilization rates for published hospital service areas were
compared to the expected rate creating observed to expected ratios
288
TABLE.
Prevalence per year (%)
2002–2003
2004–2005
Urinary incontinence
Pelvic organ prolapse
0.023
0.020
0.016
0.021
(O:E). Individual regions within NH and VT were the variance in the
O:E ratios exceeded 20% were further analyzed by hospital type
(academic medical center, community hospital, critical access
hospital) and gynecology and urology provider frequency.
Results: The prevalence of pelvic floor surgery is displayed in the
table below. Of 13 regions across NH and VT, two regions
(northwestern ME and eastern NH seacoast) had observed pelvic floor
surgery rates that exceeded 20%. Neither region had higher than mean
provider frequency and of the four regions that had higher than mean
provider frequency one had observed surgery rates 20% below
expected. In the two high O:E regions, ⬍30% of women originating
from these regions had surgery at an academic medical center. For the
period 2002–2005, 69% of urinary incontinence surgery was done in
critical access or community hospitals. Fifty-four percent of pelvic
organ prolapse surgery was performed in critical access or community
hospitals. Seventy percent of coded rectocele and cystocele surgery
was done outside of the academic medical centers, whereas 70% of
apical suspensions were done in an academic medical center.
Conclusion: There are significant variations in pelvic floor surgery
rates across northern New England. These variations, where high, do
not follow the usual pattern of higher provider frequency. Overall the
prevalence of pelvic floor surgery in northern New England was low
between 2002 and 2005. Apical suspensions were performed more
often in academic medical centers.
Disclosures: J.L. Whiteside, Duramed Incorporated, Grant/Research
Support; American Medical Systems, Consultant; M.A. McCutcheon,
None; K. Strohbehn, Duramed Incorporated, Grant/Research Support;
E.A. Gormley, None; P.D. Hanissian, Duramed Incorporated,
Incidence and Clinical Characteristics for Urethral Diverticulum: A
Population-Based Evaluation
M. M. Nunn, S. A. El-Nashar, and C. J. Klingele Mayo Clinic,
Rochester, MN
Category: Anatomy.
Objective: To determine the incidence and clinical characteristics of
urethral diverticulum (UD) from a population-based study.
Methods: Using the record linkage system of the Rochester
Epidemiology Project (REP), women diagnosed with or surgically
managed for non-congenital UD in Olmsted County (OMC) Minnesota
were identified. Incidence of UD with its corresponding 95% confidence
interval (95%CI) in OMC was determined. Demographic, clinical and
surgical data were obtained from patients treated at Mayo Clinic.
Results: From January 1980 thorough December 2006 a total of 104
cases of UD were identified. Age adjusted incidence of UD in Olmsted
County was 0.79 per 100,000 (95%CI, 0.27, 1.30). Information was
available for 96 (92%) of women. Mean age at diagnosis was 46.2 ⫾
15.6 (95% CI, 42.9 – 49.5) 关range, 18.0 – 83.1 years) with mean BMI of
27.4 (range was 26.0 –28.7 kg/m2). Caucasian women represented
93.8 % (95% CI 87.0, 97.1). Median parity was 2 (range, 0,6 and IQR
was 1,3); cesarean was performed in 15.6% (95% CI 9.7, 24.2) and
forceps assisted delivery was reported in 1% (95% CI 0.1, 5.9).
Abdominal hysterectomy was reported in 21.9 % (95% CI 14.8, 31.1%)
and vaginal hysterectomy was reported in 8.4% (95% CI 4.3, 15.7).
Anterior colporrhaphy was performed in 7.4 % (95% CI 3.6, 14.6).
Most common presenting symptoms was urinary incontinence (61.7%,
95% CI, 51.6, 70.9) with mixed incontinence observed in 41.5% (95%
CI 32.1, 51.6). Other symptoms included dysuria, 59.1% (95% CI, 49.0,
68.6); dyspareunia, 47.9% (95% CI 36.7, 59.3); hematuria, 17.2 % (95%
CI 10.9, 26.1); & pelvic pressure, 43.6% (95% CI 34.0, 53.7). Tests
used for diagnosis are illustrated in figure. Out of 96, 82 patients
(85.4%) underwent surgical treatment. Most common procedure
performed in 70 out of 82 patients was diverticulectomy followed by
marsupialization in 10 women. Post operative recurrence occurred in
13 patients (15.9 %).
Conclusion: Urethral diverticulum has a true incidence of 0.79 per
100,000. Parity and abdominal surgery may be risk factors for
development. Clinical presentation makes diagnosis challenging.
Patients are treated primarily with surgery with minimal risk of
recurrence.
Disclosures: M.M. Nunn, None; S.A. El-Nashar, None; C.J. Klingele,
None.
The Correlation of Anterior Defect, Apical Defect and Posterior
Defect in Pelvic Organ Prolapse
S. Bai, Y. Jung, H. Jung, M. Jeon, and S. Kim Department of
Category: Anatomy.
Objective: The purpose of this study is to investigate the prevalence
that one leading point brings other compartments in pelvic organ
prolapse, and to analyze the correlation between each compartment.
Methods: Two hundred ten women who underwent surgery for
pelvic organ prolapse (stage ⱖ II) were included in this study from
Abstracts
January 2000 to December 2005 at Division of Female Pelvic Medicine
and Reconstructive Surgery, Yonsei University Health System in Seoul.
The patients were divided into three groups; 121 patients with
anterior leading point, 38 patients with apical leading point, and 51
patients with posterior leading point. Patients were examined in a
supine and a 45° upright position using the Pelvic Organ ProlapseQuantification system. The coexistence of other compartmental defect
was defined when the value of its representative point was greater
than -1. This study was approved by the Institutional Review Board of
Yonsei University Health System Center. The chi-square test, Fisher’s
exact test, ANOVA test and Pearson correlation were used for
statistical analysis by using the SAS package 8.2 version (SAS Inc.,
Cary, NC, U.S.A.). p ⬍ 0.05 was determined to be significant.
Results: In case of anterior leading point, posterior defect coexisted
with anterior defect independent of stage (stage II; 86.96%, stage III;
94.57%, stage IV; 100%) and the coexistence rate of apical defect
increased, depending on developing stage (stage II; 8.70%, stage III;
50.0%, stage IV; 83.33%). In case of apical leading point, the
coexistences of anterior and posterior compartments were 87.50% in
stage III, 100% in stage IV. Posterior leading point was associated with
anterior compartment generally in all stage (stage II; 42.11%, stage III;
76.67%, stage IV; 50.0%) and was associated with apical compartment
in far advanced stage (stage II; 5.26%, stage III; 3.33%, stage IV;
100%). As a result of the relationship between each compartments,
anterior, apical and posterior compartments are significantly
correlated with other compartments (p ⬍ 0.001).
Conclusion: Anterior, apical and posterior compartmental defects
are significantly associated with others. Therefore, identification and
correction of all support defects are important to prevent recurrence
when pelvic reconstructive surgeries are being planned.
Disclosures: S. Bai, None; Y. Jung, None; H. Jung, None; M. Jeon,
None; S. Kim, None.
The Relationship of Anterior Vaginal and Apical Position to
Post Void Residual Urine
K. S. Wong,* C. K. Wieslander,† and C. M. Tarnay* *UCLA Medical
Center, David Geffen School of Medicine, Los Angeles, CA, †Olive
View-UCLA Medical Center, David Geffen School of Medicine, Los
Angeles, CA
Category: Anatomy.
Objective: To investigate the association between the severity of
anterior vaginal and apical prolapse to post void urine volume.
Methods: The charts of all women who presented to the
Urogynecology Clinic between January 2006 to December 2007 were
reviewed. Demographic data were recorded in addition to the degree
of prolapse POP-Q points Aa, Ba, C and post void residual volume
(PVR). Patients with incomplete POP-Q assessment or improperly
measured PVR were excluded.
Results: 352 patients had the requisite information for analysis.
Median age was 54 years (range 26 – 80). Mean gravidity and parity
were 4.4 and 3.7 respectively. Mean BMI was 29.9 kg/m2. 149
women had previous genitourinary surgery (cesarean section,
hysterectomy, midurethral sling, or vaginal surgery). The median
PVR was 25 cc. Forty (11.4%) patients had a PVR ⱖ 100 cc with a
median of 132 cc.
Because the biologic distribution of PVR values is skewed we
examined the relationship between the logarithm of PVR and the
289
Abstracts
covariates via bivariate and multivariate (simultaneous) regression.
Considering 16 potential PVR predictors, we found that the position
of the apex/cervix (point C) significantly correlated with an increase
in PVR and also after controlling for the other significant covariates
(rate of change b ⫽ 4.7% increase in PVR/cm, p ⫽ 0.0007, see
figure). The other significant (p ⬍ 0.05) covariates were gravidity (b
⫽ 5.6%/pregnancy), post menopausal status (b ⫽ 32.5%) and surgical
history (vaginal, sling, hysterectomy). A positive correlation did not
exist, however, for the anterior vaginal position (points Aa, Ba; r ⬍
0.10, p ⬎ 0.15). There was no difference in mean PVR in patients
with versus without a hysterectomy (p ⫽ 0.236). This model posits
that, controlling for the other covariates; PVR increases 4.7% on
average for every one centimeter increase in point C.
Conclusions: Elevated PVR values have long been linked with
prolapse of the anterior vaginal wall. This study examines for the first
time the relationship of the severity of anterior vaginal/apical prolapse
to the volume of residual urine. We found that there is a linear
association of log PVR only to the anatomic variable: point C. There
was no association of PVR with points related to the anterior vaginal
wall.
Disclosures: K. S. Wong, None; C.K. Wieslander, None; C.M. Tarnay,
Bard Urologic, Consultant; Boston Scientific, Paid Instructor.
Determinants of Vaginal Length, Thickness and Width in
Korean Women
M. Kim, and S. Kim The Catholic University, Seoul, Republic of
Korea
Category: Anatomy.
Objective: The purpose of this study is to find out the interrelation
of the vaginal length, thickness and width measured by computed
tomography, and age, height, weight, delivery experience and method
in Korean women.
Methods: 185 women were examined and measured by the
computed tomography from March in 2006 to March 2008. For an
objective test each of two clinicians in obstetrics and gynecology
department and Radiology measured twice the vaginal length,
thickness and width in optical way. Women who have received total
290
hysterectomy or who have had cervical lesion were excluded in this
test.
Result: Of 185 Korean women the ages arrange from 14 to 81. The
average age is 38.5 ⫾ 10.5, and the average vaginal length is 85.9 ⫾
10.7 mm, and the average vaginal width is 31.1 ⫾ 3.6 mm, and the
average thickness is 17.6 ⫾ 2.7 mm, and the average weight is 57.1 ⫾
9.0 kg, and the average height is 158.8 ⫾ 4.5 cm. According to the
ages(14 year to 19, 20 to 49, above 50 year), there is no
differences in vaginal length and thickness in statistics, but there is
a meaningful statistic difference in vaginal width in accordance of
ages. And the parity does not make any statistical difference of the
length and thickness of vagina, however the width of vaginal done
by normal delivery is significantly wider than that by cesarean
section.
Conclusion: This research proves that there is no difference in the
vaginal length between Korean women and Western women. And it
also shows the length of vaginal has no association with parity, ages
and physical characters, but the width of vaginal has something to do
with the increasing of the age and delivery method. It is thought that
this is rather related to functional reasons by the relaxation or weakness
of muscles and supporting structures around, and is suggested to make a
further study of the functional aspects.
Key words: Total vaginal length, Total vaginal thickness, Total vaginal
width, Computed Tomography, Parity.
Disclosures: M. Kim, None; S. Kim, None.
Nerve Injury During Uterosacral Vaginal Vault Suspension: a
Cadaver Study
S. A. Collins,* S. A. Downie,† T. R. Olson,† and M. S. Mikhail†
*AECOM, Montefiore Medical Center, Bronx, NY, †Albert Einstein
College of Medicine, Bronx, NY
Category: Anatomy.
Objective: Postoperative pain after uterosacral vaginal vault
suspension (USVVS) arising in the S 2–S3 dermatome was described in
7 of 182 cases in a series by Flynn, et al in 2006. Symptoms were
attributed to entrapment of the posterior femoral cutaneous nerve
(PFCN). No anatomic studies have confirmed this. The objective of
this study is to describe the nerve(s) vulnerable to entrapment by
sutures placed during USVVS.
Methods: Female cadavers used for the Fall-Winter term 2007– 08
Clinical and Developmental Anatomy course at Albert Einstein College
of Medicine were the subjects of this study. Cadavers were preserved
on site using traditional embalming and curing methods. Subjects
were included if they had clearly identifiable uterosacral ligaments insitu. The left ligaments were selected for use in this study for
uniformity. Each ligament was measured from the center of the cervix
or vaginal cuff to the posterior-most point at which the ligament was
clearly identifiable. It was then marked off by thirds. Before the
students’ pelvic dissection, a 2– 0 prolene suture was placed in the
middle third of each ligament as described by Buller, et al in 2001.
The suture was then tied securely, and the ends were left long. After
the students dissected the pelvic viscera and retroperitoneal
structures, each suture was re-evaluated. If a nerve was included in
the stitch, further dissection was performed to identify and
characterize it. The PFCN was also identified.
Results: Twelve sutures were placed as described. Nine remained in
place after the students’ dissection. In one, an entrapped nerve was
identified. Further dissection, including midline hemisection of the
cadaver and disarticulation of the left hemipelvis and lower extremity,
was performed. The nerve entrapped was part of the autonomic
inferior hypogastric plexus and was dissected proximally to nerve
roots S2 and S3. Its fibers radiated only to the bladder and rectum.
The PFCN was also identified in this cadaver and was located far
laterally and posteriorly to the site of the suture. All findings were
confirmed with experienced anatomists (SD and TO).
Conclusions: The nerves closest to the sutures placed during USVVS
are autonomic nerves of the inferior hypogastric plexus. Entrapment
of S2 and S3 fibers in this plexus could cause referred pain in their
respective dermatomes. The PFCN is safely lateral and posterior to the
USVVS operative site and may not be responsible for the
postoperative pain previously described.
Disclosures: S.A. Collins, None; S.A. Downie, None; T.R. Olson,
None; M.S. Mikhail, None.
Passive Constitutive Properties of the Levator ANI Muscles in
Fresh Female Cadavers
M. A. Barker,* A. Nagle,† A. Pancholy,* S. Siddighi,* B. Haridas,† and
S. Kleeman* *Advance Urogynecology and Pelvic Surgery,
Cincinnati, OH, †University of Cincinnati, Cincinnati, OH
Category: Anatomy.
Objective: To develop a protocol for measuring passive biomechanical
parameters of the levator ani muscles (LA). Current finite element models
(FEM) lack true regional variations in the passive biomechanical process
of the LA essential to predicting tissue deformations. Our study describes
a protocol to measure these properties as a function of fiber direction in
fresh female cadavers.
Methods: Five iliococcygeus sections from two fresh female cadavers
were oriented in direction of muscle fibers, cut, and measured for gauge
length, width, and thickness in the unloaded state. Samples were
mounted in TestResourcesTM system, preconditioned, and extended
uniaxially to failure while measuring load and position every 0.03s. Data
obtained before tearing was used to calculate true stress (load/current
cross sectional area) and stretch ratio (current length/original length).
Exponential-linear model was fitted using least-squares method to the test
data to identify its parameters. Toe region or nonlinear portion of the
stress-stretch curve fits to equation 1, T ⫽ 2B1B2(eB2((␭*␭)⫹(2/␭)⫺3))
( ␭-(1/␭)), and the linear portion of the stress-stretch curve to equation 2,
T ⫽ E(␭)⫹i.. T true stress, ␭ stretch ratio, B1 (dimension of stress), B2
(dimensionless measure of nonlinearity), E, the elastic modulus
(dimensions of stress and is the slope of the linear portion of the curve),
and i, the intercept, are parameters calculated from data. B1 times B2 is
initial stress-stretch slope. Results generate passive properties of the LA
showing the force on the muscle for a given lengthening.
Results: Mean width, thickness and length were 4, 3.5, and 25 mm.
Toe region parameters had a mean of 0.24 ⫾ 0.36 MPa for B1 and 12
⫾ 17 for B2. Transition point between the toe region and the linear
region was 1.07 ⫾ .03. E had a mean of 2.2 ⫾ 2.6 MPa. Figure 1
compares the stress-stretch response of the theoretical model to the
experimental data.
Conclusions:
Passive morphologic properties of the LA can be
obtained and tested from fresh cadavers. Theoretical stress-stretch
curves generated are highly variable, but may be used to accurately
predict true LA in vivo properties. Our goal is to further quantify
Abstracts
regional variations in the biomechanical properties of the LA and
incorporate this data into a FEM.
Disclosures: M.A. Barker, None; A. Nagle, None; A. Pancholy, None;
S. Siddighi, None; B. Haridas, None; S. Kleeman, None.
Is the Dorsal Nerve of the Clitoris in Danger of Damage in
Performing the Outside-In Transobturator Sling Procedure?
S. B. Tate, J. J. Clark, J. Patterson, L. Harmon-Hardin, and R. D. Acland
University of Louisville, Louisville, KY
Category: Anatomy.
Objective: An anatomical study on fresh cadavers was done to
determine whether the dorsal nerve of the clitoris is at risk in
performing the outside-in transobturator sling procedure.
Methods: In 18 hemi-pelvis specimens from 10 bodies, the dorsal
nerve of the clitoris was identified. The distance between the nerve
and the superior margin of the ischio-pubic ramus was measured.
Results: The nerve runs medially in close approximation to the
ischio-pubic ramus. In no instance did the nerve follow an aberrant
course such that it traversed the obturator foramen, thereby being
exposed to damage by passage of the hook. The distance between the
nerve and the superior margin of the ischio-pubic ramus ( the inferior
margin of the obturator foramen) represents the closest possible
passage of the hook. The mean distance between the nerve and the
superior margin of the ischio-pubic ramus was 9.3 mm, range 3–14
mm. These measurements represent the most conservative
measurement anatomically possible in these specimens.
Conclusions: Since the introducer cannot pass through the ischiopubic ramus, but must pass above it, we conclude that the dorsal
nerve of the clitoris is not in danger of damage when performing the
outside-in transobturator sling procedure. American Association of
Clinical Anatomists Twenty-third Annual Meeting Podium Presentation,
July 12, 2006.
Disclosures: S.B. Tate, Honoraria Bard, Other; J.J. Clark, None; J.
Patterson, None; L. Harmon-Hardin, None; R.D. Acland, None.
291
Abstracts
A Cadaveric Model for Determing Soft Tissue Fixation Strength
for Pelvic Reconstructive Surgery
M. Jean Michel, P. A. Castillo, and G. Davila Cleveland Clinic
Florida, Weston, FL
Category: Anatomy.
Objective: To evaluate the maximum fixation strength of several
tissue structures within the female pelvis.
Design: Internal tissue fixation is becoming the preferred approach
for suture and graft attachment in pelvic reconstructive surgery. This
is evident in many of the surgical techniques employed in addressing
vaginal vault prolapse, paravaginal defects, vaginal enteroceles, and
urinary incontinence. However, there is limited data available describing
the strength of these pelvic structures. We conducted a descriptive study
assessing the strength of various tissue sites within the female pelvis in
cadavers.
Setting: A cadaveric anatomy lab.
Patients: Five cadavers were studied by 2 examiners.
Interventions: Tissue anchors were randomly placed at 23 sites on 9
anatomical structures: the sacrospinous ligament (SSL), between 0 –1
cm, ⬎1 or ⫾2 cm, ⬎2 or ⬍/⫽3 cm of its attachment onto the ischial
spine (IS); the arcus tendineus fascia pelvis (ATFP), between 0 –1 cm,
⬎1 or ⬍/⫽2 cm, ⬎2 or ⬍/⫽3 cm of its attachment onto the pubic
symphysis (PS); the ATFP, between 0-1 cm, ⬎1 or ⬍/⫽2 cm, ⬎2 or
⬍/⫽3 cm of its attachment onto the IS; the most anteromedial aspect
of the obturator membrane (OM), between 0 –1 cm, ⬎1 or ⬍/⫽2 cm,
⬎2 or ⬍/⫽3 cm below the insertion of the adductor longus muscle
onto the pubic ramis (PR); the most posteromedial aspect of the OM,
between 0 –1 cm, ⬎1 or ⬍/⫽2 cm, ⬎2 or ⬍/⫽3 cm below the
insertion of the adductor longus muscle onto the PR; the
iliococcygeus muscle (IL), between 0 –1 cm, ⬎1 or ⬍/⫽2 cm, ⬎2 or
⬍/⫽3 cm of its attachment onto the IS; the uterosacral ligament
(USL); the paraurethral fascia (PUF); the sacral promontory (SP);
Cooper’s ligament (CL); and the rectus abdominus fascia (RAF). An
independent examiner, a pelvic anatomist, assessed accuracy of
anchor placement. Maximum pull-out strength values were obtained
using a tensiometer. Reproducibility of tissue strength was assessed
using t-test analysis.
Measurements & Main Results:
TABLE. Overall Strength
SSL
ATFP
OM
IL
USL
PUF
SP
CL
RAF
Mean per structure (lbs.)
Standard deviation
6.56
4.38
4.47
5.57
7.37
1.55
3.75
4.93
6.10
2.23
1.99
2.54
2.04
2.39
1.01
3.04
2.72
2.12
Watson, AMS, Synovis, USSurgical, Pfizer, Astellas, Adamed, Other.
Urodynamics — Comparison Between Symptoms and Outcomes
Study
K. S. Rathod, S. Chattopadhyay, S. Argandhawi, and J. Swinhoe
Barking, Havering and Redbridge Trust, King George Hospital
(London), Essex, United Kingdom
Category: UDS.
Introduction: Urodynamic Studies (UDS) are used to investigate the
function of the urinary tract system in patients with sensory, urge and
stress incontinence. The study uses physical measurements including
urine pressure, flow rate and filling cystometry.21 The test is then
correlated with the patient’s history, examination findings and
therefore a diagnosis is reached.
Aim: The aim of our study was to investigate the correlation between
patient symptoms and results from urodynamic studies.
Methods: The study was carried out prospectively over a period of 4
months. Initially, patients who were selected for UDS investigation
were requested to complete a pre-designed questionnaire, which
included questions about their symptoms and prior knowledge of the
UDS. The same patients then underwent UDS on the same day. The
results of the UDS were then compared to the patients’ answers on
the questionnaire.
Results & Analysis: A total of 50 patients took part in this study. 22
(48.90%) patients presented with stress incontinence. 20 (44.40%) of
patients complained of urge incontinence. 9 patients out of 22 (41%)
who had presented with stress incontinence showed leakage and
therefore stress incontinence during the UDS. 8 patients out of 20
patients (40%) who had presented with urge incontinence
demonstrated detrusor instability during the UDS. 11 patients (24.4%)
had a completely normal bladder during the test. We also learnt that
84.44 – 86.70% of patients understood what was involved in the
procedure and 68.9% of patients had received some form of written
information before coming for the test. In addition, we also learnt that
only 11% of patients had been given a bladder frequency chart.
Conclusions: The main conclusions from our study are that less than
half of the patients with positive symptoms of stress or urge
incontinence have a positive result during UDS. Nearly a quarter of
patients have a completely normal bladder at UDS even though they
have positive symptoms of incontinence. Hence we can conclude that
there is poor correlation between symptoms and UDS.
Conclusions: Structures currently used for suture and mesh fixation
are all quite strong, with the SSL and USL being the strongest. This
data can now be used in creating computerized pelvic floor models
for new surgical techniques.
Disclosures: M. Jean Michel, None; P.A. Castillo, None; G. Davila, AMS,
292
1
Jarvis GJ, Hall S, Stamp S et al. An assessment of urodynamic examination in incontinent women. Br J Obstet Gynaecol 1980; 87: 893– 6.
Disclosures:
K.S. Rathod, None; S. Chattopadhyay, None; S.
Argandhawi, None; J. Swinhoe, None.
Stress Urinary Incontinence in Symptomatic Pelvic Organ
Prolapse: The Role of Urodynamics
S. Ahmed, R. Adam, and T. H. Duong Emory University School of
Medicine, Atlanta, GA
Category: UDS.
Objective: To investigate whether urodynamic testing can clearly
identify stress incontinence in women with symptomatic pelvic organ
prolapse.
Methods: We conducted a retrospective cohort study of women
with symptomatic pelvic organ prolapse (POP) seen between 1999
and 2007. Study approval was obtained from the Emory University
IRB. All women underwent multi-channel urodynamic evaluation and
had POPQ stage 2 or greater POP. Patients underwent a standardized
history and physical examination and completed a 3-day urinary diary
and post void residual volume measurement. Cases were patients with
complaints of stress urinary incontinence (SUI). Controls were women
with no symptoms of stress urinary incontinence. Data was abstracted
from the medical record and demographic data and clinical
information was reviewed. Statistical analysis was performed using the
SPSS statistical package.
Results: A total of 170 patients met the inclusion criteria for the
study. Eighty patients had no complaints of SUI and 90 patients had
symptoms of SUI. There was no statistically significant differences in
mean age (62.5 ⫾ 11.0 years vs. 59.1 ⫾ 11.7 years), parity (2.8 ⫾ 1.4
vs. 2.6 ⫾ 1.3) and prior hysterectomy (51% vs. 57%), respectively.
Women with complaints of SUI were more likely to have a positive
cough stress test (62% vs. 33%, p ⬍ 0.001). Women with complaints
of SUI were also more likely to have SUI on urodynamics (69% vs.
53%, p ⬍ 0.05). Patients with complaints of SUI had higher UDI-6
scores (9.3 ⫾ 4.3 vs. 6.6 ⫾ 3.7, p ⬍ 0.001). However, there was no
statistical difference between IIQ-7 scores (7.9 ⫾ 5.6 vs. 7.1 ⫾ 5.5, p
⫽ 0.4). Patients in the control group were more likely to have a more
advanced POPQ stage when compared to the cases (3.1 vs. 2.8, p ⬍
0.001).
Conclusions: Our data indicates that patients with more advanced
pelvic organ prolapse are less likely to have complaints of stress
urinary incontinence. In patients with symptomatic pelvic organ
prolapse and no complaint of stress urinary incontinence, formal
urodynamic testing is superior to a simple cough stress test.
Disclosures: S. Ahmed, None; R. Adam, None; T.H. Duong, None.
False Negative Rate of Urodynamic Testing in Diagnosing Occult
Incontinence in Patients with Advance Prolapse
S. Hessami, K. Hassan, X. Guan, F. Diarbakerli, and M. Yung Mount
Sinai School of Medicine, Saint Joseph Regional Medical Center,
Paterson, NJ
Category: UDS.
Objective: In this study we seek to determine false negative rate of
urodynamic testing in diagnosing occult incontinence (masked
incontinence) in patients with advance prolapse. Urinary incontinence
may be masked in patients with advance prolapse (Stage 3 or 4) due
Abstracts
to kinking of the urethra. Some of these patients develop urinary
incontinence after surgery for prolapse.
Methods: Retrospective chart review of 45 consecutive patients that
had undergone pelvic reconstructive surgery for advance prolapse
from 01/01/2006 to 12/31/2006. Inclusion criteria: All patients that
had undergone pelvic reconstructive surgery for advance prolapse,
and had no subjective complaint of incontinence. Exclusion criteria:
Patient with advanced prolapse with incontinence history.
Results: The 45 patients with advanced prolapse underwent
urodynamic testing (UD testing), and 29 were identified as having
occult incontinence and 15 having no incontinence. After pelvic
reconstructive surgery, 1 out of the 15 (6.7%) continent patients
complained of post-operative urinary incontinence.
Conclusions: 1 out of 16 patients (6.3%) with advanced prolapse
and negative urodynamic testing for occult incontinence, developed
urinary incontinence post-op. A false negative rate of approximately
7% should be quoted while counseling patient for surgery with
advance prolapse but no complaint of incontinence.
Disclosures: S. Hessami, None; K. Hassan, None; X. Guan, None; F.
Diarbakerli, None; M. Yung, None.
Unmasking Occult Incontinence in Advanced Vaginal Prolapse:
Which Reducing Tool Works Best?
R. Lefevre,* J. Pollak,† C. Apostolis,* V. Aguilar,* and G. Davila*
*Cleveland Clinic Florida, Weston, FL, †Florida Center for
Urogynecology, Hollywood, FL
Category: UDS.
Objective: To compare three separate prolapse-reducing tools in
unmasking occult incontinence in women with advanced vaginal
prolapse.
Background: Occult incontinence, although not an officially
recognized condition is a marker for an increased risk of developing
post-operative stress incontinence. Various tools may be utilized to
reduce advanced vaginal prolapse during urodynamics testing. Patient
discomfort and risk of urethral occlusion often determine the tool
utilized. Standardization of a single most effective method may
increase the detection rate of occult incontinence.
Methods: 36 patients with ⱖGrade 3 prolapse and no complaints of
incontinence were recruited at two clinical sites. They were separated
into two groups and randomized as to the order of prolapse-reducing
tools used during urodynamic testing. Group 1 (18 patients):
293
Abstracts
TABLE.
Occult Inc
Tool
Unreduced
Speculum
Pessary
Packing
p-value
Detection %
10.04%
47.21%
41.64%
30.10%
0.023
95% CI
2.42
31.72
26.83
15.6
33.41
63.27
58.13
50.08
MUCP (cm H2O)
Leak/No Leak
42.20/52.35
39.68/44.55
37.52/43.58
43.05/50.13
speculum/pessary/vaginal packing and Group 2 (18 patients):
unreduced /pessary/speculum. Demographic information, prolapse
severity, occult incontinence and urodynamic parameters were
measured with each prolapse-reducing tool. Changes in the maximal
urethral closure pressure (MUCP), functional urethral length (FUL) and
leak point pressure (LPP) were recorded in order to assess any
urethral occlusive effect. Comparisons between patients with
incontinence and those who did not leak were later made using the
SAS 9.1.3 and R2.6.1 software. A significance level of 0.05 was
assumed for all analyses.
Results: The overall average MUCP (cm H2O)/LPP (cm H2O)/FUL (cm)
were calculated for each tool respectively. Speculum: 42.25/52.59/2.81,
Pessary: 41.06/50.69/2.83, Packing: 48.72/40.33/3.02 and Unreduced:
50.67/76.47/2.96. The patients were then divided based on the detection
of occult incontinence and the rates are reported below by instrument.
Comparisons of MUCP/LPP/FUL were made between the leak and no
leak groups.
Conclusion: All three devices increased the unmasking of occult
incontinence, with a speculum having the highest rate. Urethral
occlusion by prolapse-reducing tools remains a valid concern. In this
study, only the pessary affected FUL most significantly. The speculum
or vaginal packing did not have any statistical significant effect on any
of the urodynamic parameters assessed.
Disclosures: R. Lefevre, None; J. Pollak, None; C. Apostolis, None;
V. Aguilar, None; G. Davila, AMS, Adamed, Synovis Astellas Watson
Zuidex Protein Polymer Technologies Duramed, Grant/Research
Support; AMS, Watson, Adamed, Consultant; Talks/honorarium:
Assessment of Two Postoperative Techniques Used to Predict
Voiding Efficiency After Gynecologic Surgery
J. Q. Pulvino, E. E. Duecy, G. M. Buchsbaum, and M. K. Flynn
University of Rochester Medical Center, Rochester, NY
Category: UDS.
Objective: To compare two techniques used to assess adequate
voiding function after gynecologic surgery.
Study Design: This prospective, randomized control cross-over study
was approved by the institutional review board. All patients preparing to
undergo inpatient or outpatient surgery for urinary incontinence or pelvic
organ prolapse through the division of Urogynecology at our institution
who met inclusion criteria were offered the opportunity to participate.
Preoperatively, all subjects underwent history and physical examination.
Data extracted from the medical records include demographic
information, past medical history, body mass index, menopausal status,
medications, preoperative history of incomplete bladder emptying (PVR
⬎ 100 cc), history of prolonged catheterization following surgery (⬎48
294
p-value
LPP (cm H2O)
Leak/No Leak
0.25
0.25
0.16
0.28
66.83/63.80
52.42/52.73
46.65/53.58
52.61/50.48
p-value
FUL (cm)
Leak/No Leak
p-value
0.8
0.96
0.23
0.81
2.87/3.06
2.75/2.85
2.53/3.02
2.98/2.93
0.58
0.5
0.004
0.82
hours) and urodynamic results. Following surgery, subjects were
randomized using sequentially numbered sealed opaque envelops into
one of two groups for voiding trials — Group A 关autofill (bladder allowed
to fill spontaneously until the subject reported a strong urge) followed by
backfill (bladder backfilled with 300cc of fluid and the subject asked to
void within 15 minutes)兴 or Group B 关backfill followed by autofill兴. The
postvoid residual was measured by straight catheterization within 15
minutes of each individual void. A void ⬎ 66.67% of the total volume
(voided volume ⫹ post-void residual) on the second of the two voids was
considered “passed”. Those subjects were discharged home without a
urethral catheter. Those voiding less than 2/3 of the total bladder volume
were discharged with an indwelling catheter and reassessed as an
outpatient. Subjects were followed for a total of 6 weeks postoperatively.
Results: A total of 108 subjects participated and complete data were
available for 92. The mean age of our population was 55 yrs (range
33– 81), 61% were postmenopausal, and 18% had undergone a prior
incontinence procedure. Type of surgical procedures performed in
this study: 35% incontinence repair only, 35% a prolapse repair only
and 30% both. Thirty-nine percent experienced retention resulting in
discharge with a transurethral catheter and outpatient follow-up. Of
the 56 subjects discharged without a catheter, none experienced
subsequent retention. Both voiding trials showed similar rates of
retention. There was a high rate of concordance between both
approaches in subjects with retention. However, the backfill trial
regularly resulted in a higher percentage of bladder emptying (mean
53% vs. 66% p ⬍ 0.0001). There was no difference in the void trial
results with regards to sequence. The only variable predictive of
postoperative retention was evidence of Valsalva voiding on
preoperative urodynamic testing.
Conclusions: Both autofill and backfill void trial techniques reliably
predict adequate postoperative voiding function. The backfill
technique results in more complete bladder emptying.
Disclosures: J.Q. Pulvino, None; E.E. Duecy, None; G.M. Buchsbaum,
Pfizer, Grant/Research Support; Ethicon, Consultant; M.K. Flynn, None.
Preoperative Urodynamics as a Predictor of De Novo Urgency
Following Placement Of A Tension-Free Vaginal Tape Sling
R. M. Ward,* D. Masterton,* J. D. Blume,† and D. L. Myers* *Women
and Infants’ Hospital/Warren Alpert Medical School of Brown
University, Providence, RI, †Center for Statistical Sciences, Brown
University, Providence, RI
Category: UDS.
Objective: To identify preoperative urodynamic indices that are
predictive of de novo urgency following placement of a tension-free
vaginal tape (TVT) sling.
Methods: We examined a retrospective cohort of women who
underwent a TVT sling between January 2004 and December 2006 at
our tertiary center. All subjects were identified by CPT code 57288.
Inclusion criteria were preoperative urodynamics and a TVT sling.
Exclusion criteria were subjective complaints of urinary urgency or
urge incontinence preoperatively, the diagnosis of overactive bladder
syndrome or detrusor overactivity, or known neurologic disease. De
novo urgency was defined as complaints of urinary urgency, urge
incontinence or overactive bladder in the absence of a urinary tract
infection at 6 –12 weeks postoperatively and persisting at 4 –12
months postoperatively. For subjects with postoperative urinary
retention requiring catheterization, de novo urgency was considered
present only if it persisted after resolution of the urinary retention.
We hypothesized that the volume of first sensation on preoperative
urodynamics would be an important predictor of de novo urgency.
ROC curves and logistic regression were used to assess the predictive
value of first sensation alone and in concert with other participant
characteristics and multichannel urodynamic indices (e.g., age, parity,
body mass index (BMI), menopausal status, tobacco use, caffeine
intake, comorbidities, concomitant surgical procedures, preoperative
postvoid residual and bladder capacity). Descriptive statistics were
reported for patient characteristics and predictors of de novo urgency.
Results: 69 of 462 women identified by CPT code met eligibility
criteria. Women with de novo urgency were of similar age, parity and
educational status as those without de novo urgency. The mean first
sensation for women with de novo urgency was 199.1 mL compared
to 143.4 mL for women without de novo urgency, with a mean
difference of 55.7 mL (95% CI 9 mL to 101 mL; p ⫽ 0.018). Higher
volume at first sensation was the strongest predictor of de novo
urgency (AUC ⫽ 71%, 95%CI 58% to 84%). As a dichotomous
predictor, first sensation at 144 ml has a sensitivity of 83%, specificity
of 59%, PPV of 41%, and NPV of 91% for determining future de novo
urgency. The combination of first sensation, BMI, and preoperative
postvoid residual slightly improved the overall predictive ability (AUC
76%, 95% CI 62% to 89%). In this model, higher BMI and higher
postvoid residual were associated with an increased risk of de novo
urgency. No other combination of participant characteristics and
preoperative urodynamic indices was as predictive in our cohort.
Conclusions: Patients with higher volumes at first sensation on
preoperative urodynamics are at an increased risk of de novo urgency
following a TVT sling.
Disclosures: R.M. Ward, None; D. Masterton, None; J.D. Blume,
None; D.L. Myers, None.
Comparison of Urethral Closure Pressure Pre and Post
Transobturator Tape Procedure
A. L. Smith, G. Siddiqui, and V. Ali University of Texas Houston
Medical School, Houston, TX
Category: UDS.
Objective: To compare maximal urethral closure pressure (MUCP)
pre and post surgical treatment of stress urinary incontinence with
the transobturator tape (TOT) procedure.
Methods: 22 consecutive patients who consented to inclusion were
enrolled and underwent TOT procedure (outside-in). These patients
underwent standard evaluation including voiding diary, UDI-6 and IIQ7 questionnaires, urinalysis, Q-tip testing, physical exam and
multichannel urodynamics at both preoperative and postoperative
visits. Urodynamic evaluation was performed in a standardized
Abstracts
fashion, and urethral pressure profiles were performed using an
automated puller at 1mm/sec. The mean MUCP was statically
compared in each patient pre & post procedure using a paired t-test.
Results: The patients had a mean age of 54.3 ⫾ 11.8, BMI of 29.9 ⫾ 5.6,
and a mean parity of 2.9 ⫾ 1.6. Mean time to follow up was 10 weeks (6
wks–5 months). 68% patients had prolapse and underwent concomitant
prolapse surgery. Measures of quality of life at follow up significantly
improved postoperatively. UDI-6 and IIQ-7 scores showed statistically
significant improvement after TOT (p ⬍ 0.001). MUCP measurements did
not show statistically significant change post op (p ⫽ 0.14.). Also MUCP
was unchanged in patients with no documented leakage on post TOT.
Patients who scored zero on both IIQ-7 and UDI-6 surveys after surgery
(100% satisfied) revealed no statically significant change in the MUCP.
Subgroup analysis of patients with prolapse grade 3 or greater, with
pessary placed for reduction of prolapse at preoperative urodynamics
(27% of patients), showed statistically significant decrease in MUCP after
TOT (p ⬍ 0.006).
Conclusions: This is a descriptive prospective study examining the
change in MUCP after TOT procedure, to attempt to understand the
mechanism by which TOT cures incontinence. In our study there was
no significant change in MUCP after TOT. This is in contrast to prior
studies showing a increase in MUCP after TVT procedure. Our data
supports the theory that the TOT replicates the normal anatomy of
the pubourethral ligaments and therefore would not affect urethral
pressure. Our analysis also reveals that the use of pessary for
reduction of prolapse at time of pre op urodynamics may falsely
elevate MUCP.
Disclosures: A.L. Smith, None; G. Siddiqui, None; V. Ali, None.
The Utility Of The Empty Supine Stress Test as a Predictor of
Intrinsic Sphincter Dysfunction
M. H. Parekh*, and T. Ginn† *GMC, Section of Urogynecology,
Danville, PA, †GMC, Danville, PA
Category: UDS.
Objective: To assess the utility of the Empty Supine Stress Test
(ESST) to predict presence of intrinsic urethral sphincter dysfunction
(ISD) without performing any invasive testing.
Methods: The study population included all patients seen by one
provider in the urogynecology clinic who had multi-channel
urodynamic testing. The initial evaluation included a thorough history
and physical exam that included gravity, parity, menopausal status,
voiding and incontinence issues as well as previous medical and
surgical care as well as medications. The patient then had an exam
that included a cough stress and a post void empty supine stress test
as well as a post voids residual urine volume and culture and
sensitivity. Standard urodynamic testing was done at a subsequent
visit. The test indices were evaluated as to the result of the ESST, the
presence of stress urinary incontinence and or detrusor instability,
maximal urethral closure pressure, prolapse correction, and post void
residual volume. Objective data collected from the exam and
urodynamics were maximum straining cotton swab angle, maximum
cystometric capacity, maximum urethral closure pressure, presence or
absence of stress incontinence and detrusor instability, prolapse
correction for testing, post void residual, and empty supine stress test
results. The data were analysed using SAS version 9.1 (SAS Institute;
Cary, NC). Two independent samples t-test, Chi-square test and
Wilcoxon two-sample test were used to determine which variables
were significantly associated with a positive test and maximum
295
Abstracts
urethral closure pressure of ⱕ 20 cm H2O. Two by two contingency
tables were used to calculate indices.
Results: Five hundred ninety six patients qualified to be included in
the study. One hundred sixty had a positive ESST and 436 had a
negative test. The data were further evaluated as to the post void
residual volume and calculations were performed on the total group
regardless of post void residual value and those with post void
residual ⬍ 100ml. Upon analysis Diagnostic indices for using stress
urinary incontinence and positive empty supine stress test as a test for
maximum urethral closure pressure ⱕ 20 cm H2O showed sensitivity
of 31.8% of detecting intrinsic sphincter dysfunction, specificity of
73.0% of excluding it and a positive predictive value of 5.5% and a
negative predictive value of 95.6%. The post void residual data show
that there was little difference between the positive and negative
groups as to the results even when all PVR were included.
Conclusions: The empty supine stress test has been touted as a
screening test for intrinsic urethral sphincter dysfunction. Given the
data collected from a broad range of patients, the utility of this
procedure as a screening test for intrinsic sphincter dysfunction is
questionable. With the data presented, we cannot recommend this
test as a screening test for intrinsic urethral sphincter dysfunction.
Disclosures: M.H. Parekh, Astellas, Speaker’s Bureau; T. Ginn, None.
The Significance of Opening Vesical Pressure as a Parameter to
Predict Intrinsic Sphincter Deficiency
S. Bai, K. Ryu, H. Jung, M. Jeon, and S. Kim Department of
Category: UDS.
Objective: The aim of this study is to verify the opening vesical
pressure as an independent parameter to detect intrinsic sphincter
deficiency and to evaluate the relationship among valvalsa leak point
pressure, maximal urethral closure pressure and opening vesical
pressure.
Methods: This retrospective study included 530 patients who were
diagnosed as urodynamic stress incontinence and underwent antiincontinence operation from January 2002 to March 2007 at Division
of Female Pelvic Medicine and Reconstructive Surgery, Yonsei
University Health System in Seoul. The patients were divided into two
groups: urodynamic stress incontinence with intrinsic sphincter
deficiency (group 1) and urodynamic stress incontinence without
intrinsic sphincter deficiency (group 2). Intrinsic sphincter deficiency
was defined as valvalsa leak point pressure ⬍ 60 cmH2O or maximal
urethral closure pressure ⬍ 20 cmH2O. This study was approved by
the Institutional Review Board of Yonsei University Health System
Center. The Student’s t-test, ␹2 test, Fisher’s exact test and receiver
operating character curve analysis were used for statistical analysis by
using SPSS, version 12.0 (SPSS Inc., Chicago, IL, U.S.A.). p ⬍ 0.05 was
determined to be significant.
Results: Of 530 patients, 110 (20.7%) and 420 (79.3%) were included
in group 1 and 2, respectively. There was no significant difference in
the patients’ characteristics except age, menopause status and
hormone replacement therapy history. Preoperative mean values of
valvalsa leak point pressure (51.6 ⫾ 27.8 cmH2O vs. 99.1 ⫾ 29.1
cmH2O), maximal urethral closure pressure (50.5 ⫾ 29.5 cmH2O vs.
66.5 ⫾ 28.0 cmH2O) and opening vesical pressure (29.5 ⫾ 24.9
cmH2O vs. 38.4 ⫾ 30.5 cmH2O) were significantly different between
the two groups (p ⬍ 0.01). Twenty cmH2O of opening vesical
pressure, as the cut-off value, had 70% of sensitivity and 34% of
specificity under the result of the area under the receiver operating
296
character curve as 0.585. There was a positive correlation between
maximal urethral closure pressure and opening vesical pressure
(p ⬍ 0.01).
Conclusion: Opening vesical pressure may be a useful parameter to
detect intrinsic sphincter deficiency, but there is a limitation to decide
intrinsic sphincter deficiency independently.
Disclosures: S. Bai, None; K. Ryu, None; H. Jung, None; M. Jeon,
None; S. Kim, None.
Does Aging Affect Sphincter Function Differently In Continent
Vs. Stress Incontinent Women?
K. Kenton,* T. Spirka,† R. Butler,‡ M. Damaser,§ and L. Brubaker*
*Loyola University Stritch School of Medicine, Maywood, IL, †Dept.
of Biomedical Engineering, Cleveland Clinic, Cleveland, OH, ‡Dept
of Quantitative Health Sciences Cleveland Clinic, Cleveland, OH,
§Dept. of Biomedical Engineering, Cleveland Clinic, Cleveland, OH
Category: UDS.
Objective: It is well known that aging decreases the number of
striated muscle fibers present in the female urethral sphincter
decreases with age (1,2). It is not known whether the sphincteric
aging process affects continent women less than stress incontinent
women. The main goal of this study was to quantify the effects of
aging on the amount of urethral pressure generated in response to the
increases in abdominal and vesical pressure and to assess this aging
difference by stress continence status.
Methods: Following IRB approval, standardized urodynamic data,
including vesical (Pves), abdominal (Pabd), and urethral (Pura)
pressures, were acquired from 2 well-characterized groups of women:
(1) continent women and (2) stress incontinent women. Urodynamic
pressure data, including Pabd, Pves and Pura, were obtained during
cough and valsalva manoeuvres at 0.2 second intervals at maximum
cystometric capacity (MCC). The ratios of Pura/Pabd (UPAP) and
Pura/Pves (UPVP) were calculated for every time interval during each
event and the maximum and minimum ratios for each type of event in
each patient was determined. The calculated variables were then
analyzed by the method of repeat measures mixed models, both as a
single cohort, then, separately based on stress continence status. Least
squares means were computed for the calculated variables in each
category. A coefficient for the continuous variable of age was
determined to provide an estimate of the change in the maximum and
minimum ratios per year. A p value of less than 0.05 was taken to
indicate a significant difference. Data is presented as mean (range).
Results: Standardized urodynamic data were obtained from 14
continent women and 12 stress incontinent women. We did not
detect significant differences in age or MCC between the two groups.
When the whole cohort was considered, the maximum and minimum
UPAP decreased by 0.038 and 0.007 per year increase in age,
respectively. Similarly, the maximum and minimum UPVP decreased
by 0.05 and 0.005 per year increase in age, respectively.. When
dichotomized by stress continence status, there was a significant
decrease in the maximum and minimum UPAP and UPVP with age in
the continent group. In contrast, neither maximum nor minimum
UPAP nor UPVP of stress incontinent women changed significantly
with age.
Conclusion: The findings of this study provide additional evidence
and quantify the degradation of urethral function in women with
aging. Clearly, as women experience a quantifiable decrease in
urethral function as they age, the response of the urethral sphincter
complex to increases in Pabd also decreases. The decline is more
pronounced in continent women than stress incontinent women.
References:
1) Am J Obstet Gynecol (2002) 186:351–355.
2) Ann. N.Y. Acad. Sci (2007) 1101:266 –296.
Funded by: NIH NICHD 5K23HD047325 & 5K24DK064044.
Disclosures: K. Kenton, Pfizer, Grant/Research Support; T. Spirka,
None; R. Butler, None; M. Damaser, AMS, TDOC, LLC, Grant/Research
Support; TDOC, LLC, Consultant; L. Brubaker, Pfizer, Allergan,
Post Void Dribbling: It’s Incidence and Risk Factors
T. S. Ablove University of Wisconsin, Madison, WI
Category: UDS.
Objective: The primary aim of this study is to determine the incidence of
post-void dribbling in women being evaluated for pelvic floor dysfunction.
The secondary aim of this study is to determine which other conditions are
present in women with symptoms of post void dribbling.
Methods: 163 consecutive patients who underwent urodynamic
testing during 2005 and 2006 were evaluated. The testing was
performed for symptoms of incontinence, overactive bladder, urinary
retention and pelvic organ prolapse in women scheduled for surgery.
All Subjects completed a medical history questionnaire, voiding
questionnaires and a voiding diary prior to their appointments. All
patients were specifically asked in the questionnaire and confirmed
during the interview “Do you ever leak urine upon standing after you
have finished voiding on the toilet?”
A complete pelvic exam was performed including evaluation for
prolapse, measurements of the genital hiatus and perineal body, levator
strength, qtip testing, and a residual urine culture. Parameters examined
included symptoms of post-void dribbling, stress incontinence, urge
incontinence and insensible loss. Menopausal status, hormone
replacement therapy status, Age, body mass index, residual urine volume,
genital hiatus length, and evidence of pelvic organ prolapse were
recorded. During urodynamic testing maximum urethral closure pressure,
urethral length, pressure transmission ratio, and documentation of
detrusor instability or urodynamic stress incontinence were recorded.
The data was analysed using multivariate analysis.
Results: 42% of patients presenting with pelvic floor dysfunction had
symptoms of post void dribbling. Few parameters demonstrated
statistically significant differences between patients with and without
post void dribbling. The incidence of post-void dribbling significantly
decreased with age (p value ⫽ .01). In pre and peri menopausal
women there was a significant increase in post void dribbling in
women with detrusor instability (p value ⫽ .02). In post menopausal
women there was a statistically significant increase in post void
dribbling with younger age (p value ⫽ .002), higher body mass index
(p value ⫽ .01), and longer genital hiatus length (p value ⫽ .05).
Conclusion: Post void dribbling is a very common symptom found
in women presenting with complaints of pelvic floor dysfunction. The
overall incidence of post void dribbling decreases with age. Pre- and
peri-menopausal women with detrusor instability are more likely to
also have complaints of post void dribbling. Post menopausal women
with higher body mass index and genital hiatus length are more likely
to have complaints of post void dribbling. Further studies are needed
to identify the cause and potential treatments of this under-recognized
form of voiding dysfunction.
Disclosures: T.S. Ablove, None.
Abstracts
Uroflow Measurements in Healthy Female Volunteers
S. Ahmed, M. Perevich, A. McNanley, and G. Buchsbaum University
of Rochester Medical Center, Rochester, NY
Category: UDS.
Objective: To determine normal parameters for micturition flow in healthy
female volunteers on repeated spontaneous voids. To compare
spontaneous voids of study subjects to prompted voids of patients
undergoing urodynamic testing as part of an incontinence work-up in
an urogynecology practice.
Methods: Female staff at a gynecology office were recruited to participate
in this study. Excluded were potential subjects who reported any difficulty
voiding, treatments for lower urinary tract problems and pregnancy. For two
consecutive weeks, all spontaneous voids by study subjects during work
hours were recorded by uroflowmetry. One void during the two weeks was
prompted. At each void, participants reported urge to void (scale 0–10),
whether it was a typical void (yes/no) and amount of fluid intake since the
last void including amount of caffeinated beverages.
Uroflow studies of age-matched controls were reviewed. Voids
⬎50 cc from consecutive patients undergoing urodynamic testing at
an urogynecology office practice were compared to staff voids.
Results: We analyzed 118 flow studies from 12 volunteer subjects.
Average voided volume was 306.2 ml (SD ⫾ 148.3 ml), the maximum
flow rate was 49.5 ml/sec (SD ⫾ 16.3 ml/sec, median 51.0 ml/sec),
average flow rate 16.6 ml/sec (SD ⫾ 5.6 ml/sec) and voiding duration
21.4 sec (SD ⫾ 12.0 sec). Prompted voids were lower in volume 161.5
ml (p ⬍ 0.001), maximum flow 38.1 ml/sec (p ⫽ 0.024) and average
flow 13.0 ml/sec (p ⫽ 0.028) than spontaneous voids. When corrected
for volume, these differences were not significant. Self-identified “not
typical” voids did not differ in any parameter from “typical” voids.
Voids not preceded by caffeine intake had an average volume of 272.8
ml while those following caffeine consumption averaged 344.9 ml
(p ⫽ 0.007). Strength of urge to void was volume dependent. No
subject perceived an urge of less than 3 with a volume ⬎300 ml or
greater than 7 with a volume ⬍300 ml.
The maximum flow in control patients seen in the urogynecology
practice averaged 28.9 ml/s (median 27.5 ml/sec), versus 49.5 ml/s in
volunteer subjects (p ⬍ 0.001). There were no significant differences
in voided volumes, duration or average flow.
Conclusions: Uroflow parameters vary widely between normal
volunteers. Within subjects, uroflowmetry parameters appear to be
predominantly volume-dependent. Uroflow studies from prompted
voids are representative of usual urination when corrected for volume.
Caffeine intake effects voided volume but no other parameters.
Maximal flow rates of patients undergoing urodynamic evaluation as
part of an incontinence work-up were significantly lower than both
prompted and spontaneous voids of volunteer subjects. Using a
maximum flow rate of 2 SD as a cut-off for normal, a peak flow rate
of less than 17 ml/sec would be abnormally low.
Disclosures: S. Ahmed, None; M. Perevich, None; A. McNanley, None; G.
Buchsbaum, Pfizer, Grant/Research Support; Ethicon, Consultant.
Is there a Difference in Intra-Abdominal Pressure in Women
with Pelvic Organ Prolapse?
D. D. Marshall,* C. K. Wieslander,† and C. M. Tarnay* *David
Geffen School of Medicine at UCLA, Los Angeles, CA, †Olive ViewUCLA Medical Center, Sylmar, CA
297
Abstracts
Category: UDS.
Objective: To investigate if there are differences in the intraabdominal pressures in women presenting with and without pelvic
organ prolapse.
Methods: This is a prospective case control study. Study patients
were identified as women presenting to the Olive View-UCLA
Urogynecology clinic with symptomatic pelvic organ prolapse (POP)
(POP-Q ⱖ St II). Controls did not have symptomatic POP (POP-Q ⬍ St
II) and presented with other pelvic floor complaints requiring further
diagnostic testing. All patients underwent multichannel urodynamic
testing with air-charged (T-DOC) pressure catheters followed by a
series of predesigned uniform maneuvers repeated in the upright
position: cough, valsalva, and standardized lifting maneuvers with 10
and 30 lb weights. Intrabdominal (rectal) pressures were recorded
throughout both routine and provocative testing.
Results: 11 cases and 8 control subjects were enrolled with mean
age 58.6 and 53.7 years respectively. There were no significant
differences between the groups in BMI, parity, smoking, menopausal
status or history of pelvic surgery. During cough and the lifting 10 lb
maneuvers, the prolapse group had lower median intra-abdominal
pressures (64.5 and 17 cmH20) compared to the control group (134.8
and 34 cmH20) (p ⬍ 0.10). In the valsalva and lift 30 lb maneuvers,
women with prolapse also had lower median intra-abdominal
pressures (p ⬎ 0.10 in this sample size)(see figure). Using linear
regression methods, we simultaneously (multivariately) evaluated the
relation between each of the pressure outcomes controlling for six
covariates and there were no statistically significant differences
between groups.
Conclusions: In this exploratory study women with POP displayed
lower intra-abdominal pressures during all provocative maneuvers.
The difference was significant during cough and lifting 10 lbs where
pressures exhibited were nearly half of those in the controls (47.5%
and 64.3% respectively). Intra-abdominal pressure was diminished in
women with prolapse during all other maneuvers but this trend will
need validation with a larger sample size. This study underscores the
need to further evaluate the impact of pressure exerted on the pelvic
floor and its potential relationship to pelvic support.
Disclosures: D.D. Marshall, None; C.K. Wieslander, None; C.M.
Tarnay, Bard Urologic, Consultant; Boston Scientific, Paid Instructor.
298
Comparison of Room and Body Temperature Saline During
Cystometric Testing: A Prospective Randomized Double-Blind
Trial
G. McWilliams,* M. Hill,† A. Gehrich,* T. McCartin,* and W. Larsen‡
*Tripler AMC, Honolulu, HI, †Blanchfield Army Medical Hospital, Ft.
Campbell, TN, ‡Darnall Army Community Hospital, Fort Hood, TX
Category: UDS.
Objective: To determine if sterile saline solutions infused at room
temperature significantly change bladder sensations and bladder
capacity during urodynamic testing.
Methods: This prospective randomized double blinded trial enrolled
volunteers undergoing routine complex urodynamic testing for
symptomatic lower urinary tract symptoms. Patients were enrolled at
time of testing and underwent two cystometries. They were
randomized to receive either body or room temperature fluid during
the initial cystometry, after which a pressure flow study was
performed. A second cystometry was performed with the other fluid
utilizing the same standard technique. The patient, physician and
investigator were blinded to the fluid temperature. Only the
technician in charge of fluid temperature was aware of the
differences. Data collected included volume at first sensation, strong
urge and maximum cystometric capacity (MCC). Urgency and pain
sensations were further evaluated by Lickert questionnaire at the
completion of each cystometry.
Results: Forty-eight patients have been enrolled between May 2006
and April 2008. The mean body and room temperature of the
solutions were 98.3oF and 80.8oF, respectively. The mean age was
49.1 ⫾ 12.9 years. The mean gravidity and parity were 2.8 ⫾ 1.5 and
2.4 ⫾ 1.3, respectively. The mean weight was 158.9 ⫾ 36.9 lbs. No
significant difference was found between the two solutions with regard
to volume at first sensation, strong urge and MCC, nor with sensory
urgency or pain. The number of idiopathic detrusor contractions was low
and not significantly different between solutions. Further analysis looking
at order of installation also revealed no significant difference in any of the
parameters measured.
Conclusion: The temperature of instilled fluid at the time of
cystometry does not appear to significantly alter measurements of
bladder sensation or capacity, nor does room temperature more
readily evoke idiopathic detrusor overactivity.
Disclosures: G. McWilliams, None; M. Hill, None; A. Gehrich, None;
T. McCartin, None; W. Larsen, None.
Significance of Positive Urine Dipstick in Asymptomatic
Patients with Advance Prolapse
S. Hessami, K. Hassan, M. Wang, and M. Yung Saint Joseph
Regional Medical Center, Paterson, NJ
Category: UDS.
Objective: We investigated the need to perform a urine dip on
asymptomatic patients with prolapse wearing pessaries. Patients
wearing pessary devices are routinely screened for urinary tract
infection using urine dipstick. Positive dipsticks (i.e. WBC, RBC,
Leukocyte. Esterase, Nitrites,) are sent for confirmatory urine culture
before initiation of therapy.
Methods: Retrospective chart review of 50 consecutive patients with
advance prolapse, stage 3 and 4, and using a pessary device. The
inclusion criteria were: all asymptomatic patients with positive urine
dipstick, advance prolapse, and using a pessary device. Patients were
excluded if they were symptomatic (urgency, frequency, dysuria, CVA
tenderness, fever or chills).
Results: 48 patients were included in the study. 15 patients (31.25%)
had urinary C&S of ⬎ 100,000, 10 (20.83%) had C&S of
10,000 –50,000, 12 (25%) with C&S ⬍10,000, and 11 (22.92%) had no
growth.
TABLE.
Organism (>100,000)
n
%
E.coli
Klebsiella
GBS
Staph
9
2
2
2
60%
13.3%
13.3%
13.3%
Conclusions: We found that 31% of asymptomatic patients with
positive urine dipstick, had a positive culture of ⬎100,000 organisms
and 21% of the asymptomatic patients had positive bacteruria growth
of 10,000 –50,000, a total of 25 patients (52% of all patients). Taking
into consideration the advanced age and co-morbidities of these
patients, a urine dipstick and confirmatory urine culture may be
recommended.
Disclosures: S. Hessami, None; K. Hassan, None; M. Wang, None; M.
Yung, None.
Double Blinded Randomized Comparison Between Lidocaine
Jelly And Surgilube® For Urethral Straight Catheterization And
The Q-Tip Test
O. Okafor and O. Harmanli, Tufts University Baystate Medical
Center, Springfield, MA
Category: UDS.
Objective: Urethral catheterization for post void residual volume
measurement and the Q-tip test are essential elements in the evaluation
of women with pelvic organ prolapse or urinary incontinence. Despite
lack of evidence, standard textbooks recommend use of Lidocaine jelly
for these examinations. Our objective is to compare the pain perception
between 2% Lidocaine jelly and Surgilube® when they are used as
lubricants for urethral straight catheterization and the Q-tip test.
Methods: All women who presented to a single urogynecologist’s
practice were offered to participate in this study which was approved
by our institutional review board. They were randomized to either
Lidocaine jelly or Surgilube. Both the examining physician and the
Abstracts
study participant were blinded to the lubricant assignment. After the
patient was placed in a lithotomy position, the assigned lubricant was
used for insertion of, first a straight catheter and, then a cotton swab
into the urethra. Wong-Baker FACES visual scale was used to rate pain
level before any other physical manipulation. Demographic and other
relevant information was also collected on all women. All variables
were compared between the groups. Based on our power analysis
targeting a power of 0.80 (␣ ⫽ 0.05), a total sample of 132 subjects
will be sufficient, as we believe that 20% difference in pain
perception between the groups is clinically significant.
Results: In this interim analysis, a total of 79 adult women were
randomized to either Lidocaine or Surgilube arm. There were 41
(51.8%) and 38 (48.1%) women in each group, respectively. Age,
parity, race, body mass index, number of vaginal births, frequency of
diabetes, vaginal atrophy, and estrogen use were similar between the
groups. There was no statistical difference in mean visual pain scores
between the lubricants (Lidocaine: 1.0 ⫾ 1.1 and Surgilube: 1.2 ⫾ 1.0,
p ⫽ 0.06). The percentage of women who felt any degree of pain was
also statistically similar: 26/41 (63.4%) in the Lidocaine, and 30/38
(78.9%) Surgilube groups, p ⫽ 0.13.
Conclusions: In this interim analysis of our data, Surgilube® was
found to be comparable to Lidocaine jelly in pain control during
urethral catheterization and the Q-tip test in women with pelvic floor
dysfunction. We intend to present our results with adequate power at
the annual meeting.
Disclosures: O. Okafor, None; O. Harmanli, None.
Urodynamics and Interstitial Cystitis/Painful Bladder Syndrome
D. N. Sastry* and K. E. Whitmore *UMDNJ/RWJ, Cooper University
Hospital, Camden, NJ, †Drexel University College of Medicine,
Philadelphia, PA
Category: UDS.
Objective: Interstitial cystitis/Painful Bladder Syndrome (IC/PBS) is a
diagnosis based on clinical symptoms including urinary frequency,
urgency and bladder pain or discomfort in the absence of other
pathologic findings. There is a paucity of literature discussing
urodynamics and its role in IC/PBS. The objective of this study is to
evaluate correlations between symptom severity in IC/PBS and objective
data from urodynamic testing (UDT) and cystoscopy.
Methods: Patients who underwent cystoscopy and bladder
overdistention from January 1, 2006 –July1, 2007 were identified by
procedure codes. All charts were reviewed for data points,
questionnaires as a quantification of symptoms, UDT results, and
results of cystoscopy and bladder overdistention. The questionnaires
included three, ten point visual analog scales for urgency, frequency
and pain, the O’Leary-Sant Symptom Index (ICSI) and Problem Index
(ICPI), and the Short Form Urinary Distress Inventory (UDI-6). From
UDT the following were recorded: first sensation, first desire to void,
strong desire to void, maximum cystometric capacity (MCC), presence
of detrusor overactivity (DO), post-void residual, and (in the past four
months) when pain was felt upon filling. From the cystoscopy and
overdistention, bladder capacity (BC), glomerulations (0 –5), presence
of Hunner’s ulcers and mast cell counts were recorded. Subjects were
excluded if malignancy was found during the procedure, if cystoscopy
was not performed for initial diagnosis of IC/PBS, or if questionnaires
were done greater than 6 months before the date of surgery. Pearson
correlations were performed between questionnaires, urodynamic
data, and cystoscopic findings.
299
Abstracts
Results: A total of 202 charts were reviewed, out of which 128 met
inclusion criteria. Forty-nine patients of 115 who underwent UDT
expressed pain or discomfort with filling, although not explicitly
asked, with a median volume of 125 cc. Significant correlations were
found between pain felt during UDT and pain Likert scores (p ⬍ .01)
and ICPI (p ⬍ .05). Significant negative correlations were found
between pain Likert scores and first sensation, first urge, strong desire
to void and MCC (p ⬍ .05). ICSI and ICPI scores negatively correlated
with first urge, strong desire to void, and MCC. Significant correlations
were also found between strong desire and anesthetic BC and
glomerulations, and between MCC and anesthetic BC and
glomerulations.
Conclusions: Symptom severity was significantly associated with
urodynamic parameters seen in earlier first sensation, first urge, strong
desire, and lower MCC. Symptom severity, anesthetic BC and
glomerulations were also related to these urodynamic parameters. A
subset of patients revealed a correlation between urodynamic pain
and pain Likert scores which may prove to be another indicator of
pain. Assessing pain upon bladder filling may be an important key in
differentiating the persistent urge to void in IC/PBS patients versus
patients with DO or urgency seen in overactive bladder patients.
Disclosures: D.N. Sastry, None; K.E. Whitmore, Astellas Pharmaceuticals,
Consultant; Medtronics, Grant/Research Support; Advanced Bionics,
Grant/Research Support; Ortho McNeil Pharmaceuticals, Consultant.
The Incidence of Urodynamically Observed Detrusor
Overactivity in Women With Interstitial Cystitis
E. J. Stanford,* M. Noone,† D. Elser,‡ and M. Moen† *University of
Tennessee, Memphis, TN, †Illinois Urogynecology, Park Forest, IL,
‡Illinois Urogynecology, Chicago, IL
Category: UDS.
Objective: To assess the incidence of urodynamically observed
detrusor overactivity (DO) in patients with interstitial cystitis (IC).
Methods and Materials: The urodynamic results of 90 women with
IC were retrospectively analyzed to evaluate the incidence of
urodynamically confirmed DO. UD measures of interest were the first
sensation to void, maximum cystometric capacity (Max), uroflowmetry
pattern, and postvoid residual (PVR). A pelvic pain/urgency (PUF)
questionnaire was obtained on each patient from which total score
and voids per day were assessed. Statistics were evaluated with a pvalue of ⬍ 0.05 indicating significance.
Results: Seventy-two (22) of the 90 IC patients (24.4%) were found
to have UD observed DO. The overall mean PUF score was 20.9 ⫾ 6.9
(range 9 –32). There was no significant difference in PUF scores
between patients with or without DO (p ⫽ 0.38). The average voids
per day was 13.3 ⫾ 4.6 (range 6 –20) with no difference between
groups (p ⫽ 0.77). The mean first sensation to void (53 ⫾ 52 mL;
range 9 –264 mL) and maximum cystometric capacity (249 ⫾ 118 mL;
range 124 – 600 mL) also showed no difference between groups
(p ⫽ 0.66; 0.29). A PVR of ⬎ 100 mL was noted in 10 IC patients
(15.4%) of which 4 were in the DO group. Normal voiding was noted
in most patients however, Valsalva type voiding was noted in 12.
Conclusions: This retrospective analysis shows that the incidence of
urodynamically observed detrusor overactivity in women with IC is
approximately 25%. PUF scores, uroflowmetry, and UD measures are
not predictive of the presence of urodynamic DO.
Disclosures: E.J. Stanford, None; M. Noone, None; D. Elser, None;
M. Moen, None.
300
The Response of Interstitial Cystitis/Painful Bladder Syndrome
to Intravesical Dmso/Lidocaine Treatments Using the Pain
Urgency Frequency Questionnaire
D. Shalom,* S. Lin,† and A. Klapper‡ *New York Presbyterian Weill
Cornell, New York, NY, †Weill Cornell Medical College, New York,
NY, ‡NY Downtown Hospital and Weill Cornell Medical College, New
York, NY
Category: Pain/IC.
Objective: To assess the response of patients with Interstitial Cystitis
(IC)/Painful Bladder Syndrome (PBS) treated with an intravesical
solution of DMSO and 1% lidocaine as measured by the Pain Urgency
Frequency (PUF) questionnaire.
Methods: Patients with a clinical history consistent with IC / PBS,
tenderness on palpation of the bladder and PUF scores ⬎12 were
prospectively evaluated for their response to the treatment regimen.
All patients completed the PUF questionnaire prior to initiation of
treatment (baseline). Patients were treated with weekly intravesicular
infusions of a solution containing 50 ml of Rimso-50 DMSO and 10 ml
of 1% lidocaine for a total of six weeks. Patients were asked to
complete the PUF questionnaire one week following each infusion.
Total, symptom, and bother scores following each weekly visit were
compared to baseline. Results were analyzed using the paired student
t test and the Wilcoxon signed rank test.
Results: 41 patients completed the six week treatment course. No
patients were lost to follow up. Mean scores at baseline and following
each treatment are seen in Figure 1. By week two there was a
significant decrease in the mean total score (17.0 ⫾ 4.9 vs 20.5 ⫾ 3.8,
p ⬍ .0001), symptom score (11.4 ⫾ 3.3 vs 13.4 ⫾ 2.3, p ⬍ .0001) and
bother score (5.7 ⫾ 2.2 vs 7.0 ⫾ 1.9, p ⬍ .0005) compared to
baseline. After six weeks of treatment the mean total score remained
significantly decreased (10.9 ⫾ 4.7 vs. 20.5 ⫾ 3.8, p ⬍ .0001). At the
end of six weeks all but one patient experienced a decrease in total
score.
Conclusions: Weekly infusions of DMSO and 1% Lidocaine
significantly improved total, symptom and bother scores as assessed
by the PUF questionnaire. Because all women in this study received
the treatment regimen, we cannot exclude the possibility of a placebo
effect. Based on this observational study, a larger controlled trial is
warranted to further evaluate the significance of this treatment
regimen.
Disclosures: D. Shalom, None; S. Lin, None; A. Klapper, None.
Patients with Painful Bladder Syndrome have Altered Response
to Thermal Stimuli And Catastrophic Reaction to Painful
Experience
Abstracts
Grant/Research Support; M. Heneghan, None; J. Senka, None; M.
FitzGerald, Pfizer, Grant/Research Support; Allergan, Grant/Research
Support; Medtronic, Grant/Research Support.
L. Lowenstein, K. Kenton, E. R. Mueller, L. Brubaker, M. Heneghan,
J. Senka, and M. FitzGerald Loyola Medical Center, Chicago, IL
Category: Pain/IC.
Objectives: The aim of the current study is to determine if subjects
with painful bladder syndrome (PBS) demonstrate increased dermal
sensitivity to thermal and vibratory stimulation and higher score on
Pain cathstrophizing scale (PCS).
Methods: PBS group included patients who had complained of
bladder pain rated at least 4 on a visual analogue scale (VAS) from 0
’no pain at all’ to 10 “worst imaginable pain”, on average over the
previous month, (2) their bladder pain has been present for at least 3
months. Control group: if they (1) have no symptoms of incontinence
on all subscales of the MESA, and (2) have a pain-free bladder. All
participants were tested for thermal and vibratory sensory threshold at
(C6, T1, T12 and S3) using TSA (Medoc, Israel). Continuous
suprathreshold stimuli were applied at T12 and S3 to all participants
for 60 seconds. Patients were asked to rank the intensity they sensed
the stimuli in between 0- not at all, 10 very intense stimuli after 10
second and again after 55 seconds from stimulation. All participants
filled out PCS, ICS and MESA questionnaire prior to the testing. Man
Whitney was used to compare independent continues variables in
between the two groups. Spearmen’s correlation was used for
independent variables.
Results: Twenty one participants, 10 control and 11 PBS patients
took part in the study. Median age was 47 (22– 69) years old. PBS and
asymptomatic patients were not statistically significant differ in their
age, BMI or parity (p ⬎ .05). PBS patient were less sensitive to warm
sensation in T-12 dermatome compared to asymptomatic control
(36.6 ⫾ 1.1 vs. 35 ⫾ 3, p ⬍ .02). Sensitivity for thermal and vibratory
stimuli were not significantly different in between the two groups at
all other sites. Habituation to supra-threshold stimuli was more
common in controls than in PBS patients, occurring in 8 (70%) vs. 1
(9%), p ⬍ .03 and 6 (60%) vs. 1 (9%), p ⬍ .02 at T12 and S3
dermatomes respectively. Specifically, one minute of tonic
(continuous) heat stimulus was perceived at a significantly more
intense level by PBS patients at both T12 and S3 dermatomes than by
controls (5 (range 0 – 8) vs. 1 (0 – 4), p ⬍ .006 and 5 (3– 8) vs. 2 (1– 8)
, p ⬍ .005 respectively). Total PCS score was significantly higher
among PBS than controls (30(0 –52), 1(0 –11),p ⬍ .0001 respectively).
We also found total PCS to be highly correlated with ICSI and ICPI
scores (rho ⫽ .77, p ⬍ .0001 and (rho ⫽ .8, p ⬍ .0001 respectively),
the duration of PBS symptoms (r ⫽ .65, p ⬍ .03) and thresholds to
warm stimuli at T12 dermatome (rho ⫽ .5, p ⬍ .021 respectively). The
scores for rumination and helplessness, subscales of the PCS, were
inversely correlated with the degree of habituation to suprrathreshold
stimuli at supra pubic area (rho ⫽ ⫺.462, p ⬍ .035, (rho ⫽ .⫺487,
p ⬍ .025 respectively).
Conclusions: PBS patients are less sensitive to warm stimuli in the
suprapubic area. Habituation mechanism to suprathrshold stimuli is
less frequent among patients with PBS symptoms. The longer the
patient has the symptoms the more they score on pain catastrophizing
scale
Disclosures: L. Lowenstein, Pfizer, Grant/Research Support; Astellas,
Grant/Research Support; K. Kenton, Allergan, Grant/Research Support;
Pfizer, Grant/Research Support; E.R. Mueller, Allergan, Grant/Research
Support; Pfizer, Grant/Research Support; L. Brubaker, Q Med,
Grant/Research Support; Allergan, Grant/Research Support; Pfizer,
Cost Effective Analysis of Diagnosis
Interstitial Cystitis
and
Treatment
of
S. A. Barr, A. C. Steele, M. T. McLennan, and F. Leong St. Louis
University, St. Louis, MO
Category: Pain/IC.
Objective: To perform a cost effective analysis conducted from a
societal perspective on three diagnostic approaches to interstitial
cystitis (from minimal to complex).
Methods: Outlined three diagnostic pathways for the evaluation of
interstitial cystitis and evaluated the direct costs as main outcome
measures, taking into account both the cost of the work-up for IC and
the excess cost attributed to false positive and false negative test
results. Algorithms described represent minimal, intermediate, or
complex diagnostic pathways. All algorithms included a new office
visit. The conservative algorithm includes a urine culture, a PUF
questionnaire, a potassium sensitivity test, and starting treatment with
elmiron if indicated based on the results of these tests. The
intermediate algorithm adds a cystoscopy/hydrodistension before the
decision to start elmiron is made. The complex algorithm includes all
modalities of the intermediate pathway, plus a potassium sensitivity
test and urodynamic testing; however, treatment with elmiron is only
started if indicated based on cystoscopy/hydrodistension. Data on
direct cost contributed to false positive and negative diagnoses were
calculated based on reported sensitivities and specificities of individual
diagnostic modalities.
Results: The cost of the minimal work-up to evaluate a patient for
IC-⬎$153.29(Regimen #1), an intermediate evaluation cost⬎$264.11(Regimen #2), and a complex evaluation-⬎$686.54(Regimen
#3) per patient.
The cost of missed diagnosis for each of these regimens was
calculated combining costs associated with false positive and negative
diagnosis, taking into account the sensitivity and specificity of the best
diagnostic modality used for each pathway. For each regimen total
cost was calculated by adding the cost of diagnostic work-up, the cost
of false positives, and the cost of false negatives. For each 1000
patients, the cost for regimen 1 is $2,258,606.50, regimen 2 is
$264,110, and regimen 3 is $686,540. This reflects both the higher
cost of a more complex diagnostic work-up and the higher direct
medical costs associated with increased false positives/negatives when
less sensitive and specific diagnostic modalities are used. This amount
does not reflect the cost associated with a failure to consider IC and
initiate a diagnostic pathway.
Conclusions: While diagnostic evaluation costs can differ by up to
$533.25 per patient depending on the number of tests obtained, the
greatest contributor per capita comes from costs to the patient for
missed diagnosis. A diagnostic pathway starting with a sensitive, lowcost screening tool such as the PUF questionnaire, followed by
confirmation with cystoscopy/hydrodistension prior to the initiation of
therapy, provides the most cost-effective method of approaching the
disease condition.
Disclosures: S.A. Barr, None; A.C. Steele, Boston Scientific, Paid
Instructor; M.T. McLennan, GSK, Speaker’s Bureau; F. Leong, Astellas,
Speaker’s Bureau.
301
Abstracts
Use of Cromolyn Sodium 4% Solution in Treatment of
Interstitial Cystitis Through Consecutive Bladder Instillations
P. Safaeian, J. Fariello, A. Rejba, S. Kellogg-Spadt, and K. E. Whitmore
Pelvic and Sexual Health Institute, Philadelphia, PA
Category: Pain/IC.
Objective: The objective of this study was to evaluate the effects of
consecutive bladder instillations composed of Cromolyn Sodium 4%
solution and 0.5% Marcaine on patients diagnosed with Interstital
Cystitis (IC).
Methods: Ten women with the diagnosis of IC through NIDDK
guidelines participated in this preliminary study. All subjects
completed four weekly bladder instillations consisting of 40 mg/4ml
Cromolyn Sodium 4% solution and 50ml of 0.5% Marcaine. Prior to
the first bladder instillation each patient completed a questionnaire
packet consisting of the O’Leary-Sant Interstitial Cystitis Symptom and
Problem Index (ICSI and ICPI), Urogenital Distress Inventory (UDI-6),
and the Visual Analog Scale (VAS) for Urgency and Pain. Student ttests were used to analyze quantitative variables.
Results: The mean age in this study was 43 with a range from 22 to
63 years of age, with an average BMI of 22.35. Six patients (60%) also
had a diagnosis of vulvodynia and/or high tone pelvic floor
dysfunction. When comparing the pre and post ICSI these patients
had a decrease in symptoms which was significant (12 to 7.5,
p ⬍ .01). Scores for the ICPI significantly decreased (13 to 8.15,
p ⬍ .01). The UDI-6 for bladder pain and incontinence resulted in
statistically significant lower scores with an initial mean of 8.83,
reduced to 6.23 following treatment (p ⬍ .05). These patients
experienced significantly less pain as seen with the VAS score for pain
(7.92, reduced to 4.56, p ⬍ .01). Finally, these patients had a decrease
in the sense of urgency following instillation treatment as established
with the VAS score for urgency (6.33 to 3.45, p ⬍ .01).
Conclusions: Patients receiving bladder instillations consisting of
Cromolyn Sodium 4% solution and Marcaine have shown statistically
significant improvement in ICSI and ICPI scores, the UDI-6 and the
VAS of both Urgency and Pain. These results indicate a potentially
useful tool in the treatment of Interstitial Cystitis and a double blind
cross-over study is pending.
Disclosures: P. Safaeian, None; J. Fariello, None; A. Rejba, None; S.
Kellogg-Spadt, Johnson and Johnson Pharma, Zestra Laboratories,
Consultant; Pfizer, Procotor and Gamble Pharma, Zestra Laboratories,
Glaxo Smith Kline Pharma, Speaker’s Bureau; K.E. Whitmore,
Advanced Bionics, Medtronic, Pfizer, Grant/Research Support;
Medtronic, OrthoMcNeil, Consultant; OrthoMcNeil, Astellas, Speaker’s
Bureau.
Post-Operative Pain Control Using Direct Continuous
Bupivacaine Infusion After Pelvic Organ Prolapse Repair
T. M. Muffly,* A. Lovegrove,* J. Reddoch,* D. Weber,* and R. Hill†
*University of Missouri at Kansas City, Kansas City, MO, †St. Luke’s
Hospital of Kansas City, Kansas City, MO
Category: Pain/IC.
Objective: To evaluate the efficacy of continuous local anesthesia on
decreasing pain scores for patients undergoing posterior colporrhaphy
and sacrospinous ligament fixation.
Methods: Patients undergoing elective pelvic organ prolapse
procedures were randomized into two groups: the experimental
302
group (n ⫽ 16) had catheters dripping 0.5% bupivacaine on either
side of the posterior vaginal wall with the tips implanted near the
sacrospinous ligament. The control group (n ⫽ 19) was treated with a
patient-controlled analgesia pump (PCA). Morphine was administered
intravenously via a patient-controlled analgesia pump in all patients. A
visual analog pain scale and a Wisconsin Brief Pain Inventory were
completed in the post-anesthesia care unit (PACU) and each postoperative day.
Results: The two groups were comparable with regard to patient age
(58.4 ⫾ 9.5 years vs. 61.3 ⫾ 9.9 years, p ⫽ 0.39), estimated blood loss
(182.5 ⫾ 130.7 mL vs. 122.1 ⫾ 79.4 mL, p ⫽ 0.10) and length of time
in the operating room (129.7 ⫾ 31.0 mins vs. 121.3 ⫾ 36 mins,
p ⫽ 0.68), experimental and control groups respectively. Patients in
the experimental group had significantly lower mean pain scores in
the PACU (3.1 ⫾ 2) compared with the control group (4.6 ⫾ 1.9,
p ⬍ 0.025). The maximum pain score in the post-anesthesia care unit
was also significantly lower in the study group compared with control
group (4.9 ⫾ 2.4 versus 6.4 ⫾ 1.8, p ⫽ 0.045). There was a trend
towards less morphine utilization on post-operative day zero in the
experimental group (15.2 mg ⫾ 12) when compared to the PCA
group (23.7 ⫾ 14, p ⫽ 0.071). There were no other significant
differences in pain scores noted for the duration of the hospital stay
or in narcotic or NSAID consumption.
Conclusion: Our data suggest that direct continuous local infusion of
bupivacaine after elective pelvic organ prolapse surgery results in
improved short-term pain control.
Disclosures: T.M. Muffly, None; A. Lovegrove, None; J. Reddoch,
None; D. Weber, None; R. Hill, None.
Chronic Pelvic Pain: Is Pelvic Floor Physical Therapy Effective?
B. Patterson, and S. T. Mahajan Case Western University, University
Hospitals of Cleveland, Cleveland, OH
Category: PT.
Objective: To determine the therapeutic benefit of transvaginal
pelvic floor physical therapy for the treatment of myofascial pelvic
pain, including patient subjective improvement in pelvic floor
symptoms.
Methods: After obtaining IRB approval, a chart review was
performed on all patients diagnosed with myofascial pelvic referred
for transvaginal pelvic floor physical therapy (PT) between January
2005 and December 2007. All women ⱕ 18 years old or pregnant
were excluded. Only patients with initial and at least one follow-up
visit pain rating were included in this review. Myofascial pelvic pain
was defined as point tenderness in any of the striated muscles of the
pelvic floor on vaginal examination. Pelvic floor PT included
transvaginal trigger point release, skin rolling, muscle stretching, and
biofeedback. Patient demographic information, medical history, and
pelvic floor symptoms (urinary urgency, frequency, incontinence,
pelvic pressure, constipation, and dyspareunia) were collected. Pain
scores were assigned at the initial visit using a verbal scale of 0 to 10
(0 ⫽ no pain and 10 ⫽ severe pain) or verbal description and again
collected at follow-up visits. Patients were asked to rate their degree
of improvement at PT completion which was then translated into one
of three categories: 1-significant improvement (ⱖ60% better, pain
score ⱖ75% improved, or “significant” improvement); 2-moderate
improvement (⬍60% but ⱖ30% better, pain score 30%–74% improved,
or “moderate” improvement); and 3-minimal improvement (⬍30%
better, pain score ⬍30% improved, or “minimal” or “no”
improvement). Statistical analysis included the Student’s T test and chi
square. Statistical significance was set at p ⱕ 0.05 and the study was
powered to detect a 60% difference in pain scores.
Results: Of the146 patients referred for pelvic floor PT, 75 (51%)
were included in this study. Mean patient age was 48 years and 81%
were parous. Sixty-one (81%) patients reported pelvic floor
complaints, including dyspareunia (49%). Twenty-five (33%) patients
presented for all three follow-up visits, while 26 (35%) had an initial
and midway visit and 24 (32%) only an initial and final visit. Seventyfive percent of patients had an initial pain score of ⱖ7, citing ‘vaginal’
(37%), ‘pelvic’ (15%) and ‘abdominal’ (15%) pain as the most common
sites. Thirty-two (43%) patients had follow-up pain scores while 43
(57%) gave a percentage or verbal description of pain improvement.
Pain improvement was proportional to the number of PT visits
completed, with a median pain score of 5 at mid-treatment and a
median pain score of 2.5 after completing of PT. Forty-four (71%)
patients reported improved pelvic floor symptoms and 17 (45%) noted
improved dyspareunia.
Conclusions: Pelvic floor PT is an effective treatment for myofascial
pelvic pain. Given the paucity of information on sources of pelvic
pain, this study demonstrates the important role of myofascial pain
and the efficacy of pelvic floor PT as a treatment.
Disclosures: B. Patterson, None; S.T. Mahajan, None.
Is Levator Myalgia a Syndrome of Pelvic Floor Dysfunction?
S. I. Diaz,* E. J. Fuller,* T. Colin,† and J. T. Benson* *Indiana
University/Methodist Hospital, Division of Female Pelvic Medicine
and Reconstructive Pelvic Surgery, Indianapolis, IN, †Clarian
Health, Medical Research, Indianapolis, IN
Category: PT.
Objective: To compare the results of clinical assessment of the
pubococcygeus muscle between control subjects without pelvic pain
and females presenting with chronic non-cyclical pelvic pain and
tender pelvic floor muscles (levator myalgia).
Methods: The study was conducted in 10 controls and in 9 cases with
levator myalgia (LM). Participants underwent history and completed the
Pelvic Floor Distress Inventory (PFDI-20) and the Beck depression
inventory. Uroflow (Urocap III, Laborie), postvoid residual with
ultrasound (Ultramark 4 plus, ATL), pelvic floor physical examination,
anal manometry, recording length and strength of Kegel contraction
(Endotek OM-3), and surface kinesiologyc electromyography (EMG, with
a vaginal sponge electrode) at the pubococcygeus muscle to record total
electrical activity as root mean square were performed. We evaluated a
trigger point with concentric needle EMG (Dantec Keypoint, Medtronic)
for insertional, spontaneous, and voluntary activities. The needle EMG
was used to assign one of the physiologic conditions based on the
interpretation of the following parameters: recruitment, morphology, and
variability.
Results: In the control group, 2 had significant pelvic floor
dysfunction and risk factors for EMG abnormalities (prolapse and
sacral radiculopathy secondary to spinal cord tumor surgery).
Eliminating these 2 from the comparison left 8 controls. Mean ages
were 28 and 35 years for the controls and cases, respectively. Cases
had a higher BMI (29.2, p ⫽ 0.038) and higher gravity and parity (3,
p ⫽ 0.002) than controls. All of the following were more prevalent in
the cases and were statistically significant differences as compared to
the controls: urinary hesitancy (p ⫽ 0.035), slow flow (p ⫽ 0.048),
dysuria (p ⫽ 0.038), frequency (p ⫽ 0.034), urgency (p ⫽ 0.002),
Abstracts
straining with bowel movements (p ⫽ 0.005), incomplete bowel
emptying (p ⫽ 0.005), dyschezia (p ⫽ 0.006), and higher scores on
the Beck inventory (8.9, p ⫽ 0.02). There was a 77% prevalence of
abnormal needle EMG findings in the group with LM. Seven were
given a pathophysiologic classification: 3 (33%) progressive
neurogenic, 4 (44%) chronic neurogenic and 2 (22%) were normal. In
contrast, there were 2 controls (25%) classified as chronic neurogenic.
Using a one-sided Fisher’s Exact test, we found a statistically
significant difference in the needle EMG results (p ⫽ 0.044).
Conclusions: In this pilot study, neuropathy was seen in 77% of the
patients with LM. No myopathies were seen. It is not clear whether
these are primary or secondary disorders. This may result from nerve
compression from the muscle spasm or primary nerve injury that
evolves into end-organ pain. These results may also be used to
preliminary expand treatment options for patients with LM to include
therapies directed at both neuropathic pain and local muscle
treatment. This calls for a comparative study of muscle rehabilitation
vs. other treatments such as neuromodulatory drugs.
Disclosures: S.I. Diaz, None; E.J. Fuller, None; T. Colin, None; J.T.
Benson, None.
Vaginal Diazepam Suppository use in the Treatment of High
Tone Pelvic Floor Dysfunction: A Retrospective Review
P. Safaeian,* M. Rogalski,† S. Kellogg-Spadt,* J. Fariello,* A. Rejba,*
and K. E. Whitmore* *Pelvic and Sexual Health Institute,
Philadelphia, PA, †Drexel University College of Medicine,
Philadelphia, PA
Category: PT.
Objective: This a retrospective chart review evaluating the effects of
vaginal diazepam suppositories in the treatment of high tone pelvic
floor dysfunction (HTPFD).
Methods: Seventeen women were diagnosed with HTPFD through
physical exam, confirmed with perineometry and completed the
Female Sexual Function Index (FSFI) prior to treatment. All subjects
used 5 mg compounded diazepam suppositories in a silica gel base
vaginally for an average of 40 days with a range from 30 to 60 days.
Upon follow-up, physical exam, perineometer score and FSFI were
completed. HTPFD diagnosis was determined with initial baseline
perineometer score of 40cm of water or greater. Physical exam made
note of pain with palpation of the levator group with scores ranging
from 1– 4. A score of 4 indicating severe pain, 3 for moderate, 2 for
mild and 1 indicating pressure/absence of pain. Student t-tests were
used to analyze quantitative variables.
Results: Thirty two charts were evaluated, 17 were included.
Exclusion was based on receiving trigger point injections into the
pelvic floor or physical therapy treatment during this period. The
average age was 32.18, (19 to 50 years). The average Body Mass Index
(BMI) score was 25.64. Six (35.3%) subjects were not sexually active
before or after the study, four (23.5%) became active following
treatment and seven (41.2%) were sexually active throughout. The
initial baseline perineometer score was 69.31, following treatment it
was reduced to 49.92, the mean difference between baseline scores
was reduced by 19.39 cm of water. There was a significant reduction
of pain with palpation of the levator group following treatment, with
a mean of 3.17 prior to and 2.25 following treatment (p ⬍ 0.0001). A
decrease in the Pain domain of the FSFI was noted in the subset of
patients sexually active throughout treatment (7). Prior to treatment
the average Pain domain score was 4.31 (SD 1.98) which reduced to
2.74 (SD 1.92) following treatment. No side effects were noted among
these patients.
303
Conclusions: This study illustrates diazepam suppository use to be
safe and efficacious in the treatment of HTPFD. Perineometry scores
and physical exam significantly improved and a subset of sexually
active patients showed significant improvement in the Pain domain of
the FSFI and four patients became sexually active following treatment.
A double blind cross-over study is pending.
Disclosures: P. Safaeian, None; P. Safaeian, None; M. Rogalski, None;
S. Kellogg-Spadt, Johnson and Johnson Pharma, Zestra Laboratories,
Consultant; Pfizer, Proctor and Gamble Pharma, Zestra Laboratories,
Glaxo Smith Kline Pharma, Speaker’s Bureau; J. Fariello, None; A.
Rejba, None; K.E. Whitmore, Advanced Bionics, Medtronic, Pfizer,
Grant/Research Support; Medtronic, OrthoMcNeil, Consultant;
OrthoMcNeil, Astellas, Speaker’s Bureau.
Pelvic Muscle Function in Women Presenting with Pelvic Floor
Disorders
M. D. Moen, M. B. Noone, B. J. Vassallo, and D. M. Elser Illinois
Urogynecology, Ltd, Park Ridge, IL
Category: PT.
Objective: To determine knowledge, prior instruction, frequency of
performance and ability to correctly perform pelvic muscle exercises
(PMEs) in a group of women presenting for evaluation of pelvic floor
disorders.
Methods: Three hundred and twenty-five women presenting for
urogynecologic examination were questioned concerning knowledge
and performance of pelvic muscle exercises. Patients were examined
to determine their ability to perform appropriate pelvic muscle
contractions and contraction strength was reported using the Oxford
classification ranging from 0 to 5.
Results: The average age of the women in this study was 57.8 years.
236 women (73%) stated they had heard of pelvic muscle exercises,
but only 81(25%) stated they were currently performing them. 136
women (42%) stated they had been instructed to perform PMEs, with
85 (63%) stating they had received verbal instruction only and 52
(38%) stating they had been told to start and stop their urine stream.
Table 1 lists the percentage of patients with each level of PFM
strength. 38 patients (11.7%) were noted to perform Valsalva when
attempting PMEs and 144 (44.3%) were noted to have uncoordinated
contractions when attempting PMEs. Increased age, parity and stage of
pelvic organ prolapse were associated with worsening pelvic muscle
strength.
Conclusions: The majority of women with pelvic floor disorders are
familiar with pelvic muscle exercises, but do not perform them or are
unable to perform them correctly. Opportunity exists to increase the
use of PMEs in women with pelvic floor disorders, but because of the
high prevalence of pelvic muscle dysfunction in this group of women,
more intensive instruction and physiotherapy may be required in
order to achieve the potential benefits of PMEs.
Disclosures: M.D. Moen, Ethicon, Consultant; Astellas, Speaker’s
Bureau; Allergan, Speaker’s Bureau; M.B. Noone, Ethicon, Consultant;
Boston Scientific, Consultant; Ortho-McNeil, Speaker’s Bureau;
Novartis, Speaker’s Bureau; Allergan, Speaker’s Bureau; B.J. Vassallo,
Boston Scientific, Consultant; Ortho-McNeil, Speaker’s Bureau;
Novartis, Speaker’s Bureau; D.M. Elser, Ethicon, Consultant; Boston
Scientific, Paid Instructor; Novasys Medical, Grant/Research Support.
TABLE.
Contraction Strength
0 1
2
3
4
5
Percentage of patients 16% 32.6% 28% 14.2% 7.4% 1.8%
304
Pelvic Floor Muscle Training During Pregnancy: A Randomized
Single-Blind Controlled Study on Improvement of Antenatal
and Postpartum Lower Urinary Tract Symptoms
F. Dökmeci,* S. Bayramov,* B. S. Tur,† V. Bayramov,* M. Seval,* and
H. Gok† *Ankara University School of Medicine, Department of OB
& GYN, Ankara, Turkey, †Ankara University School of Medicine,
Department of Physical Medicine and Rehabilitation, Ankara,
Turkey
Category: Childbirth.
Objective: To examine the role of antenatal pelvic floor muscle
exercises on pelvic floor muscle strength, lower urinary tract symptoms
and quality of life scores during pregnancy and early postpartum period.
Methods: In this study, nulliparous pregnant women who attended
to Ankara Medical Faculty antenatal outpatient-clinic between 2005
and 2007, were studied in a prospective trial. The subjects (n ⫽ 40)
were randomized to a pelvic floor muscle training (PFMT) intervention
group and control group. Twenty four pregnant women, eleven in
exercise group and thirteen in control group, attended regularly all of
their control visits at 12th, 22th, 32th gestational weeks and postpartum
6th week. During the visits, valsalva- urethral rotation angle assessment
with perineosonography were performed. Pelvic floor muscle activity
was examined by using electromyography biofeedback with a vaginal
electrode. Examinations were carried out in lying position with knees
flexed and legs supported on pillows after a warm-up of 8 –10 low
intensity short contractions. Maximal high intensity muscle contractions
were recorded on three trials each lasting 10 second. The best trial was
considered for calculation. All study subjects were asked to complete
UDI-6, IIQ-7 and PISQ-12 questionnaires to determine their lower urinary
tract symptoms (LUTS), sexual function and quality of life scoring.
Results: Urethral rotation angle measures were decreased during
pregnancy and early postpartum period progressively, in PFMT group
(p ⬍ 0.05). Maximum pelvic floor muscle strength was increased significantly
between first and third visits in PFMT group (p ⫽ 0.03) and between first
and postpartum visits in control group (p ⫽ 0.03). Although we observed
no significant differences in scores of IIQ-7 and PISQ-12 during pregnancy
and postpartum visits.We observed significant decrease in scores of UDI-6
between first and 3rd trimester (p ⫽ 0.02) and between first trimester &
postpartum 6th week (p ⫽ 0.001). We did not observe any significant
decrease in UDI-6 scores between first & last trimester visits in control group,
however significant improvement was observed after postpartum period
(p ⬍ 0.001). This study showed that both UDI-6 scores and maximum
muscle strength were improved before and after the delivery either in
PFMT and control groups. However due to inter trimester results in
PFMT group, the improvement in UDI-6 scores, maximum muscle
strength and urethral rotation angle were also statistically comparable
from the control group.
Conclusions: The results of this study is promising to show the
positive impact of pelvic floor muscle training on pelvic floor muscle
strength during pregnancy which provides less valsalva-uretral rotation
angle also. These objective measures correlates well with improvement of
lower urinary tract symptom scoring during pregnancy progressively. A
larger randomized study is needed to show the effectiveness of PFMT
during pregnancy and postpartum period on muscle activity and
improvement of LUTS.
Disclosures: F. Dökmeci, None; S. Bayramov, None; B.S. Tur, None;
V. Bayramov, None; M. Seval, None; H. Gok, None.
Attitudes and Practice Patterns of Obstetrician-Gynecologists
Towards Cesarean Delivery on Maternal Request at a Single
Tertiary Care Institution
A. M. Friedman, A. Jayakrishnan, A. Davidson, and V. W. Sung
Women and Infants’ Hospital, Providence, RI
Abstracts
Objective: To describe the attitudes and practice patterns of
obstetrician-gynecologists regarding cesarean delivery on maternal request
(CDMR) at a tertiary care hospital.
Methods: We identified all obstetrician-gynecologists at our institution
practicing obstetrics from June 1 to August 1, 2007. Following
recruitment, obstetricians completed a survey regarding practice patterns
and attitudes towards CDMR, including knowledge regarding the NIH
State-of-the Science Conference on CDMR. Demographic data of the
physicians participating was collected, which included race, age, gender,
practice type, years in practice, marital status and number of children.
Patient population demographics as described by the obstetrician were
also collected. Descriptive statistics were performed as appropriate.
Results: We identified 70 eligible obstetrician-gynecologists. All were
enrolled, and 66 (94.2%) returned completed surveys. The mean age
of respondents was 45.0 (std 8.8), mean children was 2.2 (std 1.4),
mean years in practice was 13.1 (std 9.2), 60.6% were female, and
87.9% were white. 82% described themselves as private practice
generalists, and 67.7% reported performing ⱖ100 deliveries per year.
Regarding practice patterns, 81.5% reported ever performing CDMR
and 69.7% reported patients requested CDMR more frequently over
the past year. 58.5% reported performing CDMR more often, and
41.5% recently started performing the procedure. There were no
reports of discontinuing CDMR or performing it less often. 83.3%
believed women have the right to choose CDMR and that it is ethical
(90.9%). Most respondents believed CDMR prevents perineal injury
(86.1%), fecal incontinence (72.7%), urinary incontinence (59.1%),
pelvic organ prolapse (62.1%), and dystocia and birth trauma (63.6%).
The majority also believe CDMR causes increased operative risk with
future cesarean deliveries (98.5%), increased risk of uterine rupture
(93.9%) and placenta accreta or previa (97.0%), and increased health
care costs (74.2%). 71% would not choose CDMR for themselves or
recommend it to a partner. Respondents with patient populations
greater than 20% Latino or 20% African-American, were significantly
less likely to believe women have the right to choose CDMR(p ⫽ 0.03
and p ⫽ 0.009 respectively), and were less likely to have ever
performed CDMR (p ⫽ 0.05 and p ⫽ 0.002 respectively). Physician
age, practice type, and years practicing obstetrics were not associated
with differences in attitudes or practice patterns of CDMR. 42% of
respondents were familiar with the findings of the NIH State-of-the
Science Conference on CDMR, and of those 89% reported the
conference did not change how they felt about the practice.
Conclusions: Most obstetricians in this study population consider
CDMR ethically acceptable, have performed the procedure, and report
an increase in patient request. Obstetricians with larger minority
populations may be less comfortable with CDMR and less likely to
perform the procedure.
Disclosures: A.M. Friedman, None; A. Jayakrishnan, None; A.
Davidson, None; V.W. Sung, None.
Methods:
Nulliparous women at ⱖ34 weeks were surveyed.
Practices from 4 hospitals in 8 cities were used, including midwives.
We surveyed demographic information as well as Likert-scale (1–5
with 5 most concerned) questions about their level of concern
regarding complications during labor, delivery and postpartum. Chisquare with Fisher’s exact, student’s t-test and logistic regression were
used as appropriate.
Results: The mean age of the 294 respondents was 28.4 years
(⫾6.13 yrs SD) and the mean gestational age was 35.3 weeks (⫾2.7
wks SD). Fifteen patients (5.1%) would request CDMR if offered.
There were no significant differences on univariate analysis
between CDMR and non-CDMR patients based on patient age, primary
language, planned delivery hospital, gestational age, site of prenatal
care, insurance, education, marital status, prior pregnancy loss, use of
assisted reproductive techniques, if the pregnancy was planned, type
of provider, and maternal/fetal health problems. Patients planning to
breastfeed were less likely to desire CDMR (16.7% if bottle only vs.
3.2% breast, p ⫽ 0.029). Patients who attended childbirth classes
preferred a trial of labor over CDMR (7.5% CDMR if no classes, 2.2% if
classes, p ⫽ 0.048). There were trends toward increased demand in
clinic patients, those not privately insured, and those with less than a
college education.
On multivariate logistic regression, patients planning to breastfeed
(OR 0.125, p ⫽ 0.007, 95% CI 0.028 – 0.561) and patients with private
insurance (OR 0.119, p ⫽ 0.013, 95% CI 0.022– 0.632) were less likely
to want CDMR. Patients who were married trended toward increased
demand for CDMR (OR 4.621, p ⫽ 0.087, 95% CI 0.801–26.673).
CDMR patients were more worried in general about their
upcoming deliveries. Using the Likert-scale questions, CDMR patients
reported a mean worry score of 3.46 (⫾1.20 SD) compared to 2.72
(⫾0.96 SD) for non-CDMR patients (p ⫽ 0.0078).
Among patients choosing CDMR the most common motivations
were avoidance of pain (n ⫽ 3, 20%), belief that this is safer for
herself (n ⫽ 3, 20%), and concern that the baby won’t fit (n ⫽ 3,
20%). Only one patient was most concerned about incontinence. No
patients cited convenience of timing or wanting to avoid pushing as
top reasons.
The 196 patients who desired a trial of vaginal delivery most
commonly indicated the wish to avoid surgical pain (n ⫽ 53, 27%),
feeling as if they wouldn’t get the whole childbirth experience if they
had CDMR (n ⫽ 48, 25%), and the belief that vaginal delivery is safer
for the baby (n ⫽ 30, 15.3%).
Conclusions: Few in our sample want CDMR, and those who do
are motivated by short-term factors. We found trends toward CDMR in
publicly insured, clinic patients with less than a college education.
Disclosures: M.O. Schimpf, None; P.K. Tulikangas, None; C.A.
LaSala, GlaxoSmithKline, Speaker’s Bureau; Invited Speaker, Ethicon,
Other; M. Jacob, None; J.F. Egan, None.
Cesarean Delivery on Maternal Request: Who Requests One?
M. O. Schimpf,* P. K. Tulikangas,* C. A. LaSala,* M. Jacob,† and J. F.
Egan† *Hartford Hospital, Hartford, CT, †University of Connecticut,
Farmington, CT
Objective: There is concern about the rising rate of cesarean
delivery, especially the contribution of cesarean delivery on maternal
request (CDMR). We surveyed nulliparous pregnant women to
determine who would request CDMR.
Attitudes Toward Vaginal Delivery VS. Cesarean Section in
Nulliparous Pregnant Women
Farmington, CT
Objective: Cesarean delivery on maternal request has received
considerable attention. No study to date has studied patients’ thoughts
and impressions of the two routes of delivery, particularly with regard
305
Abstracts
to long-term impact on pelvic-floor function. We surveyed nulliparous
pregnant women to assess their attitudes about route of delivery.
Methods: Nulliparous pregnant women in the 3rd trimester were
given a survey at a routine office visit and returned it at their
convenience. Practices from four hospitals in eight cities enrolled
patients. The survey included demographic information as well as
Likert-scale (1–5 with 5 most concerned) questions regarding the
patient’s level of concern regarding complications during labor,
delivery and postpartum. Descriptive statistics, Chi-square with
Fisher’s exact, and student’s t-test were used as appropriate for this
convenience sample.
Results: The mean age of the 294 respondents at the time of
sampling was 28.4 years (⫾6.13 years SD) and the mean gestational
age was 35.3 weeks (⫾2.7 weeks).
If faced with a difficult vaginal delivery and offered operative
vaginal delivery (OVD) or CD, the majority of patients selected CD
(63.8% CD vs. 35.8% OVD). However, patients who had attended
childbirth classes were significantly more likely to request OVD rather
than CD (56.2% CD vs. 43.8% OVD, p ⫽ 0.0064). There were no
statistically significant differences between patients based on age,
race/ethnic background, site of prenatal care, level of maternal
education, or relationship status with the father of the baby.
When asked which route of delivery would be better for her in
10 –20 years, most patients picked vaginal delivery (n ⫽ 119, 41% vs.
n ⫽ 10, 3.4%). Patients who received prenatal care at a hospital clinic
most often selected vaginal delivery (54.4%), while private-practice
patients more often felt that there would be no difference in the long
term (39.1%) (p ⫽ 0.0005). There were no statistically significant
differences between patients based on age, race/ethnic background,
level of maternal education, or attendance at childbirth classes.
Conclusions: In difficult obstetrical cases, most patients in this study
prefer cesarean delivery and few patients desire OVD. Patients believe
vaginal delivery will be better for them in the long term.
Disclosures:
M.O. Schimpf, None; P.K. Tulikangas, None; C.A.
LaSala, GlaxoSmithKline, Speaker’s Bureau; Invited Speaker, Ethicon,
The sample was 65.3% white, 18.4% Hispanic, 11.6% Black/African
American, 2.7% Asian, and 2% other.
Their top concern regarding the upcoming delivery was death of
myself or my baby (n ⫽ 48, 22.2%), followed by pain during delivery
(n ⫽ 33, 15.3%), and that the baby might have a long-term problem
(n ⫽ 30, 13.9%). The highest-ranking pelvic floor concern was
episiotomy or laceration, cited by 6.5%. Concern for pelvic muscle
damage, urinary incontinence (UI), fecal incontinence (FI) or the need
for prolapse surgery was not cited by any patient.
Patients indicated a low level of concern for possible future pelvic
floor problems on the Likert questions: pelvic muscle damage (mean
2.79, median 3.0, ⫾1.3 SD), UI (mean 2.61, median 2.0, ⫾1.4),
FIp ⫽ 0.029) (mean 2.61, median 2.0, ⫾1.5), need for surgery for
prolapse (mean 2.71, median 3.0, ⫾1.4). Concern was slightly higher
for episiotomy (mean 3.35, median 4.0, ⫾1.3) or laceration/vaginal
tear (mean 2.94, median 3.0, ⫾1.3). There were no significant
differences between patients based on age, maternal education,
attendance at childbirth classes or desire for CDMR for worry
regarding episiotomy or vaginal laceration. Patients with lower levels
of maternal education were significantly more nervous about UI
(p ⫽ 0.0002) or FI (p ⫽ 0.0009) than patients with more education,
but patients who had attended childbirth classes were less worried
about UI (p ⫽ 0.0004) or FI (p ⫽ 0.0009) than those who had not
attended. There were no significant differences regarding UI based on
age or desire for CDMR. Patients ⬍30 years old (p ⫽ 0.005) were
more worried about FI, but there was no difference based on desire
for CDMR. Patients ⬍30 years old (p ⫽ 0.0004), with lower level of
maternal education (p ⬍ 0.0001), and who did not attend childbirth
classes (p ⫽ 0.0001) were more concerned about the risk of prolapse
surgery.
Conclusions: The degree of concern in this group of women for
future pelvic floor disorders was low. Younger, less educated women
were more concerned than older, more educated women.
Disclosures: M.O. Schimpf, None; P.K. Tulikangas, None; C.A.
LaSala, Glaxo-Smith-Kline, Speaker’s Bureau; Invited Speaker, Ethicon,
Concern About Pelvic Floor Problems is Low in Nulliparous
Third-Trimester Pregnant Women
Farmington, CT
Objective: The impact of pregnancy and delivery on the pelvic floor
is controversial, and no study to date has studied patients’ thoughts
and impressions of the two routes of delivery, particularly with regard
to long-term impact. We surveyed nulliparous pregnant women to
assess their attitudes about the two routes of delivery.
Methods: Nulliparous pregnant women in the 3rd trimester were
given a survey at a routine office visit. Practices from four hospitals in
eight cities enrolled patients. The survey included demographic
information as well as Likert-scale (1–5 with 5 most concerned)
questions regarding the patient’s level of concern about complications
during labor, delivery and postpartum. Descriptive statistics, Chisquare with Fisher’s exact, and student’s t-test were used as
appropriate for this convenience sample.
Results: The mean age of the 294 respondents was 28.4 yrs. (⫾6.13
yrs. SD) and the mean gestational age was 35.3 wks. (⫾2.7 wks. SD).
Postpartum Perineal Pain: Association with Genital Trauma,
Labor Care and Birth Variables
L. M. Leeman, A. M. Fullilove, N. Borders, R. Manocchio, L. L. Albers,
and R. G. Rogers University of New Mexico School of Medicine,
Albuquerque, NM
Objective: To determine rates of perineal pain and analgesic use in
postpartum women with major perineal trauma compared to women
with minor or no perineal trauma.
Methods: This is a planned secondary analysis of a prospective study
of midwifery patients who consented to documentation of genital
trauma at birth and assessment of perineal pain and analgesic use
postpartum. Data collected included patient characteristics and labor
care measures, birth events, and a detailed map of genital tract
trauma. Major trauma was defined as ⬎2nd degree laceration of the
perineum and/or trauma requiring suturing. Perineal pain was assessed
using the Present Pain Intensity (PPI) and Visual Analog Scale (VAS)
components of the short form McGill pain questionnaire; analgesic
use was assessed at discharge and at 3 months.
Results: 576 women gave vaginal birth; 11 women underwent
episiotomy and/or operative delivery and were excluded from further
306
analysis. 552/565 (98%) of women provided data regarding pain at
time of discharge and 444/565 (79%) at 3 months. 152 (27%) women
had major trauma with 104 (18%) 2nd degree lacerations; 4 (⬍1%) 3rd
and 2 (⬍1%) 4th degree lacerations. At discharge, 60% of women
reported no or mild pain on the PPI, nonetheless, women with major
trauma were more likely to report increased pain by the VAS
(2.16 ⫾ 1.61 vs. 1.4 ⫾ 1.40; p ⬍ .001) and more likely to use analgesic
medicines (76.3 vs. 23.7%, p ⫽ .002) than women with minor trauma.
Trauma groups differed in length of active pushing, education, parity,
fetal weight, use of epidurals and oxytocin. In a multivariate model,
only trauma group and length of active pushing predicted increased
pain at the time of discharge while difference in analgesic use
between groups was explained by parity. At 3 months, the majority of
women 401(90%) reported no perineal pain and average VAS scores
were not different between groups (0.19 ⫾ 1.49 vs. 0.17 ⫾ .65;
p ⫽ NS).
Conclusion: Women with spontaneous perineal trauma report low
rates of postpartum perineal pain, although women with major trauma
do report increased perineal pain compared to women with no or
minor trauma. Length of active pushing is a potentially modifiable
labor care measure to reduce postpartum perineal pain.
Disclosures: L.M. Leeman, None; A.M. Fullilove, None; N. Borders,
None; R. Manocchio, None; L.L. Albers, None; R.G. Rogers, Pfizer,
Grant/Research Support; Pfizer, Consultant; Pfizer, Speaker’s Bureau.
Risk Factors for Perineal Lacerations in Teen Deliveries
D. Patterson,* and A. F. Hundley† *Brigham and Women’s Hospital,
Boston, MA, †The Ohio State University, Columbus, OH
Objective: Severe perineal lacerations have been associated with the
development of fecal incontinence in the general population. This
study was designed to attempt to identify risk factors for severe
perineal lacerations with vaginal delivery in a teen population. Such
risk factors may, in turn, be associated with the development of fecal
incontinence.
Methods: This was a retrospective database analysis of 534 teen
term, singleton, cephalic vaginal deliveries performed at our
institution between January 2004 and December 2006. Maternal
demographics, labor and delivery characteristics, and neonatal factors
were examined. Statistical analysis consisted of univariate statistics,
Student’s t-test, chi-square and logistic regression. The primary
outcome was the occurrence of a 3rd or 4th degree laceration with
vaginal delivery.
Results: Overall 43 (8.1%) of our patients had 3rd or 4th degree
lacerations during delivery while 491 (91.9%) had either no laceration
or a 1st or 2nd degree laceration. The groups were similar in age, race,
BMI, maternal glucose intolerance, use of epidural, frequency of
occiput posterior head position, and fetal head circumference. The
severe laceration group had a higher frequency of maternal glucose
intolerance requiring insulin control (7% versus 0.8%, p ⫽ 0.014),
episiotomy (60.5% versus 18.5%, p ⬍ 0.005), operative vaginal
delivery (25.6% versus 10.4%, p ⫽ 0.01), fetal birth weight (3380 ⫾
438g versus 3196 ⫾ 406g, p ⫽ 0.005), shoulder dystocia (18.6%
versus 6.3%, p ⬍ 0.008), and length of second stage (0.77 ⫾ 0.69
versus 1.11⫾ 1.24 hours, p ⫽ 0.03). In a multivariate regression model
that controlled for each of these factors, the use of insulin,
episiotomy, operative vaginal delivery, and length of second stage all
Abstracts
maintained their significance with increased odds ratios for severe
perineal laceration.
Conclusions: Operative vaginal delivery, episiotomy, length of
second stage and the requirement of insulin for glucose control all
appear to increase the risk of severe perineal laceration at the time of
vaginal delivery in a teenage population. These findings are consistent
with similar studies in an adult population which demonstrated that
primiparity, episiotomy, and operative vaginal delivery were all risk
factors for severe perineal laceration.(1–3)
References:
1. FitzGerald MP, Weber AM, Howden N, Cundiff GW, Brown MB.
Risk factors for anal sphincter tear during vaginal delivery.
Obstet Gynecol 2007;109:29 –34.
2. Richter HE, Brumfeld CG, Cliver SP, Burgio KL, Neely CL,
Varner E. Risk factors associated with anal sphincter tear: A
comparison of primiparous patients, vaginal births after
cesarean deliveries, and patients with previous vaginal delivery.
Am J Obstet Gynecol 2002;187:1194 –98.
3. Handa VL, Danielsen BH, Gilbert WM. Obstetric anal sphincter
lacerations. Obstet Gynecol 2001;98:225–30.
Disclosures: D. Patterson, None; A.F. Hundley, None.
The Impact of Delivery on Bowel Symptoms in a
Urogynecologic Population
F. G. Khan,* J. Cunkelman,* S. Adams,* L. Lowenstein† and K.
Kenton† *Washington University School of Medicine, St. Louis, MO,
†Loyola University School of Medicine, Maywood, IL
Objectives: To determine the effects of obstetric history on bowel
symptoms in a urogynecologic population.
Methods: We reviewed charts of consecutive new patients presenting
to our urogynecologic clinic between July 2006 and April 2008.
Demographic and obstetric variables, including gravidity, vaginal parity,
weight of largest baby, and use of forceps or vacuum were recorded. All
women also answered the following question: “During delivery did you
have a tear in the rectum?” and completed the short form of the Pelvic
Floor Distress Inventory (PFDI-20). Responses to the Colorectal-Anal
Distress Inventory subscale (CRADI) PFDI-20 were scored from 0 to 100
with higher scores indicating more bother from colorectal symptoms.
Nonparametric tests were used for bivariate and correlation analyses
between independent groups. Multivariate linear regression was used to
determine independent factors associated with CRADI scores. We
included the following clinically and/or statistically significant variables in
the final model: age, race, BMI, number of vaginal deliveries, weight of
largest baby, forceps, vacuum, rectal tears and number of pregnancies.
Results: Four hundred and eight women with a median age of 57
(range 24 –91) years and BMI of 27.4 (16.8 – 60.7) were included.
Majority were (90%) Caucasian, 8% African American and 2% other.
Median number of vaginal deliveries was 2 (1–11), and median weight
of the largest baby was 8.1 lbs. (2.9 –11.6). CRADI scores were
significantly higher in women who had a forceps delivery (n ⫽ 145)
compared to those who delivered spontaneously 关25 (0 –91) vs. 18.7
(0 –100), respectively, p ⬍.02兴, and in women with rectal tears
(n ⫽ 89) compared to those without rectal tears 关34.4, (0 –100) vs.
18.8, ( 0 – 88) respectively, p ⬍.0001兴. CRADI scores did not differ in
women who had vacuum deliveries (n ⫽ 30) and who delivered
spontaneously 关25.1(0 –75) vs. 23.9(0 –100), respectively, p ⫽ .39兴.
There was no association between CRADI scores and gravidity, vaginal
307
Abstracts
parity, or weight of largest baby (p ⫽ ⬎.15). In multivariate analysis,
forceps delivery (␤ ⫽ 4.9, p ⬍.035), rectal tear (␤ ⫽ 7.4, p ⬍.001) and
BMI (␤ ⫽ .6, p ⬍.001) were significantly associated with CRADI
scores.
Conclusions: In women seeking urogynecologic care, bothersome
colorectal symptoms are associated with higher BMI and a history of
forceps-assisted vaginal delivery and rectal tear.
Disclosures: F.G. Khan, Pfizer, Grant/Research Support; Pfizer,
Speaker’s Bureau; J. Cunkelman, None; S. Adams, None; L.
Lowenstein, Astellas, Grant/Research Support; Pfizer, Grant/Research
Support; K. Kenton, Pfizer, Grant/Research Support; Pfizer,
Consultant; Pfizer, Speaker’s Bureau.
Vaginal Smooth Muscle Cell Apoptosis is Increased in Women
with Pelvic Organ Prolapse
P. Takacs,* M. Gualtieri,* N. Mehdi,† K. Candiotti,† and C. Medina
*University of Miami, Department of Obstetrics and Gynecology,
Miami, FL, †University of Miami, Department of Pathology, Miami,
FL, ‡University of Miami, Department of Anesthesia, Miami, FL
Category: Basic Science.
Objective: To compare the smooth muscle content and apoptosis of
the vagina in women with and without anterior vaginal wall prolapse.
Methods: Vaginal tissues were sampled in women with (n ⫽ 6) or
without (n ⫽ 6) anterior vaginal wall prolapse undergoing hysterectomy.
Smooth muscle of the vagina was studied by immunohistochemistry.
Digital image analysis was used to determine the fractional area of
smooth muscle in the histologic cross-sections. Apoptosis was assessed by
TUNEL assay.
Results: Immunostaining revealed a well-defined, uniform distribution
of smooth muscle in patients without POP. This is in stark contrast to
the patchy distribution of smooth muscle seen in patients with POP.
Quantitative morphometric analysis revealed that the fractional area of
nonvascular smooth muscle in the vaginal wall biopsies from women
with prolapse was significantly decreased compared to women
without prolapse {mean, range, p-value (0.36 ⫾ 0.12 vs. 0.16 ⫾ 0.12
p ⫽ 0.021). Assessment of the vaginal smooth muscle cell apoptosis
by TUNEL assay demonstrated that the smooth muscle cell apoptotic
index was significantly increased in women with POP compared to
women without POP 关mean ⫾ SD, p-value 关(0.04 ⫾ 0.01 vs. 0.02 ⫾
0.03, p ⫽ 0.041)兴. In addition, analysis of the smooth muscle cell
nuclei demonstrated a significant decrease in the number of nuclei in
women with prolapse compared to women without prolapse 关mean ⫾
SD, p-value (2370 ⫾ 467 vs. 1166 ⫾ 727), ⬍0.01兴. The total smooth
muscle cell nucleus area was significantly decreased 关mean ⫾ SD,
P-value (59135 ⫾ 18108 vs. 28780 ⫾ 23067), 0.03兴. However, the
mean smooth muscle cell nucleus area was not significantly different
between the two groups 关mean ⫾ SD, p-value (24.4 ⫾ 3 vs. 22.4 ⫾
5), NS兴.
Conclusions: The fraction of smooth muscle in the vagina is
significantly decreased, and the rate of apoptosis is higher in women
with anterior vaginal wall prolapse compared to women without
prolapse
Disclosures: P. Takacs, None; M. Gualtieri, None; N. Mehdi, None;
K. Candiotti, None; C. Medina, None.
308
Expression of Matrix Metalloproteinase-2 and Tissue Inhibitor
of Matrix Metalloproteinase-2 in Patients with Pelvic Organ
Prolapsed
S. Bai, M. Kim, H. Jung, M. Jeon, and S. Kim Department of
Objective: The uterosacral ligaments are an important part of the
pelvic support system and connective tissue alterations are thought to
contribute to the development of pelvic organ prolapse. The objective
of this study was to compare the expression of matrix metalloproteinase2 and tissue inhibitor of matrix metalloproteinase-2 in patients with or
without prolapse and to evaluate the correlation between mRNA
expression of matrix metalloproteinase-2 and tissue inhibitor of matrix
metalloproteinase-2 and clinical characteristics of patients with or without
pelvic organ prolapse.
Methods: From November 2006 through March 2007, the uterosacral
ligaments were obtained from 20 women with pelvic organ prolapse and
20 women without pelvic organ prolapsed during the hysterectomy at
Division of Female Pelvic Medicine and Reconstructive Surgery, Yonsei
University Health System in Seoul. A quantitative real-time reverse
transcriptase-polymerase chain reaction was used to analyze the
expression of mRNA of matrix metalloproteinase-2 and tissue inhibitor of
matrix metalloproteinase-2. This study was approved by the Institutional
Review Board of Yonsei University Health System. The Student’s t-test
and one way ANOVA test were used for statistical analysis by using SPSS,
version 13.0 (SPSS Inc., Chicago, IL, U.S.A.). p ⬍ 0.05) was determined to
be significant.
Results: The matrix metalloproteinase-2 expression was significantly
increased in women with pelvic organ prolapse (p ⫽ 0.044). The
tissue inhibitor of matrix metalloproteinase-2 expression was also
increased in women with pelvic organ prolapse, but there was no
statistical difference (p ⫽ 0.362). There was no significant relationship
between mRNA expression of matrix metalloproteinase-2 and tissue
inhibitor of matrix metalloproteinase-2 and clinical characteristics of
patients with or without pelvic organ prolapse.
Conclusion: Our results suggest that increased matrix metalloproteinase-2
and tissue inhibitor of matrix metalloproteinase-2 mRNA expression in
uterosacral ligament may be associated with pelvic organ prolapse.
Tissue inhibitor of matrix metalloproteinase-2 appears to be
multifunctional molecule which may, independently of their ability to
block matrix metalloproteinase-2 activity, modulate pelvic organ
prolapse progression. Correlations did not exist between mRNA
expression of matrix metalloproteinase-2 and tissue inhibitor of matrix
metalloproteinase-2 and clinical characteristics of patients with or
without pelvic organ prolapse.
Disclosures: S. Bai, None; M. Kim, None; H. Jung, None; M. Jeon,
None; S. Kim, None.
Parity is Associated with Altered Collagen Ratios in the Primate
Vagina
K. Jones,* Z. Jallah,† A. Feola,† S. Abramowitch,† and P. Moalli*
*Magee Womens Hospital, Pittsburgh, PA, †Musculoskeletal
Research Center, Pittsburgh, PA
Objective: Distinct changes in vaginal morphology occur subsequent
to vaginal delivery. The objective of this study was to define a
structural basis for this change by quantitating differences in the
amount of the fibrillar collagens I, III and V, and collagen orientation
within the vaginal subepithelium and muscularis of nulliparous vs.
parous nonhuman primates (NHPs).
Methods: Collagen subtypes I, III, and V in the subepithelium and
muscularis of primate vaginal tissue were quantitated by scanning
confocal fluorescent microscopy. Vaginal specimens from nulliparous
(n ⫽ 3) and parous primates (n ⫽ 3) were cut, fixed, and incubated
simultaneously with primary antibodies to collagens I, III, and V followed
by appropriate secondary antibody linked to a fluorophore. The
subepithelium/muscularis of the resulting fluorescent micrographs were
scanned with a laser confocal microscope interfaced to a quantitative
computer program (Metamorph, 5.0) by a blinded technician. Collagen
fiber orientation was quantified using Small Angle Light Scattering (SALS).
By this method, the intensity distribution of diffracted light was used to
define the collagen orientation index (OI) from defined points within the
subepithelium and muscularis. Results are reported as percentage of
aligned points (Table1). Students’s t-test and the Mann Whitney U were
applied where appropriate with a p-value of 0.05.
Results: Nulliparous and parous animals had similar age; however,
the BMI of parous animals was slightly higher (18.3 vs. 16.1,
p ⫽ 0.05). Median vaginal parity was 7. Parity was associated with a
decrease in the ratio of collagen I/III⫹V in the subepithelium
primarily due to an increase in collagen III. No differences were seen
in collagen subtypes or ratios within the muscularis. By SALS, the
percentage of aligned points in the subepithelium and muscularis of
the two groups were similar.
Conclusion: Parity is associated with altered collagen subtypes
resulting in a decrease in the ratio of collagen I/III⫹V, indicating
decreased tensile strength. The structural change associated with altered
collagen ratios did not impact collagen alignment. It is likely that altered
collagen ratios contribute to the progression of prolapse over time.
Disclosures: K. Jones, None; Z. Jallah, None; A. Feola, None; S.
Abramowitch, None; P. Moalli, NIH K12HD043441 and
RO1HD045590, Grant/Research Support.
Age-Related Changes in the Distribution of Extracellular Matrix
Proteins in the Anterior Vaginal Wall of Squirrel Monkeys with
and Without Prolapse
E. Higgins, S. S. Baumann, T. J. Kuehl, and L. M. Pierce Scott and
White Hospital, Temple, TX
Objective: To evaluate differences in the expression of extracellular
matrix (ECM) proteins and smooth muscle in the anterior vaginal wall
from squirrel monkeys with and without vaginal prolapse.
Methods: The vagina and urethra were harvested en bloc from 16
squirrel monkeys aged 4 to 25 years including 4 nulliparous females, 6
parous females with prolapse, and 6 parous females without prolapse
similar in age, weight, and parity to animals with prolapse. Transverse
sections from the mid-vagina were examined immunohistochemically
Abstracts
for elastin, fibrillin-1, collagen I, collagen III, and smooth muscle actin.
SigmaScan Pro 5.0 image analysis software was used to quantitate
ECM protein expression and to measure the thickness and density of
nonvascular smooth muscle beneath the mid-urethra.
Results: Elastin immunostaining was observed in the lamina propria
and in the muscularis layer between smooth muscle bundles. Fibrillin-1
localized to the basement membrane, colocalized with elastin fibers in
the lamina propria, and was also expressed by smooth muscle cells. In
general, collagen III showed more intense staining in the lamina propria
than collagen I (p ⫽ 0.01, paired t test). Statistically significant
associations were not observed between ECM protein expression and
prolapse or parity (p ⬎ 0.05). Aging, however, was positively correlated
with staining for elastin (R ⫽ 0.82, p ⬍ 0.0001), fibrillin-1 (R ⫽ 0.49,
p ⫽ 0.05), and collagen III (p ⫽ 0.003) in the lamina propria but not in
the muscularis (p ⬎ 0.05). Elderly specimens from animals with or
without prolapse had shorter, thicker, darker-staining elastin fibers than
those from middle-aged animals, while young animals had little
measurable elastin. Of note, one monkey with prolapse demonstrated
mimimal immunoreactivity for all ECM proteins examined, suggesting
abnormal vaginal connective tissue composition. A second animal with
prolapse demonstrated abnormal elastin morphology (excessive
clumping) in the lamina propria. Thickness of the suburethral muscularis
layer correlated with age (R ⫽ 0.65, p ⫽ 0.006) but not with prolapse
(p ⫽ 0.31) or parity (p ⫽ 0.10). Density of nonvascular smooth muscle
did not correlate with prolapse, parity, or age (p ⬎ 0.05). No relationship
between thickness and density was observed (R ⫽ ⫺0.22, p ⫽ 0.43).
Conclusions:
The squirrel monkey anterior vaginal wall
demonstrates age-related changes in the distribution of elastin, fibrillin1, collagen III, and nonvascular smooth muscle. Abnormal
extracellular matrix protein expression is observed in the vaginal wall
of some monkeys with prolapse.
Disclosures: E. Higgins, None; S.S. Baumann, None; T.J. Kuehl,
None; L.M. Pierce, None.
Estradiol and Progesterone Suppress the Enzyme Activity of
Matrix Metalloproteinase-13 in Vaginal Supportive Connective
Tissue Cells
W. Zong, and P. A. Moalli University of Pittsburgh, Pittsburgh, PA
Objective: The risk of developing pelvic organ prolapse accelerates
following menopause. Previous studies suggest that this may be due to
increased collagen degradation in the absence of hormones (Am J
Obstet Gynecol 2004; 190: 620). This study was to determine whether
the enzyme activity of a key collagen degrading enzyme, MMP-13, is
regulated by 17-␤-estradiol (E2) and progesterone (P4) in cells derived
from the vaginal supportive connective tissues.
Methods: Following informed consent, biopsies from an intact
portion of the arcus tendineous fasciae pelvis (ATFP) were obtained
from 3 premenopausal women and 3 postmenopausal women not on
hormone therapy for ⬎1 year undergoing a surgical repair of
prolapse. Biopsies were minced and the liberated cells were grown to
confluence before weaning to serum free media for 24 hours. Cells
were then treated with E2 (10–10–10– 8 M), P4 (10–10–10– 8 M), E2
(10– 8 M) plus P4 (10–10–10– 8 M) or E2 (10– 8 M) plus the estrogen
receptor inhibitor Imperial Chemical Industries 182,780 (ICI 182,780,
10– 8–10– 6 M), and harvested 48 hours later. Cells without hormone
treatment served as control. MMP-13 enzyme activity was quantified in
duplicate using a Fluorokine® E enzyme activity assay kit (R&D
309
Abstracts
TABLE.
Treatment
Control
E2
10⫺10 mol/L
10⫺9 mol/L
10⫺8 mol/L
P4
10⫺10 mol/L
10⫺9 mol/L
10⫺8 mol/L
E2 (10⫺8 mol/L) plus P4
10⫺10 mol/L
10⫺9 mol/L
10⫺8 mol/L
E2 (10⫺8 mol/L) plus ICI 182,780
10⫺8 mol/L
10⫺7 mol/L
10⫺6 mol/L
MMP-13 activity (ng/ml)
Premenopausal
Postmenopausal
1.31 ⫾ 0.19
1.64 ⫾ 0.19
0.43 ⫾ 0.03
0.51 ⫾ 0.17
0.69 ⫾ 0.22
0.93 ⫾ 0.14
0.95 ⫾ 0.08
0.72 ⫾ 0.11
0.63 ⫾ 0.23
0.70 ⫾ 0.11
0.73 ⫾ 0.16
0.97 ⫾ 0.23
0.86 ⫾ 0.24
0.94 ⫾ 0.25
0.79 ⫾ 0.15
0.63 ⫾ 0.03
0.70 ⫾ 0.21
0.81 ⫾ 0.22
0.97 ⫾ 0.08
0.79 ⫾ 0.17
1.45 ⫾ 0.13
1.64 ⫾ 0.33
1.68 ⫾ 0.18
1.43 ⫾ 0.30
1.49 ⫾ 0.20
1.56 ⫾ 0.44
System). Enzyme activity was normalized to the concentration of total
cellular protein. Data were analyzed at 0.05 level of significance using
one-way analysis of variance. Post-hoc pairwise comparisons were
made using Dunnet’s multiple comparison procedure
Results: Subjects in the 2 groups had similar gravidity, parity, BMI and
stage of prolapse, however, postmenopausal women were older. As
shown in the Table, E2 in the presence or absence of P4 significantly
decreased the activity of active MMP-13. This inhibitory response was
abrogated by ICI. There was no difference in the degree of inhibition by
each hormone or hormone combination. Inhibition was similar in cells
derived from premenopausal vs postmenopausal women (Ps ⬎ 0.05).
Conclusion: 17-␤-estradiol in the presence or absence of
progesterone inhibits the activity of the key collagen degrading
enzyme, MMP-13, in a process that is mediated through the estrogen
receptor. The data suggest a benefit of hormones on the integrity of
intact vaginal supportive connective tissues.
Disclosures:
W. Zong, None; P.A. Moalli, R01HD045590,
Fibroblast Proliferation is Regulated by Hoxa11: Molecular
Implications for Pelvic Organ Prolapse
K. A. Connell, M. K. Guess, R. Bercik, and H. S. Taylor Yale
University School of Medicine, New Haven, CT
Objective: The integrity of the extracellular matrix (ECM) is
maintained by a delicate balance between synthesis and degradation.
Previously, we demonstrated that Hoxa 11, a homeobox gene
responsible in differentiation of the Mullerian tract, is essential for the
development of the uterosacral ligaments (USLs) in mice and regulates
the expression of collagen type III and MMP2. We have also shown
that HOXA11 is deficient in the USLs of women with pelvic organ
prolapse (POP) compared to women with normal support. The exact
mechanism by which HOXA11 regulates pelvic floor integrity and
repair remains to be elucidated. P53 regulates several key proteins
310
p value
⬍0.001
⬍0.001
⬍0.001
0.586
required for cell proliferation at different points in the cell cycle.
When DNA is damaged after trauma, p53 functions to block the cell
cycle causing apoptosis. The aim of this study was to determine the
effect of HOXA11 expression on fibroblast proliferation, regulation of
p53 and the cell cycle in the USL cells.
Materials & Methods: We evaluated the effects of constitutive
expression of HOXA11 in a murine fibroblast cell line and in primary
cells cultured from a USL biopsy specimen obtained at the time of a
benign hysterectomy. The USL specimen was digested with collagenase
and DNAse I. These USL primary cells and NIH 3T3 cells were seeded
onto a six well plate (1⫻ 10 5 cells/well) and transfected with either a
vector carrying a HOXA11 cDNA insert or with empty vector alone as a
control. Immunohistochemistry using bromodeoxyuridine (BrdU) was
performed to evaluate cell proliferation after transfection. Real time PCR
was used to determine effect of constitutive expression of HOXA11 on
expression of p53 in USL cells.
Results: Constitutive expression of HOXA11 in murine fibroblasts
and primary USL cells resulted in significantly higher proliferation.
Cells transfected with Hoxa11 had a mean BrdU incorporation of 40.8
⫾ 8.8 cells/100 cells and 50.5 ⫹ 8.6 cells/100 cells compared with
32.2 ⫾ 7.5 cells/100 cells and 33.1 cells/100 cells in controls
(p ⫽ 0.03 for NIH 3T3 cells and p ⬍ 0.01 for human USL cells,
respectively). Overexpression of HOXA11 in USL cells resulted in a
40% decrease in expression of p53.
Conclusion: HOXA11 is necessary for USL development, promotes
proliferation of USL fibroblasts and increases type III collagen
expression in vitro. HOXA11 also mediates p53 expression, which
may be a mechanism by which HOXA11 regulates fibroblast
proliferation in vivo during growth and the acute phase response
following trauma when fibroblasts are activated to proliferate and
remodel the ECM. Previously, we have shown that expression of
HOXA11 is decreased in women with POP. It is likely that HOXA11
mediated proliferation of USL fibroblasts contributes to the tensile
strength and resilience of these structures and prevents POP.
Disclosures: K.A. Connell, None; M.K. Guess, None; R. Bercik,
None; H.S. Taylor, Wyeth, Speaker’s Bureau.
Acknowledgements: This work has been funded by the NICHD
Women’s Reproductive Health Research: K12 HD047018.
This work was presented as a poster at the Society for
Gynecological Investigation Annual Meeting, San Diego, CA, March
2008 (international meeting).
Human Mesenchymal Stem Cells (HMSC) Increase the Stiffness
of Collagen Meshes: Dependence of the Crosslink Percentage
J. E. Robles,* I. Ochoa,† M. Perez-Ilzarbe,* C. Alcaine,† J. Grasa,† F.
Prosper* and M. Doblare† *Clinica Universitaria. University of
Navarra, Pamplona, Spain, †Group of Structural Mechanics and
Materials Modelling, University of Zaragoza, Zaragoza, Spain
Introduction: The use of graft materials in urogynecology surgery
has been promoted to compensate for the inherent weakness in
autologous tissues. The advantages of collagen matrix laminates made
from porcine dermis as implantable xenograft products are well
known. Collagen-based meshes possess good mechanical properties,
strong resistance and poor antigenicity. Moreover, they allow a
secondary cellular colonization and can become less degradable if
modified.
Objective: Porcine collagen meshes (Pelvicol®, BARD) with different
crosslink degrees were tested to determine their mechanical
properties.
Material and Methods: Monotonic and cyclic uniaxial tensile tests
were carried out along the two principal directions of the mesh.
Monotonic uniaxial tensile tests were performed under displacement
control on an INSTRON 5848 microtester, using a 50 N full scale load
cell with a non-contact videoextensometer. In order to avoid
specimen drying, an ultrasonic humidifier was used, which delivered
subcooling steam, allowing a constant temperature during the test.
The specimens were loaded at a displacement rate of 0.01 mm/sec up
to rupture. Cyclic tests were performed according to the following
procedure. A maximum of 3 ramp cycles were applied, all of them
under displacement control at the same displacement rate as for the
monotonic test. When the 10, 25 and 50% of the maximum load is
attained, unloading start until reaching a force value close to zero at
which point reloading start. This protocol was repeated 3 times for
each cycle. hMSC were seeded in the different collagen meshes
(10000 cells/cm2) and cultured for one week at 37 °C in a CO2
incubator.
Results: Significant differences in mechanical properties between
samples with different crosslink percentages were observed. The
partial crosslink mesh showed higher anisotropy. The hMSC colonized
the collagen mesh and were distributed all over the mesh and also
increased the Young modulus (stiffness) of the collagen meshes
depending on the crosslink percentage. Damage accumulation due to
cyclic load (the slope of the stress-strain curve at the beginning of
unloading) depends also on the crosslink percentage.
Conclusions: Increasing the crosslink percentage produced a stiffness
gain with a decrease in the damage accumulation in the collagen
meshes. hMSC could increase the stiffness of the collagen meshes but
not of the full crosslinked ones. This increase is inversely proportional
to the crosslink degree.
Disclosures: J.E. Robles, C.R. Bard, Inc, Speaker’s Bureau; C.R. Bard,
Inc., Paid Instructor; I. Ochoa, None; M. Perez-Ilzarbe, None; C.
Alcaine, None; J. Grasa, None; F. Prosper, None; M. Doblare, None.
Abstracts
A Colia1 Gene SP1 Binding Site Polymorphism in Korean
Women with and Without Pelvic Organ Prolapse
S. Bai, H. Cho, H. Jung, M. Jeon, and S. Kim Department of
Objective: In Korea, the prevalence of women with POP stage
greater than stage II was reported to be 11.8%. Ethnic and racial
variations in the incidence of POP have been reported. The aim of
this study was to evaluate the possible influence of G3 T substitution
in transcription factor Sp1-binding site of the gene encoding ␣
´ -1 chain
of type I collagen (COLIA1 gene) on the risk of pelvic organ
prolapsed in Korean women.
Methods: This case-controlled study included 30 Korean women.
The study group consisted of 15 women with advanced stage pelvic
organ prolapse. Fifteen control subjects were matched for age and
parity among the postmenopausal women with benign ovarian cysts,
uterine myomas or adenomyosis to the study group, and thus, the two
groups had no statistical significance. DNA was obtained from
peripheral blood leukocytes. The fragments of the first intron of the
COLIA1 gene were amplified by real time polymerase chain reaction.
The polymorphism was identified by LightCycler Technology with
hybridization probes. Sequencing reactions were performed on each
template using commercial primer. This study was approved by the
Institutional Review Board of Yonsei University Health System. The
Student’s t-test, Fisher’s exact test, and Pearson chi-square test were
used for statistical analysis by using SPSS, version 13.0 (SPSS Inc.,
Chicago, IL, U.S.A.). p ⬍ 0.05 was determined to be significant.
Results: Two groups had no significant difference in medical history,
surgical, and smoking history. The homozygous peaks were noted at
57°C on melting curve analysis. Sequencing reactions confirmed the
G/G alleles in the 30 specimens tested. We could not find any
polymorphism at the Sp1-binding site in COLIA1 gene with advanced
stage pelvic organ prolapse.
Conclusion: Polymorphism of the transcription factor Sp1-binding
site in COLIA1 gene is unlikely to be of clinical value in identifying
Korean women who are at risk for the development of pelvic organ
prolapse.
Disclosures: S. Bai, None; H. Cho, None; H. Jung, None; M. Jeon,
None; S. Kim, None.
Histological Evaluation of the Uterosacral Ligament: Do Elastin,
Collagen, and Smooth Muscle Content Decrease with Increasing
Age?
S. A. Collins,* S. A. Downie,† R. S. Sellers,† T. R. Olson,† and M. S.
Mikhail† *Albert Einstein College of Medicine, Montefiore Medical
Center, Bronx, NY, †Albert Einstein College of Medicine, Bronx, NY
Objective: To determine whether smooth muscle, collagen, and
elastin content of the uterosacral ligament correlates with age.
Methods: Female cadavers in the 2007– 08 Clinical and Developmental
Anatomy course at Albert Einstein College of Medicine were subjects of
this study. Each cadaver was fixed on site using traditional embalming
and curing methods with dilute formaldehyde. This study was conducted
before the students’ pelvic dissection. Subjects were included if they had
clearly identifiable uterosacral ligaments in-situ. The right ligaments were
311
Abstracts
selected for use in this study for uniformity. Each ligament was measured
from the center of the cervix or vaginal cuff to the posterior-most point
at which the ligament was clearly identifiable. They were then marked
off by thirds, and a cross-sectional slice was taken from the center of the
middle third of each ligament. Sections were prepared with hematoxylin
and eosin (H&E), Masson’s trichrome, and Verhoeff’s Van Gieson stains.
Slides were blinded for age. The H&E slides were used to verify that the
correct tissue was isolated. Each Masson’s trichrome and each Verhoeff’s
Van Gieson slide was viewed at 20⫻ and 40⫻ magnification in 5
different fields. The trichome slides were scored by assigning percentages
to the approximate collagen and smooth muscle components in each
field to the nearest 5%. Care was taken to exclude vascular smooth
muscle from the analysis. Verhoeff’s Van Gieson slides were scored 0 for
no elastin, 1 for rare elastin, and 2 for prevalent elastin seen. The same,
blinded examiner viewed the slides multiple times and scored each twice
to maximize precision. Averages were calculated for percent collagen and
smooth muscle per field and elastin score per field. After averages were
finalized, the examiner was unblinded to age, and statistical analyses were
performed with the Student’s T-Test and ANOVA using JMP 7.0 by SAS.
Results: Sixteen cadavers met inclusion criteria for this study. Of these,
slides from 12 showed histologically typical-appearing uterosacral
ligament. The average subject age was 79 (range 59 –93). The average
percentages of smooth muscle and collagen per field were 25.6 and 74.4,
respectively. The average elastin score per field was 1.19. Although
trends suggested increasing smooth muscle, decreasing collagen, and
increasing elastin content with increasing age, there were no statistically
significant relationships. This remained true after data was stratified for
age greater than 70 or age 70 and younger.
Conclusions: Although the increased prevalence of pelvic organ
prolapse in elderly women may suggest that smooth muscle, collagen,
and/or elastin content decrease with age, our data did not confirm
this. Our findings imply that age alone is not a contraindication for
use of the uterosacral ligament for vaginal vault suspension. Further
analysis controlling for possible confounding variables is needed to
further evaluate the relationship between age and histological
composition of the uterosacral ligament.
Disclosures: S.A. Collins, None; S.A. Downie, None; R.S. Sellers,
None; T.R. Olson, None; M.S. Mikhail, None.
Magnetic Resonance Imaging and Histopathology of Anal and
Urethral Sphincters in The Squirrel Monkey
R. Huffaker, L. Pierce, V. Runge, J. Gendron, S. Baumann, and T.
Kuehl Scott & White Hospital, Temple, TX
Objective: To describe urethral and anal sphincter anatomy in the
female squirrel monkey using magnetic resonance imaging (MRI) and
histology.
Material and Methods: Axial T 1-weighted images were obtained
from 10 anesthetized nulliparous female squirrel monkeys, and 3dimensional models were constructed to obtain urethral and anal
sphincter measurements. The anal sphincter complex and urethra
with anterior vaginal wall from 16 parous and nulliparous female
monkeys ranging in age from 4 to 25 years were processed for
histology and immunofluorescence. Serial sections were stained with
Masson trichrome, hematoxylin and eosin, elastin/van Gieson, and
antibodies to smooth muscle actin. Fiber typing in the striated
external urethral sphincter (EUS) and external anal sphincter (EAS)
was performed with anti-fast (type II) and anti-slow (type I) skeletal
312
myosin antibodies. Histology and MRI were compared using side-byside analysis of acquired images.
Results: The mean length of the urethra in nulliparous females was
20.1 mm ⫾ 3.0 SD (range 16.3 to 24.9 mm). The wall of the midurethra contained different layers from the lumen to the periphery
consisting of epithelium, lamina propria (network of collagen, elastin,
and vasculature), 2 smooth muscle layers (inner longitudinal and outer
circular), and an external striated muscle layer whose fibers were
distinct from the levator ani. The EUS was identified in the middle and
distal thirds of the urethra, and in the proximal urethra the smooth
muscle layer thickened and replaced the EUS. The anal sphincter
complex included the internal sphincter (thickening of the circular
smooth muscle of the rectum), the longitudinal smooth muscle layer,
and the striated external sphincter that formed a cylinder distally
around the anal canal and internal sphincter. The EAS measured 5.8
mm ⫾ 1.5 SD dorsally (range 4.3 to 9.3 mm) in nulliparous females.
Both the EUS and EAS contained slow and fast fiber types. The
percentage of type I fibers ranged from 26% to 73% in the EUS and
from 16% to 58% in the EAS and increased with age (p ⫽ 0.019 EUS;
p ⫽ 0.035 EAS; t test). Histological evidence of chronic denervation
(extensive fibrosis, fatty replacement) or reinnervation (fiber type
grouping) was not observed in any female.
Conclusions: The urethral and anal sphincter complexes in the
female squirrel monkey are structurally similar to those in women,
suggesting that this species may be used as a model to investigate
urinary or fecal incontinence. A mixture of type I and type II fibers in
the striated urethral and anal sphincters enables the squirrel monkey
to maintain continence at rest and during stress conditions.
Disclosures: R. Huffaker, None; L. Pierce, None; V. Runge, None;
J. Gendron, None; S. Baumann, None; T. Kuehl, None.
Regeneration of Levator Ani by Muscle-Derived Stem Cells
M. H. Ho,* S. Heydarkhan,† D. Vernet,‡ I. Kovanecz,‡ M. G. Ferrini,‡
N. N. N Bhatia† and N. G. Cadavid‡ *Division of Urogynecology and
Pelvic Reconstructive Surgery, Harbor-UCLA Medical Center/Charles
Drew University of Medicine, Torrance, CA, †Division of
Urogynecology and Pelvic Reconstructive Surgery, Harbor-UCLA
Medical Center, Torrance, CA, ‡Harbor-UCLA Medical Center,
Torrance, CA
Objective: The objective of this study is to investigate whether
implantation of muscle-derived stem cells (MDSC) into atrophic and
defective levator ani in the female pelvic floor can reverse their
atrophy and regenerate the muscles. Specifically, we have investigated
in the rat models whether MDSC: a) can generate in vitro skeletal
muscles and other cell types; b) express specific markers applicable to
their detection upon implantation into the target tissues; and c) can in
vivo reverse the atrophy, regenerate the muscles, and improve the
function of levator ani with implanted stem cells.
Methods: MDSC were isolated from skeletal muscle by the preplating
technique. Cell populations were negative for CD 45 expression and
were characterized by flow cytometry for CD34 and Sca-1 expression.
Desmin expression was assessed via immunocytochemistry. CD34 and
Sca-1 are stem cell markers, whereas desmin is a myogenic marker.
For in vitro characterization, cell morphology was determined by
phase-contrast light microscopy and differentiation was tested by
immunocytochemistry (ICC), quantitative western blot, and real time
PCR. Putative MDSC markers were screened by DNA microarrays
(SuperArray) followed by RT-PCR, ICC, and western blot. To examine
multipotency, MDSC were induced to undergo myogenic, osteogenic,
and adipogenic differentiation. Short-term growth kinetics and longterm proliferation potential were examined. For in vivo studies, 1 ⫻
6
10 cells were transplanted into the atrophic/defective levator ani of
female rat models. Immunofluorescent images of dystrophin, desmin,
and MyHC were acquired.
Results: MDSC differentiated in vitro into skeletal muscle, as
determined by MyHC, and smooth muscle cells (SMC), as determined
by á-smooth muscle actin (ASMA), calponin, and smoothelin. For in
vivo studies, MDSC expressed Oct-4 and myoglobin, in addition to
myst 4, Nanog, Notch 3, Wnt 1, CD63, and muscle creatine kinase,
which are potential markers. Control group with intact levator ani and
studied group with atrophic/defective levator ani were compared.
Dual immunofluorescence was used to detect MDSC differentiation
and hematoxylin/eosin was used for histology at 4, 8, and 12 weeks
after stem cell implantations. The ability of MDSC to form myotubes
was demonstrated by fast MyHC staining. Both fluorescent nuclear
marker 4,6-diamidino-2-phenylindone (DAPI) and myoglobin antibody
detected MDSC implanted in the levator ani, and dual DAPI/MyHC
indicated their conversion into myofibers. For transplantations of lacZMDSC, cells were first labeled with retrovirus encoding for the lacZ
gene and X-gal staining was performed to quantify the total number of
these lacZ-positive nuclei and the number that were located within
new muscle fibers also indicated the regeneration of levator ani by
MDSC.
Conclusions: MDSC implanted into atrophic/defective levator ani is
a novel and promising approach for their atrophy reversion and
muscle regeneration in the pelvic floor as demonstrated in female rat
models.
Disclosures: M.H. Ho, None; S. Heydarkhan, None; D. Vernet, None;
I. Kovanecz, None; M.G. Ferrini, None; N.N. N Bhatia, None; N.G.
Cadavid, None.
Mechanisms of Mid-Urethral Sling Effects: Role of Suburethral
And Lateral Support for Anti-Incontinence Effects in a Rat
Model
S. E. McAchran,* U. Lee,* M. Kavran,* Y. Lin,* A. Hijaz† and F.
Daneshgari* *Cleveland Clinic, Cleveland, OH, †University Hospitals
of Cleveland, Cleveland, OH
Objective: Previous studies in a rat model of incontinence have
suggested that the suburethral portion of the mid-urethral sling was
not necessary to produce the effect of increased urethral resistance as
measured by leak point pressure (LPP). In response to these findings,
a composite sling model was developed to further test the hypothesis
that the lateral support, rather than the suburethral support is all that
is required to produce the anti-incontinence effect. The object of this
study was to evaluate the long term efficacy of a novel composite
mid-urethral type sling in a rodent model of incontinence.
Methods: SUI was created in XX Sprague-Dawley rats by bilateral
pudendal nerve transaction (PNT) under ketamine/xylazine anesthesia.
In 6 rats, the traditional group, vaginal dissection was performed,
followed by placement of a 2 ⫻ 0.3 cm strip of Prolene (Ethicon,
Somerville, New Jersey) mesh at the mid-urethral level. In 4 rats, the
sham group, vaginal dissection and retropubic trocar passage was
performed. In 4 rats, the composite group, no vaginal dissection was
Abstracts
performed and the composite mid-urethral type sling was placed. Four
weeks later, under urethane anesthesia, a suprapubic tube was placed
and LPP was measured using a Crede maneuver. In each animal LPP
was measured 5– 6 times and the mean was taken. Pairwise
differences in LPP between the traditional and sham slings, between
the composite and sham slings, and between the composite and
traditional slings were calculated using the Wilcoxon signed rank test
with p ⬍ 0.05 considered significantly different.
Results: The traditional sling increased LPP compared to the sham
group (54.83 vs. 38.16 cm H20, respectively, p ⫽ 0.0017). The
composite sling did not increase the LPP compared to the sham group
(36.83 vs. 38.16 cm H20, respectively, p ⫽ 0.7072).
Conclusions: In early studies, it does not appear that the composite
sling model is as effective at restoring LPP in the rat model of
incontinence induced by PNT. Further refinements in technique and
larger numbers of procedures will help us to clarify the utility of this
novel composite sling model.
Disclosures: S.E. McAchran, None; U. Lee, None; M. Kavran, None;
Y. Lin, None; A. Hijaz, None; F. Daneshgari, None.
Biomechanical Changes of Vaginal Tissue In Premenopausal
Women With Prolapse
A. Feola,* R. Duerr,† S. Abramowitch,* and P. Moalli†
*Musculoskeletal Research Center, Pittsburgh, PA, †Magee-Womens
Research Institute, Pittsburgh, PA
Objective: Little is known about the mechanical changes associated
with the development of prolapse, partly due to the small size of
biopsies that can be ethically obtained from humans that precludes
conventional testing. Developing a biomechanical test that can utilize
small biopsies would offer a means to track the development and
progression of prolapse in women with minimal risk and morbidity.
To this end, we developed a test in which the rheological viscous
properties of premenopausal age-matched women with and without
prolapse could be examined.
Methods: Histologically confirmed full-thickness biopsies from the
proximal 1⁄4 vagina (5–7 mm) were obtained from age-matched
regularly cycling premenopausal women (age: 37–50) with prolapse
(n ⫽ 6) and without prolapse (n ⫽ 11). A single lap shear test was
313
Abstracts
performed and samples were secured between a lower fixed plate and
an upper plate attached to an EnduraTEC Electro-Force Mechanical
Testing System (Model ELF 3200, Bose, Minnetonka, MN). Oscillating
sinusoidal strains (10% at 1 Hz–90 Hz) were applied and the stresses
were recorded. From these data, the parameters of consistency and
flow were used to describe the dynamic viscosity of the specimens.
While flow (slope of the dynamic viscosity vs. rate) has been shown
to be generally consistent for biological tissues, a higher consistency
(y-intercept of dynamic viscosity) indicates an increased viscosity. Data
was compared using a Student’s t-test (p ⫽ 0.05).
Results: The 2 groups had similar height, weight, body mass index,
gravidity, and parity. Most women in both groups were in the
follicular stage of the menstrual cycle. Consistency was significantly
increased in vaginal biopsies from prolapsed women (403.2 ⫾ 162.2
Pa-s) compared to nonprolapsed women (205 ⫾ 133.4 Pa-s; p ⫽
0.03). As predicted, flow was similar for the prolapsed and
nonprolapsed groups (⫺0.81 ⫾ 0.05 and ⫺0.78 ⫾ 0.02; p ⫽ 0.21) in
agreement with previous literature (Figure).
Conclusions: Rheological testing successfully identified biomechanical
differences in small biopsies of vaginal tissue in women with and without
prolapse. Future studies will aim to correlate these findings with
biochemical data in order to help gain a better insight as to how these
changes are related to prolapse.
Disclosures: A. Feola, None; R. Duerr, None; S. Abramowitch, None;
P. Moalli, None.
Parity Negatively Impacts the Biomechanical Properties of
Vaginal Non-Human Primate Vagina
K. Jones,* A. Feola,† S. Abramowitch,† and P. Moalli* *Magee
Womens Hospital, Pittsburgh, PA, †Musculoskeletal Research Center,
Pittsburgh, PA
Objective: Vaginal parity is considered the leading risk factor for the
development of pelvic organ prolapse. The aim of this study was to
determine the impact of parity on the biomechanical properties of the
vagina in the nonhuman primate.
Methods: Following a modified POP Q exam, the vaginas of three
nulliparous and six parous primates were harvested for uniaxial tensile
testing. A longitudinal section of tissue was isolated and dissected to a
dogbone shape (aspect ratio ⫽5). Cross-sectional area was measured.
Following a 0.5 N preload, a load to failure test was performed at an
elongation rate of 10 mm/min. Tensile strength, ultimate strain,
tangent modulus, and strain energy density were calculated.
Nonparametric statistical analysis was applied.
314
Results: None of the animals had ⬎ Stage II prolapse. Typical stressstrain curves are shown in Figure 1. Both curves demonstrated
nonlinear behavior with a distinct toe, linear, and failure region. The
nulliparous group displayed a significantly higher tensile strength and
strain energy density than the parous group (Table 1; p ⬍ 0.05). Its
behavior was also more nonlinear beyond 3% strain, demonstrated by
the higher slope of the stress-strain curve. However, differences were
not detected in the tangent modulus.
Conclusions: Parity has a distinct negative impact on the
biomechanical properties of the vagina demonstrated here as a
decrease in tensile strength and strain energy density. Such changes
may contribute to the development and/or progression of prolapse.
Disclosures: K. Jones, None; A. Feola, None; S. Abramowitch, None;
P. Moalli, NIH K12HD043441 and RO1HD045590, Grant/Research
Support.
Peptidomic Techniques Demonstrate Alpha-1 (I) Collagen is
Greater in the Urine of Subjects with Interstitial Cystitis
Compared To Asymptomatic Controls
M. P. Canter,* C. A. Graham,† M. H. Heit,† L. S. Blackwell,† D. W.
Wilkey,‡ J. B. Klein‡ and M. L. Merchant‡ *Urogynecology and Pelvic
Surgery Center, Arlington, VA, †Urogynecology Specialists of
Kentuckiana, Louisville, KY, ‡Clinical Proteomics Center, University
of Louisville, Louisville, KY
Objective: To use peptidomic techniques to identify differences in
high abundant urinary peptides between subjects with interstitial
cystitis (IC) and asymptomatic controls (AC).
Methods: Women diagnosed with IC (mean voiding frequency ⱖ10
times/day, mean nocturnal voids ⱖ1, and bladder pain for ⱖ six months)
were recruited with age, race, and sex matched AC. All subjects volunteered
a first morning voided urine. Urine specimens were dialyzed and separated
into low and high molecular weight protein fractions using a 10,000 Dalton
molecular weight cut-off membrane. This investigation utilized the low
molecular weight protein fraction which is composed mainly of protein
fragments or peptides. These peptides were concentrated and desalted using
solid phase extraction methods and then analyzed by Matrix Assisted Laser
Desorption Ionization-Time of Flight Mass Spectrometry (MALDI-TOF MS).
These peptides were analyzed using manual spotting onto the MS target
plates; an approach amiable to high abundant peptides. Positive ion MALDI-
TOF MS mass spectra were data acquired with a mass to charge ratio (m/z)
of 700 to 4000 m/z and evaluated using Principal Component Analysis, a
statistical method for analysis of complex data sets. These peptide profiling
methods were used to examine the detected presence of a particular peptide
in each sample. Urine peptide samples that sorted into two groups were
compared by statistical t-test techniques to discern peptides that were
present at levels statistically different between the two groups. Peptides with
a t-test probability ⱖ 95% were considered candidates. Candidates underwent
peptide fragmentation with MALDI-TOF-TOF MS. The resulting peptide
fragments were compared to potential parent protein amino acid sequences
in the Swiss-Prot database. Peptides with a total ion score ⱖ 20 were
considered homologous.
Results: A total of 36 women were enrolled (18 IC, 18 AC). One
parent protein, alpha-1 (I) collagen was found in a significantly greater
concentration in the urine of IC subjects compared to AC.
Conclusion: Many studies suggest that IC is a disease involving a
dysfunction of the urothelium. The increased concentration of alpha-1 (I)
collagen in the urine of IC subjects is consistent with these hypotheses.
This finding may indicate up-regulation of collagen at the site of wound
repair or inflammation-mediated collagenase break down of the
extracellular matrix collagen resulting in increased permeability of the
bladder and increased urinary collagen. Future studies will elucidate this
mechanism and determining the sensitivity and specificity of alpha-1 (I)
collagen in diagnosing patients with IC.
Disclosures: M.P. Canter, None; C.A. Graham, None; M.H. Heit,
None; L.S. Blackwell, None; D.W. Wilkey, None; J.B. Klein, None; M.L.
Merchant, None.
Lower Urinary Tract Phenotype of Experimental Autoimmune
Cystitis in Mouse: A Potential Animal Model for Interstitital
Cystitis
G. Liu, Y. Lin, M. Kavran, C. Altuntas, G. Gasbarro, V. Tuohy, and F.
Daneshgari The Cleveland Clinic, Cleveland, OH
Objective: We aimed to examine the bladder function in a newly
developed experimental autoimmune cystitis (EAC) model in female
SWXJ strain mice, as a potential animal model for Interstitial Cystitis
(IC).
Methods: Twenty SWXJ female mice were divided into two groups:
an EAC group immunized with mouse bladder homogenate in
complete Freund’s adjuvant (CFA) and a control group immunized
with CFA alone. Four months after injections, bladder function of
some animals (n ⫽ 6) was studied with 24-hour micturition habits
using metabolic cages, and conscious cystometrogram (CMG). The
Bladder and lung were harvested for histological examination and
assessment of Interferon-gamma (IFN-␥) mRNA analysis.
Results: Histology examination showed obviously thickened lamina
propria, infiltration of lymphocytes, giant cells, and increased mast
cells in detrusor muscle in EAC animal. The lung of EAC rat showed
normal histology. IFN-␥ mRNA expression increased significantly in
the bladder, but not in the lung of EAC rat. 24-hour micturition habits
measurements showed increased frequency of urination in the EAC
group compared to controls. Similarly, CMG measurement showed
decreased intercontraction interval and voided volume per micturition
in the EAC group compared to controls. However, there were no
significant differences in peak voiding pressure or total voiding
volume between the EAC and control group.
Abstracts
Conclusions: Our murine autoimmune cystitis model has
comparable functional and histological alterations to those observed in
human IC, and may provide a useful model for the study of the
pathogenesis and treatment of interstitial cystitis.
Disclosures: G. Liu, None; Y. Lin, None; M. Kavran, None; C.
Altuntas, None; G. Gasbarro, None; V. Tuohy, None; F. Daneshgari,
None.
Augmentation Cystoplasty: Histological Comparison of
Laboratory Made Bladder Acellular Matrix Graft Versus a
Commericial Xenograft
M. H. Parekh,* A. Cavanaugh,† M. Wilkerson,‡ P. Zangh† and L.
Rothblum† *GMC, Danville, PA, †GMC, Weis Center for Research,
Danville, PA, ‡GMC, Department of Pathology, Danville, PA
Objective: Bladder reconstruction or augmentation is one recommended
treatment for voiding disorders. Currently, a segment of small bowel is
grafted in situ for bladder augmentation. Complications include
electrolyte imbalance, mucus production, stone formation, abscess,
peritoneal adhesions, and malignant potential. An alternative that has
been tried in animal models is the preparation of an acellular matrix from
a donor bladder of the same species. This study compares bladder
augmentation in a rabbit model using allograft and xenograft acellular
matrices.
Methods: One group of 15 rabbits had bladder augmentation with a
donor allograft acellular matrix prepared from rabbit bladder after the
removal of mucosa. A second group of 15 had augmentation using a
commercially available xenograft prepared from porcine small bowel.
The bladder from 5 animals in each group (A–F) was harvested after
1, 2, and 3 months.
Results: All bladders had epithelialization of the luminal aspect of the
grafts, muscle had grown into the grafts and there was histologic
evidence of nerves. At 3-month interval rabbits receiving allograft
showed better histologic grade as compare to xenograft group,
although the difference was small (see table 1).
Conclusions: These findings suggest that bladder augmentation
using a donor acellular matrix may someday be an alternative to
the small bowel grafting that is presently offered for treatment of a
non-compliant human bladder. Further studies are needed to
315
Abstracts
compare functional differences between the two grafts as well as
longer time period for histologic normalization of augmented
tissue.
Disclosures: M.H. Parekh, Astellas, Speaker’s Bureau; A. Cavanaugh,
None; M. Wilkerson, None; P. Zangh, None; L. Rothblum, None.
Initial Experience Incorporating Robotic-Assisted Laparoscopic
Sacrocolpopexy Surgery Into a Urogynecology Training
Program
E. S. Lukacz, and C. W. Nager UCSD, La Jolla, CA
Category: Education.
Laboratory Preparation of Acellular Matrix Graft,
Augmentation Cystoplasty, from Donor Rabbit Bladder
for
M. H. Parekh,* A. Cavanaugh,† M. Wilkerson‡ and L. Rothblum†
*GMC, Section of Urogynecology, Danville, PA, †GMC, Weis Center
for Research, Danville, PA, ‡GMC, Department of Pathology,
Danville, PA
Objectives: Bladder reconstruction or augmentation is one
recommended treatment for voiding disorders. Currently, a segment of
small bowel is grafted in situ for bladder augmentation. Complications
include electrolyte imbalance, mucus production, stone formation,
abscess, peritoneal adhesions, and malignant potential. An alternative
that has been tried in animal models is the augmentation with an
acellular matrix graft. As these grafts were from different organs and
often from different species, it may fail or produce functionally
inferior neo-bladder. We modified and perfected a previously reported
process for acellular matrix graft preparation to create an acellular
bladder graft from frozen donor rabbit bladder.
Methods: The source of normal rabbit bladder tissue was obtained
commercially from PelFreez. Bladders were removed from young
rabbits and immediately frozen in liquid nitrogen by the company.
The frozen bladders were stored at ⫺80 degrees F until used. Bladders
were thawed in PBS containing 0.1% sodium azide. The bladders were
inverted and the mucosa scrapped off with a glass slide. The
remaining lamina propria and detrusor muscle were treated with 0.1M
PBS (13.8 mM NaCl, 0.27 mM KCl) containing 0.1% sodium azide with
gentle agitation overnight at room temperature. Bladders were then
washed with PBS followed incubation with 2000 Kunitz units of
DNase in 1M NaCl for overnight at room temperature. These
treatments caused cell lysis and release of the cellular components.
The samples were then treated with 4% sodium deoxycholate
containing 0.1% sodium azide overnight at room temperature. This
incubation was repeated an additional five hours. The matrix was then
washed with PBS and stored in 10% neomycin sulfate at 4 degrees
until used. A 20 ⫻ 30 mm patch was cut to perform the bladder
augmentation.
Results: These grafts were studied histologically to confirm
acellularity and implanted in recipient rabbit bladders to perform
bladder augmentation.
Conclusions: It is possible to prepare an acellular matrix graft from
donor rabbit bladder. When this acellular matrix bladder graft is used
in situ to augment a rabbit bladder it produces a functional and
histologically normal bladder. In theory, bladder acellular grafts may
provide better architecture for creation of in-vivo neo-bladder
compared to tissue from different source. Presented @ IUGA 2007,
Cancun, Mexico.
Disclosures: M.H. Parekh, Astellas, Speaker’s Bureau; A. Cavanaugh,
None; M. Wilkerson, None; L. Rothblum, None.
316
Objective: To describe our experience of incorporating robotic surgery
in an academic urogynecology fellowship program; and to report surgical
times and complications for robotic-assisted laparoscopic sacrocolpopexy
(RLSC).
Methods: A retrospective chart review of the first 51 robotic surgery
cases scheduled by 2 fellowship-trained urogynecologists at 1
institution between July 2006 and March 2008 was performed. The
first 12 cases were performed by 2 attendings while 1 attending and 1
fellow performed subsequent procedures. All RLSC procedures were
performed mimicking our standard open techniques, including
multiple sutures for mesh attachment to anterior and posterior vagina,
2 sacral sutures, and reperitonealization. Data collection included
length of vaginal dissection, number of sutures, estimated blood loss
(EBL), postoperative complications, hemoglobin, and hospital stay.
Surgical times assessed included: Set up time-calculated as ‘time in
room to incision’ and included anesthesia induction and patient
preparation, skin time-calculated as ‘incision to close,’ RLSC timecalculated as skin time minus an estimated time for the additional
procedures. Descriptive statistics were reported and RLSC time trends
were assessed using one-way ANOVA.
Results: Of the first 51 scheduled cases, 2 did not include LSC and 1
procedure was changed prior to surgical start because of a short torso
preventing safe placement of ports. Of the 48 RLSC procedures, 3(6%)
were converted: 1 vaginal repair due to difficult exposure of the sacrum,
1 open abdominosacrocolpopexy (ASC) due to respiratory acidosis, and 1
aborted due to a rectosigmoid injury - repaired robotically. The mean age
⫾ SD (range) of the 48 subjects was 59 ⫾ 8 (37–79) yrs and mean
weight was 146 ⫾ 26 (104 –229) lbs. Median POPQ stage was 3 (Ba ⫽
⫹2, C ⫽ ⫺2, D ⫽ ⫺6.5, Bp ⫽ ⫺2.0). Mean times in minutes: set up
⫽46 ⫾ 12 (15–73), skin ⫽302 ⫾ 72 (196 – 495), RLSC ⫽247 ⫾ 53
(130 – 430). Mean RLSC time decreased from the first 5 to the last 5
patients in the series (320 ⫾ 64 vs. 202 ⫾ 51 min, p ⬍ 0.01). Median
length of dissection and number of sutures was 6 cm and #7 anteriorly,
and 7 cm and #7 posteriorly. Median EBL was 100 (25–350) ml. Three
colpotomies and 1 cystotomy were recognized intraoperatively and
repaired robotically. Postoperatively, mean hemoglobin change was 2.9
⫾ 1.1 mg/dl and 1 patient received a blood transfusion for bleeding from
a horseshoe kidney over the sacrum. Mean hospital stay was 1.2 ⫾ 0.5
(1–3) days. One patient was transiently admitted to the ICU for
respiratory acidosis and 1 had extended admission (3 days) for electrolyte
imbalance and fluid overload.
Conclusions: For surgeons performing open ASC, the RLSC
approach is feasible with acceptable conversion and complication
rates. Operative times appear long, but there is a steep learning curve
and surgical time reduces even when incorporating a fellow training
experience. We anticipate that increased experience will further
improve these outcomes. Long-term follow up is needed to assess the
overall utility of RLSC.
Disclosures: E.S. Lukacz, Pfizer, Inc., Consultant; Medtronic Corp.,
Gamble Pharmaceuticals, Speaker’s Bureau; Intuitive Corp., Speaker’s
Bureau; C.W. Nager, None.
Abstracts
TABLE. Representative (9 of 34 reported) Procedures and Percent of Fellows Reporting Competence
Mean
Range
Mean
Range
Mean
Range
All
Fellows
Mean
3
7
12
18
21
17
3
6
10
19
34
27
5
4
14
30
24
57
4
6
12
52%
76%
88%
9
45
19
128
25
116
19
79%
17
8
12
8
2
34
26
33
25
4
33
37
41
17
7
175
317
317
136
74
24
23
29
12
4
60
162
302
61
12
26
26
30
13
5
88%
60%
76%
60%
76%
1st Yr
Pubovaginal sling
Abdominal Burch
Abdominal
sacrocolpopexy
Sacrospinous ligament
fixation
Vaginal USS
Apical suspension kit
AR with Mesh/Graft
Vaginal PVR
Sphincteroplasty
2nd Yr
Urogynecology Fellowship Surgical Experience And SelfAssessment
E. E. Weber LeBrun,* A. N. Morse,* S. P. Baker† and S. B. Young,*
*University of Massachusetts Medical Center, Worcester, MA,
†University of Massachusetts Medical School, Worcester, MA
Objective: To determine the surgical experience within urogynecology
fellowship programs and to ascertain fellows’ impression of their training.
Methods: A pilot study based on fellows’ recollection of surgical
cases was previously presented. 50 current or recent urogynecology
fellows responded to a new online survey. Procedures completed
were reported from their case logs. Trainees noted if they felt
competent to perform each procedure and indicated if a surgical
rotation at another institution would enhance training. The cases were
weighted based on completed training-to-date.
Results: Respondents-7 first, 15 second, 14 third year fellows and 6
recent graduates. Programs-93% Urogynecology FPMRS, 90% three
year, 61% Board approved. Location-47% Northeast (NE), 21%
Southeast (SE) and 31% West of the Appalachian Mountains (West).
Yearly mean number of cases performed (Table 1). West fellows did
fewer vaginal uterosacral suspensions (USS) (NE p ⫽ 0.016), apical
kits (NE p ⫽ 0.001, SE p ⫽ 0.029) and anterior repairs (AR)/posterior
repairs (PR) with graft or mesh (NE p ⫽ 0.002, SE p ⫽ 0.005) than
those in the eastern states. Accredited programs performed more
abdominal Burches (p ⫽ 0.002), AR with native tissue (NT) (p ⫽
0.018) and sphincteroplasties (p ⫽ 0.044) and felt more competent in
abdominal Burches (p ⫽ 0.023), robotic USS (p ⫽ 0.038), rectovaginal
fistula repairs (p ⫽ 0.049) and Martius transplants (MT) (p ⫽ 0.014).
Trainees
desiring
additional
surgical
training
did
fewer
laparoscopic/robotic (L/R) USS (p ⫽ 0.021), L/R paravaginal repairs
(PVR) (p ⫽ 0.025) and MT (p ⫽ 0.004). They felt less competent at
PVR (vaginal p ⫽ 0.014, abdominal p ⫽ 0.044,) and extended
perineorrhaphy (p ⫽ 0.048). Some third year trainees performed no
traditional pubovaginal slings (3), abdominal Burches (2), sacrospinous
ligament fixations (2), AR/PR with NT (1), PVR (2), sphincteroplasties
(1), diverticulectomies (2) or MT (7). Less than half of fellows feel
competent to perform L/R surgery and MT. 59% of all trainees desire
outside surgical training.
Conclusion: FPMRS surgical experience differs significantly between
regions and types of programs. Trainees recognize deficiencies in their
surgical training and appreciate the value of additional outside
rotations.
3rd Yr
%
Competent
Disclosures: E.E. Weber LeBrun, None; A.N. Morse, None; S.P. Baker,
None; S.B. Young, None.
Feasibility of Using Motion Analysis To Quantify Vaginal
Surgical Skills
G. B. Diwadkar, A. J. van den Bogert, M. D. Barber, and J. E. Jelovsek
Cleveland Clinic, Cleveland, OH
Objective: To determine the feasibility of applying motion analysis to
vaginal surgery with the hypothesis that there are differences between
novice and expert surgeons allowing for targeted areas of
improvement.
Methods: Videotapes were obtained from 13 vaginal hysterectomies
(VH) performed by surgical trainees from post-graduate years 1 to 7.
Analyses were performed using SiliconCoach Pro® and Logger Pro®
software by a single investigator blinded to the identity of the
surgeons. This analysis focused only on the specific task of clamping,
transecting, and suturing the left uterosacral ligament during VH.
Time, path distances, velocity, angles between instruments (retractor,
needle-driver, and Heaney clamp), and trajectories of hand motion
were measured. Cumulative translational motion (smoothness) and
cumulative, maximum and mean velocity were calculated. These
variables were compared to training level, number of VH performed,
and scores on the Vaginal Surgical Skills Index and Global Rating
Scales. Trainees were grouped as novice (PGY 1–3, N ⫽ 3),
intermediate (PGY-4, N ⫽ 5), and expert (PGY 5–7, N ⫽ 5).
Results: When suturing the left uterosacral ligament, the angle
between the vertical axis (bladder retractor) and Heaney clamp
decreased with level of training: novice 124° (95% CI 108 –140),
intermediate 98° (CI 86 –110), and expert 92° (CI 79 –104) (p ⫽ 0.01).
Level of training had a moderate correlation with this angle (R ⫽ 0.6,
p ⫽ 0.03), as did the number of VH performed by each trainee (R ⫽
0.7, p ⫽ 0.05). The angle between the clamp and vertical axis
remained constant from insertion to removal of the needle from the
tissue with a difference of only 4 –5°. This demonstrates that clamp to
retractor angle, rather than needle-driver to retractor angle, is a critical
skill separating surgeon level. Cumulative translational motion and
hand trajectory (Figure 1) demonstrated interesting trends with level
of training.
317
Abstracts
Conclusions: Video motion analysis is feasible to quantify surgical
performance and has considerable potential as a tool for surgical
education. In this feasibility study, a technique was identified, angle of
the clamp during suturing, that differed between levels of experience
and provides a potential area where education can be targeted.
Disclosures: G.B. Diwadkar, None; A.J. van den Bogert, None; M.D.
Barber, American Medical Systems, Grant/Research Support; J.E.
Jelovsek, None.
Teaching Pelvic Anatomy to Obstetrics And Gynecology
Residents: the Benefits of Using 3 Dimensional Online
Interactive Images of the Pelvis and Perineum
N. P. Bhatia, J. Hutchinson-Colas, and C. Ananth UMDNJ/Robert
Wood Johnson Medical School, New Brunswick, NJ
Objective: To determine whether using online interactive 3dimensional images along with lecture is more effective than lecture
alone when teaching female pelvic anatomy to OBGYN residents.
Methods: A randomized, controlled, prospective study of 22 OBGYN
residents at our institution is being conducted. After taking a pretest
containing 60 questions on female pelvic anatomy, residents are
randomized to either the study or subject group for each of the two
lectures. Controls for lecture #1 are study subjects for lecture #2, and
study subjects from lecture #1 are controls for lecture #2. One week
318
prior to lecture #1 on female pelvic and perineum muscle anatomy,
study subjects for lecture #1 are given access to 3D images specific to
lecture #1 only. Following lecture #1, a 30 question multiple choice
posttest specific to the anatomy of the female pelvis and perineum
muscles is given. After completing the first lecture, and one week
prior to the second lecture, study subjects for lecture #2 are given
access to 3D images specific for lecture #2 (the female bony pelvis
and ligaments). Following lecture #2, a multiple choice posttest
containing 30 questions specific to the anatomy of the female bony
pelvis and ligaments is given. The test questions were created by the
investigators based upon CREOG objectives for pelvic and perineum
anatomy. Out of a pool of 100 questions, 60 questions were randomly
selected for the tests, with 30 questions from each subject area. The
same instructor gives each of the 30 minute anatomy lectures to the
residents and is blinded to which questions are asked until after both
lectures are given. The pretests and post tests contain the same
questions asked in different numerical order.
Results: Thus far the use of 3D images of the female pelvis and
perinuem along with lecture enhance residency education compared
to lecture alone. Complete results will be available prior to abstract
presentation.
Conclusions: Understanding pelvic anatomy is both complex and
essential to obstetricians and gynecologists. To date there have been
studies done on using clay models, cadavers, and even virtual reality
images to enhance teaching of pelvic anatomy to OBGYN residents.
Cadaver labs and virtual reality programs have been shown to be
helpful; however they are costly and not readily available to all
OBGYN residents in training. While clay models have also been
shown to be helpful, residents may be restricted to the time they can
spend learning with these models due to availability. Online 3
dimensional interactive images allow individual access 24 hours a day.
Residents can choose from views of the whole pelvic region or focus
on specific areas including the pelvic floor, bony pelvis, and pelvic
ligaments. Layers of anatomy can be viewed from skin to bone and
the models rotated at any stage to view and identify any anatomical
structure. The use of these interactive online 3 dimensional anatomy
programs along with formal lecture on the subject of pelvic anatomy
can greatly enhance resident education.
Disclosures: N.P. Bhatia, None; J. Hutchinson-Colas, None; C.
Ananth, None.
Evaluating Patient Learning After an Educational Program on
Incontinence and Pelvic Prolapse
R. Geoffrion, M. Robert, S. Ross, D. VanHeerden, G. Neustaedter, S.
Tang, and J. Milne University of Calgary, Calgary, AB, Canada
Objective: Conservative interventions such as pelvic floor muscle
exercises (PFME), bladder training, fluid intake or dietary
modifications and weight loss are mainstays of initial therapy for
pelvic floor symptoms. Despite growing evidence in support of these
self-care strategies, they are often performed sporadically. Women’s
awareness of pelvic floor health remains limited. To enhance patient
and general public access to pelvic health information, we
implemented a 2.5-hr workshop run by a nurse continence advisor
several times a month. There is some evidence to suggest that focused
patient education can positively impact knowledge, quality of life,
pelvic symptoms and PFME performance. The objective of the current
study was to evaluate participant knowledge regarding pelvic floor
Abstracts
issues before, immediately after and 3 months after our workshop.
Related quality of life and symptoms were also evaluated before and 3
months after our workshop.
Methods: We used a prospective cohort design. All women who
registered for our workshop between April 2007 and January 2008
were mailed an introductory letter and invited to participate. A
convenience sample of 50 participants was chosen. Before the
workshop, women provided demographic data and information on
pelvic floor symptoms. They also completed a knowledge
questionnaire, developed based on workshop material, before,
immediately after and 3 months after the workshop. Conditionspecific, validated symptom and quality of life questionnaires (PFDI20, PFIQ-7) were completed before and 3 months after the workshop.
To minimize the confounding impact of additional information or
care, women who had individual appointments with a pelvic floor
health care professional in the 3 month follow-up interval were
excluded. Descriptive statistics and paired t-tests were used for data
analysis.
Results: 125 women consented to participate. Complete 3-month
follow-up data were available for 50 women. 51% of initial recruits
were excluded because of additional interventions in the 3 months
following the workshop. Response rate for questionnaire completion
at 3 months was 83%. Characteristics of the 50 study participants
were as follows: mean age 62 (SD 11); 47 (94%) Caucasian; 32 (64%)
higher education; 27 (54%) had UI, majority stress predominant
(20,38%). 44 (88%) had prolapse symptoms. Knowledge scores
significantly improved from baseline immediately after the workshop
(p ⬍ 0.001, 95% CI 6.3–7.6) and at 3 months (p ⬍ 0.001, 95% CI
3.7–5.6). Symptom and quality of life scores significantly improved
from baseline at 3 months (PFIQ: p ⫽ 0.004, 95% CI 4.3–21.5; PFDI: p
⬍ 0.001, 95% CI 9.8 –29.9). Differences were most marked for the
bladder subscales of the PFIQ-7 and PFDI-20.
Conclusions: Women’s pelvic floor health knowledge and symptoms
significantly improved after our workshop. This study provides
adequate evidence in support of our decision to offer this workshop
in rural or outlying areas and to strongly recommend attendance for
all patients referred to our clinic.
Disclosures: R. Geoffrion, None; M. Robert, None; S. Ross, Boston
Scientific, J&J, unrelated grants, Grant/Research Support; D.
VanHeerden, None; G. Neustaedter, None; S. Tang, None; J. Milne,
None.
Cincinnati, OH). The gynecologic procedures evaluated were: total
abdominal hysterectomy (TAH), total vaginal hysterectomy (TVH),
laparotomy, incontinence/pelvic floor surgery, operative laparoscopy,
hysteroscopy, cervical conization, and surgical sterilization. Our
analysis considered each institution and its residents separately. The
total number of each procedure performed by residents graduating in
2007 was compared to those of residents graduating in 2003. We also
compared the numbers of each procedure performed as the primary
surgeon. The mean number of procedures performed during their
residency was compared between those graduating in 2003 and 2007.
The mean difference in number of procedures was defined as the
mean number performed by 2007 graduates minus the mean number
performed by 2003 graduates.
All comparisons were analyzed using a two-sided, two-sample t-test
with a type I error level of 5%.
Results: In the year 2003, Mayo Clinic and Good Samaritan Hospital
each had 4 residents graduate. In the year 2007, Mayo Clinic had 3
residents graduate and Good Samaritan Hospital had 4 residents
graduate.
At Mayo Clinic, 2007 graduates logged significantly less cervical
conizations than 2003 graduates (p ⫽ 0.006). This was also seen for
the number of cervical conizations logged as primary surgeon (p ⫽
0.013).
At Good Samaritan Hospital, 2007 graduates logged significantly
more surgical sterilizations (p ⬍ 0.001). The same findings were seen
for the number of sterilizations (p ⬍ 0.001) in which the 2007
graduate was the primary surgeon.
Conclusions: We observed little impact on the number of gynecologic
surgeries performed by residents since the implementation of duty-hour
restrictions. There were no significant differences in the number of the
abdominal hysterectomies or vaginal hysterectomies performed by
residents. Graduates in 2007, from the institutions we evaluated,
performed fewer conizations and more sterilizations when compared to
2003 graduates. Institution numbers can impact resident surgical
experience and may be partially responsible for the differences found.
Those who opposed the duty-hour restrictions believed that limiting
work hours would negatively affect resident surgical experience;
however, our study does not support this. Further investigation is
warranted to more completely evaluate this topic.
Disclosures: J.A. Occhino, None; T. Hannigan, None; M.S. Baggish,
None; J.B. Gebhart, None.
Duty-Hour Restrictions and their Effect on Resident Operative
Experience in Obstetrics and Gynecology
J. A. Occhino,* T. Hannigan,† M. S. Baggish† and J. B. Gebhart*
*Mayo Clinic, Rochester, MN, †Good Samaritan Hospital,
Cincinnati, OH
Objective: Our objective was to determine the effect of duty-hour
restrictions on the operative experience of obstetrics and gynecology
residents.
Methods: We compared operative numbers of gynecologic surgeries
between 2 groups of residents: those graduating residency in 2003
(entire residency completed without duty-hour restrictions) and those
graduating residency in 2007 (entire residency completed with dutyhour restrictions). Resident’s operative numbers were obtained from
two separate, midwestern institutions, one academic (Mayo Clinic,
Rochester, MN) and one community-based (Good Samaritan Hospital,
Do we Know the Literature? Trends in Publication of
Urogynecology Research in Obstetric and Gynecology Journals
M. T. McLennan, A. C. Steele, and F. Leong St. Louis University, St.
Louis, MO
Objective: Urogynecology has experienced many changes over the past
10 years: accredited fellowship status; proposed boards; innovations in
treatment of incontinence/prolapse; new medical therapies all resulting in
increased interest in the field. One would therefore hypothesize that the
number of publications in the Ob/Gyn literature would increase during
this time. The goal of this study was to determine the numbers and types
of urogynecology publications in the American Journal of Obstetrics &
Gynecology (grey) and Obstetrics & Gynecology (green) over time.
Methods: All original scientific articles in the grey and green journal
from 1996 –2007 were reviewed. Articles were classified into the
following categories: obstetrics; gynecology; oncology; urogynecology;
319
Abstracts
ultrasound; education. Trends over time were assessed. Urogynecology
articles were categorized into one of 14 types: epidemiology; anatomy;
basic science; surgery for USI; surgery for POP for example.
Results: A total of 10,192 articles (6,153 in grey and 4039 in green)
were published and evaluated. The breakdown was: 5874 obstetrics;
2086 gynecology; 776 urogynecology; 591 oncology; 454 education; 396
ultrasound. The percentage of urogyn articles in the grey journal varied
from 2.46% in 1999 to 16.10% in 2005 and from 4.04% in 1999 to
10.63% in 2001 for the green. In the grey journal, two clear trends were
noted: the percentage of urogyn articles increased (correlation with year
r ⫽ 0.845; p ⬍ 0.05) and the percentage of Ob articles decreased
(negative correlation r ⫽ ⫺0.589; p ⬍ 0.05). There appeared to be two
time points where a sharp increase in average percentage of urogyn
articles occurred: between 2000 –2001 (4.26% vs. 9.53%) and 2004 –2005
(6.65% vs. 16.1%). This appears to correspond to the acceptance for
publication of AUGS meeting presentations in 2001 and publication of
combined SGS and AUGS in 2005. Overall for the green journal, the
number of urogyn articles increased with time with a strong positive
correlation of r ⫽ 0.743; p ⬍ 0.05. Similar to the grey, there was a jump
in the percentage of urogyn articles published from 2000 –2001 (6.91%
vs. 10.63%) but not quite as strong in 2004 –2005 (8.8% vs 10.36%). The
most common type of article published was in epidemiology (187/776,
24%) followed by anatomy (15%), surgery for POP (13.4%), surgery for
USI (11.8%), testing (11.7%), and basic science (7%) with pharmaceutical
therapy at 0.7%. Epidemiology had a strong correlation with year of
publication (r ⫽ 0.817 and 0.688; p ⬍ 0.05).
Conclusions: The numbers of urogynecology articles published in
the general Ob/Gyn literature has increased with time. Trends towards
increasing publication appear to be related to presentation at national
meetings. Types of publications reflect desire for understanding of the
scope and nature of problems within the specialty and do not appear
to be in response to industry or pharmaceutical advances at this time.
Disclosures: M.T. McLennan, GSK, Speaker’s Bureau; A.C. Steele,
Boston Scientific, Paid Instructor; F. Leong, Astellas, Speaker’s Bureau.
Influence of Resident, Attendings, or Physician Assistants As
Surgical Assistants in Benign Gynecologic and Urogynecologic
Surgeries
K. J. Stepp, A. Dharmani, C. Wilkins, and M. Uy-Kroh MetroHealth
Medical Center/Case Western, Cleveland, OH
Objective: To determine the effect that type of surgical assistant has on
operative time and peri-operative complications in benign gynecologic
and urogynecologic surgery.
Methods: IRB exempt status was confirmed. A retrospective chart
review of patients who underwent urogynecologic or gynecologic
surgery by the principle investigator between July 2005 and February
2008 was performed. Type of surgical assistant was identified as resident,
attending, or physician assistant. In general, residents and attendings
performed at least 50% of the surgical procedure except for advanced
urogynecologic procedures. Demographics, comorbidities, and intraoperative and post-operative (⬍6 weeks) complications were recorded.
Patients with minor general gynecologic, primary oncologic or colorectal
surgeries, and sacral neuromodulation were excluded. Charlson
Comorbidity Index was calculated to summarize the patients overall perioperative risk. Analysis was performed including and excluding minor
vaginal urogynecologic procedures. Chi-Square, Fisher’s exact test, and
ANOVA were used to compare surgical assistant, type of surgery, and
320
peri-operative variables. Logistic regression was used to identify
independent risk factors for peri-operative complications.
Results: Five hundred sixty-five patients were identified. Four
hundred seventy-three patients met inclusion criteria. The mean age of
patients was 50 ⫾ 15 (range 13–94). Seventy-eight percent were
white, 13% were African-American, and 8% were other minorities.
Patients had a mean BMI of 29.2 ⫾ 6.8 (range 17– 62) and a median
Charlson Comorbidity Index of 0 (range 0 – 6). Surgery was performed
using the vaginal approach in 51.1% of patients, laparoscopic
approach in 32.4%, abdominal approach in 4.2%, and a combined
approach in 12.3%. The primary surgical assistant was a resident in
40.8%, physician assistant in 24.1%, the referring attending in 24.3%,
and no assistant in 10.8%. Of the 51 cases when no assistant was
used, 40 were mid-urethral slings. Regardless of type of surgical
assistant, there was no difference in length of surgery for laparoscopic
sacral colpopexy (p ⫽ 0.59), laparoscopic hysterectomy (p ⫽ 0.48),
laparoscopic excision of advanced endometriosis (p ⫽ 0.08),
laparoscopic prolapse or incontinence surgery (p ⫽ 0.51), or all nonminor surgeries (p ⫽ 0.11). Abdominal approach was an independent
risk factor regardless of surgical assist for a peri-operative
complication (OR 6.78, 95% CI 2.4 –19.1). Younger age was mildly
protective against a peri-operative complication (OR .969, 95% CI
0.95– 0.99).
Conclusion: In this study, surgical assistant is not an independent
risk factor for increased surgery time or peri-operative complication.
Disclosures: K.J. Stepp, Medtronic, Grant/Research Support;
Covidien, Consultant; Cooper Surgical, Consultant; Immersion Medical,
Consultant; Covidien, Speaker’s Bureau; A. Dharmani, None; C.
Wilkins, None; M. Uy-Kroh, None.
Security of Different Surgical Knots Used for Cuff Closure in a
Vaginal Hysterectomy Model
S. Balgobin, C. A. Hamid, M. D. Ruff, S. A. Brown, and C. Y. Wai
University of Texas Southwestern Medical Center, Dallas, TX
Objective: Knot security and tying technique have been identified as
etiologic factors for dehiscence and evisceration after vaginal
hysterectomy. Many techniques have been described for vaginal cuff
closure using different types of surgical knots. The objective of this
study was to compare the strength and integrity of 3 different types of
sliding knots commonly used to close the cuff during vaginal
hysterectomy.
Methods: A bench model was constructed to simulate surgical knottying during cuff closure following vaginal hysterectomy. Using
synthetic absorbable braided 0 – 0 polyglactin suture (Vicryl, Ethicon,
Somerville, NJ), non-identical sliding (NS), parallel sliding (PS), and
loop-to-strand sliding (LTS) knots with four throws each were tested.
One faculty surgeon wearing surgical gloves and blinded to the study
objective was instructed to tie 15 of each different type of knot on
the model for a total of 45 sets of knots. A random number table was
used to determine the sequence of the type of sliding knots tied. The
surgeon was observed for proper technique and each set of knots was
examined microscopically to confirm configuration. Another faculty
surgeon, unblinded to the study objective, repeated the protocol for
an additional 45 sets of knots.
Knot tails were trimmed to 3 mm and the loops were divided
opposite the knots. After presoaking in 0.9% NaCl for 60 seconds,
knots were distracted at 50 mm/min using an Instron tensiometer
until knot failure, defined as slippage beyond 3 mm or knot rupture.
The maximum load required to cause slippage or rupture and the
mode of failure were recorded. Maximum failure loads for each knot
type were expressed as the mean ⫾ SEM. Statistical analysis was
performed using analysis of variance with P-values of ⬍0.05
considered statistically significant.
Results: A total of 90 sets of knots were tied and the results were
pooled. Mean ⫾ SEM failure loads for NS, PS, and LTS knots were
5.1⫾1.4 Newtons (N), 42 ⫾ 1.1 N, and 6.8 ⫾ 1.5 N, respectively. PS
knots were significantly stronger than either the NS or LTS knots (p ⬍
0.05), with no difference in failure strength between NS and LTS
knots. While almost all the NS (97%) and LTS (97%) knots failed by
slippage, 97% of the PS knots failed by rupture at the knot site. These
differences were similar when the data were stratified according to
surgeon, with the PS knots failing at a significantly higher force than
either the NS or LTS knots (p ⬍ 0.05). There were no statistically
significant differences in the strengths of each knot type tied between
the two surgeons. Conclusions: Parallel sliding knots using 0-vicryl
knots with four throws are significantly stronger than non-identical
sliding and loop-to-strand sliding knots when subjected to tension
under experimental conditions and should be considered when
closing the cuff during vaginal hysterectomy. Disclosures: S. Balgobin,
None; C.A. Hamid, None; M.D. Ruff, None; S.A. Brown, None; C.Y.
Wai, None.
Methods Used by Physical Therapists to Learn Pelvic Floor
Muscle Examination
E. R. Shelly Beth Shelly PT, Bettendorf, IA
Objective: To investigate current methods by which physical therapists
(PTs) in the United States learn how to perform pelvic floor muscle
(PFM) examination. Treatment of PFM dysfunction is a growing specialty
in physical therapy. There is no scientific evidence that identifies the
methods by which PTs learn to perform PFM examination.
Method: One thousand one hundred and seventy five (N ⫽ 1,175)
women’s health PTs were invited to participate in a 38 question webbased survey that had been validated using four content experts. Subjects
were solicited from the APTA Section on Women’s Health, BCIA EMG
courses, and personal PT contacts. All students, PTAs and international
Abstracts
PTs were excluded from participation. Questions addressed professional
(entry-level, post-professional, and continuing) education in PFM
dysfunction (hours, types of diagnoses, types of assessments discussed
and practiced); and current type of assessments used in physical therapy
practice. Descriptive statistics were used to examine the data.
Results: Two hundred and three (n ⫽ 203) PTs completed the
survey (17.3% response rate). There appears to be increasing
exposure to PFM dsyfunction in entry level professional education
with 55.4% of subjects reporting some discussion of the topic. Seven
subjects reported practicing the vaginal palpation of the PFM in their
entry level education. The most common method of learning PFM
examination is post professional continuing education (96.1%). One
hundred and twenty eight (128, 62.1%) of subjects reported more
than nine days of continung education in PFM therapy. Most students
practice on class mates (84.5%). Physical therapists specialized in PFM
dysfunction provided the majority of this edcuation (99%). Most PTs
used vaginal palpation (73.9%) and perineal observation (68.5%) to
examine the PFM.
Conclusion: Most PTs are receiving instruction in PFM examination in
post professional continuing education courses and most are using
vaginal palpation to examine the muscles. Documentation of current US
physical therapy practice allows comparision with other professions in
the US and other PTs around the world. In addtion, future studies may
show changes in practice patterns and educational methods.
Disclosures: E.R. Shelly, None.
Combined Effects of Behavioral Intervention and Tolterodine In
Subjects Dissatisfied with their Previous Overactive Bladder
Medication
K. Burgio,* J. Wyman,† C. Klutke,‡ Z. Guan,§ F. Sun,§ K. Rivera,§
S. Berriman,§ and T. Bavendam§ *Birmingham/Atlanta Geriatric
Research, Birmingham, AL, †University of Minnesota, Minneapolis,
MN, ‡Washington University School of Medicine, St. Louis, MO,
§Pfizer Inc., New York, NY
Category: Overactive Bladder.
Objective: To assess the effect of tolterodine extended release (TER)
in conjunction with behavioral intervention on treatment satisfaction
and clinical outcomes in subjects with overactive bladder (OAB) who
were dissatisfied with their most recent antimuscarinic therapy.
TABLE. PFM Examination Techniques Practiced by PTs in Different Education Programs
Entry-Level
Professional Education
None
Examination of the PFM by observation of
perineal mobility
Examination with vaginal and or rectal
palpation by the therapist
EMG biofeedback assessment with intravaginal sensor
EMG biofeedback assessment with external
sensor
Assessment with real-time ultrasound
Pressure biofeedback assessment
Assessment of pelvic floor muscle pain
Post-Professional
College
Education
Post-Professional
Continuing Education
78 (85.7%)
7 (7.7%)
19 (36.5%)
30 (57.7%)
3 (1.4%)
193 (95%)
7 (7.7%)
29 (55.8%)
195 (96.1%)
10 (11%)
28 (53.9%)
184 (90.6%)
8 (8.8%)
26 (50%)
160 (78.8%)
0 (0%)
5 (5.5%)
6 (6.6%)
5 (9.6%)
18 (34.6%)
26 (50%)
21 (10.3%)
79 (38.9%)
174 (85.7%)
321
Abstracts
Methods: Eligible subjects (men and women, aged ⱖ 18 y) in this 16week, multicenter, single-arm, open-label study reported dissatisfaction
with their prior antimuscarinic OAB medication; had a mean of ⱖ8
micturitions, ⱖ1 urgency urinary incontinence (UUI) episode, and ⱖ2
urgency-related micturitions per 24 hours in a 5-day bladder diary at
baseline; and had self-reported OAB symptoms for ⱖ3 months. All
subjects received TER plus self-administered behavioral intervention
(educational handouts and counseling) for 8 weeks. Satisfied subjects
continued on the same program, and dissatisfied subjects received TER
plus individualized therapy (clinic-based pelvic floor muscle training with
tailored behavioral techniques) for an additional 8 weeks. Endpoints were
the proportion of subjects who were at least “a little satisfied” with
treatment at weeks 8 and 16, the proportion dissatisfied with treatment
at week 8 who became satisfied at week 16, and changes from baseline
in OAB symptoms at weeks 8 and 16.
Results: Among subjects dissatisfied with previous TER or other
antimuscarinic therapy, 92% and 90%, respectively, were at least “a
little satisfied” with TER plus behavioral intervention at week 16; 70%
and 59%, respectively, were “very satisfied” (Table). Among subjects
dissatisfied with treatment at week 8, 76% became satisfied at week
16. At 8 and 16 weeks, all groups reported improvements in total
micturitions and UUI episodes per 24 hours compared with baseline
(paired t test, P ⬍ 0.0001).
Conclusion: TER plus behavioral intervention resulted in high
treatment satisfaction and improved symptoms in subjects with OAB
who were previously dissatisfied with antimuscarinic therapy, even
among those who were dissatisfied with previous TER therapy.
Further research is needed to delineate the contribution of self- and
clinician-administered behavioral intervention in the context of drug
therapy.
Prior Presentation: SUNA 2008.
Disclosures: K. Burgio, Investigator — Pfizer Inc., Other; J. Wyman,
Pfizer Inc., Consultant; Investigator — Pfizer Inc., Other; C. Klutke, Pfizer
Inc., Consultant; Lecturer — Pfizer Inc., Other; Z. Guan, Employee —
Pfizer Inc., Other; F. Sun, Employee — Pfizer Inc., Other; K. Rivera,
Pfizer Inc., Consultant; S. Berriman, Employee — Pfizer Inc., Other; T.
Bavendam, Employee — Pfizer Inc., Other.
Evaluation of Urgency with a Validated Urgency Severity and
Impact Questionnaire (USIQ)
L. Lowenstein, M. FitzGerald, K. Kenton, L. Hatchet, R. DurazoArvizu, K. Goldman, and L. Brubaker, Loyola Medical Center,
Chicago, IL
322
Objective: Attempts to measure urgency are confounded by
difficulties in understanding its definition and the context of the
normal urge to void. This may be partly due to the controversy
surrounding the term ⬘urgency’ and possibly also because there is no
widely available, validated, clinical tool with which we can evaluate
the severity of urgency symptoms and related bother. The objective of
this study was to develop a validated, clinically useful, patient-oriented
questionnaire to assess urgency and associated life impact.
Methods: After IRB approval we interviewed 6 urogynecologists and
urologists and 10 patients with overactive bladder (OAB) symptoms
about urinary urgency, methods to evaluate its severity, and its effect on
patients’ everyday lives. Based on this data, we composed the first draft
of our Urgency Severity and Impact Questionnaire (USIQ). A focus group
of OAB patients completed and provided feedback on the USIQ draft.
The revised questionnaire has two parts: symptom severity (USIQ-S) and
related quality of life (USIQ-QOL). The questionnaire was given to
patients clinically diagnosed OAB or with urodynamically confirmed
Urodynamic Stress Incontinence (USI), Detrusor Overactivity
Incontinence (DOI) to establish face, content and discriminatory validity.
Fifty three women with a mean age of 56 (29 – 87) years participated
in this study. Most participants were Caucasian (87%).
Item Reduction: All items had a good loading scores ranging from
0.48 to 0.85 (Table 1). Internal consistency for the USIQ-S and USIQQOL as measured by Cronbach’s alpha was excellent; 0.85 and 0.90
respectively. USIQ-S and USIQ-QOL scores moderately correlated (r ⫽
0.69, p ⬍ 0.001), thus supporting the association between the two
parts of the questionnaire.
Criterion Validity: USIQ-QOL, which measures the effect of urgency
on HRQOL, correlated with existing, validated HRQOL questionnaires;
UDI-6 (r ⫽ 0.49, p⬍0.001), IIQ-7 (r ⫽ 0.77, p ⬍ 0.001) and OAB-q (r
⫽ 0.73, p ⬍ 0.001). Similar correlations were found between the
USIQ-S and UDI-6 (r ⫽ 0.34, p ⬍ 0.02), IIQ-7 (r ⫽ 0.42, p ⬍ 0.002)
and OAB-q (r ⫽ 0.73, p ⬍ 0.001). Except for a strong inverse
correlation between USSBQ-QOL and the volume at which patients
had strong desire to void (r ⫽ ⫺0.81, p ⬍ 0.015), neither USIQ -S nor
USIQ-QOL scores correlated with other urodynamic parameters.
Discriminant Validity: Mean USIQ-QOL and USIQ-S scores differed
by clinical diagnosis. OAB patients had higher mean USIQ-S and USIQQOL scores than patients with USI (66⫾18 vs. 34⫾24, p ⬍ 0.001 and
48⫾22 vs. 19⫾25, p ⬍ 0.005, respectively). The area under the ROC
curve, which was used to assess “urgency” discrimination, was 0.87
and 0.82 for USIQ-S and USIQ-QOL, respectively.
Conclusions: This new questionnaire has an excellent internal
consistency, good construct, face and discriminatory. The USIQ is an
easily-understood questionnaire with adequate validity for use in
research and in clinical practice to describe the severity and life
impact of urinary urgency.
Disclosures: L. Lowenstein, Pfizer, Grant/Research Support; Astellas,
Grant/Research Support; M. FitzGerald, Pfizer, Grant/Research
Support; Allergan, Grant/Research Support; Medtronic, Grant/Research
Support; K. Kenton, Pfizer, Grant/Research Support; Allergan,
Grant/Research Support; L. Hatchet, None; R. Durazo-Arvizu, None; K.
Goldman, None; L. Brubaker, Allergan, Grant/Research Support; Pfizer,
Grant/Research Support; Q Med, Grant/Research Support.
Continuous Measure of Lower Urinary Tact Sensation During
Bladder Filling in Women with Detusor Overactivity
L. Lowenstein,* T. Pham,* S. Abassy,* K. Kenton,* K. Kenton,* L.
Brubaker,* E. Mueller,* Y. Vardi,† I. Gruenwald† and M. FitzGerald*
*Loyola Medical Center, Chicago, IL, †Rambam Medical Center,
Haifa, Israel
Objectives: Clinicians and clinical investigators express increased
interest in direct measures of lower urinary tract (LUT) sensation to
supplement information from bladder diaries, symptom questionnaires
and routine urodynamic testing. An instrument that allows patients to
continuously report their LUT sensation in real time during
urodynamic testing provides an opportunity to study the relationship
between changes in sensation and other urodynamic events. The
objective of this analysis was to describe the temporal relationship
between increases in LUT sensation measured in real time and
changes in detrusor and/or urethral pressures.
Methods: We reviewed 33 multichannel urodynamic tracings that
included a continuous recording of LUT sensation and that
demonstrated detrusor overactivity incontinence (DOI) or detrusor
overactivity (DO). For each urodynamic tracing reviewed, we
evaluated each detrusor contraction. For this analysis, we considered
an episode of DO or DOI to be present if a phasic detrusor
contraction with an elevation of at least 5 cm H2O over baseline
occurred. We considered a rise in LUT sensation as present if the
sensation reading increased by at least 5 units. We defined a fall in
urethral pressure as when the urethral pressure decreased by at least
10%. Four physician-urodynamicists reviewed the tracings separately
and together reached agreement about each data-point.
Results: The median age of the 33 patients was 60 (36 – 82) years.
Fourteen (42%) had urodynamic diagnoses of mixed incontinence, 18
(55%) had DOI, and 1(3%) had DO without DOI. We reviewed 119
episodes of detrusor overactivity from the 33 recordings. The number
of DO/DOI episodes per UDS recording ranged from 1–9, with a
median of 3 episodes. We found no difference in change in sensation
level when comparing DO episodes with DOI episodes or between
different urodynamic diagnosis (p ⬎ .5). There was no dominant
temporal pattern seen for the whole group (p ⫽ 0.84) i.e. there was
no evidence that the change in sensation level was more likely to
occur before, during, or after DO/DOI episodes. Interestingly when
evaluating the temporal relationship between the onset of change in
sensation recording and change in urethral pressure, the most
common pattern seen was an increase in sensation level after a fall in
urethral pressure. For each patient, the temporal relationship between
DO/DOI episodes and changes in LUT sensation was also variable.
Conclusions: Using real-time recordings of LUT sensation, we closely
examined the temporal relationships between observed urodynamic
events and LUT sensation. We found tremendous variability in those
relationships. Importantly, we found that increases in sensation level
commonly precede increases in detrusor pressure and/or changes in
urethral pressure implying that at least some of the time, increased
LUT sensation during DO/DOI is not caused by measurable alterations
Abstracts
in bladder or urethral pressure. Possibly, another event triggers
increased urinary urgency at those times.
Disclosures: L. Lowenstein, Astellas, Grant/Research Support; Pfizer,
Grant/Research Support; T. Pham, None; S. Abassy, None; K. Kenton,
Pfizer, Grant/Research Support; K. Kenton, Pfizer, Grant/Research
Support; Allergan, Grant/Research Support; L. Brubaker, Pfizer,
Grant/Research Support; Q Med, Grant/Research Support; Allergan,
Grant/Research Support; E. Mueller, Allergan, Grant/Research Support;
Pfizer, Grant/Research Support; Y. Vardi, None; I. Gruenwald, None;
M. FitzGerald, Pfizer, Grant/Research Support; Medtronic,
Grant/Research Support; Allergan, Grant/Research Support.
Impact of Antimuscarinics on Mean Heart Rate Evaluated in a
Randomized, Double-Blind, Placebo-Controlled, 3-Way Crossover
Trial
B. Olshansky,* U. Ebinger,† J. Brum,‡ M. Egermark§ and L. Rekeda,†
*University of Iowa Hospitals, Iowa City, IA, †Novartis
Pharmaceuticals Corporation, East Hanover, NJ, ‡Procter and
Gamble Pharmaceuticals Corporation, Cincinnati, OH, §Novartis
Pharma AG, Basel, Switzerland
Objective: Antimuscarinic drugs (AMDs) for overactive bladder
(OAB) may differ in their potential to increase heart rate (HR) via
effects on cardiac M2 muscarinic receptors. A faster resting HR has
been associated with increased risk of cardiovascular (CV) events and
death,1 raising concerns for OAB patients who tend to be older, to
have CV comorbidities and to be taking comedications.2 This is the
first head-to-head analysis of the effects of once daily darifenacin 15
mg (DAR) and tolterodine ER 4 mg (TOL) on HR over 24 hours (h)
under steady-state conditions.
Methods: A prospective, double-blind, double-dummy, 3-way crossover study in healthy volunteers (ⱖ50 years) randomized to 1 of 6
treatment sequences with DAR, TOL and placebo (PBO) over three 7day study periods, preceded by 14-day washouts. HR was assessed via
24-h Holter monitoring at baseline and end of each study period.
Between treatment effects were measured using analysis of covariance
with drug, study period and subject as main effects and baseline value
as covariate.
1
2
Fox K et al. J Am Coll Cardiol 2007;50:823–30.
McGrother CW et al. Age Ageing 2006;35:16 –24.
TABLE. Adjusted Mean Change from Baseline (⌬ ) in Mean HR at the End of Each Study Period
HR Parameter
(bpm)
Change from Baseline Adjusted
Mean
DAR
TOL
PBO
⌬ Mean HR over
24 h
⫺0.388
1.450
0.029
⌬A Mean HR in
first 8 h
⫺0.876
2.283
0.291
Treatment
Comparison
DAR–TOL
DAR–PBO
TOL–PBO
DAR–TOL
DAR–PBO
TOL–PBO
Treatment difference
(95% Confidence
Interval)
⫺1.84
⫺0.42
1.42
⫺3.16
⫺1.17
1.99
(⫺2.68, ⫺1.00)
(⫺1.26, 0.42)
(0.59, 2.25)
(⫺4.56, ⫺1.75)
(⫺2.58, 0.25)
(0.59, 3.39)
p value
⬍0.0001
0.3280
0.0009
⬍0.0001
0.1056
0.0054
323
Abstracts
Results: Of 162 randomized subjects (mean 58 years, 70.4% women),
140 completed all 3 study periods. TOL significantly increased mean
HR/24 h vs PBO. DAR did not affect HR/24 h vs PBO but decreased
HR vs TOL 关Table兴. The proportion of subjects with an increase of ⱖ5
beats per minute (bpm) in mean HR/24 h was significantly greater
with TOL compared to DAR (25% vs 8.9%; p ⫽ 0.0004, McNemar test)
or PBO (26.5% vs 12.8%; p ⫽ 0.0114). Greatest treatment effect (vs
PBO) occurred at times close to Tmax for each drug: at 5 h for
tolterodine (increase of 3.89 bpm) and at 7 h for darifenacin (decrease
of 2.24 bpm). Post-hoc analyses showed numerically more
pronounced changes from baseline in mean HR during the first 8 h
than over the whole 24-h interval 关Table兴. The most common adverse
event was dry mouth (12.5% DAR, 3.3% TOL, 3.3% PBO). There were
no deaths or serious adverse events.
Conclusion: TOL but not DAR causes an increase in mean HR. Thus,
careful consideration may be warranted when prescribing AMDs to
OAB patients who may have an increased susceptibility to the
negative effects of increased HR.
Disclosures: B. Olshansky, Novartis Pharmaceuticals Corporation,
Consultant; U. Ebinger, Novartis Pharmaceuticals Corporation,
Shareholder; Employee, Novartis Pharmaceuticals Corporation, Other;
J. Brum, Procter and Gamble Pharmaceuticals Corporation,
Shareholder; Employee, Procter and Gamble Pharmaceuticals
Corporation, Other; M. Egermark, Novartis Pharma AG, Shareholder;
Employee, Novartis Pharma AG, Other; L. Rekeda, Employee, Novartis
Pharmaceuticals Corporation, Other.
Patients with Severe Overactive Bladder Symptoms: Impact of
Solifenacin on Urgency and other symptoms
M. Toglia,* M. Karram,† C. Laramée,‡ S. Forero-Schwanhaeuser,§ and
W. He¶ *Urogynecology Associates of Philadelphia, Media, PA,
†Advanced Urogynecology, Cincinnati, OH, ‡Clinical Research of
West Florida, Inc, Clearwater, FL, §GlaxoSmithKline, King of
Prussia, PA, ¶Astellas Pharma US, Inc., Deerfield, IL
Objective: Urgency is widely recognized as the cardinal symptom of
OAB. The VESIcare Efficacy and Safety in PatieNts with Urgency Study
(VENUS) is the first large US-based trial to focus on reduction in
urinary urgency in OAB patients, using both objective and subjective
patient-reported outcomes (PROs). Here we report a post hoc analysis
of VENUS evaluating the efficacy of solifenacin in the subgroup of
patients with severe OAB at baseline.
Methods: VENUS was a randomized, double-blind, placebocontrolled, 12-week study of solifenacin (5 or 10 mg/day, flexible
dosing) in OAB patients. The primary endpoint was mean change
from baseline to study end in urgency episodes/day using 3-day
bladder diaries. Secondary endpoints included mean changes in all
other diary-recorded OAB symptoms (Table), and median change in
warning time (WT; time from first sensation of urgency to voiding).
PROs including the Indevus Urgency Severity Scale (IUSS), Urgency
Perception Scale (UPS), Patient Perception of Bladder Condition
(PPBC) scale, and Overactive Bladder Questionnaire (OAB-q) were also
assessed.
Results: In total, 158 (22%) patients had severe OAB (PPBC score ⱖ5
关1 ⫽ no problems, 6 ⫽ many severe problems) in the full analysis set
(FAS; n ⫽ 707). Solifenacin reduced mean urgency episodes/day in
the severe subgroup, similar to the significant improvements (p ⬍
0.0001) observed in the FAS vs placebo (Table). Patients with severe
OAB also showed reductions in daily micturitions and incontinence vs
placebo comparable to the significant reductions seen in the FAS.
Patients in the severe subgroup showed improved scores on IUSS and
UPS (urgency-related PROs), and there were improvement trends in
WT, PPBC scale, and OAB-q vs placebo of comparable magnitude to
TABLE.
Severe Subgroup
Parameter
Urgency episodes/d‡
Micturitions/d‡
Incontinence
episodes/d‡
Nocturia episodes/d‡
Nocturnal voids/d‡
WT (sec)§
IUSS score‡
UPS score
PPBC score‡
OAB-q symptom
bother score‡
OAB-q overall HRQoL
score
VENUS FAS
Placebo Baseline
Solifenacin Baseline
(Change*) n ⴝ
(Change*) n ⴝ 357
350
Solifenacin Baseline
(Change*) n ⴝ 84
Placebo Baseline
(Change*) n ⴝ 74
7.9 (⫺4.6)
12.1 (⫺2.9)
4.5 (⫺3.3)
7.9 (⫺3.1)
12.7 (⫺2.4)
4.2 (⫺2.1)
6.2 (⫺3.9)
11.7 (⫺2.7)
2.8 (⫺2.1)
6.0 (⫺2.73)
11.7 (⫺1.9)
2.6 (⫺1.2)
⬍0.0001
⬍0.001
⬍0.0001
1.8 (⫺0.6)
2.2 (⫺0.7)
99.0 (23.0)
2.4 (⫺1.2)
1.8 (0.5)
5.2 (⫺2.1)
69.5 (⫺41.1)
1.9 (⫺0.8)
2.5 (⫺0.9)
52.0 (9.0)
2.5 (⫺0.8)
1.6 (0.4)
5.2 (⫺1.3)
71.3 (⫺25.5)
1.7 (⫺0.6)
2.0 (⫺0.7)
67.8 (31.5)
2.0 (⫺0.9)
2.0 (0.4)
3.8 (⫺1.0)
52.4 (⫺28.0)
1.6 (⫺0.5)
2.0 (⫺0.6)
65.0 (12.0)
2.0 (⫺0.5)
2.0 (0.2)
3.9 (⫺0.6)
51.5 (⫺18.5)
0.208
0.191
⬍0.05
⬍0.0001
0.002
⬍0.0001
⬍0.0001
40.9 (35.6)
38.4 (25.2)
60.4 (22.6)
60.5 (17.2)
⬍0.001
p-value†
*Adjusted mean change from baseline.
†
Based on the comparison between treatment groups for the change from baseline in the FAS (p-values not reported for the severe subset
owing to the post hoc nature of the analysis and small sample size).
‡
Negative score change indicates improvement.
§ Median.
FAS⫽full analysis set; d ⫽ day; WT ⫽ warning time; IUSS ⫽ Indevus Urgency Severity Scale; UPS ⫽ Urgency Perception Scale; PPBC ⫽ Patient
Perception of Bladder Condition; OAB-q ⫽ Overactive Bladder Questionnaire; HRQoL ⫽ health-related quality of life.
324
those seen in the FAS. Treatment-emergent adverse events (AEs) were
mostly mild/moderate, and there were few AE-related discontinuations
(severe subgroup: solifenacin 4.5%, placebo 6.5%; FAS: solifenacin
6.5%, placebo 4.6%).
Conclusions: Although patient numbers were small, in those with
severe OAB, solifenacin-associated improvements in urgency and other
OAB symptoms, as assessed using diary records and PROs, were of
comparable magnitude to the significant improvements observed in
the VENUS FAS.
Disclosures: M. Toglia, Astellas, Consultant; GlaxoSmithKline,
Consultant; Ethicon Women’s Health, Consultant; Ortho McNeil,
Consultant; Astellas, Speaker’s Bureau; Ethicon Women’s Health,
Speaker’s Bureau; Ortho McNeil, Speaker’s Bureau; Ethicon Women’s
Health, Paid Instructor; M. Karram, Astellas, Grant/Research Support;
Gynecare, Grant/Research Support; American Medical Systems,
Grant/Research Support; Pfizer, Grant/Research Support; Allergan,
Grant/Research Support; Gynecare, Consultant; Astellas, Consultant;
Cooper Surgical, Consultant; C. Laramée, Astellas, Consultant;
GlaxoSmithKline, Consultant; S. Forero-Schwanhaeuser, Employee GlaxoSmithKline, Other; W. He, Employee - Astellas Pharma US Inc.,
Other.
Effects of Fesoterodine on Symptom Relief and Patient
Satisfaction In Subjects With Overactive Bladder
E. Goldfischer,* J. J. Wyndaele,† J. D. Morrow,‡ J. Gong,‡ L. J.
Tseng,‡ and M. S. Choo§ *Hudson Valley Urology, P.C.,
Poughkeepsie, NY, †Universitiet en Universitair Ziekenhuis
Antwerpen, Antwerp, BELGIUM, ‡Pfizer Inc., New York, NY,
§University of Ulsan College of Medicine, Seoul, Republic of Korea
Objective: To assess whether flexible-dose fesoterodine (FESO)
improves overactive bladder (OAB) symptoms, treatment satisfaction,
and health-related quality of life (HRQL) measures in subjects
previously treated and dissatisfied with tolterodine (TOL).
Methods: In this 12-week, open-label, single-arm, flexible-dose study,
adults reported ⱖ8 micturitions and ⱖ3 urgency episodes per 24 h in
5-day baseline diaries and dissatisfaction with TOL or TOL extended
release received ⬍2 y prior to study. Subjects received FESO 4 mg QD
for 4 weeks; this was maintained or increased to 8 mg, based on
efficacy and tolerability as assessed by subject and investigator.
Subjects recorded micturitions, urgency urinary incontinence (UUI)
episodes, and rated micturition-related urgency on the 5-point Urinary
Sensation Scale (1 ⫽ no urgency, 5 ⫽ UUI) in 5-day diaries at baseline
and week 12; urgency and severe urgency episodes were rated ⱖ3
and ⱖ4, respectively. Subjects completed the validated Treatment
Satisfaction Question at week 12 and the Patient Perception of
Bladder Condition (PPBC) and Overactive Bladder Questionnaire
(OAB-q) at baseline and week 12. Mean changes from baseline were
assessed using paired t test.
Results: Among 516 subjects, 90% completed the study; about 50%
opted for dose escalation to 8 mg at week 4. At week 12, micturitions
(mean change, ⫺3.0), UUI episodes (⫺1.7), urgency episodes (⫺5.0),
and severe urgency episodes (⫺3.5) per 24 h were significantly
improved (p ⬍ 0.0001; Table). 80% of subjects reported treatment
satisfaction at week 12, including 38% “very satisfied.” Mean PPBC
scores were significantly improved (p ⬍ 0.0001) at week 12; 83%
reported improvement and 59% reported ⱖ2 point improvement.
OAB-q Symptom Bother and HRQL scale and domain scores were all
significantly improved (p ⬍ 0.0001). The most common adverse
Abstracts
events (AEs) were dry mouth (23%) and constipation (5%); most AEs
(94%) were of mild or moderate severity. No serious AEs were
deemed treatment related.
Conclusions: In this open-label study FESO significantly improved
OAB symptoms, treatment satisfaction, PPBC, bother, and HRQL in
subjects previously treated and dissatisfied with TOL ⬍2 y prior to
study. About 50% of subjects opted for the 8-mg dosage. FESO was
well tolerated.
Disclosures: E. Goldfischer, Pfizer Inc., Consultant; J.J. Wyndaele,
Pfizer Inc., Consultant; J.D. Morrow, Employee—Pfizer Inc., Other; J.
Gong, Employee - Pfizer Inc., Other; L.J. Tseng, Employee - Pfizer Inc.,
Other; M.S. Choo, Pfizer Inc., Consultant.
Satisfaction with Darifenacin Treatment for Overactive Bladder
(Oab) in Patients Dissatisfied with Prior Antimuscarinic
Therapy
N. Zinner,* K. C. Kobashi,† U. Ebinger,‡ P. Koochaki,§ A. Luthra,‡ G.
Ligozio‡ and M. Egermark¶ *Western Clinical Research, Inc.,
Torrance, CA, †Virginia Mason Medical Center, Seattle, WA,
‡Novartis Pharmaceuticals Corporation, East Hanover, NJ, §Procter
and Gamble Pharmaceuticals Corporation, Cincinnati, OH,
¶Novartis Pharma AG, Basel, Switzerland
Objectives: Patient-reported outcome (PRO) tools provide important
assessments of treatment benefits. We evaluated patient satisfaction
with treatment benefits received from darifenacin (DAR) in OAB
patients dissatisfied with prior extended-release (ER) oxybutynin
(OXY) or tolterodine (TOL) treatment.
Methods: This was a 12-week, open-label study in DAR-naı̈ve adults
(ⱖ18 years), with OAB symptoms for ⱖ6 months, dissatisfied with
prior OXY-ER or TOL-ER treatment. Following a 2-week screening and
1-week baseline period, patients received DAR 7.5 mg once daily
(o.d.) for 2 weeks, then were offered up-titration to 15 mg o.d., with
stable dose thereafter. The primary efficacy variable was the change
from baseline to Week 12 (or last visit) in the Patient’s Perception of
Bladder Condition (PPBC), a validated PRO tool.1 Satisfaction was
measured with the Patient Satisfaction with Treatment Benefit (PSTB)
questionnaire, a new PRO measure consisting of a global question on
overall satisfaction (Part I) and 23 questions (Part II) on satisfaction
with DAR for improving specific problems associated with OAB that
patients report.
Results: 500 patients enrolled, 497 were treated (mean age 60.9
years, 84.1% women) and 437 completed the study. PPBC scores
improved significantly from baseline to treatment end (median: 4.0 to
3.0, mean ⫾ SD: 4.5 ⫾ 0.77 to 3.1 ⫾ 1.25). This corresponds to a
change in the PPBC scale from “my bladder causes me some
moderate/severe problems” to “my bladder causes me some minor
problems”. Results did not differ significantly between patients
previously treated with OXY ER vs TOL ER.
405 (85.6%) respondents to the PSTB questionnaire Part I were at
least somewhat satisfied with DAR treatment at last visit. Satisfaction
325
Abstracts
was more frequently reported by women than men (87.2% vs 77.0%),
but did not differ significantly between age groups (87.0% vs 83.7%
⬍65 vs ⱖ65 years) or prior antimuscarinic treatment groups (84.1% vs
86.8% OXY ER vs TOL ER, respectively). PSTB Part II questions
showed that satisfaction with DAR for specific benefits including
“reduced the number of times I urinated during the day” (85%
patients satisfied), “gave me more time between visits to the
bathroom” (83.6% satisfied), and “reduced how often I felt a sudden
urge to urinate” (84.4% satisfied) was very high.
The most common adverse events were dry mouth (20.1%) and
constipation (14.1%), infrequently leading to discontinuation (1.6%
and 0.8% patients, respectively).
Conclusions: Patients with OAB dissatisfied with previous
antimuscarinic treatments, OXY ER or TOL ER, reported significant
improvement in their bladder condition and a high level of satisfaction
with treatment benefits when treated with a flexible-dose regimen
with darifenacin (7.5/15 mg o.d.). Physicians may want to consider
alternative antimuscarinic therapies when patients report being
dissatisfied with their prescribed therapy.
References: 1. Coyne KS et al. Eur Urol 2006;49:1079 – 86.
Disclosures: N. Zinner, Allergan, Eli Lilly, Esprit, Glaxo SmithKline,
Indevus, Novartis, Pfizer, and Watson, Consultant; K.C. Kobashi, Novartis,
Astellas, and Coloplast, Consultant; U. Ebinger, Novartis Pharmaceuticals
Corporation,
Shareholder;
Employee,
Novartis
Pharmaceuticals
Corporation, Other (please specify type of relationship and company
name); P. Koochaki, Employee, Procter and Gamble Pharmaceuticals
Corporation, Other (please specify type of relationship and company
name); A. Luthra, Employee, Novartis Pharmaceuticals Corporation, Other
(please specify type of relationship and company name); G. Ligozio,
Employee, Novartis Pharmaceuticals Corporation, Other (please specify
type of relationship and company name); M. Egermark, Novartis Pharma
AG, Shareholder; Employee, Novartis Pharma AG, Other (please specify
type of relationship and company name).
Mixed Incontinence: Comparing Definitions In Women Having
Stress Incontinence Surgery
L. Brubaker,* A. Stoddard,† H. E. Richter,‡ P. Zimmern,§ P. Moalli,¶
S. Kraus,储 P. Norton,** E. Lukacz,†† L. Sirls,‡‡ H. Johnson,§§ L.
Nyberg¶¶ and Urinary Incontinence Treatment Network储储 *Loyola
University Chicago, Maywood, IL, †New England Research Institute,
Watertown, MA, ‡University of Alabama at Birmingham,
Birmingham, AL, §University of Texas Southwestern Medical Center,
Dallas, TX, ¶University of Pittsburgh, Pittsburgh, PA, 㛳University of
Texas, San Antonio, IL, **University of Utah, Salt Lake City, IL,
††University of California, San Diego, IL, ‡‡Beaumont Hospital,
Detroit, MI, §§University of Maryland, Baltimore, MD, ¶¶NDDK,
Bethesda, MD, 㛳㛳NIDDK, Bethesda, MD
Objective: To determine a scientifically sound definition of mixed
urinary incontinence (MUI) in trial participants randomized to fascial
sling vs. Burch colposuspension.
Methods: Participants were assessed at baseline using standardized
baseline measures including the Medical, Epidemiologic and Social
Aspects of Aging (MESA), the Urogenital Distress Inventory (UDI), a
three-day urinary diary and urodynamic studies (UDS). Eligibility at
baseline required participants to have a MESA stress subscale score ⬎
MESA urge subscale score.
Several different definitions for mixed incontinence using these
baseline measures were explored and tested against the clinical outcome.
At 24 months post surgery, treatment success was based on a composite
measure (negative stress test, no SUI retreatment, reduction in MESA
stress symptoms, incontinence episodes on voiding diary and pad weight)
Logistic regression analysis was used to estimate the association between
this outcome and MUI. All analyses were carried out using the personal
computer version of SAS statistical software (SAS Institute, Inc, Cary, NC.
Version 9.1). Statistical significance was defined by a p-value ⬍ 0.05.
Results: Of the 655 participants, the proportion of women with MUI
varied substantially according to the definition of MUI used, ranging
from 93.3% to 8.3% (Table 1).
All definitions were associated with severity as measured by the
frequency of incontinence episodes at baseline; however very little of the
variability was explained by any definition. No strict cut-off value for
these baseline measures was identified by ROC analysis to predict clinical
outcomes.
Conclusions: As currently defined, mixed incontinence definitions do
not adequately categorize clinically relevant UI subgroups. Use of the UDI
and MESA categorized nearly all participants of this surgical trial into
mixed category. Given the high prevalence of this condition in a surgical
TABLE. Definition of “Mixed Incontinence” Based on MESA, UDI and UDS
Definition
MESA Questionnaire
Low threshold MUI definition: any answer ⱖ1 on urge
subscale (rarely, sometimes, quite a bit):
Intermediate threshold MUI definition: Total urge score⬎2
(Urge index ⬎ 11%):
High threshold MUI definition: any answer ⱖ2 (Sometimes,
quite a bit):
Ratio (MESA score converted to a percentage based on the
number of items)
UDI Questionnaire
Low threshold MUI definition: ‘No’ to QC2, or ‘Yes’ to QC2
and ‘No’ to QC3 or Response to QC3a⬎“not at all”
Intermediate MUI definition: UDI Irritative Symptom
Scale⬎20
Urodynamics
326
Stress (N, %)
MUI (N, %)
Pure Stress 44 (6.7%)
611 (93.3%)
Stress predominant 116 (17.7%)
539 (82.3%)
521 (79.5%)
Pure stress 44 (6.7%) Stress
predominant 281 (42.9%)
Pure Stress 254 (39%)
397 (61%)
USI 91.7%
Mixed 330 (50.4%)
Mixed 538 (82.5%)
USI and DO 8.3%
population, a scientifically sound and clinically relevant definition is
needed.
Disclosures: L. Brubaker, Pfizer, Allergan, Grant/Research Support; A.
Stoddard, None; H.E. Richter, Pfizer, Grant/Research Support; P.
Zimmern, None; P. Moalli, None; S. Kraus, None; P. Norton, None; E.
Lukacz, None; L. Sirls, None; H. Johnson, None; L. Nyberg, None; &.
Urinary Incontinence Treatment Network, None.
The Association of Detrusor Overactivity Pressure with
Overactive Bladder Symptom Severity and Urge Urinary
Incontinence
T. L. Gamble,* S. O. Aschkenazi,* A. Nguyen,* V. Rivas,† H. Du,‡ S.
M. Botros,* R. P. Goldberg* and P. K. Sand* *Evanston Northwestern
Healthcare/ Northwestern University Feinberg School of Medicine,
Evanston, IL, †Northwestern University, Evanston, IL, ‡Center for
Outcomes Research and Education Evanston Northwestern
Healthcare, Evanston, IL
Objective: To evaluate the relationship between detrusor overactivity
(DO) pressure and overactive bladder (OAB) symptom severity and its
impact on urge urinary incontinence (UUI).
Methods: All female patients attending a single tertiary uroygnecologic
referral center between 6/05–8/05 and diagnosed with detrusor overactivity
on urodynamic testing were included. High Pressure DO (HPDO) was
defined as an involuntary detrusor contraction with a maximum rise from
baseline exceeding 40 cm H2O. Subjects with and without HPDO were
compared with regards to OAB symptoms, presence of UUI severity,
Urodynamic Stress Urinary Incontinence (USUI), and response to various
treatments. In univariate analysis, continuous covariates were compared
using two sample test (independent t or Wilcoxon). Pearson’s Chi-square or
Fisher’s exact test was used to assess the association between categorical
covariates and HPDO. Parameter estimates (odds ratios and 95% confidence
intervals) were obtained using logistic regression with the maximum
likelihood method in both univariate and multivariable analysis. Two-tailed
alpha of 0.05 was used as the significance level.
Results: DO was diagnosed in 383/551 women (70%) with 17% having
HPDO. Mean age (range) was 63 (18–89); BMI 28 (15–47) cm/m2, and
parity 3 (0–4 ⫹). No significant differences were found in age, parity, or BMI
between women with with HPDO versus women whose DO pressure was
ⱕ 40 cm H2O. Univariate analysis revealed that UUI episodes per week
tended to be more prevalent in the HPDO group compared to ⱕ 40 cm
H2O (21.4 vs. 13.6, p ⫽ .064). Patients with DO pressures of ⬎40 cmH2O
were significantly less likely to have improvement with treatment (p ⫽
0.003), more likely to have more severe UUI (⬎21 episodes per week) (p ⫽
0.002) and less likely to have USUI (p ⬍ 0.001). Marginal significant
differences in urgency (p ⫽ 0.055) and nocturia (p ⫽ 0.062) were also
noted. After controlling for age, BMI, cystocele ⱖ Stage II, hysterectomy,
post void residual ⱖ100 cc, and UTI, HPDO was directly associated with
urgency, frequency, and nocturia. Women with HPDO were significantly
more likely than those without HPDO to have ⱖ 21 UUI episodes per week
(Odds Ratio (OR): 2.23, 95% Confidence Interval (CI): 1.74–4.24, p ⫽
0.015). Women with HPDO were also significantly less likely to have USUI
(OR: 0.29, 95% CI: 0.16–0.53, p ⬍ 0.001) or improvement with
antimuscarinics, behavioral therapy, and/or prolapse surgery (OR: 0.47, 95%
CI: 0.25–0.89, p ⫽ 0.020).
Conclusions: “High pressure” Detrusor Overactivity was significantly
associated with more severe OAB symptoms and a less favorable
response to treatment. DO pressure can be a useful indicator of OAB
Abstracts
symptom severity and whether a patient responds to various
treatments. Future studies are warranted to evaluate if more aggressive
treatment of HPDO will lead to better control of OAB symptoms and
improved quality of life.
Disclosures: T.L. Gamble, None; S.O. Aschkenazi, None; A. Nguyen,
None; V. Rivas, None; H. Du, None; S.M. Botros, None; R.P. Goldberg,
Boston Scientific, Grant/Research Support; Boston Scientific,
Consultant; Boston Scientific, Speaker’s Bureau; P.K. Sand, Boston
Scientific, AMS, Speaker’s Bureau; Allergan, Astellas, Boston Scientific,
Grant/Research Support; Coloplast, AMS, Indevus, Consultant.
Difference in Quality of Life In Women with Urge Urinary
Incontinence Compared to Women with Stress Urinary
Incontinence
M. O. Schimpf, M. Patel, D. M. O’ Sullivan, and P. K. Tulikangas
Hartford Hospital, Hartford, CT
Objective: Urinary incontinence has been shown to negatively
impact quality of life, and worsening severity of incontinence has
been correlated with worsening quality of life (QOL) scores. Due to
the unpredictability of urge urinary incontinence (UUI) and the
potential for large-volume urine loss, this condition can be socially
debilitating. We evaluated whether women with UUI have lower QOL
than women with other forms of incontinence.
Methods: Patients coming to the Division of Urogynecology from
7/1/06 – 8/31/07 prospectively completed the Pelvic Floor Distress
Inventory (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7) and
the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function
Questionnaire (PISQ-12). Based on their responses, women were
divided into four groups: those with symptoms of stress urinary
incontinence (SUI), UUI, both SUI and UUI (mixed UI), and neither
SUI nor UUI (controls). Statistical comparisons used analysis of
variance with post hoc Scheffe’s test. All results yielding p ⬍ 0.05
were deemed statistically significant using SPSS v.14.0.
Results: A total of 465 women were included in the analyses: 53
women with UUI (11.4%), 101 with SUI (21.7%), 200 with mixed UI
(43%) and 111 controls (23.9%).
The mean PFIQ bladder scale scores were 17.07 for controls,
22.31 for SUI, 32.67 for UUI, and 36.83 for mixed UI. This was a
statistically significant difference (p ⬍ 0.001). There was no significant
difference between the controls and SUI patients, although there was
between controls and UUI (p ⫽ 0.009) and mixed UI (p ⬍ 0.001).
Individually, all seven questions in the PFIQ bladder domain were
significantly different by group type (p ⱕ 0.001). Patients with UUI
were significantly more impaired than control patients for
entertainment, travel, ability to socialize, emotional health and feelings
of frustration.
UUI patients also reported a significantly lower rate (p ⬍ 0.001) of
sexual activity (37.3% UUI vs. 79.8% SUI vs. 71% mixed UI vs. 64.1%
controls).
UUI patients were older (mean 62.58 years); there was a statistically
significant difference in age between the four groups (p ⫽ 0.006).
Otherwise, there were no significant differences between the groups for
number of pregnancies, history of forceps use, number of vaginal or
cesarean deliveries, largest birth weight, prior hysterectomy/bladder
surgery/other pelvic surgery, or current/prior smoking.
Conclusions: Women with UUI and mixed UI have lower QOL
scores than women without incontinence or with only SUI. Women
with UUI also report lower rates of sexual activity.
327
Abstracts
Disclosures: M.O. Schimpf, None; M. Patel, None; D.M. O’Sullivan,
None; P.K. Tulikangas, None.
Correlation Between Improvements in Incontinence Pad Usage,
Bladder Diary Variables, and Health-Related Quality of Life
Measures in Sexually Active Women Treated for Overactive
Bladder
R. Rogers,* M. Gurule,* F. Sun,† J. T. Wang,† T. Bavendam,† and J. D.
Morrow† *Univ of New Mexico School of Medicine, Albuquerque,
NM, †Pfizer Inc., New York, NY
Objective: To investigate the association between improvements in
incontinence pad usage and improvements in bladder diary variables
and health-related quality of life (HRQL) measures in sexually active
women with overactive bladder (OAB) and urgency urinary
incontinence (UUI) treated with tolterodine extended release (TER).
Methods: A post hoc analysis was conducted using data from a
double-blind, placebo (PBO)-controlled trial. Eligible women had selfreported OAB and UUI for ⱖ 3 mo; recorded ⱖ8 micturitions per
24 h, including ⱖ3 urgency-related micturitions and ⱖ0.6 UUI
episodes per 24 h, in 5-day bladder diaries at baseline; reported at
least “some moderate” bladder-related problems; and were sexually
active and in a heterosexual relationship for ⱖ6 mo. Subjects
randomized to TER or PBO completed 5-day bladder diaries, pad
counts, and the Overactive Bladder Questionnaire (OAB-q), which
includes a Symptom Bother scale and a HRQL scale with 4 domains, at
baseline and week 12. Associations between week 12 changes in
incontinence pad usage and changes in bladder diary variables and
OAB-q scores were assessed by Pearson correlations.
Results: A total of 411 subjects were randomized and received study
treatment (TER, n ⫽ 201; PBO, n ⫽ 210). The median percentage
reduction in UUI episodes from baseline to week 12 was significantly
greater in the TER group vs PBO (100% vs 82.5%; p ⫽ 0.0003); 57% of
subjects receiving TER reported no UUI episodes in 5-day diaries at
week 12 compared with 42% of subjects receiving PBO (p ⫽ 0.0039).
Total micturitions, urgency-related micturitions, and all OAB-q scales
and domains were significantly improved in the TER group vs PBO (all
p ⬍ 0.05). Incontinence pad usage by TER-treated subjects was
significantly decreased at 12 weeks vs PBO (LS mean change, ⫺1.5 vs
⫺1.0 pads/day; p ⫽ 0.0024). Among subjects who used pads at
baseline, the proportion of subjects who reported no pad use during
the week 12 diary period was significantly higher in the TER group
(28.2%) than in the PBO group (12.1%; P ⫽ 0.0004). Moderately sized
but statistically significant positive correlations were observed
between reductions in incontinence pad usage and improvements in
bladder diary variables (total micturitions, |r| ⫽ 0.350; urgency-related
micturitions, |r| ⫽ 0.448; UUI episodes, |r| ⫽ 0.421; all p ⬍ 0.0001)
and between reductions in pad usage and improvements in all OAB-q
scales and domains (Symptom Bother, |r| ⫽ 0.331; total HRQL, |r| ⫽
0.339; Concern, |r| ⫽ 0.319; Coping, |r| ⫽ 0.289; Sleep, |r| ⫽
0.303; Social Interaction, |r| ⫽ 0.268; all p ⬍ 0.0001).
Conclusion: TER significantly improved bladder diary variables and
HRQL and reduced symptom bother and incontinence pad usage in
sexually active women with OAB and UUI vs PBO. Reductions in pad
usage were significantly correlated with improvements in bladder
diary variables and OAB-specific measures of symptom bother and
HRQL. Reduced pad usage likely contributes to improvements in
HRQL and reduced bother in patients with OAB and UUI treated with
TER.
328
Disclosures: R. Rogers, Pfizer Inc., Consultant; M. Gurule, None; F.
Sun, Employee—Pfizer Inc., Other (please specify type of relationship
and company name); J.T. Wang, Employee—Pfizer Inc., Other (please
specify type of relationship and company name); T. Bavendam,
Employee—Pfizer Inc., Other (please specify type of relationship and
company name); J.D. Morrow, Employee—Pfizer Inc., Other (please
specify type of relationship and company name).
Sexual Dysfunction: Women in an Inner City Population
B. L. Worly, M. Gopal, and L. Arya University of Pennsylvania,
Philadelphia, PA
Category: Quality of Life.
Objectives: The prevalence and risk factors for female sexual
dysfunction in inner city women has not been reported. Our primary aim
was to assess the prevalence of sexual dysfunction in inner city women
reporting to a resident GYN clinic. Secondarily, we investigated risk
factors that are associated with sexual dysfunction in this population.
Methods: We used a descriptive cross section study design. 102
consecutive women reporting to an urban GYN clinic were enrolled in
this study. Women were included if they were sexually active. Exclusion
criteria were women with neurologic disease, pregnancy and women
unwilling to participate in the study. All women were administered the
Female Sexual Function Index (FSFI), Center for Epidemiologic Studies
Depression Questionnaire (CES-D), a Partner Sexual Function
Questionnaire (Partner), the Revised Life Orientation Test (LOT-R), and
Question for Urinary Incontinence Diagnosis (QUID). Demographic data
and a health information survey were also collected. Female Sexual
Dysfunction was defined as a FSFI score less than 27. Data was analyzed
using univariate and multivariate techniques.
Results: The prevalence of sexual dysfunction in our population was
37%. Mean age was 30 ⫾ 11.3 and mean BMI was 27.6 ⫾ 6. The
specific aspects of sexual dysfunction reported were lack of desire
(100%), problems with the arousal phase (100%), insomnia (53%),
difficulty with orgasm (97%), decreased lubrication (97%), decreased
satisfaction (97%), and dyspareunia (100%). On univariate analysis,
women reporting sexual dysfunction were significantly more likely to
be older, taking antidepressant medications (OR 2.3, 95% CI 1.1, 4.9),
were currently unemployed (OR 0.4, 95% CI 0.2, 0.9), experienced
urge incontinence (OR ⫽ 2.5, 95% CI 1.03, 6.2), and had lower levels
of optimism (OR 6.2, 95% CI 3.3, 9.1) than women not reporting
sexual dysfunction. The following partner related factors were also
associated with sexual dysfunction: erectile dysfunction (OR ⫽ 0.2,
95% CI 0.1, 0.9), and initiation of sexual intimacy by the woman (OR
⫽ 14.2, 95% CI 2.7, 76.4). Women with a history of depression, prior
hysterectomy and diabetes had elevated risk of sexual dysfunction but
did not reach significant levels. On multivariate analysis, significant
risk factors for sexual dysfunction were age (OR ⫽ 1.3, 95% CI 1.1,
1.6), erectile dysfunction (OR ⫽ 0.2, 95% CI 0.1, 0.8), initiation of
sexual intercourse by the woman (OR ⫽ 4.8, 95% CI 1.2, 18.9), and
low levels of optimism (OR ⫽ 0.5, CI 0.3, 1.0).
Conclusion: Sexual dysfunction is common in an urban, inner city
population. Contributing factors include mental health issues,
unemployment and partner sexual function. This information suggests
the need for increased awareness and routine screening for sexual
dysfunction in this population.
Disclosures: B.L. Worly, None; M. Gopal, None; L. Arya, None.
Global Assessment of Recent Stress In Women with Pelvic Floor
Disorders
Abstracts
A Modification of the Duration Subscale of the Brink Scale
S. O. Aschkenazi, T. Gamble, A. Nguyen, A. Ching, S. Botros, P. K.
Sand, and R. P. Goldberg Northwestern University, Feinberg School
of Medicine, Evanston, IL
T. Gregory,* S. Hamilton Boyles,† M. Denman,* R. Edwards,* V. King,*
T. Worstell,* and A. Clark* *Oregon Health & Science University,
Urogynecology & Reconstructive Pelvic Surgery, Portland, OR,
†Urogynecology Associates, Portland, OR
Objective: To assess the relationship between current stress in
women with pelvic-floor symptoms, as well as depressive symptoms,
sexual dysfunction and/or pelvic bladder pain, all entities related to
pelvic floor dysfunction.
Objective: Recently, the Brink scale showed poor correlation to
pelvic floor symptom questionnaires in a multicenter study. We
sought to determine if expanding the maximum number of seconds in
the duration subscale would improve its correlation to symptom and
pelvic muscle evaluation tools.
Methods: This was a cross-sectional survey administered to 354
sister-twins attending a annual twin-gathering in 2007. Identical and
fraternal twins participated and scores compared. Demographic data
and self-report, validated questionnaires were completed, including:
Global Assessment of Recent Stress (GARS) Scale, Pelvic Floor Distress
Inventory-20 (PFDI-20), the Modified Dysfunctional Voiding Scoring
System (DVSS) for assessment of childhood voiding dysfunction, Beck
Depression Inventory-II, the short form of the Pelvic Organ
Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and the
Pain and Urgency/Frequency symptom scale (PUF).
The GARS scale is a validated questionnaire allowing respondents
to appraise the overall feeling of stress. Respondents are asked to rate
7 areas of their lives on a line with ten rating points for amount of
stress. The eighth item is an overall global rating of stress. The GARS
has high acceptability being simple to use, short and very uniform in
its scoring system.
The BDI-II was administered to assess depressive symptoms using a
cutoff of ⱕ 13. The PUF scale evaluates bladder-origin pelvic pain,
assessing urinary urgency/frequency, pelvic pain and sexual
dysfunction. A cut-off score of ⱖ 15 was used. Sexual function was
assessed by the PISQ-12. Mixed effects linear models for clustered data
were used for group comparisons on summary scores, and generalized
estimating equations were used for comparisons of categorical
measures. Spearman correlation coefficients were calculated.
Results: There were 354 women enrolled, with 256 (72%) identical-,
and 98 (28%) fraternal twins. Of these, 290 questionnaires were
complete for analysis (82%). All demographics were similar in all
subgroups and were adjusted for. No differences in stress levels were
noted between identical and fraternal twins. There was a highly
significant correlation between the total mean scores of all the
questionnaires and the total GARS stress scale scores (p-value 0.002 to
⬍ 0.0001, spearman coefficient, 0.22– 0.37), as well as with the final
global stress item assessing overall level of pressure (p-value 0.009 to
⬍0.0001, spearman coefficient, 0.24 – 0.32).
Conclusions: This study demonstrated that pelvic floor disorders and
related entities including, painful bladder, depression and sexual
dysfunction are significantly associated with elevated stress levels
measured by a validated scale, not only in specific areas of life, but
most importantly, affecting the overall global level of perceived stress.
Identifying high-stress responders among women with pelvic floor
disorders using the GARS scale can improve treatment directed to
stress-reduction, with better success rates, functionality and overall
quality of life.
Disclosures: S.O. Aschkenazi, None; T. Gamble, None; A. Nguyen,
None; A. Ching, None; S. Botros, None; P.K. Sand, Boston Scientific,
AMS, Indevus, Estella;, Consultant; R.P. Goldberg, Boston Scientific,
Paid Instructor.
Methods: Our study is a secondary analysis of a prospective cohort
study of primigravid women who underwent evaluation during the
3rd trimester and at 2 weeks postpartum. At each visit, subjects
completed questionnaires: Sandvik urinary incontinence scale; Urinary
Distress Inventory (UDI-6) and Urinary Incontinence Impact
Questionnaires (IIQ-7); the Fecal Incontinence Severity Index (FISI)
and the Fecal Incontinence Quality of Life Index (FIQL). Examiners
blinded to the questionnaires, but not to pregnancy status, evaluated
pelvic floor muscle function by the Brink scale and maximum
perineometer pressures. In addition to the published duration subscale
of the Brink scale, we recorded the actual number of seconds (ANS)
that a participant maintains peak pressure. Means and frequency
distributions for the baseline evaluations were determined. Based on
the distribution curve of ANS, 2 new duration subscales were
proposed. Spearman correlations were performed. For those subjects
who had completed a 2-week postpartum exam, we additionally
performed paired t-tests or Wilcoxon tests.
Results: We performed baseline evaluations on 127 women. 59%
reported any urinary incontinence. The mean FISI score was 7.6 (SD
9.8) with 66% of the subjects reporting FI to gas at least once
monthly. The displacement and pressure subscales of the Brink scale
were normally distributed, whereas the duration was skewed toward
the maximum score. The mean scores for the subscales were 2.7 ( SD
0.9), 2.9 (SD 0.7) and 3.3 (SD 0.7) for displacement, pressure and
duration subscales respectively. Respective correlations to
perineometer pressures were r ⫽ 0.5, r ⫽ 0.6, r ⫽ 0.4 (all p ⬍
0.001). The 2 alternative duration subscales were normally distributed,
however the means were statistically similar to the original. The
Sandvik score correlated to the displacement and pressure subscales,
(r ⫽ 0.4, p ⫽ 0.001), but not to the original or the 2 proposed
duration scales. Neither the FISI nor the FIQL correlated to the Brink
scale. In 103 women who have undergone 2-week postpartum exams,
the changes in pressure, displacement and original duration subscales
from antepartum values were 0.5, 0.5 and 0.65 (all p ⬍ 0.001). In
contrast, the 2 proposed alternative duration subscales changed by 0.1
(p ⫽ 0.7) and 0.2 (p ⫽ 0.3).
Conclusions: Correcting the skewed distribution of the duration
subscale of the Brink scale does not improve its symptom correlation.
In fact, these modifications may decrease the responsiveness of the
scale to change. To improve correlation to pelvic floor symptoms,
additions, rather than simple modification, may be needed.
Disclosures: T. Gregory, Intuitive Surgical, Consultant; S. Hamilton
Boyles, None; M. Denman, Depuy. Spouse is Paid Instructor, Other
(please specify type of relationship and company name); R. Edwards,
Pfizer, Speaker’s Bureau; V. King, None; T. Worstell, None; A. Clark,
None.
329
Abstracts
Normative Data for Commonly used Validated Pelvic Floor
Disorder Questionnaires in Women Presenting for Routine
Gynecologic Care without Prolapse
J. L. Lowder, C. Ghetti, P. Moalli, R. Ellison, and H. Zyczynski
Division of Urogynecology, Department of Obstetrics and
Gynecology, University of Pittsburgh, Pittsburgh, PA
Objective: To report measures of central tendency for the Pelvic
Floor Distress Inventory (PFDI) questionnaire, Pelvic Floor Impact
Questionnaire (PFIQ), and the Pelvic Organ Prolapse-IncontinenceSexual Function Questionnaire (PISQ)-12 in women presenting for
routine gynecologic care without pelvic organ prolapse.
Methods: This is a secondary analysis of 67 women who participated
as controls in an IRB approved case-control study of the Body Image
in Pelvic Organ Prolapse. Controls were recruited from a general
gynecology office. Inclusion criteria for control participants included:
1) Presenting complaint for evaluation could not be symptoms of
incontinence or prolapse; 2) Answered “NO” to both of the following
questions: A) Do you usually have a sensation of bulging protrusion
from the vaginal area? B) Do you usually have a bulge or something
falling out that you can see or feel in the vaginal area? 3) Pelvic Organ
Prolapse Quantification (POPQ) examination stage ⱕ I; 4) No history
of surgery for prolapse or incontinence. Means, medians, standard
deviations, and ranges were determined for the PFDI, PFIQ, and PISQ12. Demographics were reported for the study population.
Results: Mean age of controls were 54 ⫾ 8 years (Range: 40 –75 years),
mean Body Mass Index was 29 ⫾ 10, 93% were Caucasian, 5% AfricanAmerican, 91% non-smokers, 59% self-declared as post-menopausal, and
24% had a hysterectomy. The majority had POPQ stage I (64%) and mean
leading edge of prolapse was ⫺2 ⫾ .6 cm. Questionnaire results listed in
Table 1. Reliability testing with Cronbach’s ␣ was performed for each of
these measures in this population: PFDI (␣ ⫽ .930), PFIQ (␣ ⫽ .978), and
PISQ-12 (␣ ⫽ .469).
Conclusions: Knowledge of normative data for existing pelvic floor
symptoms questionnaires in women with no or minimal pelvic floors
symptoms is important so we can better assess outcomes after
reconstructive surgery and determine if previously symptomatic
women return to symptom scores consistent with non-symptomatic
women.
330
Disclosures: J.L. Lowder, None; C. Ghetti, None; P. Moalli, None; R.
Ellison, None; H. Zyczynski, Johnson and Johnson Home Products,
Ethicon Women’s Health and Urology, Grant/Research Support.
Psychometric Validation of the King’s Health Questionnaire in
Patients with Overactive Bladder in the United States
K. S. Coyne,* M. K. Margolis,* V. Vats,† and C. Kelleher‡ *United
BioSource Corporation Center for Health Outcomes Research,
Bethesda, MD, †Pfizer Inc., New York, NY, ‡St. Thomas’ Hospital,
London, United Kingdom
Objective: This study assesses the content and psychometric validity
of the King’s Health Questionnaire (KHQ) in patients with overactive
bladder (OAB) in the United States.
Methods: Data from a multicenter, double-blind, placebo-controlled,
randomized trial of patients with OAB in the United States were
analyzed to assess the psychometric properties of the KHQ. Mean
baseline scores, internal consistency reliability, discriminant validity,
effect size, and standard error of mean were calculated. General linear
models were used to compare KHQ mean change scores from
baseline to end of therapy at 12 weeks by change category,
controlling for site, age, treatment group, and baseline visit KHQ
subscale score. Content validity was assessed in a stand-alone study.
One-on-one interviews were conducted with patients with OAB to
obtain feedback about the KHQ, including instructions, items, and
response options. Content and descriptive analyses were used for
content validity.
Results: 798 patients were included in the analysis. Mean age was 58.9
⫾ 13.1 years; 82% of the participants were white and 76% were women.
Cronbach alpha values ranged from 0.64 – 0.91 at baseline to 0.72– 0.93 at
week 12. Mean scores on each subscale improved significantly from
baseline to week 12 (p ⬍ 0.0001). Among the 9 subscales, 8
(Incontinence impact, Role limitations, Physical limitations, Social
limitations, Personal relationships, Emotions, Sleep/energy, and
Incontinence severity measures; Exception: General health perceptions)
significantly discriminated between patients who perceived a worsening
or no change in his or her condition (n ⫽ 291) from baseline to week 12
vs those who perceived an improvement (n ⫽ 371, all p ⬍ 0.0001).
Among the 9 subscales, 8 (General health perceptions, Incontinence
impact, Role limitations, Physical limitations, Social limitations, Emotions,
Sleep/energy, and Incontinence severity measures; Exception: Personal
relationships) significantly discriminated between patients who were not
satisfied with treatment (n ⫽ 352) vs those who were satisfied (n ⫽ 324,
all p ⬍ 0.05). The Severity Measures subscale consistently discriminated
between patients who reported worsened or no change in micturition
variables in bladder diaries from baseline to follow-up vs those that
reported an improvement. The Sleep/Energy subscale significantly
discriminated between patients who reported worsened or no change in
the number of nocturia episodes (n ⫽ 246) from baseline to follow-up vs
those that reported an improvement (n ⫽ 381; p ⬍ 0.001). Patients with
OAB understood the content of the instructions, questions, and response
options of the KHQ, with a few minor suggestions for improvement.
Conclusion: The KHQ demonstrates acceptable content validity and
psychometric properties, including reliability and validity, in patients
with OAB in the United States.
Disclosures: K.S. Coyne, Pfizer Inc., Consultant; M.K. Margolis,
Pfizer Inc., Consultant; V. Vats, Employee—Pfizer Inc., Other (please
specify type of relationship and company name); C. Kelleher, Pfizer
Inc., Consultant.
Assessing the Responsiveness of
Satisfaction Questionnaire (Oab-S)
the
Overactive
Bladder
L. Brubaker,* E. Piault,† J. Trocio,‡ K. Fitzgerald,† C. Evans,† T.
Bavendam,‡ and Z. Jumadilova‡ *Loyola University Chicago,
Maywood, IL, †MAPI Values, Boston, MA, ‡Pfizer Inc., New York, NY
Objective: To assess the responsiveness of the OAB-S multi-item
domain scores measuring satisfaction with overactive bladder (OAB)
control (SAT), satisfaction with impact of OAB on daily activities
(IDL), and the OAB-S single item measuring overall satisfaction with
medication.
Methods: This was a 4-week observational study of 54 patients
diagnosed with OAB who were naive to OAB medication at
enrollment. Enrollment occurred 14 ⫾ 2 days before baseline (day 0);
a follow-up visit occurred 14 ⫾ 2 days after baseline. Longitudinal
analyses (within-group paired t tests) were conducted to assess the
mean change occurring between baseline and follow-up for 2 groups
of patients: 1 reporting no change vs 1 reporting improved OAB
symptoms. Student t tests were used to compare the differences in
mean change between the 2 groups. Cross-sectional analyses (Student
t tests) were also performed to evaluate the differences in scores
between the groups at follow-up. Standardized effect size (SES) and
Cohen’s d were used to evaluate the magnitude of within-group
change and between-groups differences, respectively.
Results: Between baseline and follow-up, as expected, the IDL
domain and the overall satisfaction item did not show a statistically
significant change in scores (⌬ ⫽ 0.49, SD ⫽ 14.33, p ⫽ 0.8855, SES
⫽ 0.02 and ⌬ ⫽ 0.22, SD ⫽ 0.94, p ⫽ 0.3313, SES ⫽ 0.19,
respectively) for the unchanged group (n ⫽ 18). For the improved
group (n ⫽ 31), SAT domain and overall satisfaction item scores were
significantly increased (⌬ ⫽ 7.59, SD ⫽ 10.33, p ⫽ 0.0004, SES ⫽
0.39 and ⌬ ⫽ 0.26, SD ⫽ 0.63, p ⫽ 0.0300, SES ⫽ 0.36, respectively).
Overall, the between-groups comparison of mean change was
significant with a very large effect size for the SAT domain (p ⬍
0.0001, Cohen’s d ⫽ 1.11), but nonsignificant with a small effect size
for the IDL domain (p ⫽ 0.2631, d ⫽ 0.35) and a negligible effect size
for the overall assessment item (p ⫽ 0.8740, d ⫽ 0.04). In the crosssectional between-group comparisons of follow-up scores, the
differences were statistically significant, with higher scores for the
improved group than the unchanged group on the measures (SAT and
IDL domains, p ⬍ 0.0001; overall satisfaction item, p ⫽ 0.0016). The
between-groups effect size for the overall satisfaction item and for the
SAT was high (d ⫽ 0.73 and p ⫽ 1.38, respectively).
Conclusion: Results on the IDL domains indicated that subjects need
more than 4 weeks to translate the improvement of their OAB
symptoms into satisfaction with their ability to perform their daily
tasks. For the multi-item domain and the overall assessment item,
larger differences were found between groups when comparing endof-study satisfaction than when comparing differences in mean change
in satisfaction. This suggests that satisfaction endpoints may be better
assessed on a cross-sectional basis at the end of a study than by
comparing changes in satisfaction occurring during the study. The
SAT domain and the single overall satisfaction item demonstrated
good responsiveness in subjects who were naive to OAB medication.
Disclosures: L. Brubaker, Pfizer Inc., Consultant; E. Piault, Pfizer
Inc., Consultant; J. Trocio, Employee - Pfizer Inc., Other; K. Fitzgerald,
Pfizer Inc., Consultant; C. Evans, Pfizer Inc., Consultant; T. Bavendam,
Employee—Pfizer Inc., Other; Z. Jumadilova, Employee—Pfizer Inc.,
Other.
Abstracts
Symptoms, Surgery, And The Urogynecology Patient: Predicting
Treatment Choice
M. A. Denman,* A. Clark,† and T. Gregory* *Oregon Health Sciences
University, Portland, OR, †Portland Providence Medical Center,
Portland, OR
Objective: This study examined the clinical application of two
validated symptom questionnaires; the short forms of the Pelvic Floor
Distress Inventory (PFDI-20) and the Pelvic Floor Impact
Questionnaire (PFIQ-7). We evaluated these tools, along with clinical
characteristics, as predictors of subsequent pelvic reconstructive
surgery.
Methods: We performed a retrospective cohort study. Subjects were
identified as new patients presenting to the University urogynecology
practice from 2002-present who completed the PFDI-20 and/or the
PFIQ-7 as part of a standard intake questionnaire. Electronic medical
record review identified subjects who underwent subsequent pelvic
reconstructive surgery. Demographic and physical exam data were
abstracted. Parametric and nonparametric tests were used where
appropriate.
Results: In total, 1748 subjects were identified. Subjects were 93%
Caucasian, 67% menopausal, with a mean age of 56.5 years. The mean
score of the PFDI-20 was 102 (SD ⫾ 61); the PFIQ-7 was 69 (SD ⫾
66).
We identified 449 surgical cases. Results are summarized in Table
1. The mean global score of the PFDI-20 was significantly higher in
subjects undergoing surgery. This significant finding held true for the
urinary, pelvic organ prolapse, and colorectal subset analysis as well.
The mean score of the PFIQ-7 was higher in surgical versus
conservative treatment but failed to reach significance. Subset analysis
of the PFIQ-7 showed significantly higher scores with only the pelvic
organ prolapse questions for surgical subjects. In multivariate analysis,
the leading edge of prolapse was the only significant predictor of
surgery.
Conclusions: The PFDI-20 discriminated between groups globally
and in all subsets, whereas the PFIQ-7 discriminated only for the POP
subset. Symptoms were more sensitive than lifestyle impact in
distinguishing between groups. Neither predicted surgical
management, reflecting the multi factorial nature of surgical decision
making. This study is limited by the referral nature of the population
examined, where higher scores on these instruments would be
expected, thus reducing discriminatory ability. The large population
studied demonstrates the wide range of symptom scores possible in
patients seeking specialty care.
TABLE. Univariate Analysis of Subject Characteristics in
Surgical versus Conservative Management
Factor
Age
BMI
Vaginal Parity
Leading Edge of
Prolapse
PFDI-20 Score
PFIQ-7 Score
POPIQ
Surgery*
Conservative
Management*
p
58.7 (13.6)
29.7 (13.0)
2.5 (1.5)
⫹0.9 (2.6)
55.7 (16.2)
27.9 (9.4)
2.1 (1.6)
⫺1.5 (2.0)
⬍0.001
0.02
⬍0.001
⬍0.001
115.0 (61.0)
73.6 (68.3)
22.7 (28.8)
97.8 (60.6)
67.6 (65.4)
19.2 (28.7)
⬍0.001
0.17
0.004
*mean (SD).
331
Abstracts
Disclosures: M.A. Denman, Spouse is a paid Instructor for Depuy
Spine, Other; A. Clark, None; T. Gregory, Intuitive Surgical,
Consultant.
Patient Opinions On Hysterectomy
K. Hanaway, E. Elkadry, A. Disciullo, L. Hota, T. Ferzandi, P.
Dramitinos, and P. Rosenblatt Boston Urogynecology Associates,
Cambridge, MA
Objective: Hysterectomies are often performed solely or in conjunction
with other reconstructive procedures to correct uterovaginal prolapse.
Many ‘uterine-sparing’ procedures have been described that are effective
at correcting prolapse. The purpose of this study was to determine
women’s opinions on hysterectomy. If given the choice, would they
prefer to keep their uterus at the time of prolapse surgery and what is
the reason for their decision?
Methods: We developed a questionnaire addressing whether or not a
patient would opt to have her uterus removed, and the reasons
behind that decision. We also inquired about age, parity, the reason
for their visit, and whether or not they were sexually active. For those
women who had previously undergone a hysterectomy, we asked
about symptoms of dyspareunia and pelvic pain and whether they
thought those symptoms were due to the hysterectomy. This
questionnaire was given to all new patients presenting to our office
over a period of three months. The setting was a urogynecology and
pelvic reconstructive surgery office affiliated with a community
teaching hospital of a medical school.
Results: Questionnaires were correctly completed by 53 patients. Of
these, 16/53 (30%) had already undergone a hysterectomy. Of the
remaining 37 responders, if given the choice, 29/37 (78%) would opt
to keep their uterus at the time of prolapse repair. The average age of
this group was 50 years. The respondents were more likely to choose
to keep their uterus due to the fact that there was nothing wrong
with it, or they were concerned that a hysterectomy would adversely
affect sexual function. Of the 8/37 (22%) who would choose to have
their uterus removed at the time of prolapse repair, their average age
was 55 years. These women would choose hysterectomy because they
wanted to reduce their risk of cancer or they felt that there was no
reason to keep their uterus. Of the 16 women who had undergone a
hysterectomy, 4/16 (25%) attributed symptoms of pelvic pain and
dyspareunia to their hysterectomy. The remaining 12/16 (75%) did not
attribute any symptoms to their hysterectomy.
Conclusion: This questionnaire, given to our new office patients,
suggests that women want alternatives to hysterectomy when
undergoing surgery to correct their pelvic organ prolapse. Uterine
sparing procedures should be considered an option for patients who
do not want a hysterectomy, but still desire definitive treatment of
their pelvic organ prolapse.
Disclosures: K. Hanaway, None; E. Elkadry, None; A. Disciullo,
None; L. Hota, None; T. Ferzandi, None; P. Dramitinos, None; P.
Rosenblatt, None.
Psychosocial Impact of Pelvic Floor Disorders in Women
B. Ridgeway,* K. J. Stepp,† and M. D. Barber* *Cleveland Clinic,
Cleveland, OH, †MetroHealth Medical Center, Cleveland, OH
332
Objective: To determine the correlation of conditions of bladder
dysfunction, bowel dysfunction, and pelvic organ prolapse with the
extent of psychosocial impact on women as measured by the Pelvic
Floor Impact Questionnaire (PFIQ).
Methods: One hundred seventy-six patients who were recruited at 2
different medical centers for one of three studies validating the Pelvic
Floor Impact Questionnaire (PFIQ) are the subjects of this study. All
patients presented with one or more pelvic floor symptom. Each
underwent a comprehensive urogynecologic evaluation that included
structured history and pelvic examination using the Pelvic Organ
Prolapse Quantitation system. Subjects with advanced prolapse (stage
3– 4) or urinary complaints underwent complex urodynamics. All
subjects completed the PFIQ, a validated condition specific quality of
life instrument for women with pelvic floor disorders. The PFIQ
assesses life impact and has 3 scales: Urinary Impact Questionnaire
(UIQ), Colorectal-anal Impact Questionnaire (CRAIQ), and the Pelvic
Organ Prolapse Impact Questionnaire (POPIQ). Increasing PFIQ score
correlates with greater adverse impact on quality of life.
Results: Fifty percent of subjects in this study had urinary
incontinence with 30% having urodynamic stress incontinence (USI)
and 20% having detrusor overactivity (DO) or mixed urinary
incontinence. Forty-five percent had stage 3 or 4 pelvic organ
prolapse, 42% had voiding dysfunction, 16% had fecal incontinence,
and 21% had defecatory dysfunction. Fifty-five percent had more than
one pelvic floor diagnosis. Increasing number of pelvic floor disorders
correlated with increasing psychosocial impact on all three PFIQ
scales (p ⬍ 0.001 for each). The number of urinary incontinence
episodes correlated weakly with increasing UIQ scores (r ⫽ 0.25, p ⬍
0.0001), number of fecal incontinence episodes correlated weakly
with increasing CRAIQ scores (r ⫽ 0.28, p ⬍ 0.01), and prolapse
stage correlated moderately with increasing POPIQ scores (r ⫽ 0.43, p
⬍ 0.0001). Urinary incontinence and voiding dysfunction each had
greater psychosocial impact than did advanced prolapse in this
population (p ⬍ 0.01). Detrusor overactivity impacted travel activities
more than USI or advanced prolapse, but not more than bowel
dysfunction (p ⬍ 0.05). The activity or emotion most commonly
affected in subjects with urinary incontinence was concern about
visiting places with unknown restrooms (34.2%). In subjects with
fecal incontinence, increased nervousness and anxiety was cited most
often (40%). The most commonly affected activity in subjects with
advanced prolapse was the ability to have sexual relations (35.8%).
Conclusions: Pelvic organ prolapse, bladder dysfunction, and bowel
dysfunction affect a woman’s quality of life in different ways. Bladder
disorders appear to have more adverse psychosocial impact than
advanced pelvic organ prolapse. Objective measures of severity of
pelvic floor disorders correlate only weakly to moderately with their
impact on women’s lives.
Disclosures: B. Ridgeway, None; K.J. Stepp, None; M.D. Barber,
American Medical Systems, Grant/Research Support.
Prevalence and Degree of Bother from Pelvic Floor Disorders in
Obese Women Seeking Medical Weight Reduction Compared to
Community-Dwelling Women
E. L. Whitcomb,* E. S. Lukacz,* D. A. Baja,* S. A. Menefee,† J. M.
Lawrence,‡ C. W. Nager,* and K. M. Luber† *University of California
San Diego, La Jolla, CA, †Kaiser Permanente San Diego Medical
Center, San Diego, CA, ‡Kaiser Permanente Southern California,
Pasadena, CA
Objective: To assess the prevalence and degree of bother from pelvic floor
disorders (PFD) in obese women enrolled in a managed health care plan
who participated in a medical weight loss program compared to obese
women from the same health plan not enrolled in the program. We
hypothesized that obese women seeking medical weight reduction would be
more bothered by PFD than obese women who were not in the program.
Methods: A validated questionnaire identifying PFD including pelvic organ
prolapse (POP), stress urinary incontinence (SUI), overactive bladder (OAB),
and anal incontinence (AI) was administered to a convenience sample of 128
obese (body mass index 关BMI兴 ⱖ 30 kg/m2) women enrolled in a medical
weight loss program. Responses from these women were compared to those
from a cohort of 1,155 obese women from the same health plan. Degree of
bother for each PFD was assessed using a 100 mm visual analog scale (VAS).
T-tests were used to compare mean VAS scores between those enrolled in
the medical weight management program and community-dwelling obese
women. Chi-squared and Mann Whitney U tests were used to compare the
demographic and clinical characteristics of the two groups. Multivariable
logistic regression analysis was used to assess the relative impact of each PFD
on enrollment in a medical weight management program while controlling
for confounding variables. Associations with a two-sided p-value of ⬍ 0.05
were considered significant.
Results: The mean age ⫾ SD of the women seeking medical weight
loss (n ⫽ 128) was 49.0 ⫾ 12.7 years and the mean BMI was 39.3 ⫾
6.2 kg/m2, and 56.4 ⫾ 14.8 years and 35.3 ⫾ 5.3 kg/m2 for those not
in the program (n ⫽ 1,555), p ⬍ 0.001. The prevalence of POP, SUI,
AI and any one or more PFD in the group of women seeking medical
weight loss was not significantly different than those not in the
program (POP 8% vs. 9%, SUI 20% vs. 24%, AI 26% vs. 29%, and any
PFD 42% vs. 48%, all p ⬎ 0.05). Of all PFD, only the OAB prevalence
was higher in community-dwelling versus women enrolled in a
medical weight loss program (23% vs. 14%, p ⬍ 0.05). There were no
significant differences in degree of bother for any of the PFD between
the two groups. After adjustment for age, BMI, race, parity, mode of
delivery, depression, diabetes, neurologic disease, pulmonary disease,
recurrent urinary tract infection, hormone and menopausal status, and
chronic lifting, enrollment in the medical weight loss program was
positively associated with depression (1.83, 1.34 –2.93) and BMI (1.09,
1.05–1.13), and negatively associated with age (0.96, 0.95– 0.98), and
OAB (0.49, 0.25– 0.97).
Conclusions: PFD are common and associated with significant bother in
obese women, however the presence of PFD did not predict enrollment in a
medical weight loss program. Rather, younger age, higher BMI and
depression were the major correlates of enrollment in a medical weight
management program in this population. Providers should recognize the
common co-existence of obesity and PFD, and future study should evaluate
the relationships between PFD and weight reduction.
Disclosures: E.L. Whitcomb, None; E.S. Lukacz, Pfizer Inc.,
Medtronic Corp., Consultant; Novartis Pharmaceuticals, Proctor &
Gamble Pharmaceuticals, Intuitive Corp, Speaker’s Bureau; D.A. Baja,
None; S.A. Menefee, None; J.M. Lawrence, None; C.W. Nager, None;
K.M. Luber, Pfizer Inc., Watson Pharmaceuticals, Astellas, Consultant;
Pfizer Inc., Watson Pharmaceuticals, Astellas, Speaker’s Bureau.
Urinary Symptoms In Women With Pelvic Organ Prolapse
J. Gleason, H. S. Harvie, E. K. Saks, M. Gopal, G. Northington, and L.
A. Arya University of Pennsylvania, Philadelphia, PA
Abstracts
Background: Urinary symptoms are common in women with pelvic
organ prolapse (POP). Relatively few studies have described the type
of urinary symptoms in women with POP using validated
questionnaires.
Objective: To describe urinary symptoms in patients with POP using
validated questionnaires.
Methods: 116 consecutive women with grade 2 or greater POP
presenting for initial evaluation to the Urogynecology clinic were
included in this study. Women with neurologic disease were
excluded. All women were administered the Pelvic Floor Distress
Inventory (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7), and
Incontinence Severity Index (ISI). All women underwent a complete
urogynecologic examination and multi-channel urodynamics. Data was
analyzed using univariate and multivariate techniques.
Results: Mean age and parity were 60.6 ⫾ 12.9 and 2.6 ⫾ 1.5,
respectively. The most common bladder symptom reported on the
UDI-6 was frequency of urination (60%), followed by leakage with
urgency (49%), and leakage with stress (46%). The most commonly
affected quality of life measure on the UIQ-7 was feeling frustrated
(47%) followed by ability to do physical activities (45%). There was a
significant association of increasing number of compartments of POP
and both UIQ-7 and UDI-6 scores (test for trend p ⫽ 0.03 and p ⫽
0.02, respectively). There was a significant association of increasing
cystocele grade with UIQ-7 score (test for trend p ⬍ 0.001). UDI-6
score was positively correlated with the UIQ-7 score (0.38, p ⫽
0.0001). The bladder symptoms on the UDI-6 that were significantly
associated with higher UIQ-7 score were leakage with urgency (p ⫽
0.008) and difficulty emptying bladder (p ⫽ 0.013). Based on the ISI,
27% had mild, 23% had moderate, 12% had severe, and 9% had very
severe urinary incontinence. Urinary incontinence as determined by
urodynamic diagnosis was: stress 13%, urge 23%, and mixed 32%. The
severity of urinary incontinence as determined by the ISI was positively
correlated with both the UDI-6 (0.48, p ⬍ 0.001) and the UIQ-7 (0.31, p
⫽ 0.0017) scores. Urodynamic diagnosis was significantly associated with
UDI-6 symptoms of leakage with urgency (p ⫽ 0.004) and leakage with
stress (p ⫽ 0.024). On multivariate analysis, increasing grade of cystocele
(p ⫽ 0.006) and UDI-6 score (p ⫽ 0.001) remained significantly
associated with increasing UIQ-7 score.
Conclusion: In addition to the presence of urinary symptoms, the
severity of cystocele has a significant impact on the quality of life in
women with pelvic organ prolapse.
Disclosures: J. Gleason, None; H.S. Harvie, None; E.K. Saks, None;
M. Gopal, None; G. Northington, None; L.A. Arya, None.
PFIQ Scores Improve after Prolapse Surgery in Women with
Depressive Symptoms but Remain Higher than in Women
Without Depressive Symptoms
C. Ghetti, J. L. Lowder, R. Ellison, M. A. Krohn, and P. A. Moalli
Objective: Little is known about depressive symptoms in women
with pelvic organ prolapse (POP). Our objective was to compare
pelvic floor related QOL scores following reconstructive surgery in
women with and without depressive symptoms at baseline.
Methods: This is a secondary analysis of an IRB-approved prospective
cohort study of 75 women with ⱖ stage II POP planning surgery.
Subjects were enrolled as part of a larger case-control study designed to
assess the impact of POP on body image. Subjects were enrolled from a
urogynecology referral practice and completed self-administered measures
333
at baseline and at 6 months after surgery. Measures included: Pelvic Floor
Distress Inventory (PFDI), Pelvic Floor Impact Questionnaire (PFIQ), and
Patient Health Questionnaire-9 (PHQ-9). PHQ-9 is a validated measure of
depression severity. Total scores of ⱖ10, correlate with moderate to
severe depressive symptoms. Mean values and 95% confidence intervals
were determined for the PFDI, PFIQ and change in scores.
Results: Complete baseline and 6 month data were available for 58
women. Participants had a mean age of 60 ⫾ 8 years, mean BMI of 28 ⫾
5 kg/m2, were predominantly Caucasian (96%), postmenopausal (82%),
and 56% had a prior hysterectomy. Baseline POPQ stage distribution:
stage II 6/57 (10%), stage III 47/57 (83%), and stage IV 4/57 (7%). At
baseline 17/75 (23%) had moderate to severe depressive symptoms,
58/75 (77%) had none to minimal symptoms. Similar numbers of subjects
in the two groups listed antidepressant medication at baseline (9/57
(16%) vs. 4/17 (25%) (NS). Surgeries included: sacrocolpopexy 42/57
(57%), uterosacral ligament suspension 7/57 (12%), total vaginal mesh
6/57 (11%), and posterior colporrhaphy 2/57 (3%). Women with
depressive symptoms had higher PFIQ scores compared to women
without symptoms at baseline. Women with depressive symptoms had
improved PFIQ scores after surgery but remained elevated compared to
women without depressive symptoms. See Table 1.
Conclusions: Pelvic floor disorders appear to have a greater impact
in women with depressive symptoms as measured by PFIQ before and
after surgery. The relationship between depression, quality of life and
pelvic floor symptoms needs further study to understand the true
impact of POP on women.
Disclosures: C. Ghetti, None; J.L. Lowder, None; R. Ellison, None;
M.A. Krohn, None; P.A. Moalli, None.
Health Related Quality of Life: Utility Preference Score for
H. S. Harvie, L. A. Arya, E. K. Saks, N. L. Guerette, J. S. Schwartz, and
J. A. Shea University of Pennsylvania, Philadelphia, PA
Background: While utility preference scores have been developed
for urinary incontinence, currently there are no measures for pelvic
organ prolapse (POP). Utility scores on a scale of 0 (death) to 1
(perfect health) measure health-related quality of life and are used to
calculate quality adjusted life years (QALYs) for cost-effectiveness
analysis.
Objective: Evaluation of construct validity of utility scores for pelvic
organ prolapse.
Methods: Prospective observational study of consecutive new
patients with POP presenting to urogynecology clinic. Three common
multi-attribute health state classification systems and a visual analog
334
scale (VAS) were used to determine utility scores: Health Utilities
Index Mark 3 (HUI3), EQ-5D, and Short Form 6D (SF-6D). Pelvic floor
symptoms were measured by the Pelvic Floor Distress Inventory
(PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7), and Prolapse
and Incontinence Sexual Function Questionnaire (PISQ-12). The QUID
and Incontinence Severity Index (ISI) were used to assess diagnosis
and severity of urinary incontinence. Pearson correlations and t-tests
examined relationships between scores and between group
differences.
Results: 42 women were enrolled. Mean age, parity and BMI were 57
⫾10.3, 2.8 ⫾ 1.2, and 28.3 ⫾ 4.5 respectively. All women had stage 2
or greater prolapse. Concomitant urinary incontinence as determined
by the QUID was: urge 14%, stress 21%, and mixed 26%. Concomitant
fecal incontinence was 29%. Mean Charlson comorbidity index score
was 0.24 ⫾ 0.48. All utility scores were positively correlated with
each other and with self reported health status, Table 1. Utility scores
were significantly correlated with PFDI-20 and PFIQ-7 scores as well
as with their bladder, bowel, and prolapse subscales. Maximum stage
of POP was significantly correlated only with the HUI3 (p ⫽ 0.03).
Significant differences in utility score with concomitant urinary
incontinence was noted only for the SF-6D with the urge component
(p ⫽ 0.011). However, presence of concomitant fecal incontinence
was associated with significantly lower utility scores on SF-6D (p ⫽
0.049) and HUI3 (p ⫽ 0.0001).
Conclusion: Pelvic organ prolapse symptoms have significant
relationships with health utility preference scores.
Disclosures: H.S. Harvie, None; L.A. Arya, None; E.K. Saks, None;
N.L. Guerette, American Medical Systems, Consultant; J.S. Schwartz,
None; J.A. Shea, None.
Urinary Symptoms and Impact on Quality of Life in Women
Following Treatment for Endometrial Cancer
E. A. Erekson, V. W. Sung, R. Becher, P. A. DiSilvestro, and D. L.
Myers Alpert Medical School at Brown University, Providence, RI
Objective: The primary aim of this study is to describe urinary
symptoms in women after treatment for endometrial cancer. The
secondary aim is to compare urinary symptoms and impact on disease
specific quality of life (QOL) in women treated with adjuvant radiation
therapy after hysterectomy versus women treated with hysterectomy
alone.
Methods: We preformed a cross-sectional survey of women who had
undergone surgical treatment for endometrial cancer and were
returning for surveillance visits at the Gynecologic Oncology division
at a tertiary care center. Exclusion criteria included: women who
retained their uterus during cancer treatment, adjuvant treatment with
chemotherapy, recurrence of endometrial cancer, and other concurrent
pelvic cancers. Women were asked to fill out anonymous surveys
including demographic and clinical information. Urinary symptoms were
quantified by the Sandvik Severity Index (SSI) and the Urinary Distress
Inventory- 6 (UDI-6). Impact of urinary symptoms on QOL was measured
using the Incontinence Impact Questionaire-7 (IIQ-7). Statistical analysis
included descriptive statistics, chi-square test, Fisher’s exact test, and two
sample t-test, as appropriate.
Results: Our study included 64 women treated for endometrial
cancer; 21 women reported adjuvant radiation therapy after surgical
staging. The mean age was 58.5 years (⫾12.1) and 90.6% of women
reported their race as white. Mean body mass index was 33.4 kg/m2
(⫾9.8). Complete surgical staging which included pelvic and paraaortic lymph node dissection was performed in 81.3% (52/64) of
women.
For our first objective, symptom severity measured using the
Sandvik Severity Index was absent, mild, moderate, and severe in
21.5%, 27.7%, 35.4%, and 15.4% of women, respectively. Overall, the
mean UDI-6 and IIQ-7 scores for the study population were 40.7 (⫾
23.5) and 15.0 (⫾23.6), respectively.
For our second objective, women were categorized into two
groups: adjuvant radiation therapy and no radiation therapy. No
significant differences in age, race, education level, vaginal parity,
BMI, or smoking status were found between the two groups. Mean
UDI-6 scores for women treated with adjuvant radiation therapy
trended towards higher symptom distress compared to women with
no adjuvant radiation therapy (48.6 (⫾20.9) vs. 36.9 (⫾27.1) p ⫽
.09)), although this did not reach statistical significance. Mean IIQ-7
scores were significantly higher (higher scores suggest more severe
impact on quality of life) in women treated with adjuvant radiation
therapy compared to women who were not (27.0 (⫾29.4) vs. 8.8
(⫾17.0) (p ⫽ .016)).
Conclusions: This pilot study suggests a high prevalence of urinary
symptoms in women treated for endometrial cancer. Women treated
with adjuvant radiation therapy report a significantly greater impact of
incontinence symptoms on disease specific quality of life. Reasons for
the differences in incontinence QOL impact needs further study.
Disclosures: E.A. Erekson, NICHD T32 HD0406740-04, Grant/Research
Support; V.W. Sung, 5 K12 HD0500108 02WIH, Grant/Research Support;
R. Becher, None; P.A. DiSilvestro, None; D.L. Myers, None.
Bowel Symptoms affect Quality of Life in Women with Pelvic
Organ Prolapse
E. A. Frankman,* J. L. Lowder,* C. Ghetti,* L. J. Burrows,† M. A.
Krohn,* and H. M. Zyczynski* *Magee-Womens Hospital, University
of Pittsburgh, Pittsburgh, PA, †The Center for Vulvovaginal
Disorders, Washington, DC
Category: Defecatory Dysfunction.
Objective: To determine if leading edge of pelvic organ prolapse is
associated with bowel symptoms, distress, and quality of life.
Methods: 336 women with ⱖ stage I prolapse were enrolled in this
cross-sectional study. Subjects completed the Pelvic Floor Distress
Inventory (PFDI) and the Pelvic Floor Impact Questionnaire (PFIQ)
prior to evaluation. Bowel symptom presence and bother was assessed
using the Colorectal-Anal Distress Inventory (CRADI) subscale of the
Abstracts
PFDI. Bowel symptom impact on quality of life was measured with the
Colorectal-Anal Impact Questionnaire (CRAIQ) subscale of the PFIQ.
Prolapse was evaluated with the Pelvic Organ Prolapse Quantification
(POPQ) examination. Multivariable linear regression models were
developed to estimate the effect of factors on leading edge of prolapse.
Polytomous logistic regression modeling was used to estimate the factors
that raised the CRADI and CRAIQ total scores.
Results: The study population had a mean age of 62 ⫾ 13 years and
was predominantly Caucasian (91%). Three women had stage I prolapse
(⬍1%), 129 (38.4%) stage II prolapse, 176 (52.4%) stage III prolapse, and
27 (8.3%) stage IV prolapse. The predominant compartment of prolapse
was anterior or apical in 277 women, while 41 (13%; n ⫽ 18 missing
values) women had posterior-predominant prolapse. Bowel symptoms, as
measured by CRADI total and subscale scores, and bowel-related quality
of life scores, as measured by CRAIQ total and subscale scores, did not
change as prolapse progressed by POPQ stage. When compared to
women with anterior or apical-predominant prolapse, women with
posterior-predominant prolapse reported significantly higher CRAIQ total
and subscale scores (p ⬍ 0.05). Multivariable linear regression showed
that an increase in the CRADI was associated with an increase in the
leading edge of prolapse (100 point increase in CRADI associated with a
1.0 cm increase in the leading edge of prolapse) after adjusting for age.
When a multivariable linear regression model was developed for
participants with posterior-predominant prolapse, only age (␤ ⫽ .36, p ⫽
0.01) and history of a prior incontinence procedure (␤ ⫽ ⫺.24, p ⫽
0.005) were significantly associated with leading edge of prolapse.
Polytomous logistic regression demonstrated that prior hysterectomy (OR
⫽ 3.6 to 6.4; p ⬍ 0.008) was a significant predictor of higher total
CRADI and CRAIQ scores. Prior incontinence procedure was associated
with higher CRAIQ scores (RR ⫽ 2.6 to 5.4; p ⬍ 0.04).
Conclusions: Bothersome bowel symptoms that negatively impact a
woman’s quality of life may occur with any amount of prolapse and
more severe symptoms may be related to the extent of prolapse. Prior
hysterectomy appears to have the largest influence on bowel
symptom scores and quality of life scores.
Disclosures: E.A. Frankman, None; J.L. Lowder, None; C. Ghetti,
None; L.J. Burrows, None; M.A. Krohn, None; H.M. Zyczynski, None.
Bowel Symptoms and their Effect on Quality of Life in Women
with Pelvic Organ Prolapse
E. K. Saks, M. Gopal, U. Umoh, H. S. Harvie, N. N. Mahmoud, and L.
A. Arya University of Pennsylvania, Philadelphia, PA
Objective: To describe bowel symptoms and their effect on quality
of life in women with pelvic organ prolapse using validated
questionnaires.
Methods: 116 consecutive women presenting for initial evaluation to
the Urogynecology office were included if they had pelvic organ prolapse
grade 2 or greater on clinical exam. Women with neurologic disease
were excluded. All women were administered the short forms of the
Pelvic Floor Distress Inventory (PFDI-20) and the Pelvic Floor Impact
Questionnaire (PFIQ-7). Data pertaining to bowel symptoms (CRADI-8
and CRAIQ-7) were analyzed. Presence of a rectocele was defined as
presence of grade 2 rectocele or greater. A positive CRAIQ-7 score was
defined as a positive response to any of the items on the CRAIQ-7.
Associations between individual bowel symptoms and CRAIQ-7 scores
were evaluated by univariable and multivariable logistic regression.
Results: Mean age, BMI and parity were 60.6 ⫾ 12.9, 27.3 ⫾ 5.1 and
2.6 ⫾ 1.5 respectively. The most common type of prolapse was apical
335
Abstracts
defect (84%) followed by anterior wall defect (76%) and posterior wall
defect (23%). 73% of women had prolapse affecting more than one
compartment. Mean CRADI-8 score was 18.5 ⫾ 18.3 and mean
CRAIQ-7 score was 11.0 ⫾ 19.5. The most common bowel symptoms
reported on the CRADI-8 was incontinence of flatus (49%), followed
by the feeling of incomplete bowel emptying (43%) and straining to
have a bowel movement (40%). The most commonly affected quality
of life measure on the CRAIQ-7 was the “feeling of frustration (29%).”
The mean CRAIQ-7 score of women with a rectocele was significantly
greater than that of women without a rectocele (15.2 ⫾ 17.0 vs. 9.8
⫾ 20.2, p ⬍ 0.05). There was no significant difference in the mean
CRADI-8 score among women with and without a rectocele (p ⫽
0.17). On univariable analysis, factors associated with a positive
CRAIQ-7 score were presence of a rectocele (OR 3.1; 95% CI 1.2,8.4),
incontinence of flatus (OR 3.3; 95% CI 1.4,8.0), the sense of
incomplete emptying (OR 5.6; 95% CI 1.9,16.0) and splinting with a
bowel movement (OR 4.3; 95% CI 1.4,13.4). With increasing number
of compartments affected by prolapse, women were more likely to
have a positive CRAIQ-7 score (test for trend p ⬍ 0.01). On
multivariable regression analysis, incontinence of flatus (OR 4.6; 95%
CI 1.2,17.1), sense of incomplete emptying (OR 7.9; 95% CI 1.4,45.8)
and the presence of prolapse in two compartments (OR 4.3; 95% CI
1.1,17.3) remained significantly associated with positive CRAIQ-7
scores. The presence of a rectocele was no longer associated with a
positive CRAIQ-7 score on regression analysis.
Conclusion: The most common bowel symptom associated with pelvic
organ prolapse was incontinence of flatus while the most commonly
affected quality of life measure was the feeling of frustration. The
presence of bowel symptoms, rather than the presence of a rectocele,
had a significant impact on quality of life.
Disclosures: E.K. Saks, None; M. Gopal, None; U. Umoh, None; H.S.
Harvie, None; N.N. Mahmoud, None; L.A. Arya, None.
Self-Report of Difficult Defecation is Associated with Overactive
Bladder Symptoms, but Not Urinary Incontinence
A. K. Pelletier Cameron, D. E. Fenner, J. O. DeLancey, and D. M.
Morgan University of Michigan, Ann Arbor, MI
Objective: The impact of dysfunctional bowel elimination on lower
urinary tract symptoms is well known in children, but not in adults. It
is our objective to assess lower urinary tract symptoms in women that
report difficult defecation.
Methods: This is a secondary analysis of 2812 women, aged 35– 64,
who participated in a telephone interview as part of an epidemiologic
study of urinary incontinence (UI) prevalence among women. All subjects
were asked “When you move you bowels, does the stool come out
easily?” Difficult defecation (DD) was considered present in those
answering “yes”. All subjects were queried regarding bladder storage
symptoms per ICS Standardized terminology (nocturia, the presence of
urgency, and UI), daytime urinary frequency, urinary infections in the
past year, dysuria, feelings of incomplete emptying, self perceived health
status, medical history and demographics. Symptoms of stress
incontinence (5 items), urge incontinence (5 items) and the impact of
these symptoms on their quality of life as assessed by the incontinence
impact questionnaire-7 (IIQ-7) were solicited from subjects reporting
more than 12 episodes of UI in one year. Logistic regression was used to
calculate unadjusted and adjusted odds ratios.
TABLE.
Urinary Symptoms
Lower urinary tract
symptoms: Storage
symptoms
Other lower urinary
tract symptoms
Quality of Life and
health status
Data presented are mean ⫾
std error unless otherwise
noted
Frequent strong sudden urges
to urinate (n ⫽ 2739)
Nocturia, episodes (n ⫽ 2741)
Any urinary incontinence in
past 12 months (n ⫽ 2747)
ⱖ12 episodes of UI in the past
year (n⫽1227)
Daytime urinary frequency,
episodes (n⫽2750)
Locate nearest toilet as soon as
arriving at a new place
(n⫽2739)
Dysuria (n⫽ 2750)
UTI in past year (n⫽ 2750)
Sense of incomplete emptying
(n ⫽ 2743)
IIQ-7 (n ⫽ 555)
Number of comorbidities
(n⫽2733)
Self perceived health status (n
⫽ 2750): Excellent to very
good Good Fair/poor
Difficult Defecation
Present
Absent
Unadjusted OR*
(95% CI)
Adjusted OR**
(95% CI)
47.6%
29.2%
2.20 (1.71–2.81)
1.77 (1.36–2.30)
1.8 ⫾ 0.1
61.1%
1.3 ⫾ 0.02
42.9%
1.32 (1.20–1.44)
2.09 (1.63–2.68)
1.19 (1.08–1.32)
1.95 (1.49–2.54)
56.0%
44.4%
1.59 (1.16–2.20)
1.39 (0.99–1.96)
8.2 ⫾ 0.3
7.2 ⫾ 0.1
1.06 (1.03–1.09)
1.04 (1.01–1.07)
32.17%
18.7%
2.06 (1.58–2.67)
1.65 (1.24–2.18)
22.9%
18.8%
55.6%
13.7%
12.2%
28.2%
1.41 (1.12–1.79)
1.67 (1.22–2.31)
3.19 (2.48–4.09)
1.33 (1.05–1.68)
1.37 (0.97–1.91)
2.82 (2.18–3.66)
7.0 ⫾ 0.6
1.9 ⫾ 0.1
5.0 ⫾ 0.2
1.4 ⫾ 0.02
1.07 (1.03–1.11)
1.37 (1.24–1.50)
1.06 (1.01–1.10)
1.21 (1.08–1.36)
31.3%
34.0%
34.7%
47.6%*
35.1%
17.3%
* p ⬍.004 for all values.
** Logistic regression controlling for age, menopausal status, medical comorbidities, self perceived health status, and race. p value ⬍ 0.05
considered significant.
336
Results: DD was reported by 10.4% (288/2779) of women. Bladder
storage symptoms (nocturia, urinary urgency, and higher rates of any
incontinence), increased daytime frequency, dysuria, and symptoms of
incomplete bladder emptying were all more commonly reported by
women with DD (see table). Among women reporting more than 12
episodes UI in the past year, the rates of stress and urge incontinence did
not differ between the groups on any of the items. However, IIQ-7 scores
were higher among those with DD, suggesting that UI symptoms have a
more negative impact on their quality of life. Women with DD were
more often menopausal, reported a fair or poor self reported health
status, and had a higher number of comorbidities, less formal education
and lower annual household income.
Conclusions: Women with symptoms of DD have an increased rate
of bladder storage symptoms, consistent with the diagnosis of
overactive bladder without incontinence. The pathophysiology
underlying this association is worthy of future research.
Disclosures: A.K. Pelletier Cameron, None; D.E. Fenner, None; J.O.
DeLancey, Johnson & Johnson, Consultant; D.M. Morgan, None.
Bowel Symptoms: The Underreported Urogynecologic Complaint
F. G. Khan,* J. Cunkelman,* L. Lowenstein,† K. Kenton,† and L. Wall*
*Washington University School of Medicine, St. Louis, MO, †Loyola
University School of Medicine, Maywood, IL
Objectives: To determine the prevalence and impact of bowel
symptoms in a urogynecologic population.
Methods: We reviewed charts of consecutive new patients presenting to
our urogynecologic clinic between July 2006 and April 2008. Women
completed 2 bowel symptom questionnaires: (1) a non-validated
questionnaire inquiring about symptoms of fecal/flatal incontinence, painful
bowel movements, difficulties in bowel movement and the need for
splinting; (2) the validated, Colorectal-Anal Distress Inventory
(CRADI)subscale of the short form of the Pelvic Floor Distress Inventory
(PFDI-20). The CRADI was scored from 0 to 100 according to standard
scoring, with higher scores indicating more bother. Demographic and clinical
information including previous surgical history, bowel and concomitant
medical conditions were extracted from patients’ charts.
For analysis, we categorized age to the following 3 groups: ⬍40,
40 – 65 and ⬎65, and BMI according to CDC guidelines: ⬍20 kg/m2
(low body weight), 20 –24 (normal weight), 25–29 (overweight), and
ⱖ30 (obese). Nonparametric tests were used to compare independent
groups. We included the following clinically and/or statistically
significant variables in the final linear regression model: age, race,
BMI, concomitant medical disease, symptoms of pelvic organ prolapse
and urinary incontinence.
Results: Four hundred and sixty three women with a median age of
56 years (range19 –94) and a BMI of 27(16 – 64) were included. Most
women were (88%) Caucasian, 9% African American, and 3% other.
Though only 3% (n ⫽ 15) of women presented to our clinic with a
defecatory dysfunction or fecal incontinence as their chief complaint,
76% (n ⫽ 350) reported at least one bowel symptom. The most
common bowel symptoms was difficulty in having bowel movements
(BM) 42% (n ⫽ 191), followed by flatal incontinence 34% (n ⫽ 148),
and fecal incontinence 19% (n ⫽ 84).
Middle-age women (40 to 65 years) (n ⫽ 79) had significantly higher
CRADI scores (25 (0 –100)) than younger women (⬍ 40 years) (n ⫽ 245)
16(0 – 88), p ⬍ .02). Similarly BMI was also found to be associated with
the severity of bowel symptoms. Overweight women (BMI of 25–30
Abstracts
kg/m2) (n ⫽ 144) had higher CRADI scores 25 (0 –100) than normal
weight women (BMI of 20 –25 kg/m2) (n ⫽ 118) 15(0 –78), (p ⬍ .002).
In multivariate analysis, only BMI and history of concomitant cardiac
disease or hypertension were independently associated with CRADI
scores. The adjusted mean score difference for every 5 unit increase in
BMI, the CRADI score increased by 2.units (p ⬍ .0004). Similarly, the
adjusted CRADI mean score was 4.9 units higher in patients with
concomitant cardiac disease and/or hypertension (p ⬍ .049).
Conclusion: Our data demonstrate that women rarely seek
urogynecologic care primarily for bowel symptoms, although, most
bowel symptoms are highly prevalent in this population. Patients with
higher BMI and concomitant medical disease tend to be more
bothered by bowel symptoms. Bowel symptoms should be evaluated
in all women presenting for urogynecologic care.
Disclosures: F.G. Khan, Pfizer, Grant/Research Support; Pfizer, Speaker’s
Bureau; J. Cunkelman, None; L. Lowenstein, Astellas, Grant/Research
Support; Pfizer, Grant/Research Support; K. Kenton, Pfizer, Grant/Research
Support; Pfizer, Consultant; Pfizer, Speaker’s Bureau; L. Wall, None.
Health Care Cost and Utilization in Patients with Chronic
Constipation
T. Nguyen,* O. Palsson,* M. Von Korff,† A. Feld,‡ R. Levy,‡ M.
Washington, Seattle, WA
Objective: Determine health care cost and utilization in patients with
chronic constipation (CC) compared to healthy controls.
Methods: HMO patients were recruited into 2 groups: those with a
clinical diagnosis of constipation (ICD-9CM codes 564.0X) in the last
year vs. those without a clinical diagnosis of constipation for the
previous 5 years. Questionnaires identified subjects who met Rome III
criteria for CC. The 520 subjects with both clinical and Rome III
diagnosis of CC (KCC) were compared to 416 non-consulters (NKCC)
who met Rome III criteria for CC but did not have a clinical diagnosis
of CC and 614 subjects who did not fulfill clinical or Rome III
diagnostic criteria (HC). Health care cost in US$ and utilization data
for the previous 5 years were extracted from administrative claims.
Means and 95% confidence intervals are reported.
Results: The KCC, NKCC and HC groups were similar in age, race,
marital status, education and personal income. However, KCC and
NKCC subjects were more likely to be female than the HC subjects
(73.1% vs. 73.3% vs. 64.6%, p ⫽ 0.002 and p ⫽ 0.003). Mean annual
health care costs were significantly higher in KCC vs. HC groups p ⬍
0.001). Previous year costs showed similar differences. The NKCC
group had intermediate costs in all categories and was significantly
different from both KCC and HC groups except previous year GI cost.
Healthcare utilization showed a similar pattern. Compared to the
HC group, the KCC group had higher mean annual outpatient visits
and non-GI outpatient visits. Annual outpatient visits for NKCC were
intermediate between the KCC and HC and were significantly
different from both except previous year outpatient GI visit.
Conclusions: Subjects with a clinical diagnosis of CC confirmed by
Rome III criteria had higher GI-related and non-GI related health care
costs and utilization than those without a clinical or Rome III
diagnosis of CC. Subjects who met Rome criteria for CC but had not
seen a physician had intermediate health care costs and utilization.
337
Abstracts
Satisfaction with Laxatives in Chronic Constipation and
Irritable Bowel with Constipation
T. Nguyen,* O. Palsson,* M. Von Korff,† A. Feld,‡ R. Levy,§ M.
Wahington, Seattle, WA, §University of Washington, Seattle, WA
Objective: Determine frequency of using laxative regimens, perceptions
of effectiveness, side effects (SE) severity and satisfaction with laxative
treatment in patients with chronic constipation (CC) and irritable bowel
with constipation (IBS-C).
Methods: HMO patients were recruited into 2 groups: those with a
clinical diagnosis of constipation (ICD-9CM codes 564.0X) in the last
year vs. those without a diagnosis of constipation for the previous 5
years. Postal questionnaires were used to identify subjects in both
groups meeting Rome III criteria for CC or IBS-C. Subjects with CC or
IBS-C but without a medical diagnosis of constipation were designated
non-consulters.
Results: There were 447 CC and 320 IBS-C subjects (consulters and
non-consulters pooled). Groups were similar in race, education and
income. However, CC were older (mean age 70 vs. 61 years, p ⬍
0.001), more likely to be male (34% vs. 21%, p ⬍ 0.001) and widowed
(20% vs. 13%, p ⫽ 0.01). CC were less likely than IBS-C to consult
physicians (47% vs. 59%, p ⫽ 0.001) and less likely to use laxatives
(33% vs. 47%, p ⬍ 0.001). When they did use laxatives, CC reported
less SE (mean rating 0 vs. 1 on a 0 – 4 scale, p ⬍ 0.001) and greater
satisfaction (5 vs. 4 on a 1– 6 scale, p ⬍ 0.001) compared to IBS-C.
There were no differences in effectiveness rating (2 vs. 2 on a 0 – 4
scale, p ⫽ 0.36).
Ordinal regression tested the combined effects on satisfaction with
laxatives of age, gender, race, consultation, diagnosis (CC vs. IBS-C),
SE severity and perceived effectiveness. Significant predictors were
perceived effectiveness p ⬍ 0.001), less SE severity p ⬍ 0.001) and
CC diagnosis by Rome III criteria p ⫽ 0.049). Total variance explained
was 58.4%.
Conclusions: Laxatives were equally effective in CC and IBS-C, but
subjects with CC had less severe SEs and were more satisfied with
laxative treatment.
Sacral Neuromodulation in Patients with Multiple Sclerosis
K. C. Hubert,* A. Hijaz,* C. Moore,† H. B. Goldman,† R. R. Rackley,†
and S. Vasavada† *University Hospitals Case Medical Center, Case
Western Reserve University School of Medicine, Cleveland, OH,
†Glickman Urological and Kidney Institute, The Cleveland Clinic,
Cleveland, OH
338
Category: Neuromodulation.
Objective: We present results of sacral nerve neuromodulation (SNS)
in patients with multiple sclerosis (MS) and lower urinary tract
dysfunction.
Methods: This is a retrospective case series of 28 patients with MS and
lower urinary tract dysfunction who underwent SNS. Lower urinary tract
dysfunction was divided into three categories based on urodynamics:
overactive bladder (OAB), detrusor sphincter dyssynergia (DSD) and
retention. Success was defined as greater than 50% improvement in
clinical symptoms.
Results: Mean age was 49.7. There were 21 females and 7 males.
Nineteen of 28 patients (68%) had greater than 50% improvement in
clinical symptoms and underwent implantation: 11 of 16 (69%) with
OAB, 1 of 4 (25%) with DSD and 7 of 8 (88%) with retention. Twelve
of nineteen (63%) maintained improvement in clinical symptoms at a
mean follow-up of 16 months: 7 of 12 (58%) with OAB and 5 of 12
(42%) with retention. Six of nineteen (32%) had the device explanted:
two for infection, two for loss of response, and two for progression of
multiple sclerosis and need for magnetic resonance imaging.
Conclusion: SNS is an effective treatment for lower urinary tract
dysfunction in patients with multiple sclerosis.
Disclosures: K.C. Hubert, None; A. Hijaz, Pfizer, Speaker’s Bureau;
C. Moore, None; H.B. Goldman, Johnson & Johnson, Consultant; NDI
Medical, Inc., Consultant; Johnson & Johnson, Speaker’s Bureau;
Pfizer, Speaker’s Bureau; Novartis, Speaker’s Bureau; Investigator, NDI
Medical, Other; R.R. Rackley, Generic Medical Devices, Consultant;
NDI Medical, Inc., Consultant; Novartis, Consultant; Pfizer, Consultant;
Boston Scientific, Consultant; Novartis, Speaker’s Bureau; Pfizer,
Speaker’s Bureau; Founder, Generic Medical Devices, Inc., Other;
Founder, NDI Medical, Inc., Other; S. Vasavada, None.
Lead Migration After Sacral Neuromodulation: Fascial Versus
Tined Anchoring Systems
N .Y. Siddiqui, C. L. Amundsen, E. G. Corey, and J. M. Wu Duke
University Medical Center, Durham, NC
Objective: Sacral neuromodulation (InterStim®) utilizes an implanted
electrical lead and generator to treat urinary retention or overactive
bladder symptoms. Traditionally, sacral leads were anchored to the
lumbodorsal fascia using permanent sutures. The development of the
tined lead has allowed for a less invasive anchoring technique. One
potential complication of either anchoring system is lead migration.
Our objective was to compare the rates of lead migration using the
traditional fascial anchoring system versus tined leads.
Methods: We performed a retrospective cohort study of patients
who received an InterStim® implant at a single academic center
between January 2000 and December 2006. Our two cohorts
consisted of subjects receiving fascial versus tined anchoring systems.
We collected data regarding demographics, medical co-morbidities,
body mass index (BMI), adverse events, and length of follow-up. Our
primary outcome was lead migration, confirmed by radiologic
imaging. Statistical analyses consisted of Student’s t-test, Pearson’s chisquare, Fisher’s exact, and multivariate logistic regression. KaplanMeier curves were constructed and compared with the log-rank test.
Results: Of 112 patients, 28 (25%) underwent fascial anchoring and
84 (75%) received tined leads. There were no significant differences
between our two cohorts with respect to age, race, gender, BMI,
diabetes, immunosuppressive medications, or tobacco use. However,
patients with fascial anchors were followed for a longer duration of
time (57.7 ⫾ 24.3 vs 20.7 ⫾ 15.7 months, p ⬍ 0.001). Lead migration
occurred in a total of 20 (17.9%) patients. The fascial anchoring
system was associated with a higher risk of lead migration compared
to tined leads (42.9% vs 9.5%, p ⬍ 0.001). In a logistic regression
model controlling for age, race, BMI, and tobacco use, fascial
anchoring remained significantly associated with lead migration (OR
6.2, 95% CI: 2.0 –19.4). Although there were fewer lead migrations
with tined anchors, these events occurred at an earlier interval after
implantation (mean 7.5 ⫾ 7.4 vs 30.7 ⫾ 20.8 months, p ⫽ 0.003).
Kaplan-Meier curves confirmed a significant difference in time to
migration (p ⫽ 0.02).
Conclusions: Tined leads for sacral neuromodulation resulted in
fewer lead migrations when compared to the fascial anchoring system.
However, these events tend to occur at an earlier interval after
implantation. Longer follow-up data on tined leads will determine if
these lower rates are maintained over time.
Disclosures: N.Y. Siddiqui, None; C.L. Amundsen, None; E.G. Corey,
None; J.M. Wu, None.
Pre-Clinical Evaluation of the Stability of a Lead Designed to be
Placed in Adipose Tissue Near the Dorsal Genital Nerve
J. Mangel,* J. Mrva,† J. Boggs,† R. Strother,† S. Rubin,† and J. Grill†
*MetroHealth Medical Center, Cleveland, OH, †NDI Medical,
Cleveland, OH
Objectives: A recent study indicates that electrical stimulation of the
dorsal genital nerve (DGN) may reduce overactive bladder symptoms
when stimulation is applied through a percutaneous electrode lead for
1 week. Those results suggest that long-term reduction in overactive
bladder symptoms may be feasible if stimulation can be applied
through a lead permanently implanted in the adipose tissue near the
DGN. The present study used a pre-clinical animal model to evaluate
the stability of the lead in adipose tissue over time, the force required
to remove the lead over time, and the tissue response to the lead.
Methods: Twenty-five leads were implanted in the adipose tissue of
four miniature Yucatan swine and followed for a four-week period at
a contract research facility according to an IACUC approved protocol.
Four of these leads (one per animal) were connected to an IPG and
positioned near a motor nerve such that activation thresholds could
be measured over time. These leads were placed in the hip of the
swine and were subjected to motion and pressure associated with
animal activity over the four-week period. Sixteen leads were
subjected to pull-out removal, and the force required to remove the
leads was recorded. Eight leads and six IPGs were dissected and
subjected to histological analysis after 4 weeks of implantation.
Results: Threshold measurements made at 1 week increased slightly
over thresholds at time of implant, and thresholds remained stable
between 1 and 4 weeks post-implant. All leads were pulled out clean and
intact, whether they were removed at time of implant, at 1 week, or at 4
weeks. The force required to remove the leads at 4 weeks (mean 4.1N)
was substantially greater than the force required to remove the
percutaneous leads used in a clinical feasibility study (mean 0.59N). The
leads were removed easily and without trauma to tissue or the device.
The range of tissue response to the lead and IPG was heterogeneous and
consistent with the range of responses observed around other stimulating
electrodes implanted in the subcutaneous space, within or on skeletal
Abstracts
muscle, or around peripheral nerves. The response included variable
degrees of cellular activity surrounded by a collagen matrix. The degree
of cellular activity was higher around the tines and the IPG, and
substantially higher around a lead and IPG that cultured positive.
Conclusions: The threshold measurements suggest tissue encapsulation
of the leads was achieved during the first week and the following
stabilization of thresholds indicate the leads did not migrate during the
four-week period. The force required to remove the lead indicates its
resistance to migration after implantation. The removal force for the lead
is greater than the forces expected to be experienced by the lead due to
movement and stresses in the proposed abdominal location. The tissue
response indicates that the lead is suitable for human use. The results of
this study suggest that the lead will remain stable in human adipose
tissue under the stresses anticipated in clinical application.
Disclosures: J. Mangel, None; J. Mrva, None; J. Boggs, None; R.
Strother, None; S. Rubin, None; J. Grill, None.
Cost-Effectiveness of Sacral Neuromodulation Versus Intravesical
Botulinum a Toxin for Treatment of Refractory Urge Incontinence
N. Y. Siddiqui, C. L. Amundsen, A. G. Visco, E. R. Myers, and J. M.
Wu Duke University Medical Center, Durham, NC
Objective: Sacral neuromodulation (SNS) and intravesical botulinum
A toxin (BoNT-A) are promising treatment options for patients with
refractory urge incontinence. Both are potentially costly modalities,
but the cost-effectiveness of these procedures has not been
established.
Methods: We developed a Markov decision model to compare costs
(2008 US dollars) and effectiveness (quality-adjusted life-years, QALYs) of
InterStim® SNS and BoNT-A for the treatment of refractory urge
incontinence. Efficacy and adverse event rates were estimated from a
comprehensive literature search. Costs were estimated using the
Medicare reimbursement and national physician fee schedules. We
conducted this analysis from a societal cost perspective using cycles of
three months over a two-year time period, discounted at a standard rate
of 3% per year. Our primary outcome was the incremental costeffectiveness ratio (ICER), which was defined as (SNS cost-BoNT-A
cost)/(SNS QALY-BoNT-A QALY). Sensitivity analyses were performed
varying efficacy, costs, and adverse events over the range of reported
values.
Results: In the base case, the SNS treatment strategy was more
expensive ($15,743 vs $4,392) and more effective (1.73 vs 1.63
QALYs) than the BoNT-A treatment over a two-year period. However,
the incremental cost-effectiveness ratio was $116,427/QALY. Using the
conventional ICER threshold of $50,000/QALY, SNS was not costeffective. In sensitivity analyses, we varied the following probabilities:
BoNT-A failure (8 – 40%), receiving repeat BoNT-A injections
(25–100%), urinary retention after BoNT-A (4 – 43%), failure of SNS test
stimulation (12–34%), any complication related to SNS implant
(2–33%), complications requiring surgical revision (30 –100%), cost of
BoNT-A injection ($820 – 4090), cost of SNS lead placement
($4,730 –7,700),
and
cost
of
SNS
generator
placement
($10,940 –12,530). Despite varying these parameters, botulinum toxin
A remained cost-effective.
Conclusion: In this cost-effectiveness analysis conducted over a twoyear time period, botulinum A toxin was cost-effective for the
treatment of refractory urge incontinence. Additional data regarding
BoNT-A effectiveness with repeat injections, time to failure after
339
Abstracts
injection, and long-term SNS complications will be helpful for future
cost-effectiveness studies.
Disclosures: N.Y. Siddiqui, None; C.L. Amundsen, None; A.G. Visco,
Intuitive Surgical, Consultant; Intuitive Surgical, Paid Instructor; E.R.
Myers, Merck, Grant/Research Support; Precision Diagnostics,
Grant/Research Support; Merck, Consultant; Precision Diagnostics,
Consultant; J.M. Wu, None.
Does Current Perception Threshold Testing & ThermalVibratory Sensory Analyzer System Testing Selectively Measure
Different Populations of Afferent in the Genital Area?
L. Lowenstein, C. Davis, K. Jesse, and K. Kenton Loyola Medical
Center, Chicago, IL
Evaluation of Botulinum a Toxin for The Treatment of Detrusor
Overactivity Incontinence Refractory to Interstim Sacral
Neuromodulation
A. Shariati, C. D. McDermott, E. Fuller, C. Terry, and D. Hale
Methodist Hospital/Indiana University School of Medicine,
Indianapolis, IN
Objectives: To describe the effect of botulinum toxin injections into
the detrusor muscle on urinary frequency, urge incontinence, and
quality-of-life in those patients with detrusor overactivity incontinence
(DOI) who are refractory to InterStim sacral neuromodulation.
Methods: Patients with DOI who had subjectively and objectively
failed treatment with anticholinergics and sacral neuromodulation
were recruited for the study. Prior to injection, patients were asked to
complete a 48 hour bladder diary as well as the Incontinence Impact
Questionnaire (IIQ) and the Urogenital Distress Inventory (UDI).
Under cystoscopic guidance, 300 units of botulinum A toxin with
indigo carmine were injected into the detrusor muscle. Patients then
repeated a 48 hour bladder diary and the IIQ and UDI questionnaires
at intervals of 10 days, one month, three months, and six months
following injection.
Results: Nine women were enrolled into the study with an average
age of 61 and an average Body Mass Index of 38. When compared to
baseline, urinary frequency decreased by an average of 1.8 voids/24
hours at 10 days post-injection (p ⫽ 0.08), 2.7 voids/24 hours at one
month post-injection (p ⫽ 0.1), 2.6 voids/24 hours at three months
post-injection (p ⫽ 0.16), and 5.0 voids/24 hours at six months postinjection (p ⫽ 0.04). Conversely, the average voided volume when
compared to baseline increased by 37 mL at 10 days post-injection (p
⫽ 0.04), by 75 mL at one month post-injection (p ⫽ 0.001), by 105
mL at three months post-injection (p ⫽ 0.06), and by 42 mL at six
months post-injection (p ⫽ 0.13). The number urge incontinence
episodes decreased from baseline by an average of 2.6 episodes/24
hours at 10 days post-injection (p ⫽ 0.04), 3.3 episodes/24 hours at
one month post-injection (p ⫽ 0.003), 3.2 episodes/24 hours at three
months post-injection (p ⫽ 0.02), and 1.4 episodes/24 hours at six
months post-injection (p ⫽ 0.45). Averaged UDI scores showed
statistically significant improvement at all follow-up intervals p ⬍0.05).
Averaged IIQ scores showed statistically significant improvement at
one month, three month, and six month intervals p ⬍0.05), but
improvement in averaged score at 10 days post-injection was not
found to be statistically significant (p ⫽ 0.16).
Conclusions: Botulinum toxin detrusor injection is a reasonable
treatment option for patients with DOI who have previously failed
sacral neuromodulation. This study demonstrates reduced urinary
frequency, increased voided volume, decreased episodes of urge
incontinence, as well as improved quality-of-life following botulinum
toxin detrusor injection, with effects lasting as long as six months.
Disclosures: A. Shariati, None; C.D. McDermott, None; E. Fuller,
None; C. Terry, None; D. Hale, None.
340
Objectives: While multiple pelvic floor disorders are clearly
associated with afferent neural changes, which warrant further
investigation to further our understanding of the pathophysiology and
treatment of pelvic floor disorders, we are currently unable to
compare changes in the lower urinary tract and genital region
secondary to limitations in techniques. Given the accumulating
literature using CPT and QST in the genito-urinary tract, and the
limited data regarding selectivity and reproducibility in this area, we
aimed to determine the relationship between Current Perception
Threshold (CPT) testing ( 2000 Hz, 250 Hz and 5 Hz) and Quantative
Sensory Testing (QST) using vibratory and heat thresholds, to find if
the methods are selectively activating the same afferent neurons in the
genital area; and to assess the reproducibility of both methods.
Methods: Sixteen asymptomatic women were enrolled in the study.
Each woman underwent CPT and QST testing on a single day. CPT
testing was done using a Neurometer®. Stimuli at 2000 Hz, 250 Hz
and 5 Hz frequencies (corresponding to A-␤, A-␦, and C fibers,
respectively) were applied to the distal third of the anterior vaginal
wall. The Genital Thermal and Vibratory Sensory Analyzer (GSA) was
used for thermal (C fibers), vibratory (A-␤ fibers) and cold (A-␦ and C
fibers) testing on the vaginal wall at the same place. Ten women
underwent repeated CPT and QST testing one week apart to
determine reproducibility.
Results: Study participants had a mean age of 34 (22–52) years. Median
BMI was 28.5(20 – 44). Most women were Caucasian, 62% (10); 32% (6)
were African American; 6%were Hispanic(1). Mean PFDI score was 5.32
⫾ 10. None of the women had stress or urge incontinence according to
their response on MESA questionnaire. Patient’s median parity and POP
staging were 0.6 (0 –2) and 0.5 (0 –2), respectively. Only one participant
had POP stage II.
We found a moderate correlation between CPT at 5 Hz and thermal
sensory testing both of which correspond to C fiber pathways
(Spearman’s ␳ ⫽ 0.77, p ⫽ 0.002). Current perception thresholds at 2000
Hz and vibratory sensory thresholds, which correspond to A-␦ fibers,
were also moderately correlated (Spearman’s ␳ ⫽ 0.6, p ⫽ 0.01). Cold
stimuli correlated neither with CPT at 250 Hz stimuli which correspond
to A-␦ (p ⫽ 0.29), nor with CPT 5 Hz which correspond to C fibers (p ⫽
0.55). The repeated thermal vibratory and cold threshold tests were
found to have moderate to high concordance correlation (rhoc⫽.83, p ⬍
.001, rhoc ⫽ .96, p ⬍ .001 and rhoc ⫽ .77, p ⬍ .001 respectively).
Similarly, repeated CPT 5 HZ, and 2000 Hz tests done one week apart
were found to have moderate concordance correlation (rhoc ⫽ .69, p ⬍
.001, rhoc ⫽ .7, p ⬍ .001 respectively). Repeated CPT at 250 Hz was not
correlated when repeated one week apart (rhoc ⫽ .2, p ⫽ .45 ).
Conclusions: CPT and QST testing stimulate similar afferent nerve
fiber populations in the vaginal region. Both modalities proved to
have good reproducibility while QST was found to be more reliable
tool for evaluating A-␦ fibers.
Disclosures: L. Lowenstein, Pfizer, Grant/Research Support;
Astellas, Grant/Research Support; C. Davis, None; K. Jesse, None;
K. Kenton, Allergan, Grant/Research Support; Pfizer, Grant/
Research Support.
Noninvasive Screening for Pudendal Neuropathy in Women
with Overactive Bladder.
M. K. Guess,* S. B. Nosseir,† R. Bercik,* and K. A. Connell*
*Division of of Urogynecology & Reconstructive Pelvic Surgery,
Department of Obstetrics, Gynecology, & Reproductive Sciences. Yale
University School of Medicine, New Haven, CT, †Department of
Obstetrics and Gynecology, Bridgeport Hospital, Bridgeport, CT
Objective: The UDI-6 is a validated scale designed to assess
genitourinary complaints in women, particularly those with
incontinence. Biothesiometry is a proven method used to evaluate
neurological function. Using a validated questionnaire, urodynamic
testing, and biothesiometry, our goal was to determine if subtle
neurological deficits of the pudendal nerve exist in patients with
symptoms of overactive bladder (OAB) and decreased bladder
capacity.
Methods: One hundred and fifty eight patients were recruited from
Urogynecology and Gynecology clinics. Subjects were screened for
symptoms of OAB using the UDI-6 and a medical history was obtained
using a demographic worksheet. Urodynamics was performed when
indicated. Exclusion criteria included having a significant neurological
history, diabetes, previous surgery for prolapse/incontinence, isolated
stress urinary incontinence, and incomplete questionnaire or
biothesiometry test. Neurological integrity of the pudendal nerve was
evaluated with biothesiometry at the S2 dermatome level. Testing sites
included the vulva, clitoris, external urethral meatus, and the right and
left sides of the perineum. Vibratory thresholds were determined using
the method of limits. Data was analyzed using Mann-Whitney U Test and
Spearman’s Correlation.
Results: Fifty six women were enrolled of which thirty nine subjects
showed symptoms of OAB. Twenty five percent were menopausal.
The mean age was 42 ⫾ 15.4 years. The mean parity was 1.6 ⫾ 1.42.
Overall, women with symptoms of OAB had decreased genital
sensation at the labia p ⫽ .035), clitoris (p ⫽ .06), right perineum (p
⫽ .02) and left perineum p ⬍ .01).
More specifically, a negative correlation was found between
decreasing bladder capacity and increasing vibratory thresholds
(indicating decreased genital sensation) at the clitoris (p ⫽ .045),
external urethral meats (p ⫽ .014), and the right perineal body (p ⫽
.029).
Conclusion: Patients with symptoms of overactive bladder and/or
decreased bladder capacity may have an underlying pudendal
neuropathy. Biothesiometry may serve as a potential non-invasive
technique in identifying patients at risk for refractory overactive
bladder symptoms, who may require higher doses of anticholinergics
and benefit from adjunct neurostimulation.
Disclosures: M.K. Guess, None; S.B. Nosseir, None; R. Bercik, None;
K.A. Connell, None.
Diagnoses of Patients Referred to Urogynecologist for Recurrent
Urinary Tract Infections
L. Lipetskaia,* G. Northington,† E. Saks,† and L. Arya† *St.Luke’s
Bethlehem Hospital, Bethlehem, PA, †University of Pennsylvania,
Philadelphia, PA
Category: Other.
Abstracts
Objectives: Our primary aim was to explore the spectrum of final
diagnoses for women presenting to a urogynecology practice with a
referral diagnosis of recurrent urinary tract infection (UTI).
Methods: We performed a retrospective chart review of electronic
medical records for patients referred by primary care physicians to a
urogynecology practice for recurrent UTI from 04/2006 to 01/2007.
Demographic and clinical data were extracted from the medical
records of women with the referral diagnosis of recurrent UTI.
Additionally, results from the urinalysis, urine culture, urodynamic
exam and cystoscopy were recorded. In a subset of patients, detailed
treatment history from primary care physicians was also recorded. The
final diagnosis as assigned by a single urogynecologist was noted for
each patient. Descriptive data that is normally distributed are reported
as means with standard deviations. Non-parametric data are presented
as medians.
Results: One hundred and three (10.4%) women were referred with
a diagnosis of recurrent UTI during the study period. The mean age of
the women with a referral diagnosis of recurrent UTI was 51.9
(⫹20.8) and mean parity was 1.45 (⫹1.41) Prior to referral, mean
number of courses of antibiotics taken by women was 2.8 (⫾2.3). The
most commonly prescribed antibiotic was ciprofloxacin (46%)
followed by Bactrim (24.4%) and Macrobid (17.3%). Detailed prereferral treatment history was available for 45 women. In this
subgroup, the median number of telephone calls and visits related to
lower urinary tract symptoms to primary care physicians was 3 and 2,
respectively. The median number of urinalysis and urine cultures
performed prior to referral was 3 for both tests. Following complete
evaluation, the final diagnosis of recurrent UTI was confirmed in 48
(47%) women. Fifty three percent of these women (N ⫽ 55) received
diagnosis other than UTI. Overactive bladder (18.4%), mixed urinary
incontinence (7.8%) and interstitial cystitis (7.8%) were the three most
frequent diagnoses. There was no significant difference in the mean
age, parity and hormone status of women with and without final
diagnosis of recurrent UTI.
Conclusion: There is a significant disagreement between referral
diagnoses provided by primary care physician and final diagnosis of
the urogynecologist.
Disclosures: L. Lipetskaia, None; G. Northington, None; E. Saks,
None; L. Arya, None.
Low Dose 17-␤-Estradiol Cream: Serum and Vaginal Responses
T. L. Wheeler, II, H. E. Richter, M. G. Conner, P. S. Goode, A. D.
Markland, and C. R. Parker University of Alabama at Birmingham,
Birmingham, AL
Category: Other.
Objective: A pilot study to describe the systemic (serum) and local
(vaginal) responses to 50ug of intravaginal 17-␤-estradiol (E2) cream.
Methods: Twenty women, 65 years or older, applied 50 ug intravaginal
cream nightly for 8 weeks followed by a maintenance frequency of twice
a week for an additional 8 weeks. This is a substudy of the clinical
outcomes for this translational pilot project. Repeated measures analysis
assessed for changes in vaginal maturation indexes (VMI), epithelial
thickness, glycogen content, radioimmunoassays for serum E2 level,
pelvic floor symptoms (Pelvic Floor Distress Inventory, PFDI and Pelvic
Floor Impact Questionnaire, PFIQ)and atrophy questions at baseline, 8
weeks and 16 weeks. Tukey’s HSD corrected for multiple testing.
Results: The mean, SD age was 72.4, 6.3 years (median 70, range
65– 84). The mean, SD BMI was 24.9, 3.0 (median 25.3, range
341
Abstracts
TABLE. Clinical Outcomes with 50ug of Intravaginal Estradiol Cream
Serum Estradiol pg/ml (mean, SD)
Vaginal Maturation Index Score (mean, SD)
Epithelial thickness, mm (mean, SD)
Glycogen present (%)
Vaginal Dryness (%)
-Never
-Rarely
-Sometimes
-Often
Vaginal Itching (%)
-Never
-Rarely
-Sometimes
-Often
Baseline
8 Weeks
16 Weeks
p-value
7.7, 3.3
34.2, 18.3
0.14, 0.07
25.0
9.7, 5.7
56.7, 13.1
0.31, .10
88.2
8.7, 5.8
54.5, 11.3
0.27, .10
76.5
0.2365
⬍0.0001
⬍0.0001
0.0195*(8weeks)0.3247**(16weeks)
⫺25
⫺5
⫺45
⫺25
⫺21
⫺26
⫺16
⫺37
⫺35
⫺15
⫺35
⫺15
0.0295
⫺30
⫺30
⫺30
⫺10
⫺16
⫺26
⫺47
⫺11
⫺25
⫺50
⫺25
⫺0
0.0202
*8 weeks compared to baseline.
**16 weeks compared to baseline.
18.9 –29.8). No statistical difference was found in serum E2 levels
between time points, while improvement in the VMI score and
thickness content occured, with no difference found between 8 and
16 weeks (Table). The presence of glycogen improved at 8 weeks.
There was marginal evidence that serum E2 level correlated with VMI
p-value ⫽ 0.0579). In this small cohort, vaginal dryness and itching
did improve (Table), but improvements in vaginal discomfort p-value⫽
0.6024), discharge p-value⫽ 0.9168), and dyspareunia p-value ⫽
0.2792) did not, as these were rare at baseline. Again, likely due to
low occurrences at baseline, pelvic floor symptoms did not improve
(CRADI p ⫽ 0.1845, CRAIQ p ⫽ 0.8178, IIQ p ⫽ 0.5200, UDI p ⫽
0.4190, POPDI p ⫽ 0.2633, POPIQ p ⫽ 0.1746).
Conclusions: Older women using 50 ug of intravaginal estradiol nightly
for 8 weeks followed by twice a week for 8 weeks had improvements in
their vaginal maturation index and vaginal symptoms of dryness and itching
without significantly elevating their serum estradiol levels when sampled
with a highly sensitive immunoassay. There was no difference in pelvic
lower urinary tract symptoms. This information may be useful when
counseling older women with vaginal atrophy who may be concerned about
initiating intravaginal estrogen therapy.
Part of this abstract was presented at the 2008 AGS Annual
Meeting, Washington, DC.
Disclosures: T.L. Wheeler II, Pfizer, Speaker’s Bureau; H.E. Richter,
Pfizer, Speaker’s Bureau; M.G. Conner, None; P.S. Goode, None; A.D.
Markland, None; C.R. Parker, None.
Levator-Ani Necrosis-A Rare Complication Following Pelvic
Floor Repair of Apical and Posterior Vaginal Prolapse
H. Yasmin, and M. L. Mokrzycki Saint Peters University Hospital,
New Brunswick, NJ
Category: Other.
Objective: Necrosis of the levator ani muscle is extremely rare
following pelvic reconstructive surgery. It is a complication that may
result in severe constipation or worrying concern over a firm mass in
the gluteal region. We present a 78 year old female who had necrosis
of the levator ani muscle following the repair of apical and posterior
vaginal prolapse resulting in a firm mass in the levator ani area.
342
Methods: The patient is a 78 year old female who initially presented to our
office 3 years prior with a long history of vaginal bulging, pressure and
discomfort as well as urinary incontinence. On examination in the supine
lithotomy position, her vaginal apex and posterior vaginal wall extended 3
centimeters distal to the hymenal ring. Subsequently she underwent an
uncomplicated sacrospinous ligament fixation, a posterior colporrhaphy
augmented by a Gynemesh® graft. Finally, the pubovaginal sling was
performed placing the Tension Free Transvaginal Tape System in a ‘U’
configuration underneath the midurethra. Her hospital course and postoperative follow-up was uncomplicated. She presented later with a five
month history of a hard mass in the area of her right buttock. The mass was
firm and mobile and did not cause any pain. There was a change in her
bowel habits with a fluctuation between constipation and diarrhea. On
pelvic exam in the supine lithotomy position, the posterior vaginal wall
revealed a defect in the right levator ani muscle area where a firm mobile
mass was palpated. The size of the mass was approximately 10 cms in
diameter. On rectal exam the mass was confirmed to be the impacted stool
in an area of the rectum that had prolapsed into the right levator ani muscle
area. The stool was partially removed with resolution of the mass.
Results: This defect in levator ani complex could have possibly
resulted from haemorrhagic necrosis after either of the above two
procedures or secondary to nerve damage during surgery leading to
weakness of the Levator ani complex . This could have possibly
resulted in a weakness defect of Levator ani causing prolapse of
bowel into this defect. This patient had minimal symptoms related to
bowel function and so was effectively managed with dietary
modifications.
Conclusions: This complication of levator ani necrosis associated with
apical and posterior vaginal prolapse repair should be acknowledged as a
postoperative possibility by all surgeons performing this procedure.
Disclosures: H. Yasmin, None; M.L. Mokrzycki, None.
Pelvic Reconstructive Surgery in Renal Transplant Recipients A Retrospective Chart Review
D. Shveiky*, A. Blatt†, A. I. Sokol,* B. I. Kudish,* I. C. Green,* and C.
B. Iglesia* *Washington Hospital Center, Washington, DC,
†Georgetown University Hospital, Washington, DC
Category: Other.
Objective: In 2007 approximately 3000 postmenopausal women
underwent renal transplantation. Similar to the general U.S. population,
women with renal transplants may also have pelvic organ prolapse
and/or urinary incontinence complaints, the latter of which often
becomes more symptomatic after transplantation. Very little is known
about the safety and efficacy of pelvic reconstructive procedures in renal
transplant patients. The aim of this study was to describe our series of
female renal transplant recipients undergoing pelvic reconstructive
surgery.
Methods: Retrospective chart review of surgical logs identified 4
patients undergoing renal transplantation and pelvic reconstructive
surgery in our division, from 1/2000 –3/2008. Data included medical
and surgical history, POP-Q, as well as perioperative complications.
Results: The mean age was 56.5 (range 50 –70). The origin of the
transplanted kidneys was cadaver in two, and living related in the other
two. All transplanted kidneys were located in the pelvis and all ureters
were implanted in the bladder dome. For these four patients, a total of
two vaginal hysterectomies with utero-sacral ligament suspension, three
anterior repairs, two posterior repairs and two suburethral sling
procedures (TVT and TOT) were performed. There were no
intraoperative or postoperative complications (Dindo grade 1 or more).
At a mean follow-up period of 14.5 months (range 4 –36 months), all
patients were cured of their prolapse (defined as ⬍ Stage 2 POP-Q) and
were free of urinary incontinence symptoms. Case description is
provided with an emphasis on the unique medical and surgical
considerations of pelvic surgery in these patients.
Conclusions: In well selected patients and with special
consideration for their unique needs, pelvic reconstructive surgery
can safely be performed in renal transplant patients.
Disclosures: D. Shveiky, None; A. Blatt, None; A.I. Sokol, None; B.I.
Kudish, None; I.C. Green, None; C.B. Iglesia, None.
Barriers to Study Recruitment in Individuals with an Isolated
Symptom of Nocturia
M. M. South, J. H. Maynor, A. C. Weidner, and C. L. Amundsen Duke
University Urogynecology and Pelvic Reconstructive Surgery,
Durham, NC
Category: Other.
Objective: Nocturia is the complaint of needing to wake at night one
or more times to void (International Continence Society, 2002
definition) and is one of several lower urinary tract symptoms
reported as extremely bothersome by men and women. Although
anticholinergic medications are not specifically indicated for treatment
of nocturia, several studies have shown that anticholinergic treatment
for an overactive bladder is associated with improvement in nocturia.
The objective of this study was to evaluate the efficacy of tolterodine
compared to placebo in men and women complaining of nocturia due
to decreased functional night-time bladder capacity.
Methods: This was a randomized placebo-controlled crossover
study evaluating men and women over 18 years of age complaining
of voiding two or more times per night. Subjects were recruited
from urology and urogynecology clinics and a posted
advertisement. The advertisement read “Are you getting up
regularly two or more times per night to empty your bladder?”
Each subject was asked to complete a 3-day bladder diary to
confirm nocturia and exclude nocturnal polyuria. Subjects were
randomized to either placebo or study drug for 6 weeks, followed
by a one week “wash-out” period and then “crossed over” to the
Abstracts
alternate arm for 6 additional weeks. Subjects were required to
complete a total of three 3-day voiding diaries and present for
three 30-minute study visits.
Results: From October 2005 through October 2007, a total of 106
individuals were screened for participation in the study. Most of
the individuals (98%) responded to the posted advertisement. All
individuals screened were female. Only nine (8.5%) were ultimately
enrolled in the study. Thirteen individuals (12.3%) did not meet
inclusion
criteria.
Forty-five
individuals
(42.5%)
refused
participation citing the following reasons: unwilling to collect and
measure urine (9.4%), unwilling to take medication (15.1%), study
is too involved and time consuming (12.3%), unwilling to take
placebo (1.9%), work or transportation conflict (2.8%), and subject
desired alternative therapy (0.9%). Finally, thirty-nine individuals
(36.8%) did not respond to email or phone calls after they were
mailed the consent form. The study was discontinued due to
inadequate recruitment.
Conclusions: Published literature regarding nocturia would suggest
that this symptom is not only prevalent, but also bothersome.
However, the majority of individuals who were interested in
participating in this study met criteria for the diagnosis but ultimately
refused or did not pursue participation. This is relevant to the utility
of the current ICS definition of nocturia. Researchers wishing to study
individuals with nocturia may choose to add a level of bother in the
screening criteria to facilitate recruitment.
Disclosures: M.M. South, None; J.H. Maynor, Pfizer, Grant/Research
Support; A.C. Weidner, None; C.L. Amundsen, Pfizer, Grant/Research
Support.
Case Report of Vesicovaginal Fistula After Bladder Stone
G. A. Azam LSU-HSC, New Orleans, LA
Category: Other.
A rare case of a vesicovaginal fistula following vesical calculi is
presented. The patient complained of intermittent incontinence and
vaginal discharge. Diagnosis was made clinically radiologically and
endoscopically. Transvesical minilaparotomy with cystostomy followed
by transvaginal (juxtacervical ) fistula repair and cystoscopy were
done. The patient recovered very well postoperatively.
Disclosures: G.A. Azam, None.
Recurrent Adductor Abscess Secondary to Transobturator
Synthetic Sling
T. B. Hutchings, R. F. Flora, T. Murray, and D. Chonko Summa
Health System, Akron, OH
Category: Other.
Background: Transobturator mid-urethral slings were developed
as an alternative surgical technique in the treatment of female
stress urinary incontinence. The transobturator approach
reportedly decreases bladder perforations as compared to the
retropubic approach and is generally considered a low morbidity
procedure.
Case: The orthopedic and urogynecology service was consulted on a
40 year old female with a ten month history of recurrent left medial
adductor abscess. She twice had an incision and drainage performed
343
with multiple courses of antibiotics over the previous ten months. Her
history was significant for placement of a Mentor Obtape
transobturator mid-urethral sling 2 years earlier and a chronic vaginal
discharge for one year. On vaginal exam exposed vaginal mesh was
visualized to both the right and left of the urethra. A combined
vaginal removal of mesh and adductor incision and drainage took
place. The patient remained hospitalized for 6 days post op and was
discharged home on PO antibiotics. The patient is doing well with no
complaints five month post op.
Conclusions: Adductor abscess is a rare complication following a
transobturator synthetic sling. To our knowledge this represents the
first report of a recurrent adductor abscess following placement of a
transobturator mid-urethral sling. Both urogynecologic and orthopedic
surgeons need to be aware of this complication. As in this case, most
reported abscess are in relation to vaginal mesh erosion. In order to
avoid recurrent adductor abscess we suggest that strong consideration
be given to vaginal removal of mesh with incision and drainage on all
patients with thigh abscess and a history of transobturator midurethral slings.
Disclosures: T.B. Hutchings, None; R.F. Flora, None; T. Murray,
None; D. Chonko, None.
Impairment of Lung Function in Postmenopausal Women with
S. Bai, H. Jung, M. Jeon, and S. Kim Department of Obstetrics and
Gynecology, Seoul, Republic of Korea
Category: Other.
Objective: The objective of this study was to determine whether
impairments of lung function are present in postmenopausal women
with pelvic organ prolapse considering to a link between pelvic organ
prolapse and connective tissue.
Methods: This was a prospective, case-control study. The study
population consisted of 207 women with pelvic organ prolapse
(defined as POP-Q stage ⱖ II) and 207 women without pelvic organ
prolapse (defined as POP-Q stage 0 or I) matched for age, height, and
years after menopause. All of them were postmenopausal without
hormone replacement therapy and clinical signs or histories that are
known to affect the pulmonary function. Each patient underwent a
standard medicosurgical and urogynecology questionnaire, complete
physical examination, chest X-ray and spirometric test. This study was
approved by the Institutional Review Board of Yonsei University
Health System. The Student’s t-test, ANOVA and Pearson correlation
were used for statistical analysis by using SPSS, version 12.0 (SPSS
Inc., Chicago, IL, U.S.A.). p ⬍ 0.05 was determined to be significant.
Results: There was significant decrease of forced vital capacity and
peak expiratory flow in cases compared to controls (Forced vital
capacity; 2.04 ⫾ 0.46 L (93.21 ⫾ 11.34 %) vs. 2.41 ⫾ 0.45 L (99.89 ⫾
14.11 %), p-value ⫽ 0.049 (0.046) and Peak expiratory flow; 4.12 ⫾
1.44 L (82.73 ⫾ 19.05 %) vs. 4.63 ⫾ 1.67 L (91.87 ⫾ 20.77 %), pvalue ⫽ 0.019(0.031)). Significant difference in the mean forced vital
capacity was shown among stages II, III, and IV (stage II: 2.41 ⫾ 0.53
L (99.90 ⫾ 15.04 %), stage III 2.11 ⫾ 0.46 L (89.42 ⫾ 14.74 %), stage
IV: 2.01 ⫾ 0.56 L (87.60 ⫾ 18.51 %), p-value ⫽ 0.047 (0.020)). There
was a positive correlation between the percentage of predictive value
of forced vital capacity and peak expiratory flow and the age at the
development of pelvic organ prolapse (p-value ⬍ 0.000 and ⬍ 0.000).
Conclusion: We demonstrated a relationship between pelvic organ
prolapse and impairment of lung function of restrictive pattern and
pelvic organ prolapse. Patients have the behavioral tendency to limit
the activity that can increase abdominal pressure. The pulmonary
impairment of pelvic organ prolapse patients aggravates in advanced
stages of pelvic organ prolapse and early developed pelvic organ
prolapse. This suggests the connection between the basic connective
344
tissue defect and the development of pelvic organ prolapse. This is
why that we have to give attention to management of lung function of
those who develop pelvic organ prolapse earlier in life.
Disclosures: S. Bai, None; H. Jung, None; M. Jeon, None; S. Kim,
None.
Poster Video Presentations
Presentation Number: Poster Video 1
Surgical Anatomy of The Retropubic Space: An Educational Tool
R. M. Ward, and C. R. Rardin Women and Infants’ Hospital/
Warren Alpert Medical School of Brown University, Providence, RI
Clinical Problem: There is an increasingly complex array of minimally
invasive
surgical
procedures
for
the
treatment
of
female pelvic floor dysfunction. While these techniques may be performed
blindly, a thorough understanding of pelvic anatomy, and especially the
retropubic space, is critical in order to achieve safe outcomes.
Surgical Solution: Knowledge of this complex anatomic space can
minimize the risk of vascular and bladder injuries, as well as enable
the surgeon to appropriately handle retropubic complications.
Methodology: This video reviews the anatomy and surgically
pertinent landmarks of the retropubic space with original illustrations,
cadaveric dissections and laparoscopic video footage. It also reviews
two commonly performed retropubic surgeries: a paravaginal repair
and Burch urethropexy.
Outcome: This video may be used as an educational tool to augment
the knowledge of physicians-in-training and pelvic surgeons who will
be performing retropubic procedures.
Disclosures: R.M. Ward, None; C.R. Rardin, Boston Scientific,
Consultant; Novartis, Speaker’s Bureau.
Large Vesicovaginal Fistula Repair
M. Jean-Michel,* L. Espaillat,† and G. Davila* *Cleveland Clinic
Florida, Weston, FL, †Temple University Hospital, Philadelphia, PA
Clinical Problem: An 83 year old multiparous female developed a 5 cm
vesicovaginal fistula as a result of a neglected pessary, which had eroded into
the bladder. The fistula was located on the proximal aspect of the anterior
vaginal wall with a second-degree midline cystocele.
Surgical Solutions: Vesicovaginal fistula repair was performed via a
vaginal approach.
Methodology: The fistulous tract was dissected and ultimately
excised after wide mobilization of the endopelvic fascia and bladder
off the anterior vaginal wall. The bladder mucosa was reapproximated
without tension in 2 layers and the endopelvic fascia was closed in 2
layers including a midline plication. The most proximal plication
suture incorporated the pubocervical fascia and the cervix, restoring
the continuity of the pubocervical fascia to the apex. The vaginal
mucosa was then closed. Cystoscopy demonstrated an intact bladder
and patent ureters.
Outcome: Large vesicovaginal fistula repair is an uncommon
complication of pessary use. This can be managed successfully from a
vaginal approach by adhering to basic principles of fistula repair: wide
tissue mobilization, tension-free closure, double-layer repair, and good
hemostasis.
Disclosures: M. Jean-Michel, None; L. Espaillat, None; G. Davila, AMS,
A Modified Transurethral Collagen Injection Technique for the
Management of Stress Urinary Incontinence.
G. M. Buchsbaum, and J. Q. Pulvino University of Rochester
Medical Center, Rochester, NY
Clinical Problem: Transurethral collagen injections are one of the
treatment options for women with stress urinary incontinence (SUI) in
the presence of intrinsic sphincter deficiency with a fixed urethra. These
injections are traditionally performed by injecting small amounts of
bovine collagen at the 3 and 9 o’clock positions at the bladder neck to
reduce the lumen of the proximal urethra. In the short term, they have
been shown to be very effective. However, the effectiveness of the
injections appears to diminish with time, and patients often require
repeat injections, limiting overall satisfaction with this technique.
Surgical Solution: In an effort to enhance long term results we have
modified our injection technique. Rather than injecting collagen solely at
the bladder neck as reported in previous studies, we inject collagen along
the entire length of the urethra. We present a video demonstrating this
technique followed by the results of a recent retrospective chart review
detailing our experience.
Methodology: Collagen injections are performed transurethrally
under IV sedation using a 12 degree lens through a 22 French array.
Under direct cystoscopic visualization while slowly backfilling the
bladder Contigen (purified bovine dermal glutaraldehyde cross-linked
collagen, C. R. Bard Inc., Covington, Georgia) is injected at 2 to 4
sites starting in the proximal urethra and extending distally to level of
the bladder neck. Collagen is injected until the walls of the urethra
are completely coapted over the entire visible length.
Outcome: Our technique for transurethral injection of collagen for the
treatment of stress urinary incontinence appears to be comparable to the
Abstracts
more traditional technique in the short-term and shows promise in the longterm. Like the traditional method, it is minimally invasive and can be done
under local with or without conscious sedation without any additional risks
to the patient. Based on our findings, this technique appears promising and
worthy of further study.
Disclosures: G.M. Buchsbaum, Pfizer, Grant/Research Support;
Ethicon, Consultant; J.Q. Pulvino, None.
New Modification of Vesicovaginal Fistula Repair Using
Interposition Graft and Retention Sutures; Increases Successes
And Endurance of Fistula Repair
B. Alnaif Western Branch Center for Women, Washington, DC
Introduction: Most vesicovaginal fistulas (VVF) in United States
result from surgical complications and typcially present as urinary
incontinence. Factors which influence success of fistula repair include
the fistula characteristics (size, location and numbers), health of the
surrounding tissue, anatomical location and risk of infection.
Objective: To improve success and endurance of fistula repair using
minimally invasive technique with less morbidity and shorter
recovery.
Description of Technique: We followed the principles of fistula
repair, which include excising the tract, tension-free repair of healthy
tissue to healthy tissue in layers with adequate hemostasis, bladder
drainage, and infection control. We found that separating the two
epithelial surfaces by adding interposition graft decreases the risk of
recanalization, thus increasing success as well as endurance. Moreover,
the tension on the repair was decreased with retention sutures that were
also designed to stabilize the graft in place. Surgisis graft was chosen
because it is gentile, promotes healing and is not prominent.
We performed this technique on eight patients; three had failed
previous repairs. All patients had developed fistula as a result of a
simple abdominal or vaginal hysterectomy. All repairs were performed
vaginally in outpatient setting and without complications. Indwelling
catheters were left in for a duration of 10 –14 days. Cure, defined as
achieving full continence with normal bladder function, and
resumption of sexual function without pain or incontinence, was
achieved in all these patients. Patients experienced minimal
postoperative discomfort and returned to work early.
Conclusion: This new modification of fistula repair which includes
the use of interposition graft secured in place with retention sutures
would increase success and endurance of vesicovaginal fistula repair.
We used the same technique successfully to repair rectovaginal fistula,
and in urethral diverticulum repair.
Disclosures: B. Alnaif, None.
345

Abstract Supplement

Transcription

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