Society of Urologic Nurses and Associates

SERIES
SPECIAL SERIES
ON
PESSARIES
Pessary Care: Follow Up and
Management of Complications
Katharine O’Dell and Shanna Atnip
E
ven after a successful pessary fitting, a woman’s
level of satisfaction and
duration of pessary use
are difficult to predict. In one
qualitative study, successful pessary use was described by participants as a learning process, leading to increasing comfort and
confidence (Storey, Ashton,
Price, Irving, & Hemmens, 2009).
Women initially reported feelings of isolation and embarrassment about pessary use. However, through encouraging interactions with providers, most
commonly the office nursing
staff, positive attitudes toward
wearing a pessary developed
during follow up, and visits
became anticipated social outings for several users (Storey et
al, 2009).
Katharine O’Dell, PhD, CNM, WHNP-BC,
is an Assistant Professor of OB/GYN, the
Division of Pelvic Medicine and Reconstructive Surgery, UMass Memorial
Medical Center, Worcester, MA.
Shanna Atnip, MSN, WHNP-BC, is a Nurse
Practitioner, the Division of Urogynecology
and Reconstructive Pelvic Surgery,
Parkland Health & Hospital System, and the
University of Texas Southwestern Medical
Center, Dallas TX.
Note: Objectives and CNE Evaluation Form
appear on page 137.
Statement of Disclosure: The authors
reported no actual or potential conflict of
interest in relation to this continuing nursing
education activity.
This learning activity was partially funded
by an unrestricted educational grant from
CooperSurgical, Inc.
126
© 2012 Society of Urologic Nurses and Associates
O’Dell, K., & Atnip, S. (2012). Pessary care: Follow up and management of complications. Urologic Nursing, 32(3), 126-137, 145.
Successful use of vaginal support pessaries requires provider and patient understanding of expected symptom-relief, potential complications, self-care options,
and evaluation and treatment of pessary-related problems. This second article in
a three-part series summarizes clinical recommendations and evidence related
to pessary management.
Key Words:
Pelvic organ prolapse, pessary, therapy, complications.
Objectives:
1.
Describe complications that may arise in women who use pessaries.
2.
Explain the course of pessary follow up, including instructions, intervals
between office visits, and pessary surveillance.
3.
Discuss pessary management and prevention of pessary-related complications.
The first article in this series
(Atnip & O’Dell, 2012) discussed
clinical issues related to initiating
support pessary use, including a
summary of evidence related to
patient and pessary selection, and
the likelihood of symptom relief.
This article summarizes evidence
related to pessary use, follow up,
and complications; describes current recommendations for clinical practice where data are not
available; and identifies potential
areas for future research.
Duration of Pessary Use
Because women use pessaries
for different reasons (for example,
to totally avoid or defer surgery),
duration of pessary use can be
expected to vary. Reported use
continuation rates range from
56% to 70% in up to three years
of follow up (Clemons, Aguilar,
Sokol, Jackson, & Myers, 2004;
Komesu et al., 2007). One longterm follow-up study concluded
that women are more likely to
Urologic Nursing Editorial Board Statements of Disclosure
In accordance with ANCC-COA governing rules Urologic Nursing Editorial Board statements of disclosure are published with each CNE offering. The statements of disclosure for
this offering are published below.
Susanne A. Quallich, ANP-BC, NP-C, CUNP, disclosed that she is on the Consultants’
Bureau for Coloplast.
All other Urologic Nursing Editorial Board members reported no actual or potential
conflict of interest in relation to this continuing nursing education activity.
UROLOGIC NURSING / May-June 2012 / Volume 32 Number 3
Pessary Follow Up
While it seems clear that regular pessary follow up is important, both appropriate intervals
for follow-up and interim selfcare recommendations continue
to be largely based on expert
opinion (Cundiff, Weidner, Visco,
UROLOGIC NURSING / May-June 2012 / Volume 32 Number 3
Initial Instructions
New pessary users are generally instructed to note improvement in symptoms and report
new problems, such as pain or
discomfort, genital bleeding,
abnormal vaginal discharge, sexual problems, and problems with
elimination of urine or stool
(Atnip, 2009). Optimal intervals
for self-care have not been determined, and recommendations
vary. For example, one pessary
manufacturer’s packet instruction states that in ideal circumstances, users should be taught to
remove all styles of pessary
nightly for cleaning and reinsertion (CooperSurgical, 2008).
Optional daily removal and
cleaning are encouraged during
the use of some pessaries, and
referred to as mandatory during
use of latex inflatable and Cube
pessaries, the latter without reference to the presence or absence
of drainage holes.
For the newer silicone inflatable pessary, manufacturer recommendations suggest removal
for cleansing every day or two
(Panpac Medical Corporation,
2010). When pessaries are removed, they can be washed with
soap and water, rinsed thoroughly, and re-inserted, or stored for
future use. While providers may
offer women optional teaching
related to self-removal and reinsertion, some may not be either
able or willing to perform selfcare (Sarma et al., 2009).
In addition, women initiating pessary use are likely to have
many questions related to how
pessary use may affect their
lifestyle and activities. Some
answers will require experience.
For example, women who are of
reproductive age may need to
experiment to identify their preference for management of their
127
PESSARIES
The importance of on-going,
regular re-evaluation, even for
women who are comfortable and
asymptomatic during pessary
use, must be emphasized to all
providers and users. Because
there is no centralized reporting
option, true pessary complication incidence is not known.
In the 14-year follow-up of
Australian Ring pessary users,
56% reportedly had some type of
complication, including genital
bleeding, involuntary pessary
expulsion, unusual vaginal discharge, pain, and constipation
(Sarma et al., 2009). Unfortunately, this study design
does not help women compare
risks of pessary use with risks of
untreated prolapse.
While mild and/or transient
symptoms appear to be fairly
common during pessary use, rare
serious adverse effects can also
occur, particularly if pessary
care is neglected. In a review of
individual case studies published between 1950 and 2007,
serious adverse events related to
pessary use included vesicovaginal and rectovaginal fistulas,
impaction or entrapment of the
pessary requiring surgical re-
Bump, & Addison, 2000; Gorti,
Hudelist, & Simons, 2009; PottGrinstein & Newcomer, 2001).
The following sections discuss
common self-care and provider
care options.
ON
Potential Complications During
Pessary Use
moval, bowel perforation and
sepsis, and uremia, urosepsis,
and/or kidney damage due to
infection and/or obstruction
(Arias, Ridgeway, & Barber, 2008).
Although these cases represent severe morbidity and occasional mortality, only 39 of these
major complications were reported during a period of more
than 50 years. Most cases occurred in women with neglected
or forgotten pessaries, though
two cases of vesicovaginal fistula
occurred in older adult women
who were obtaining regular care.
The first was discovered two
hours after initial insertion of a
Ring pessary, suggesting a possible pre-existing, unidentified
vaginal wall abnormality. The
second occurred in a woman
using a Gehrung (arch) pessary
over a 12-year period. During
that time, she reportedly performed daily self-removal, cleaning, and re-insertion, and attended regular follow-up visits. The
latter case reminds providers
and pessary-users that occasional serious complications may
occur even with the most diligent care.
Finally, in a recent case
report, an 82-year-old woman
experienced vaginal evisceration
during initial fitting, causing displacement of the pessary into the
abdomen, with resultant emergency colpocleisis (Rubin, Jones,
& Harmanli, 2010). While the
scarcity of reports suggests an
overall low-risk of serious pessary complications, these publications highlight the need for
careful assessment prior to pessary placement at each routine
visit and whenever new symptoms occur.
SPECIAL SERIES
continue pessary use if they are
over 65 years or have comorbidities that increase surgical risk
(Clemons, Aguilar, Sokol et al.,
2004). In a case series of women
seeing a single provider in
Australia (n = 273), 60% continued pessary use for four weeks,
while 14% were continuing
users over an average follow up
of seven years (range: 2 to 14
years) (Sarma, Ying, & Moore,
2009). During their period of follow up, 44% of initial pessary
users opted to return to no intervention, and 30% proceeded to
surgery. These findings confirm
that some, though not all, women
can expect to experience an
extended period of satisfactory
pessary use.
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Table 1.
Self-Care Options for Women Using Vaginal Support Pessaries
Removal Intervals Between Visits:
•
•
•
•
Regularly (nightly, weekly, monthly) and re-insert post-cleansing
Regularly removed and leave out overnight
Occasionally out (for intercourse, cleaning, temporary discomfort)
Occasionally in (for increased activity or sporting event, as with
incontinence pessary)
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ON
PESSARIES
Pessary Cleaning
• Remove, wash with soap and water, rinse, and re-insert
Genital Cleansing
• With pessary in place, cleanse external genitals only with bath or shower
• With pessary in place, insert acidifying douche, gel, or prescribed medication
• With pessary removed, insert acidifying douche, gel, or prescribed medication
Enhancing Regular Follow Up
• Develop an informed consent for patients to sign; retain a copy and give a
copy to the patient
• Schedule follow-up visits before the patient leaves the office
• Suggest use of a Med-alert bracelet for cognitively impaired women as a
reminder to care providers
menses, either by pessary removal through the entire menses,
or by more frequent removal and
reinsertion after cleaning. As
noted in the first article of this
series (Atnip & O’Dell, 2012),
some pessaries, such as the Ring,
are expected to be more compatible with use during intercourse;
however, couples’ preferences
may vary. Well-fit pessaries are
expected to allow women to perform a full range of physical
activities and exercise comfortably, but experience may identify
extreme activities that are not
pessary-compatible for an individual. Women may also express
concern about pessary use during
medical
testing,
such
as
colonoscopy and diagnostic
imaging. Because preferences
may vary, women may be best
advised to query the provider
performing the endoscopic procedure or imaging regarding the
need for pessary removal.
Women planning Magnetic
Resonance Imaging can usually be
reassured that silicone pessaries
do not include metal; however,
confirmation of this should be
sought through the pessary manu128
facturer. Finally, women often
have questions about the implication of pessary use for security
surveillance. While metal detectors will not respond to siliconeonly pessaries, newer surveillance technologies, including fullbody scanning, are likely to identify a pessary in place. Although the
utility is unclear, some clinicians
provide women with confirmation
of pessary use via brochure, written
prescription, or form letter on practice letterhead to help preclude
potential delay or embarrassment
(Bradway, 2011). Table 1 presents
additional provider-generated selfcare options for women who use
pessaries.
Intervals Between Office
Follow Up
Regardless of the follow-up
plan, if pessary users report
warning symptoms between regular return visits, they will need
to be triaged to emergent or
urgent care related to the severity
of symptoms. Triage options have
not been well studied. Clinical
judgment related to symptom
severity must be used with pain,
bleeding, and acute retention of
urine or stool likely to be reasons
for emergent care.
Recommendations for appropriate routine intervals for follow
up of women reporting comfortable, effective pessary use also
vary, typically based on expert
opinion. For example, one manufacturer’s product insert for a
variety of pessary types instructs
providers to require women to
return within 24 hours of initial
fitting, again in 72 hours, and
every few months, with schedule
variations based on clinical judgment (Cooper Surgical, 2008).
Another manufacturer’s package
insert for the Inflatable Donut
pessary also provides a mix of
very specific recommendations
(for example, the device can only
be prescribed by a physician, and
fitting should be followed within
24 to 48 hours to rule out allergy
to the product) with instructions
that are more vague (for example,
subsequent follow-up visits can
be planned to fit the needs of
the patient) (Panpac Medical
Corporation, 2010). This review
of manufacturer concerns suggests that allergic reactions to
pessaries may have occurred,
and inclusion of the risk may be
needed in informed consent discussions, even though cases have
not appeared in the medical literature.
When providers make follow-up decisions that deviate
from manufacturers’ recommendations, decisions should be
based on available evidence.
However, there is a dearth of
interval comparison trials. In
observational follow up, 104
women were successfully fitted
with Ring pessaries with or without support membrane, and six
with Cube pessaries, with the
presence or absence of drainage
holes not reported (Wu, Farrell,
Baskett, & Flowerdew, 1997).
These women were followed initially at two weeks post-fitting,
then every three months for the
first year, and every six months
thereafter in the absence of erosion. The authors concluded that
UROLOGIC NURSING / May-June 2012 / Volume 32 Number 3
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•
•
•
•
•
•
•
•
•
Lower urinary tract symptoms
Bowel status
Abnormal discharge/bleeding/odor
Pelvic pressure/pain
Vaginal bulge beyond pessary
Sexuality issues
Current self-care regimen
Medication changes
Social changes (caregiver status, employment, exercise or weight management
regimens, new sexual partner)
Targeted Physical Examination
• Regional lymphadenopathy or rashes
• Abdominal tenderness or masses
• External genital examination
Routine Pessary Care
• Pessary removal and cleaning
• Inspection for vaginal or cervical irritation or erosion
• Replacement of stained or damaged pessary
PESSARIES
In the absence of a definitive
evidence base comparing surveillance practices, standards of care
at pessary return visits also rely
on expert opinion. These visits
generally include some combination of focused history, pessary
removal and cleaning, and vaginal inspection, with or without
irrigation or topical treatment
(Atnip, 2009). Components of a
typical interim-focused history
are listed in Table 2.
Removal techniques also
remain unstudied. Suggestions to
Focused History of Interim Changes in Systemic and Pelvic Status
ON
Pessary Surveillance
Table 2.
Components of a Return Pessary Visit
Other Components Based on Findings
• Vaginal microscopy (irritation, increased discharge or odor)
• Vaginal irrigation (suspected vaginitis)
• Urinalysis (dysuria, change in continence status)
aid difficult removals include
tenaculum or Ring forceps, pessary removers, or dental floss
tied to the pessary as a loop prior
to insertion. Tips for removal of
different shapes of pessaries are
summarized in Table 3.
Once the pessary has been
removed, an appropriately sized
vaginal speculum is used to aid
careful inspection of the vaginal
epithelium for mechanical irritation (Kaaki & Mahajan, 2007). A
proctology swab or other displacement device can be used to
increase visualization of cervical
fornices or the vaginal apex (see
Figure 1). Following complete
hysterectomy, the vaginal apex
may be as thin as 2 to 4 mm
(Tulikangas, Walters, Brainard, &
Weber, 2001), increasing the risk
of life-threatening erosion into
the peritoneum. Careful manipulation of any folds of redundant
vaginal tissue, especially of areas
that may be more difficult to
visualize in standard lithotomy
or semi-Fowler’s position (in-
UROLOGIC NURSING / May-June 2012 / Volume 32 Number 3
SPECIAL SERIES
participants had no serious complications, although 15 women
developed vaginal abrasions (all
using Ring pessaries), eight
developed vaginal erosions (five
with Cube pessaries and three
with Rings, p < 0.001), and 10
reported pelvic pain (three Cubeusers and seven Ring-users).
Complication management was
not addressed in the Wu et al.
(1997) publication.
In a subsequent survey of
pessary providers, the most common follow-up interval pattern
was one week, one month, and
every three months thereafter,
with no variation specified related to type of pessary (PottGrinstein & Newcomer, 2001).
Standard practice recommendations are also published as incidental elements of broader discussions. One case discussion
suggests office-visit intervals
varying from three to six months,
with closer intervals for pessaries
that are self-retaining or lack
drainage holes (Kaaki & Mahajan,
2007). Responding to a survey in
the United Kingdom, providers
also reported intervals between
pessary visits ranging from 3 to
12 months with low complication rates, although patient characteristics, self-care practice, and
pessary type were not ascertained (Gorti et al., 2009). These
reports support the practice of
longer intervals between pessary
removal and cleaning as safe,
standard, and cost-effective care.
cluding the anterior vaginal wall,
cervical fornices, or vaginal cuff
post-hysterectomy) is important
for identifying mechanical injury
of the vaginal epithelium. Typical areas of injury that may result
from different styles of pessary
are illustrated in Figure 2.
Vaginal cleansing at pessary
follow-up visits or during routine
self-care is not universally performed, and there is currently no
evidence to support routine irrigation. If excessive discharge is
observed in the absence of identifiable pathogens, the vagina can
be cleansed in a variety of ways.
One cleansing option is wiping of
the vagina with a proctology swab
moistened with water, saline,
vaginal water-based lubricant, or a
mild antiseptic solution prepared
with diluted povidone-iodine or
chlorhexidine gluconate. Similar
solutions may also be used for
vaginal lavage using a 10 to 60 cc
syringe with size choice based on
clinical determination of vaginal
diameter (Atnip, 2009). Lavage
129
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Table 3.
Tips for Providers at Return Visits
Lubricate the vaginal introitus for pessary removal.
Draw pessary down toward introitus for easier removal using a Ring forceps,
tenaculum, the manufacturer’s loop, or an added loop of waxed dental tape.
SPECIAL SERIES
ON
PESSARIES
Consider 2% lidocaine gel application to the introitus 5 minutes prior to removal
for women who report extreme sensitivity.
Consider ongoing treatment with vaginal estrogen if superficial fissures occur
with pessary removal.
If lavage is indicated, collect water with towels/emesis basin; ask patient to
cough to expel residual liquid before pessary reinsertion.
Slight changes in pessary color and odor are common.
Options to aid self-removal:
• Add a dental tape loop.
• Try different positions (standing with foot on chair, lying back in
Semi-Fowler’s, seated on toilet).
• Valsalva or cough during removal.
• Lubricate the vaginal opening again for reinsertion.
• Gently tilt or cork screw pessary diagonally to increase opening diameter
and avoid sensitive urethral area.
• Try careful use of a pessary remover device (generally recommended for
provider use only).
Figure 1.
Proctology Swab Used in Examination of
Mechanical Vaginal Erosion
fluid can be contained using
waterproof pads, toweling, and/or
a collection vessel, such as an
emesis basin.
Clinicians should take care if
vaginal cleansing products are
used. Both chlorhexidine and
povidone-iodine have been studied for pre-operative and obstetric
vaginal use in attempts to decrease wound infection. While
chlorhexidine (4%) has been
identified as more effective than
povidone-iodine (10%) in reducing vaginal wall bacteria within
five minutes (Vorherr, Vorherr,
Mehta, Ulrich, & Messer, 1984),
this may not translate to decreased infection risk (Webster &
Osborne, 2007), is off-label use
(Van Wicklin, 2006), and may
result in significant irritation,
including acute desquamation of
the vaginal epithelium (Shippey &
Malan, 2004). To avoid this risk,
providers may prefer to perform
any pessary-related vaginal cleansing with simple saline or water
and treat identified microbial
infections as discussed below.
Prevention of Pessary-Related
Complications
Although providers often
advise routine use of vaginal
products in conjunction with
pessary use, the relative costs,
preventive role, and comparative
outcomes of these products have
not been well-studied. Current
evidence related to the role of
three strategies is summarized
below, including topical estrogen
treatment of urogenital atrophy,
vaginal moisturizers, and vaginal
acidification.
Vaginal Estrogens
Urogenital atrophy due to
low estrogen levels results in
thinning of the epithelial lining,
loss of elasticity, contraction of
the introitus, and dryness due to
decreased vascularity and transudate (Freedman, 2008). Factors
that contribute to urogenital atrophy include post-menopausal
status, smoking (which increases
130
UROLOGIC NURSING / May-June 2012 / Volume 32 Number 3
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Figure 2.
Mechanical Injury from A) Ring, B) Gellhorn, and C) Cube Pessaries
Estradiol (Estrace )
Dose*
0.1 mg/gram
Use Instructions
Use measured applicator.
Initial: 2 to 4 grams daily for 1 to 2
weeks. Gradually reduce to 1 to 2
grams for 1 to 2 weeks.
Maintenance: 1 gram one to three times
a week; adjust dose as needed to
control symptoms.
Note: Attempt to taper or discontinue at
3 to 6 month intervals.
Conjugated equine
estrogen
(Premarin®)
0.625
mg/gram
Initial: 0.5 gram daily for 21 days; off for
7 days. May increase to 2 grams based
on clinical response.
For dyspareunia: 0.5 grams twice a
week continuously.
Estradiol (Vagifem®)
10 mcg
Insert to upper vagina using applicator.
Initial: Once daily for 2 weeks.
Maintenance: Twice weekly.
Adjust dose as needed to control
symptoms, attempt to taper or
discontinue periodically.
Estradiol (Estring®)
0.0075 mg/
24 hours
Insert into the upper third of the vagina
for 90 days, then remove.
Replace for additional therapy; attempt
to taper or discontinue at 3 to 6 month
intervals.
Source: Micromedex Healthcare Series, 2011.
UROLOGIC NURSING / May-June 2012 / Volume 32 Number 3
131
PESSARIES
®
ON
Generic Estrogen
(Trade Name)*
SPECIAL SERIES
Table 4.
Options Approved by the FDA for Treatment of Moderate to Severe
Vaginal Atrophy Using Vaginally Placed Estrogen
estrogen metabolism), and use of
certain medications and breast
cancer treatments, such as some
selective estrogen receptor modulators (Al-Baghdadi & Ewies,
2009). Atrophic changes can
result in increased discomfort or
tissue injury with pessary insertion and removal, and have been
associated with higher rates of
mechanical vaginal erosion during pessary use (Arias et al.,
2008). It may be possible to modify problems related to pessary
use in the presence of vaginal
atrophy by modifying reversible
risks (such as through smoking
cessation). In the absence of comparative evidence, provider prescription of vaginal estrogen continues to vary and includes use
prior to initial pessary fitting as
needed during ongoing pessary
follow up and/or continuously
throughout pessary use (Arias et
al., 2008; Sarma et al., 2009).
Estrogens used vaginally are
more effective than systemic
estrogens in relieving symptoms
of urogenital atrophy (North
American Menopause Society
[NAMS], 2010). Vaginally applied estrogen relieves vulvovaginal symptoms by promoting
epithelial cell growth and cellular
maturation, fostering re-colonization with normal lactobacilli,
enhancing vaginal blood flow,
decreasing vaginal pH to premenopausal levels, increasing
vaginal wall thickness and elasticity, and improving sexual response (Freedman, 2008).
Several options for low-dose
or ultra-low-dose vaginal estrogen therapy are available and
listed in Table 4. It is important
for women to understand that
estrogens used vaginally do not
offer the same risks and benefits
as systemic hormone therapy.
For example, while topical estrogen use can improve dyspareunia, recurrent urinary tract infection (UTI), and urinary urgency,
low doses do not improve vasomotor symptoms or osteoporosis,
or affect breast cancer risk
(NAMS, 2010).
SPECIAL SERIES
ON
PESSARIES
SERIES
In addition, concomitant use
of progestogens is not required for
endometrial protection in women
with intact uteri, although surveillance to confirm this recommendation during intermittent use or
for use longer than 12 months is
still not available (NAMS, 2010).
Although bioidentical hormones (those that are chemically
identical to ovarian estrogens) are
increasingly marketed, there is no
evidence to support claims of
their enhanced safety or efficacy
(NAMS, 2010).
Generally, the lowest effective estrogen dose needed to
decrease symptoms is recommended (NAMS, 2010). One new
option, an ultra-low-dose vaginal
tablet containing 10 micrograms
of estrogen, has been shown to
result in serum estradiol levels
that are 50% lower than prior
25 microgram vaginal tablets
(Eugster-Hausmann, Waitsinger, &
Lehnick, 2010). However, because
ultra-low-dose products have not
been tested in pessary users, it is
not yet clear if they provide sufficient estrogenic effect to improve
comfort or decrease complications during pessary use, or what
the optimum dose interval and
duration will be.
Vaginal Acidification
The normal vaginal pH in
women who are of reproductive
age is typically 3.5 to 4.5 but rises
to greater than 4.5 within 12
months of becoming hypoestrogenic (Freedman, 2008). This
alkaline environment is thought
to be a risk factor for atypical bacterial over-growth. Some women
report increased discharge or odor
during pessary use, and acidification of the vagina has been suggested as a potential deterrent or
remedy. One pessary manufacturer includes an acidifying gel for
use with all their pessaries
(CooperSurgical, 2006). While
some pessary users report a positive clinical response to vaginal
acidification, there appears to be
little data to support a universal
recommendation. In woman of
132
reproductive age, vaginal acidification has not been shown to
decrease the risk of pathogenic
bacterial overgrowth (Holley,
Richter, Varner, Pair, & Schwebke,
2004). Outcomes related to
vaginal acidification in postmenopausal women are even less
well studied.
When vaginal acidification is
part of the follow-up plan, two
options include douching with
vinegar and water, and using an
acidifying gel. Generally, vaginal
douching remains contra-indicated in pre-menopausal women
because of concerns of altered
vaginal flora and increased risk
of vaginal and upper genital tract
infections (Cottrell, 2010). These
concerns may have little application to post-menopausal pessary
users with atrophy-related absence of normal vaginal flora, or
to women who have undergone
hysterectomy and/or bilateral
salpingo-oophorectomy. In those
cases, clinicians may be best
advised to review potential risks
and benefits, allow women to
make their own choice and help
them evaluate their individual
symptom outcomes during subsequent visits. If douching is chosen because optimal solutions,
intervals, and outcome expectations are understudied, specific
practice is based on expert opinion and preferences of the individual pessary user. One suggested option involves weekly use of
a solution of one-fourth cup of
vinegar mixed in one cup of
warm water (Atnip, 2009).
A non-prescription acidifying
gel recommended to pessary users
contains triethanolamine, hydroxyquinolone sulfate, and sodium
lauryl sulfate in a glycerin base
(Trimosan™) (CooperSurgical,
2006). It is recommended for use
two to three times per week,
reportedly to adjust and maintain
a vaginal pH of 4.0, and lubricate
the vaginal walls, reducing odorcausing bacteria (CooperSurgical,
2008). While no specific supportive references are provided, the
pessary manufacturer describes
the product as non-perfumed,
and compatible with latex and
silicone pessaries. The gel
appears to be a low-risk intervention, which may improve temporary lubrication, comfort, and
pessary satisfaction for symptomatic women who prefer a nonhormonal choice.
Vaginal Moisturizers
Vaginal moisturizers have
also not been widely studied with
pessary use but offer another overthe-counter option to counter-act
symptoms associated with atrophic vaginal changes. Unlike
more temporary vaginal lubricants, they affect epithelial cells
directly. For example, some moisturizers contain the negatively
charged bioadhesive polymer,
polycarbophil (Fiorilli, Molteni,
& Milani, 2005). This polymer
has both acidifying and watercarrying qualities, and adheres to
the superficial cells of the vaginal
epithelial tissue until they are
normally shed in two to three
days. This adherence is thought
to temporarily increase intracellular electrolyte and water volume, and may have a vasodilating
effect, increasing blood flow.
Polycarbophil products have
been shown to lower vaginal pH,
improving signs of bacterial overgrowth seen with bacterial vaginosis (Fiorilli et al., 2005; Wu,
Fielding, & Fiscella, 2007). On the
other hand, non-polymer-based
moisturizers, such as those with
a pectin base, may offer similar
temporary symptom relief (Caswell
& Kane, 2002). In comparison trials with estrogen-products, polycarbophil-based moisturizers provided only transient symptom
improvement, and did not provide the sustained subjective and
objective changes seen with the
use of vaginal estrogen products
(Biglia et al., 2010). With regular
use, vaginal moisturizers may
limit vaginal discharge, odor, and
dyspareunia for pessary users,
but are unlikely to prevent ongoing atrophic change or associated
mechanical irritation and ero-
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sion. Pending conclusive data,
helping women extrapolate research results such as these may
also help them evaluate the costs
and benefits of various self-care
products.
Management of Pessary
Complications
Symptom or Sign
Management Options
Increased pelvic
pressure, pain, or
obstruction of
elimination
(urine or feces)
Pessary removal, with re-fitting, or decision to proceed
to alternate treatment (observation or surgery).
Bleeding, mechanical
irritation, or erosion of
the vaginal epithelium
Evaluate need for endometrial biopsy.
Consider initiation of vaginal estrogen use if
appropriate.
Consider biopsy of erosions or lesions that persist
despite intervention.
SPECIAL SERIES
AND
Remove pessary and re-evaluate in 2 to 4 weeks.
OR
Rule out erosion.
Decrease intervals between pessary removal and
cleansing.
Acidify the vagina (using appropriate vaginal
moisturizers or topical estrogen).
Treat any identified specific vaginal infection.
Consider replacing or sterilizing pessary.
PESSARIES
Vaginal odor or
unusual discharge
Remove pessary and re-fit with alternate shape or size
of pessary to moderate points of pressure.
ON
Complications can occur
even in women who initially
report satisfactory pessary-related symptom relief and comfort.
Problems may present as genital
bleeding, unusual vaginal discharge, pain or pressure, and/or
defecatory complaints, or may
only be identified on routine
vaginal examination (Sarma et
al., 2009; Wu et al., 1997). Some
pelvic symptoms, including constipation, urinary frequency,
dysuria due to UTI, and incomplete or difficult bladder emptying, are also common in postmenopausal women without pessaries, and the relative rate of
symptoms in users and non-users
is not well studied. Although
management of these common
problems is beyond the scope of
this article, when they occur in
pessary users, the pessary’s
potential role as an aggravating
or mitigating factor should be
carefully evaluated. In addition,
all clinicians providing pessary
care must consider their own
knowledge base and scope of
practice, the resources available
in their office setting, and the
general health or frailty of each
pessary user in deciding which
complications to manage and
which to refer to specialty care.
Generally, when clinical assessment of any complication suggests
pessary use as an etiology, management options include refitting for
pessary size and shape, temporary
or permanent removal of the pessary, treatment of any active infection, and/or modifying the vaginal
environment with acidifying products or vaginal estrogen. Table 5
describes general clinical suggestions for common pessary-related
problems. Management of two
Table 5.
Clinical Management Options for Common
Pessary-Related Problems
common pessary-related problems – mechanical injury of the
vaginal epithelium and abnormal
discharge – is presented in greater
depth below.
Mechanical Injury of the
Vaginal Epithelium
Vaginal inspection at regular
visits detects early signs of significant mechanical injury, allowing
for alterations in the clinical plan
to avoid serious sequelae, such as
fistula formation. To determine
which women were at higher risk
of mechanical epithelial injury,
Wu and colleagues (1997) assigned study participants to visually determine categories using
assessment criteria not extrapolated in the text. Women were
described as having epithelium
that was normal thickness (n =
14), moderate thickness (n = 28),
or atrophic (n = 33). Atrophic tissue was more likely to develop
UROLOGIC NURSING / May-June 2012 / Volume 32 Number 3
epithelial abrasion when compared to the other two groups
(range = 0% to 18%; p ≤ 0.05),
and abrasion occurrence was
more common in Cube versus
Ring pessary users (83% versus
3%, p ≤ 0.001). There was no correlation related to oral estrogen
use. These findings support current recommendations for more
frequent return visits for users of
self-retaining pessaries (such as
Cubes) and for the use of vaginal
estrogens for treatment of atrophy.
Description and management
of epithelial pressure injury has
not been as well studied as cutaneous pressure wounds (National
Pressure Ulcer Advisory Panel,
2010). When mechanical erosion
is identified, follow-up planning
is based on clinical factors (such
as the location and depth of the
injury related to fistula risk, friability and use of anticoagulants
133
SPECIAL SERIES
ON
PESSARIES
SERIES
related to bleeding risk, degree of
atrophy and potential benefits of
vaginal estrogen use, evidence of
treatable infection, and risk of coexisting pathology, such as cancers of the vagina, cervix, or
endometrium) (Kaaki & Mahajan,
2007; Kenton, 2003). Temporary
pessary removal to eliminate
mechanical pressure is often recommended (Wu et al., 1997).
Typical practice then includes a
recheck in two to four weeks,
depending upon the extent of the
epithelial injury (Atnip, 2009;
Sarma et al., 2009). During that
time, any exposed vaginal
epithelium is typically protected
from dryness and chaffing on
clothing or pads. Potential treatment products, including vaginal
acidifiers, moisturizers, vaginal
estrogens, and/or oral or vaginal
antimicrobials, are described in
more depth elsewhere in this
article, although their comparative effectiveness has not been
studied. Once repeat vaginal
inspection confirms epithelial
health, a follow-up routine is reinitiated, typically including pessary re-fitting, with or without
modifications in size or shape
and/or ongoing use of treatments,
such as vaginal estrogen.
Although temporary pessary
removal can be expected to
quickly relieve mechanical pressure and facilitate healing, some
women experience serious, acute
symptoms during pessary removal. These can include acute
prolapse recurrence, pain, urinary retention, UTI, and bowel
dysfunction. For these women, a
trial of other options may be beneficial. For example, use of a different shape or size of pessary
may alter the area of mechanical
pressure enough to allow healing. Another unstudied option
might be temporary use of an
inflatable Donut pessary that is
removed nightly. If an alternate
pessary does not seem safe or
practical, other options must be
formulated. For example, acute
urinary retention due to recurrence of anterior compartment
134
prolapse might be mitigated
through use of intermittent support of the anterior vaginal wall
digitally or with a device such as
a proctology swab, which can
straighten the urethra and allow
voiding. If this is unsuccessful,
intermittent self-catheterization
or temporary use of an indwelling urinary catheter may be
necessary.
When erosions do not
resolve within one month, biopsy is indicated because occasional cases of vaginal and cervical
cancer in pessary users have
been reported (Schraub et al.,
1992). In addition, recurring or
poorly healing mechanical injuries may make pessary use impractical, suggesting the need to
re-examine benefits and risks of
alternate treatments, such as surgery.
Abnormal Discharge
Typical complaints related to
vaginal discharge during pessary
use include changes in discharge
amount, color, or odor. Some
temporary increase in vaginal
discharge is commonly reported
by new pessary users, which may
be reassuring for some women to
hear. When bothersome symptoms continue, treatment planning is generally based on extrapolation of data from other contexts and on expert opinion.
Initial assessment of changes
in discharge should include very
careful inspection of the vaginal
epithelium in its entirety, looking
for mechanical injury. Vaginal pH
and microscopy can be assessed,
although little is known about the
implications of typical changes
seen in post-menopausal pessary
users (Alnaif & Drutz, 2000).
Vaginal culture is typically not
helpful unless otherwise unidentified yeast organisms are suspected. If vaginal bleeding is
present, an endometrial biopsy
should be considered even when
vaginal erosion is identified to
rule out co-existing problems,
such as endometrial hyperplasia
or cancer.
Management strategies for
abnormal discharge in pessary
users may include a variety of
options: the woman can opt for
temporary or permanent removal
of the pessary; pessary drainage
holes can be added to limit pooling of vaginal exudate, a potential
medium for growth of odor-producing micro-organisms; atrophy
or vaginal infections can be treated; or acidifying products may be
used (see also “Vaginal Acidification” and “Vaginal Moisturizers” sections above). If an overgrowth of yeast or bacterial
pathogens is suspected, treatment options include the use of
antimicrobials in regimens extrapolated generally from vaginitis
treatment guidelines.
Use of antimicrobials. Comparisons of the typical vaginal
microscopy findings in symptomatic and asymptomatic pessary
users have not been described,
and implications in clinical practice are not known. One study
reported higher rates of gram
stain findings consistent with
bacterial vaginosis (BV) in pessary users than in controls (32%
versus 10%, relative risk of
developing BV 4.37, 95% confidence interval, 2.15 to 9.32)
(Alnaif & Drutz, 2000). Although
it is not clear whether the pessary
users were symptomatic, the
authors hypothesized that pessary removal 10 days pre-operatively might normalize vaginal
flora and decrease risk of vaginal
cuff cellulitis. There is no direct
evidence that treatment of pessary users with findings consistent with BV is beneficial related
to decreasing vaginal discharge
symptoms, prevention of upper
tract infection, or protection of
vaginal epithelium from future
injury.
If overgrowth of abnormal
microbes, such as bacteria or
yeast, is suspected from clinical
signs, symptomatic relief is the
treatment goal. If yeast is identified, any available over-the-counter or oral anti-fungals may be helpful. It is not known whether pes-
UROLOGIC NURSING / May-June 2012 / Volume 32 Number 3
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UROLOGIC NURSING / May-June 2012 / Volume 32 Number 3
Conclusion
As the population ages and
rates of obesity increase, increasing numbers of women will need
care for pelvic floor dysfunctions, including urinary and fecal
incontinence and pelvic organ
prolapse (Nygaard et al., 2008).
Because vaginal support pessaries offer a satisfying, low-risk
option for symptom management
for many women, a pessary trial
should be offered even to women
who present with a pre-existing
desire for surgery (Clemons,
Aguilar, Tillinghast, Jackson, &
Myers, 2004). To optimize safe
pessary use, providers must be
knowledgeable of pessary-related
risks and benefits, vigilant in pessary follow up, and prepared to
appropriately refer women with
pessary-related problems that
exceed their scope of practice. In
a safe and supported environment, women’s satisfaction with
pessary use can also be enhanced
by clarifying goals of treatment,
optimizing individual regimens
for use and follow up, and evaluating outcomes based on those
goals.
While the evidence base to
support successful pessary use
has expanded in recent years,
much remains to be studied. This
includes the comparative safety of
follow-up recommendations and
135
PESSARIES
As this article has illustrated,
many recommendations for pessary follow up and complication
management are based on expert
opinion or extrapolation from
research done in other areas of
women’s health. This emphasizes
the need and opportunity for
ongoing research. For example,
there is a need for further research
related to prolapse treatment in
general. The overall comparative
safety and cost-effectiveness of all
prolapse treatment options,
including observation, pessary,
physical therapy, or surgery at
each life stage, remains unclear.
Pelvic floor muscle training
can also decrease symptoms,
such as stress incontinence (Bø,
2004), and prolapse-related feelings of bulging and vaginal heaviness (Braekken, Majida, Engh, &
Bø, 2010); however, the potential
enhanced effect of pessary use in
combination with regimens of
pelvic muscle strengthening has
not been well studied. Pessaries
may be able to play a larger role
in surgical outcome prediction
for symptoms such as low backache that may not be improved
by prolapse treatment (Heit,
Culligan, Rosenquist, & Shott,
2002), and further inquiry in this
area is suggested.
develop and activity levels
decrease.
Prevention and treatment of
vaginal atrophy relates both to
symptom improvement and
potential pessary complications.
Emerging treatments, including
selective estrogen receptor modulators (Bachmann, Komi, & the
Ospemifene Study Group, 2010),
and the estrogen precursor
dehydroepiandrosterone (DHEA)
(Labrie, 2010) are demonstrating
efficacy in treatment of genital
atrophy. Alternatives such as
these may become important as
non-estrogenic treatment options
to improve outcomes for pessary
users.
ON
Areas for Future Research
For pessaries in particular,
the comparative costs and optimal intervals for self- and clinician-provided care options, especially as they relate to different
pessary types (for example, pessaries that are retained by an
intact introitus versus those that
are self-retaining) are also needed. Further studies of pelvic
function in the presence of pessary-support may be aided
through the use of real-time
ultrasound (Fox, 2009). Innovations in pessary design continue to be described (Jones &
Harmanli, 2010). Advances in
material and biomedical sciences
may offer opportunities for clinical partnerships to develop additional alternatives for pessary
shape and content, devices to aid
pessary self-care, and agents to
protect and rapidly heal damaged epithelium.
The role of pessaries in preventing prolapse progression is
not well understood. Initial
research suggests that pessary
use may improve prolapse, at
least temporarily, in some
women (Handa & Jones, 2002).
However, it is not clear whether
pessaries significantly change
stress or strain on pelvic support
tissue, or whether some degree of
pelvic tissue support can regenerate under supported conditions. In addition, while women
may question whether earlier initiation of pessary use might slow
or prevent symptomatic prolapse
progression, there is little evidence to inform this area of decision-making.
The needs of an aging population require additional research
in several areas related to pessary
use. For example, there may be
increasing opportunity to understand normal aging of the genitalia in very old women (over age
85) and to collect data for very
long-term pessary use (20 years
or more), where advancing atrophy may result either in increasing prolapse as support weakens,
or decreasing pessary need as
vaginal strictures and adhesions
SPECIAL SERIES
sary removal during treatment
would improve outcomes. If bacterial infection is suspected, oral
treatment options recommended
in the United States include
metronidazole, clindamycin, or
tinidazole (Centers for Disease
Control and Prevention [CDC],
2010). Recommended topical
vaginal antimicrobials include
creams containing clindamycin
(CleocinTM) or metronidazole
(MetrogelTM) (CDC, 2010). Outcome studies in pessary users
have not been reported. Associated options, such as pessary
sterilization, replacement, or temporary removal during treatment,
can be considered but have not
been studied.
SPECIAL SERIES
ON
PESSARIES
SERIES
the cost-effectiveness of support
pessaries versus other prolapse
treatment strategies (Adams,
Thomson, Maher, & Hagen, 2004).
Currently, pessary providers are
encouraged to combine their best
clinical knowledge and judgment
with informed patient preference
and expert recommendation to
maximize treatment satisfaction
with these simple, effective pelvic
support devices.
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