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The Leading News Source for Urologists
Robotic RP raises surgical
volume, lowers morbidity
ROBOTIC RP: BEFORE & AFTER
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UrologyTimes.com
Cheryl Guttman Krader
Inside
THIS ISSUE
SEPTEMBER 2012
UT CONTRIBUTING EDITOR
VOL. 40, NO. 10
AtlantaÑHospital adoption of robotic tech-
MEAN
LENGTH
OF STAY
Getty Images /Jason Reed/Photodisc
MEDIAN
RP
VOLUME
Source: Jeffrey K. Mullins, MD
nology leads to an increase in overall volume
of radical prostatectomy cases and has a positive impact on patient morbidity, according
to research undertaken by urologists at Johns
Hopkins University’s James Brady Buchanan
Urological Institute, Baltimore.
First author Jeffrey K. Mullins, MD, a
urologic surgery resident at Johns Hopkins,
reported the findings at the AUA annual
meeting in Atlanta. The data used were
derived from the Maryland Health Services
Cost Review Commission (HSCRC), a state
agency that prospectively collects data for 30
days after index admission for all inpatient
discharges from nonfederal hospitals. The
study included men who underwent radical
prostatectomy between 2000 and 2011 at 28
Prostate
health month
PROSTATE CANCER PROSTATITIS BPH
page
page
8
14
page
17
Practice Management
CODING Q&A
40 Avoid unbundling
instillation, in/out catheter
For more practice management
articles, see page 40
Columns
PERSPECTIVE
4 Robotic vs. open RP:
Who pays the cost?
Please see ROBOTIC RP, on page 39
WHAT’S YOUR EXPERIENCE?
24 Focus on men’s health can
AUA guidelines marked by
rigorous reviews, timely updates
strengthen urology, patient care
WASHINGTON AND YOU
55 Election Day holds many keys to
docs’ future
Departments
AUA Guidelines
J. Stuart Wolf, Jr, MD
Q
A
Please start by telling us what the
AUA clinical practice guidelines are.
Clinical practice guidelines are a group
of recommendations given to the practicing urologist to help improve patient care.
The AUA is taking a number of steps to ensure that its clinical
practice guidelines are scientifically rigorous and timely. In
this interview, J. Stuart Wolf, Jr, MD, chair of the AUA Practice Guidelines Committee, discusses those steps, the value of
clinical guidelines, and the challenge of disseminating and
implementing them. Dr. Wolf is professor of urology, director
of the division of endourology, and associate chair for clinical
operations at the University of Michigan, Ann Arbor. He was
interviewed by Urology Times Editorial Consultant Stephen
Y. Nakada, MD, professor and chairman of urology at the
University of Wisconsin, Madison.
UROLOGY TIMES ONLINE
IN BRIEF
SPEAK OUT
NEW PRODUCTS & SERVICES
MEETING CALENDAR
IN THE PUBLIC EYE
UT by the Numbers
How important is ensuring your
male patientsÕ overall health?
Not at all
5%
Please see GUIDELINES, on page 33
Somewhat
20%
Very
75%
Source: Responses to UT online survey, August 2012
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ES120160_UT0912_001.pgs 08.29.2012 09:15
ADV
For your OAB patients with urge urinary incontinence
Any moment is an accident
waiting to happen.
TOVIAZ provides powerful efficacy.1,2
Median % reduction from baseline in
UUI episodes at Week 12
Mean UUI episodes
per 24 hours at baseline
Mean UUI episodes
per 24 hours at Week 12
*P≤0.001 vs placebo.1
Placebo
TOVIAZ 4 mg
TOVIAZ 8 mg
3.7
3.8
3.7
(n=211)
(n=199)
(n=223)
-50%
-80%*
2.5
1.8*
-88%*
1.4*
Results of a 12-week, fixed-dose, randomized, double-blind, placebo- and active-controlled
international ex-US study to assess the efficacy, tolerability, and safety of TOVIAZ in adults
with overactive bladder. The coprimary efficacy end points were change in micturitions per
day and change in UUI episodes per day. Subjects (N=1132) were treated once daily with
placebo, TOVIAZ 4 mg or 8 mg, or an active-control agent (an oral antimuscarinic). The
median percent change in micturitions at Week 12 was 19% for TOVIAZ 8 mg, 17% for
TOVIAZ 4 mg, and 11% for placebo (P<0.001). The least squares (LS) mean change in
micturitions at Week 12 was -1.9 episodes for TOVIAZ 8 mg, -1.8 episodes for TOVIAZ 4 mg,
and -1.0 episodes for placebo (P<0.001). The median percent reduction in UUI episodes at
Week 12 was 88% for TOVIAZ 8 mg, 80% for TOVIAZ 4 mg, and 50% for placebo (P≤0.001).
The LS mean change in UUI episodes at Week 12 was -2.2 episodes for TOVIAZ 8 mg, -2.0
episodes for TOVIAZ 4 mg, and -1.1 episodes for placebo (P≤0.001).1
TOVIAZ is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Important Safety Information
TOVIAZ is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma, and in patients with
known hypersensitivity to the drug or its ingredients or to DETROL® (tolterodine tartrate) tablets or DETROL® LA (tolterodine tartrate extended
release capsules).
Angioedema of the face, lips, tongue, and/or larynx has been reported with fesoterodine, in some cases after the first dose. Patients should
be advised to promptly discontinue fesoterodine therapy and seek immediate medical attention if they experience edema of the tongue,
laryngopharynx, or difficult breathing.
TOVIAZ tablets should be used with caution in patients with clinically significant bladder outlet obstruction, decreased gastrointestinal motility,
controlled narrow-angle glaucoma, or myasthenia gravis.
The recommended starting dose of TOVIAZ is 4 mg once daily swallowed whole. Based upon individual response and tolerability, the dose may
be increased to 8 mg once daily. Doses greater than 4 mg are not recommended in patients with severe renal insufficiency (CLCR <30 mL/min),
or in patients taking a potent CYP3A4 inhibitor. TOVIAZ is not recommended for use in patients with severe hepatic impairment (Child-Pugh C).
The most frequently reported adverse events (≥4%) for TOVIAZ were:
dry mouth (placebo, 7%; TOVIAZ 4 mg, 19%; TOVIAZ 8 mg, 35%) and
constipation (placebo, 2%; TOVIAZ 4 mg, 4%; TOVIAZ 8 mg, 6%).
OAB=overactive bladder.
References: 1. Chapple C, Van Kerrebroeck P, Tubaro A, et al. Clinical efficacy, safety, and tolerability of
once-daily fesoterodine in subjects with overactive bladder. Eur Urol. 2007;52(4):1204-1212. 2. Data on file.
Protocol SP583 table SCS763 13.2.1.1.1. Pfizer Inc, New York, NY.
For more information, visit www.ToviazHCP.com.
PUSH BACK ON OAB
Please see brief summary of prescribing information on next page.
FSD01158B/FSD432709
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© 2012 Pfizer Inc.
All rights reserved.
February 2012
ES115761_UT0912_CV2_FP.pgs 08.23.2012 02:56
ADV
TOVIAZ® (fesoterodine fumarate) extended release tablets
Rx only
BRIEF SUMMARY OF PRESCRIBING INFORMATION.
The following is a brief summary only; see full Prescribing Information for complete product
information.
INDICATIONS AND USAGE Toviaz is a muscarinic antagonist indicated for the treatment of overactive bladder
with symptoms of urge urinary incontinence, urgency, and frequency.
CONTRAINDICATIONS Toviaz is contraindicated in patients with urinary retention, gastric retention, or
uncontrolled narrow-angle glaucoma. Toviaz is also contraindicated in patients with known hypersensitivity to the
drug or its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules.
WARNINGS AND PRECAUTIONS
Angioedema: Angioedema of the face, lips, tongue, and/or larynx has been reported with fesoterodine. In some
cases angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be lifethreatening. If involvement of the tongue, hypopharynx, or larynx occurs, fesoterodine should be promptly
discontinued and appropriate therapy and/or measures to ensure a patent airway should be promptly provided.
Bladder Outlet Obstruction: Toviaz should be administered with caution to patients with clinically significant
bladder outlet obstruction because of the risk of urinary retention.
Decreased Gastrointestinal Motility: Toviaz, like other antimuscarinic drugs, should be used with caution in
patients with decreased gastrointestinal motility, such as those with severe constipation.
Controlled Narrow-Angle Glaucoma: Toviaz should be used with caution in patients being treated for narrowangle glaucoma, and only where the potential benefits outweigh the risks.
Hepatic Impairment: Toviaz has not been studied in patients with severe hepatic impairment and therefore is not
recommended for use in this patient population.
Renal Impairment: Doses of Toviaz greater than 4 mg are not recommended in patients with severe renal
impairment.
Concomitant Administration with CYP3A4 Inhibitors: Doses of Toviaz greater than 4 mg are not
recommended in patients taking a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin). No
dosing adjustments are recommended in the presence of moderate CYP3A4 inhibitors (eg, erythromycin,
fluconazole, diltiazem, verapamil and grapefruit juice). While the effect of weak CYP3A4 inhibitors (eg, cimetidine)
was not examined by clinical study, some pharmacokinetic interaction is expected, albeit less than that observed
with moderate CYP3A4 inhibitors.
Myasthenia Gravis: Toviaz should be used with caution in patients with myasthenia gravis, a disease
characterized by decreased cholinergic activity at the neuromuscular junction.
ADVERSE REACTIONS
Clinical Trials Experience: The safety of Toviaz was evaluated in Phase 2 and 3 controlled trials in a total of
2859 patients with overactive bladder, of which 2288 were treated with fesoterodine. Of this total, 782 received
Toviaz 4 mg/day, and 785 received Toviaz 8 mg/day in Phase 2 or 3 studies with treatment periods of 8 or 12
weeks. Approximately 80% of these patients had >10 weeks exposure to Toviaz in these trials.
A total of 1964 patients participated in two 12-week, Phase 3 efficacy and safety studies and subsequent openlabel extension studies. In these two studies combined, 554 patients received Toviaz 4 mg/day and 566 patients
received Toviaz 8 mg/day. In Phase 2 and 3 placebo-controlled trials combined, the incidences of serious adverse
events in patients receiving placebo, Toviaz 4 mg, and Toviaz 8 mg were 1.9%, 3.5%, and 2.9%, respectively. All
serious adverse events were judged to be not related or unlikely to be related to study medication by the investigator,
except for four patients receiving Toviaz who reported one serious adverse event each: angina, chest pain,
gastroenteritis, and QT prolongation on ECG.
The most commonly reported adverse event in patients treated with Toviaz was dry mouth. The incidence of dry
mouth was higher in those taking 8 mg/day (35%) and in those taking 4 mg/day (19%), as compared to placebo
(7%). Dry mouth led to discontinuation in 0.4%, 0.4%, and 0.8% of patients receiving placebo, Toviaz 4 mg, and
Toviaz 8 mg, respectively. For those patients who reported dry mouth, most had their first occurrence of the event
within the first month of treatment.
The second most commonly reported adverse event was constipation. The incidence of constipation was 2% in
those taking placebo, 4% in those taking 4 mg/day, and 6% in those taking 8 mg/day.
Table 1 lists adverse events, regardless of causality, that were reported in the combined Phase 3, randomized,
placebo-controlled trials at an incidence greater than placebo and in 1% or more of patients treated with Toviaz 4
or 8 mg once daily for up to 12 weeks.
Table 1. Adverse events with an incidence exceeding the placebo rate and reported by ≥1% of
patients from double-blind, placebo-controlled Phase 3 trials of 12 weeks treatment duration
System organ class
Gastrointestinal
disorders
Infections
Preferred term
Placebo
N=554
%
Toviaz
4 mg/day
N=554
%
Toviaz
8 mg/day
N=566
%
Dry mouth
7.0
18.8
34.6
Constipation
2.0
4.2
6.0
Dyspepsia
0.5
1.6
2.3
Nausea
1.3
0.7
1.9
Abdominal pain upper
0.5
1.1
0.5
Urinary tract infection
3.1
3.2
4.2
Upper respiratory tract infection
2.2
2.5
1.8
Eye disorders
Dry eyes
0
1.4
3.7
Renal and urinary
disorders
Dysuria
0.7
1.3
1.6
Urinary retention
0.2
1.1
1.4
Respiratory
disorders
Cough
0.5
1.6
0.9
Dry throat
0.4
0.9
2.3
General disorders
Edema peripheral
0.7
0.7
1.2
Musculoskeletal
disorders
Back pain
0.4
2.0
0.9
Psychiatric disorders
Insomnia
0.5
1.3
0.4
Investigations
ALT increased
0.9
0.5
1.2
GGT increased
0.4
0.4
1.2
Rash
0.5
0.7
1.1
Skin disorders
ALT = alanine aminotransferase; GGT = gamma glutamyltransferase
Patients also received Toviaz for up to three years in open-label extension phases of one Phase 2 and two Phase
3 controlled trials. In all open-label trials combined, 857, 701, 529, and 105 patients received Toviaz for at least 6
months, 1 year, 2 years, and 3 years, respectively. The adverse events observed during long-term, open-label
studies were similar to those observed in the 12-week, placebo-controlled studies, and included dry mouth,
constipation, dry eyes, dyspepsia, and abdominal pain. Similar to the controlled studies, most adverse events of
dry mouth and constipation were mild to moderate in intensity. Serious adverse events, judged to be at least
black
possibly related to study medication by the investigator and reported more than once during the open-label
treatment period of up to 3 years, included urinary retention (3 cases), diverticulitis (3 cases), constipation (2
cases), irritable bowel syndrome (2 cases), and electrocardiogram QT corrected interval prolongation (2 cases).
Post-marketing Experience: The following events have been reported in association with fesoterodine use in
worldwide post-marketing experience: Eye disorders: Blurred vision; Cardiac disorders: Palpitations; General
disorders and administrative site conditions: hypersensitivity reactions, including angioedema with airway
obstruction, face edema; Skin and subcutaneous tissue disorders: Urticaria, pruritus. Because these spontaneously
reported events are from the worldwide post-marketing experience, the frequency of events and the role of
fesoterodine in their causation cannot be reliably determined.
DRUG INTERACTIONS
Antimuscarinic Drugs: Coadministration of Toviaz with other antimuscarinic agents that produce dry mouth,
constipation, urinary retention, and other anticholinergic pharmacological effects may increase the frequency and/
or severity of such effects. Anticholinergic agents may potentially alter the absorption of some concomitantly
administered drugs due to anticholinergic effects on gastrointestinal motility.
CYP3A4 Inhibitors: Doses of Toviaz greater than 4 mg are not recommended in patients taking potent CYP3A4
inhibitors, such as ketoconazole, itraconazole, and clarithromycin. Coadministration of the potent CYP3A4 inhibitor
ketoconazole with fesoterodine led to approximately a doubling of the maximum concentration (Cmax ) and area
under the concentration versus time curve (AUC) of 5-hydroxymethyl tolterodine (5-HMT), the active metabolite of
fesoterodine. Compared with CYP2D6 extensive metabolizers not taking ketoconazole, further increases in the
exposure to 5-HMT were observed in subjects who were CYP2D6 poor metabolizers taking ketoconazole.
There is no clinically relevant effect of moderate CYP3A4 inhibitors on the pharmacokinetics of fesoterodine.
Following blockade of CYP3A4 by coadministration of the moderate CYP3A4 inhibitor fluconazole 200 mg twice
a day for 2 days, the average (90% confidence interval) increase in Cmax and AUC of the active metabolite of
fesoterodine was approximately 19% (11%-28%) and 27% (18%-36%) respectively. No dosing adjustments are
recommended in the presence of moderate CYP3A4 inhibitors (eg, erythromycin, fluconazole, diltiazem, verapamil
and grapefruit juice). The effect of weak CYP3A4 inhibitors (eg, cimetidine) was not examined; it is not expected
to be in excess of the effect of moderate inhibitors.
CYP3A4 Inducers: No dosing adjustments are recommended in the presence of CYP3A4 inducers, such as
rifampin and carbamazepine. Following induction of CYP3A4 by coadministration of rifampin 600 mg once a day,
Cmax and AUC of the active metabolite of fesoterodine decreased by approximately 70% and 75%, respectively,
after oral administration of Toviaz 8 mg. The terminal half-life of the active metabolite was not changed.
CYP2D6 Inhibitors: The interaction with CYP2D6 inhibitors was not tested clinically. In poor metabolizers for
CYP2D6, representing a maximum CYP2D6 inhibition, Cmax and AUC of the active metabolite are increased 1.7and 2-fold, respectively. No dosing adjustments are recommended in the presence of CYP2D6 inhibitors.
Drugs Metabolized by Cytochrome P450: In vitro data indicate that at therapeutic concentrations, the active
metabolite of fesoterodine does not have the potential to inhibit or induce Cytochrome P450 enzyme systems.
Oral Contraceptives: In the presence of fesoterodine, there are no clinically significant changes in the plasma
concentrations of combined oral contraceptives containing ethinyl estradiol and levonorgestrel.
Warfarin: A clinical study has shown that fesoterodine 8 mg once daily has no significant effect on the
pharmacokinetics or the anticoagulant activity (PT/INR) of warfarin 25 mg. Standard therapeutic monitoring for
warfarin should be continued.
Drug-Laboratory Test Interactions: Interactions between Toviaz and laboratory tests have not been studied.
USE IN SPECIFIC POPULATIONS
Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies using Toviaz in pregnant
women.
No dose-related teratogenicity was observed in reproduction studies performed in mice and rabbits. In mice at 6
to 27 times the expected exposure at the maximum recommended human dose (MRHD) of 8 mg based on AUC
(75 mg/kg/day, oral), increased resorptions and decreased live fetuses were observed. One fetus with cleft palate
was observed at each dose (15, 45, and 75 mg/kg/day), at an incidence within the background historical range.
In rabbits treated at 3 to 11 times the MRHD (27 mg/kg/day, oral), incompletely ossified sternebrae (retardation of
bone development) were observed in fetuses. In rabbits at 9 to 11 times the MRHD (4.5 mg/kg/day, subcutaneous),
maternal toxicity and incompletely ossified sternebrae were observed in fetuses (at an incidence within the
background historical range). In rabbits at 3 times the MRHD (1.5 mg/kg/day, subcutaneous), decreased maternal
food consumption in the absence of any fetal effects was observed. Oral administration of 30 mg/kg/day
fesoterodine to mice in a pre- and post-natal development study resulted in decreased body weight of the dams
and delayed ear opening of the pups. No effects were noted on mating and reproduction of the F1 dams or on the
F2 offspring.
Toviaz should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.
Nursing Mothers: It is not known whether fesoterodine is excreted in human milk. Toviaz should not be
administered during nursing unless the potential benefit outweighs the potential risk to the neonate.
Pediatric Use: The pharmacokinetics of fesoterodine have not been evaluated in pediatric patients.The safety and
effectiveness of Toviaz in pediatric patients have not been established.
Geriatric Use: No dose adjustment is recommended for the elderly. The pharmacokinetics of fesoterodine are not
significantly influenced by age.
Of 1567 patients who received Toviaz 4 mg/day or 8 mg/day in the Phase 2 and 3, placebo-controlled, efficacy
and safety studies, 515 (33%) were 65 years of age or older, and 140 (9%) were 75 years of age or older. No
overall differences in safety or effectiveness were observed between patients younger than 65 years of age and
those 65 years of age or older in these studies; however, the incidence of antimuscarinic adverse events, including
dry mouth, constipation, dyspepsia, increase in residual urine, dizziness (at 8 mg only) and urinary tract infection,
was higher in patients 75 years of age and older as compared to younger patients.
Renal Impairment: In patients with severe renal impairment (CLCR <30 mL/min), Cmax and AUC are increased
2.0- and 2.3-fold, respectively. Doses of Toviaz greater than 4 mg are not recommended in patients with severe
renal impairment. In patients with mild or moderate renal impairment (CLCR ranging from 30-80 mL/min), Cmax and
AUC of the active metabolite are increased up to 1.5- and 1.8-fold respectively, as compared to healthy subjects.
No dose adjustment is recommended in patients with mild or moderate renal impairment.
Hepatic Impairment: Patients with severe hepatic impairment (Child-Pugh C) have not been studied; therefore
Toviaz is not recommended for use in these patients. In patients with moderate (Child-Pugh B) hepatic impairment,
Cmax and AUC of the active metabolite are increased 1.4- and 2.1-fold, respectively, as compared to healthy
subjects. No dose adjustment is recommended in patients with mild or moderate hepatic impairment.
Gender: No dose adjustment is recommended based on gender. The pharmacokinetics of fesoterodine are not
significantly influenced by gender.
Race: Available data indicate that there are no differences in the pharmacokinetics of fesoterodine between
Caucasian and Black healthy subjects following administration of Toviaz.
OVERDOSAGE
Overdosage with Toviaz can result in severe anticholinergic effects. Treatment should be symptomatic and
supportive. In the event of overdosage, ECG monitoring is recommended.
Manufactured by:
Aesica Pharmaceuticals GmbH, Galileistraße 6, 08056 Zwickau, Germany
Distributed by: Pfizer Labs, Division of Pfizer Inc, NY, NY 10017
LAB-0381-10.0
Revised November 2011
FSD01151B/FSD423507-01
© 2011 Pfizer Inc.
All rights reserved.
December 2011
ES115750_UT0912_003_FP.pgs 08.23.2012 02:55
ADV
4
❳Perspective❲
SEPTEMBER 2012 VOL. 40, NO. 10
The Leading News Source for Urologists
UrologyTimes.com
❳Mission❲
Robotic vs. open RP:
Who pays the cost?
A
n article in this issue of Urology Times discusses the cost of robotassisted versus retropubic radical prostatectomy in the state of
Maryland, with study results showing the robotic procedure costs
40% more than the open approach (page 8). Although high surgical volume
was associated with lower cost, the cost of robotic prostatectomy remained
higher than that of open prostatectomy.
There is no doubt that robot-assisted
radical prostatectomy is more expensive
than an open prostatectomy performed
through a lower midline incision or a
perineal approach. A recent report in
the New England Journal of Medicine
(2010; 363:701-4) stated that a robotic
prostatectomy adds about $2,200 per
operation for additional supply costs and
operating room time. In addition, capiDr. Albertsen, a member
tal costs and maintenance add $400 to
of the Urology Times Edito$4,800, depending upon the utilization
rial Council, is professor
of a specific machine.
of surgery and chief of
What does the patient or society gain
urology at the University of
from the additional resources expended?
Connecticut Health Center,
Extensive marketing by surgeons and
Farmington.
hospitals suggests major advantages, but
proponents of robot-assisted radical prostatectomy have been unable to document them. At a 2-day conference, the
world’s leaders in robotic surgery performed an exhaustive review of the
world’s literature (Eur Urol 2012;
62:368-81). They concluded that
robotic prostatectomy achieves
I suspect that experienced,
cancer control equivalent to that
of
the more traditional open
high-volume surgeons
prostatectomy and may offer
performing either robotic or advantages in the postoperative
recovery of urinary continence
open procedures will have
and erectile function. I suspect
remarkably similar outcomes. that experienced, high-volume
surgeons performing either
robotic or open procedures will have remarkably similar outcomes.
Who should pay for these extra expenses? While hospitals do not
receive extra reimbursement for robotic procedures, the costs are being
passed back to the health care system. Ezekial Emanuel, MD, PhD, an
oncologist and former White House adviser, commented in a New York
Times editorial that the robot was a “fake innovation” that the “Affordable
Care Act will not reward” (May 27, 2012:A15). Governments are under
increasing pressure to lower health care costs. I am not sure where the
cuts will come, but simply performing more robotic procedures by highvolume surgeons in high-volume hospitals will not lower the additional
marginal costs sufficiently to make robotic prostatectomy cost effective.
Peter C. Albertsen, MD
Feedback
Peter C. Albertsen, MD
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Send your comments to
Dr. Albertsen c/o Urology Times,
at [email protected]
Urology Times takes the lead in providing news analysis of key advances in surgical and nonsurgical techniques, treatments and practice management. As the #1 read publication reaching
the full universe of specialists treating urologic disorders, Urology Times keeps urologists up to
date so they can quickly provide better patient care while running a more efficient practice.
❳Editorial Consultants❲
Leading urologic surgeons, with broad experience,
who help ensure the quality of our editorial
J. Brantley Thrasher, MD Professor and Chair of Urology | University of Kansas Medical Center, Kansas City
Philip M. Hanno, MD, MPH Professor of Urology | University of Pennsylvania, Philadelphia
Stephen Y. Nakada, MD Professor and Chairman | Department of Urology | University of Wisconsin, Madison
❳Editorial Council❲
Experts in 12 key subspecialties of urology who direct
in-depth coverage of their field
BPH Steven A. Kaplan, MD Professor of Urology | Weill Cornell Medical College, New York
CLINICAL EPIDEMIOLOGY Peter C. Albertsen, MD Chief of Urology | University of Connecticut Health Center, Farmington
ERECTILE DYSFUNCTION John Mulcahy, MD, PhD | Private Practice, Madison, AL
FEMALE UROLOGY Shlomo Raz, MD Professor of Surgery/Urology | University of California School of Medicine, Los Angeles
INFECTIONS Anthony Schaeffer, MD Professor and Chairman of Urology | Northwestern University Medical School, Chicago
MALE REPRODUCTIVE MEDICINE Craig S. Niederberger, MD Professor and Head of Urology | University of Illinois, Chicago
PEDIATRICS Howard Snyder, III, MD Professor of Surgery in Urology | University of Pennsylvania School of Medicine, Philadelphia
SOCIOECONOMICS William F. Gee, MD Private Practice, Lexington, KY
STONES/ENDOUROLOGY Dean G. Assimos, MD Professor and Chair of Urology | University of Alabama, Birmingham
TRAUMA/RECONSTRUCTION Allen F. Morey, MD Professor of Urology | UT Southwestern Medical Center, Dallas
UROLOGIC CANCER Leonard G. Gomella, MD Professor and Chairman of Urology | Thomas Jefferson University, Philadelphia
UROLOGIC LAPAROSCOPY J. Stuart Wolf, Jr, MD Professor of Urology | University of Michigan, Ann Arbor
❳Private Practice Board❲
Urologists who inform the editors of issues facing
physicians “in the trenches”
Tracy W. Cannon-Smith, MD Grapevine, TX
Gerald J. Frankel, MD Houston
Sheila K. Gemar, MD Willmar, MN
Daniel M. Kaplon, MD Sarasota, FL
❳Editorial❲
Sivaprasad D. Madduri, MD Poplar Bluff, MO
Barry R. Rossman, MD Princeton, NJ
Neal D. Shore, MD Myrtle Beach, SC
Steven M. Wahle, MD Cedar Rapids, IA
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ES108330_UT0912_004.pgs 08.16.2012 08:35
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ES120128_UT0912_005_FP.pgs 08.29.2012 07:40
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Bicycle setup may
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cyclists, according to
a study in the Journal
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(2012; 9:1367-73).
Bike handlebars
positioned lower
than the saddle were
associated with decreased genital sensation. The authors
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In the Southeast,
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controversial offer
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Low handlebars may impair
Sterilization for addicts
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PSA controversy prompts
urologist to wax poetic
Urologist Sivaprasad Madduri, MD, decided the best way to
express his anger about new recommendations on prostate
cancer screening was through poetry. Read his creative take
on the PSA controversy, “I’m PSA and I am Furious,” at:
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ES116503_UT0912_006.pgs 08.23.2012 12:01
ADV
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8
Prostate
September 2012
health month
∣
Urology Times
Prostate CanCer Prostatitis BPH
page
page
8
14
page
17
robotic rP remains more costly than open technique
Disparity persists even at high-volume surgical centers, researchers report
Ut CONtrIbUtING eDItOr
Atlanta—A robot-assisted laparoscopic radical
prostatectomy costs 40% more than a retropubic radical prostatectomy, according to a review
of hospital data from one state.
UTSTAT
High surgeon volume was
associated with a lower cost of
robotic and retropubic RP (p<.001),
whereas high hospital volume was
associated with a lower cost for robotic
rP only (p<.001).
“High surgical volume was associated with
lower cost of radical prostatectomy,” said first
author Elias S. Hyams, MD, a former endourology fellow at Johns Hopkins University in
Baltimore, working with Brian R. Matlaga,
MD, MPH, and colleagues. “However, even
at high surgical volume centers, the cost of
robotic prostatectomy exceeded that of open
prostatectomy.
“As robotic surgery has come to dominate the health care marketplace, strategies
to increase the role of high-volume providers
may be needed to improve the cost-effectiveness of prostate cancer surgical therapy,”
added Dr. Hyams, who is now at DartmouthHitchcock Medical Center, Lebanon, NH.
He presented the study results at the AUA
annual meeting in Atlanta.
The state of Maryland requires acutecare hospitals to report encounter-level and
hospital discharge data to the state’s Health
Service Cost Review Commission. The data
were collected prospectively, and 97% of
hospitals in the state report data to the commission, Dr. Hyams said. Availability of that
data for analysis provided an opportunity to
examine the impact of robotic technology
and surgical volume on the cost of radical
prostatectomy.
Total costs comprised several components,
including operating room costs, room and
board, radiology, pharmaceuticals, laboratory, supplies, and miscellaneous therapies.
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For their analysis, the
authors defined high-volume
“As robotic surgery has come to dominate the
hospitals as facilities that had
an annual prostatectomy volhealth care marketplace, strategies to increase
ume >60 cases. High-volume
surgeons were those who perthe role of high-volume providers may be needed
formed >40 prostatectomies
to improve the cost-effectiveness of prostate
annually.
The analysis included 1,499
cancer surgical therapy.”
men who underwent robotic
and 2,565 men who had retroElias s. Hyams, mD
pubic prostatectomy between
2008 and 2011. The two groups did not differ Retropubic RPs also were performed more
significantly with respect to age, race, patient often at high-volume hospitals (83.3% vs.
complexity level, or proportion of Medicare/ 74.8%, p<.001).
Medicaid patients.
The robotic procedure was associated with Costs driven by OR, supply charges
a significantly shorter length of stay (1.7 vs. During the study period, the cost of a robotic
1.9 days, p<.001), but the proportion of patients prostatectomy averaged $14,000 compared with
requiring a stay in the intensive care unit did $10,100 for retropubic (p<.001). The difference
not differ (1.3% amd 1.6% with robotic and ret- was driven primarily by higher operating room
ropubic RP, respectively).
and supply charges. A significant difference
In the robotic surgery group, 50.6% of persisted even among high-volume hospitals
procedures were performed by high-volume (p<.001), said Dr. Hyams.
surgeons. In contrast, high-volume surgeons
Both high-volume surgeons and high-volperformed 70.2% of retropubic RPs (p<.001). ume hospitals were associated with a lower
overall cost for retropubic surgery (p<.001).
High surgeon volume was associated with
a lower cost of robotic and retropubic RP
Average cost of robotic
(p<.001), whereas high hospital volume
UT Figure vs. open prostatectomy
was associated with a lower cost for robotic RP only (p<.001).
During the discussion that followed his
15,000
p<.001
presentation, Dr. Hyams acknowledged
14,000
that lack of information about the reported
charges and true costs of the procedures
was an inherent limitation of the database.
“It’s a proxy for true costs, but it captures
a very large percentage of the data within
10,100
the state, so we’re trading some granular
detail for statistical power,” he said.
The estimates did not take into consideration the capital costs associated with
requiring robotic surgery systems, which
would have resulted in even larger differences between the two types of procedures,
Dr. Hyams told Urology Times.
“Those capital costs are sizable, on the
order of a couple of million dollars, but it
0
robotic group open group
is difficult to estimate the per-procedure
premium that robotic technology adds to
Source: elias S. Hyams, mD
the total cost of a radical prostatectomy,”
he said. UT
❳
❲
average cost ($)
Charles Bankhead
ES119921_UT0912_008.pgs 08.28.2012 14:23
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UrologyTimes.com
∣
September 2012
Prostate
9
Prostate CanCer health month
Study: Oncologic outcomes similar for robotic, open RP
Approaches appear to make no difference in hands of experienced surgeons
Wayne Kuznar
Ut COrreSpONDeNt
Atlanta— In the hands of high-volume sur-
geons, there is no evidence to suggest that
robot-assisted laparoscopic prostatectomy
results in worse oncologic outcomes then open
radical prostatectomy, even in patients with
high-risk cancer, according to a retrospective
study of patients operated on at a large tertiary
care center.
The equivalent outcomes could be attributed to “adherence to the oncologic principles
of the operation, which included a thorough
pelvic lymph node dissection and a focus on
surgical techniques to reduce positive margins,” said lead author Jonathan Silberstein,
MD, a urologic oncology fellow at Memorial
Sloan-Kettering Cancer Center, New York. He
presented the data at the AUA annual meeting
in Atlanta.
Using a case-mixed adjusted comparison,
early oncologic outcomes were compared
between a group of 961 patients who underwent
“Differences between surgeons were
larger than differences between
surgical approaches.”
JonatHan silbErstEin, mD
open prostatectomy and 493 who underwent
robotic RP performed by four high-volume surgeons at Memorial Sloan-Kettering between
2007 and 2010. Patients were excluded if they
underwent surgery using the surgeon’s nondominant technique, if they underwent salvage
surgery, or if they received adjuvant therapy.
“Overall, this was a higher risk population as demonstrated by the NCCN [National
Comprehensive Cancer Network] risk; 66%
undergoing open RP and 70% undergoing
robot-assisted RP had medium- or high-risk
features,” said Dr. Silberstein, who worked on
the study with Vincent P. Laudone, MD, and
colleagues.
Confirming the high-risk features, about
half of the patients in each group had clinical
Gleason 7 disease and more than one-third in
each group had extracapsular extension. Ten
percent in the open group and 8% in the robotic
group had positive lymph node invasion. Margins were found to be positive in 15% of each
treatment group.
The pelvic lymph node dissection was
performed using a template that included,
at a minimum, the external, obturator, and
internal nodal packets. Pelvic lymph node dissection was performed in 94% of patients, as
it was omitted in some patients with NCCN
low-risk disease. Complete or partial nerve
sparing was performed in all but 2% of the
patients.
Biochemical recurrence was defined as a
UTSTAT
The hazard ratio for biochemical
recurrence for robotic versus open
RP (adjusting for pre-op risk) was
0.88, which was not significant.
PSA level ≥1.0 ng/mL or any measurable PSA
followed by further therapy for cancer.
Postoperatively, 10% had Gleason ≥8 disease (11% who underwent open RP vs. 8% who
underwent the robotic procedure) and 15% had
positive surgical margins.
Difference in recurrence not significant
Using a multivariable Cox regression model,
the hazard ratio for biochemical recurrence for
robotic compared with open RP (adjusting for
preoperative risk) was 0.88, which was not significant (p=.6). Using NCCN risk as the covariate in a Cox model yielded virtually identical
results (hazard ratio: 0.74; p=.2).
The overall adjusted 2-year probability of
recurrence was 4.1% for open and 3.3% for
robotic RP. Two-year probability of recurrence
analyzed by surgeon, adjusted for risk, ranged
from a low of 2.5% to a high of 4.8%.
“Differences between surgeons were larger
than differences between surgical approaches,”
said Dr. Silberstein. UT
InBrief❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯❯
For up-to-date news, visit urologytimes.com/InBrief
PSA, 5-ARIs help identify
hard-to-diagnose prostate Ca
❯❯
Researchers from New York-Presbyterian/Weill Cornell Medical Center
in New York have successfully developed and
tested a new prostate cancer screening method
that uses the combined power of a novel drug
therapy and changes in PSA levels over time
to identify men with a high PSA who are
more likely to have aggressive prostate cancer
despite negative biopsies.
Their study, which was published in the
Journal of Urology (2012; 188:757-61), was
conducted in two phases and enrolled 276
men who had a PSA greater than 4.0 ng/mL,
a normal digital rectal examination, and two
or more negative biopsies.
In the first phase, 97 patients, who were giv-
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en the 5-alpha reductase inhibitor finasteride
(Proscar), 5 mg daily, or dutasteride (Avodart),
0.5 mg daily, had their PSA measured at 6 and
12 months, a transrectal ultrasonography, and
a biopsy performed at 1 year. Study results
show that 1 year of the drug therapy reduced
PSA in all the men—an average of 48%—but
the magnitude of reduction was significantly
greater in men with benign disease and significantly less in 28% of the patients whose
prostate biopsy detected cancer.
In the study’s second phase, 179 patients
received the same drug therapy but underwent
a biopsy only if their PSA showed a change
of 0.4 ng/ml. The authors, led by Steven A.
Kaplan, MD, successfully identified cancer
cases in men who participated in the second
phase with the combined drug therapy and
evaluation of PSA trends by sending those
with minimal changes for biopsy. This meant
that men who didn’t need a biopsy did not
have one, unlike all the men in the first phase.
BCG formulation for bladder
cancer in short supply
❯❯
Due to manufacturing issues, a formulation of the bladder cancer treatment
bacillus Calmette-Guérin (TheraCys) is currently unavailable from one manufacturer.
TheraCys is forecast to remain unavailable
until late 2013, according to manufacturer
Sanofi Pasteur, Ltd.
The FDA said it has been working with
Organon Teknika, Corp. LLC, to increase
the production of TICE BCG, the other U.S.
licensed source of BCG, to assist with meeting critical patient needs during this shortage.
ES119922_UT0912_009.pgs 08.28.2012 14:23
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10
Prostate
health month
September 2012
∣
Urology Times
Prostate CanCer
Agent also may have pre-chemo role
Antiandrogen for PCa shows improvement in survival, QoL
Charles Bankhead
nistic effect on the androgen receptor in preclinical models. Development of the drug has evolved
Chicago—Men with previously treated cas- amid growing recognition that a
tration-resistant prostate cancer (CRPC) lived substantial proportion of men with
almost 5 months longer when they received the advanced prostate cancer benefit
androgen receptor signaling inhibitor enzaluta- from second-line hormonal therapy.
mide, data from an international study showed.
Enzalutamide was recently
The secondary endpoints of time to first granted priority review status by the
skeletal-related event and health-related qual- FDA, with a user fee action date of
ity of life were also significantly improved in Nov. 22, 2012 for the review of the
enzalutmide-treated patients versus placebo.
agent’s new drug application.
Median overall survival was 18.4 months
Phase I-II investigation of enzalutamide demamong men who received enzalutamide (for- onstrated activity in patients with and without
merly MDV3100) versus 13.6 months with pla- prior exposure to chemotherapy. A majority
cebo. Median progression-free survival was 8.3 of patients had PSA responses irrespective of
chemotherapy history (Lancet
2010; 375:1437-46). The promisresults from early studies led
“[Enzalutamide]... prolongs survival ing
to a phase III, randomized, plaand improves quality of life across the cebo-controlled trial conducted
at 156 centers in 15 countries
board, making better all secondary
on five continents. The study
measures of health-related outcomes involved 1,199 patients with
progressive CRPC after treatand antitumor activity.”
ment with docetaxel (Taxotere).
The patients were randomJOHANN S. DE BONO, MD, PHD
ized 2:1 to either oral enzalutamide, 160 mg/day, or matched
months with enzalutamide and 3.0 months with placebo. Treatment continued until radiographplacebo.
ic evidence of progression by bone scan.
“I think these are some of the best survival
“This is an important change for us with both
data we have seen in the post-chemotherapy set- the abiraterone and MDV3100 trials,” said Dr.
ting,” said first author Johann S. de Bono, MD,
PhD, consultant physician at the Royal MarsTime to first SRE:
den Hospital in Sutton, the United Kingdom.
“[Enzalutamide] is well tolerated and proUT Figure Enzalutamide vs.
longs survival and improves quality of life
placebo
across the board, making better all second20
ary measures of health-related outcomes and
p<.0001
antitumor activity.”
Data were presented at the American Soci16.7
ety of Clinical Oncology annual meeting in
Chicago and recently published online in the
New England Journal of Medicine (Aug. 15,
13.3
2012).
The benefits of enzalutamide treatment
extended to the time to first skeletal-related
event (16.7 vs. 13.3 months, p<.0001). Quality of life response, as defined by at least a
10-point increase in the Functional Assessment of Cancer Therapy-Prostate Version
instrument, occurred in 43.2% of the enzalutamide patients and 18.3% of the placebo
0
group (p<.0001).
enzalutamide group
Placebo group
Enzalutamide targets androgen receptor
Source: Johann S. de bono, mD, phD
signaling and affects multiple steps in the signaling pathway. The agent has shown no ago-
Ut CONtrIbUtING eDItOr
time to first sre (months)
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“There might also be interest in
using this drug as monotherapy in
patients with biochemical relapse
after localized therapy.”
NEAL SHORE, MD
de Bono. “The overall aim was to continue therapy despite minor PSA changes. This is very
important for clinical practice not to change
therapy purely based on PSA changes.”
The patients had a median age of 69 years,
more than one-fourth had visceral involvement,
half had received three or more hormonal regimens, and one-fourth had received two prior
chemotherapy regimens.
A planned interim analysis occurred after
520 deaths, at which time the independent data
monitoring committee recommended stopping
the trial, unblinding treatment assignment,
and offering enzalutamide to placebo-treated
patients. The 4.8-month difference in overall
survival translated into a 37% decrease in the
hazard ratio versus placebo (p<.0001). The survival benefit was consistent across all prespecified subgroups, said Dr. de Bono.
The difference in progression-free survival
represented a 76% reduction in the progression hazard (p<.0001). Moreover, 54% of the
enzalutamide arm had >50% reduction in PSA
level compared with 2% of the placebo group
(p<.0001), and 25% of enzalutamide-treated
patients had >90% reduction in baseline PSA
value (p<.0001).
Enzalutamide was generally well tolerated,
said Dr. de Bono, as rates of adverse events,
serious adverse events, discontinuation
because of adverse events, and fatal adverse
events did not differ significantly between
treatment groups.
Five patients (0.6%) in the enzalutamide arm
had seizures compared with none in the placebo
arm, although potential confounding factors
were identified in some of the cases. However,
Dr. de Bono said the fact that no placebo recipient had a seizure should not be overlooked.
Urologist Neal Shore, director of the
Carolina Urologic Research Center in Myrtle Beach, SC, and a co-author of the New
England Journal study, said enzalutamide
“will help fill a therapeutic need for patients
with advanced prostate cancer who have progressed after treatment with docetaxel. There
please see ANTIANDROGEN, page 13
ES119510_UT0912_010.pgs 08.28.2012 10:07
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UrologyTimes.com
∣
Prostate
September 2012
Prostate CanCer health month
13
Urine markers help predict prostate tumor volume
Values may enhance selection, monitoring of active surveillance candidates
Wayne Kuznar
completed data for interim analysis. Eightythree percent were treated after a first biopsy; 86% had at least 10 biopsy cores. Biopsy
Atlanta—An interim analysis of a validation Gleason 6 cancer was detected in 41% and
study suggests that urine prostate cancer anti- pathologic Gleason 6 in 17%. Sixty-two pergen 3 (PCA3) levels and urine TMPRSS2:ERG cent were upgraded at biopsy from Gleason 6
(T2:ERG) have additive utility in
to Gleason ≥7. Seventy percent had
predicting clinically significant
organ-confined disease (pT2) and 8%
prostate tumor volume, and their use
had lymph node disease (N1). Sixtytogether may enhance the selection
three percent had tumor volume >0.5
and monitoring of candidates with
cc. Some 87% had significant canlow-volume/low-grade disease for
cer, defined as tumor volume >0.5
active surveillance.
cc, Gleason score >6, or non-organNew markers are needed to select
confined cancer.
patients for active surveillance given
Serum PSA level, urine PCA3, and
the lack of specificity of PSA testurine T2 were significantly higher in
Dr. Davis
ing. Previous studies have shown
specimens with significant cancer.
that urine PCA3 levels correlated
Median values for insignificant versus
with positive versus negative biopsies and significant cancer were 3.0 ng/mL versus 5.0 ng/
total tumor volume in radical prostatectomy mL (p<.0001) for PSA, 18 versus 39 (p<.0001)
specimens, said first author John Davis, MD, for urine PCA3 score, and 6 versus 23 (p=.0262)
assistant professor of urology at the University for urine T2:ERG score.
of Texas MD Anderson Cancer Center, HousSimilarly, for cancers that were pathologic
ton, one of three sites participating in the study. Gleason score <7 versus ≥7, urine PCA3 score (19
Expression of fusions between the transmem- vs. 39; p<.0001) and urine T2:ERG score (7 vs. 24;
brane protease, serine 2 (TMPRSS2) and v-ets p=.011) were significantly lower. Both scores were
erythroblastosis virus E26 oncogene homolog also significantly lower when comparing organ(avian) (ERG) genes occur uniquely in prostate confined versus non-organ-confined cancers and
cancer, and more than half of PSA-screened biopsy Gleason 6 versus upgraded disease.
prostate cancers harbor such fusions.
Of the 105 patients with a biopsy Gleason 6
Dr. Davis reported interim findings from a score who are candidates for active surveillance
large, prospective, validation study conducted or treatment, the median PCA3 score was 31
at MD Anderson, Cleveland Clinic, and the and the median T2:ERG score was 18.
University of Washington, Seattle. The goal
Of the patients with biopsy Gleason 6 disease,
was to correlate PCA3 with tumor volume from 40 (38%) had pathologic Gleason 6 disease and
men undergoing prostatectomy, with a second- 65 (62%) were upgraded. The median PCA3
ary goal of assessing the additive prediction score in those not upgraded was 19 versus 37
from a novel urine assay of T2:ERG.
in those who were upgraded (p=.0003), and
Of the planned 300 participants, 257 had the median T2:ERG score was 5 in those not
Ut COrreSpONDeNt
a n t i a ndrog e n
continued from page 10
is no need for concomitant steroids, and the
drug can be taken with or without meals.”
A pre-chemotherapy role?
While the recent phase III data pertains to
use of enzalutamide in the post-chemotherapy
prostate cancer setting, the androgen receptor
signaling inhibitor is being evaluated in the prechemotherapy setting, as well.
“There should be significant interest in
a once-daily drug that has a novel and more
profound mechanism of action against the
androgen receptor. There might be interest in
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using enzalutamide in combination therapy for
androgen-sensitive patients in the setting of traditional androgen deprivation therapy. A phase
III pre-chemotherapy (M1CRPC) trial is also
nearing accrual completion,” said Dr. Shore.
“There might also be interest in using this
drug as monotherapy in patients with biochemical relapse after localized therapy. Enzalutamide is being studied in these arenas; the trials
are under development, and we optimistically
await the data.”
The development of enzalutamide continues
the recent and dramatic transformation of the
therapeutic landscape for prostate cancer. Within the past 2 years, four new targeted therapies
have emerged, in addition to two chemotherapeutic drugs.
upgraded versus 24 in those upgraded (p=.0862).
The receiver operating characteristic area under
the curve for all three markers combined for
upgrading was 0.7184, which was superior
to the markers individually (PCA3=0.7164,
T2:ERG=0.6066, PSA=0.6521).
The PCA3 score increased significantly when
tumor volume increased from <0.5 cc to 0.5 to 2.0
cc, “but the increase in PCA3 score for tumors
>2.0 cc was not significant,” said Dr. Davis.
Using area under the curve relative to significant cancer, the data suggest a meaningful
improvement when PCA3 and T2:ERG scores
are added to serum PSA, with a difference in
sensitivity of 12.7% at 90% specificity, but this
improvement was not statistically significant.
High predictive values for PCA3, T2 scores
Predictive values were high for very high PCA3
and T2 scores: For a PCA3 cutoff of 70, the
positive predictive value (PPV) was 98.3%, and
for a T2:ERG cutoff of 160, the PPV was 100%.
“The clinical utility might be that if the PSA
biopsy scores are telling you the patient is a
good surveillance candidate but you’re off the
charts on the other two [PCA3 and T2:ERG], it
may be a red flag that it’s not the proper candidate and needs to be looked at further,” he said.
“Overall, the vision in using these [urinary
markers] is in what I call ‘sifting populations.’
When the biopsy looks good for surveillance, it
may be an indication to re-sift that population
with additional urinary markers, and people
might incorporate imaging and other strategies,”
he added. “The idea is that most Gleason 6
biopsy patients are good surveillance candidates
but a few of them can come up and bite you, and
to the extent that we can find those and treat
them properly, it’s an important advance.” UT
“We have recently experienced enormous
advances; I think we must recognize and embrace
these achievements. We have gone from few
options to a plethora of choices,” Dr. Shore said.
“We have begun to ask how we can optimally combine these therapies, when can we
optimally combine them, and how do we most
appropriately sequence them. Those are great
questions to be asking, and we’ll hopefully have
those answers in the near term.”
Dr. de Bono has an employment or leadership position with the Institute of Cancer
Research and has a consultant/advisory role
for and receives honoraria from Astellas Pharma, Johnson & Johnson, and Medivation. Dr.
Shore is a consultant/adviser and investigator
for Medivation. UT
ES119508_UT0912_013.pgs 08.28.2012 10:07
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14
Prostate
health month
September 2012
∣
Urology Times
Prostatitis
marijuana use prevalent among cP/cPPs patients
majority who use it for pain find drug beneficial in treating, relieving symptoms
Penny Allen
Ut COrreSpONDeNt
Atlanta—It’s a topic that’s taboo for many urol-
ogists, but one that needs to be discussed—
medical marijuana.
With marijuana legalized for medical use in
Canada since 2001 and now in 17 U.S. states
and the District of Columbia, beginning with
California in 1996, urology patients in pain
have been turning to marijuana for relief. We
need to find out if they’re getting it.
Dean Tripp, PhD, associate professor of
psychology at Queen’s University in Kingston, Ontario, took a first step to do just that
by surveying patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS)
about their use of marijuana and whether it
relieved their pain.
He and colleagues at Queen’s University
posted an Internet survey on the topic and
invited CP/CPPS patients to participate from
the tertiary care urology clinic at Queen’s
as well as internationally through Web site
notices.
In all, 421 patients participated, 206 of whom
(49%) had reported previous cannabis use. Of
the respondents, 29% (59) said they used it for
pain relief. Users of marijuana
for any purpose were somewhat
UT Table Marijuana use in
younger than never users (mean
Cp/CppS patients
age, 45 years), but with a mean
age of 38 years, the pain users
recreational
were actually somewhat youngPain relief
use
er than the recreational users,
mean pain score (niH
whose mean age was 45 years.
13.47
12.40
chronic Prostatitis
Not surprisingly, the mean
symptom index)
pain score was higher in the
impact of cP/cPPs on
pain users than in the recre8.03
7.16
QoL (short Form Health
survey)
ational users (13.47 vs. 12.40
on the NIH Chronic Prostatitis
suicidal ideation
0.57
0.38
Symptom Index), as was the
(Patient Health Questionnaire for depression)
impact of CP/CPPS on quality
of life (8.03 in the pain users vs.
Source: Dean tripp, phD
7.16 in recreational users on the
Short Form Health Survey). Also
not surprisingly, suicidal ideation was higher other pain therapies. Marijuana can offer added
in the pain users than in the recreational users relief, as a study at San Francisco General Hos(0.57 vs. 0.38 on the Patient Health Question- pital showed. Vaporized cannabis was found
naire for depression).
to augment the analgesic effects of opioids
Although the survey did not ask questions in chronic pain patients without significantly
about degree of pain relief from or access to altering plasma opioid levels (Clin Pharmacol
traditional pain management medications and Ther 2011; 90:844-51).
techniques, it seems likely that many users of
There were no differences between the pain
marijuana for pain are those who haven’t had users and recreational users in the degree of
adequate relief from prescribed medications or
please see MariJUana, page 16
❳
❲
IC prevalence in men higher than previously thought
Data suggest condition may be more prevalent than chronic prostatitis
Penny Allen
Ut COrreSpONDeNt
Atlanta—Nearly as many American men as
women may suffer from interstitial cystitis/
bladder pain syndrome (IC/BPS) symptoms.
And more men may have IC/BPS symptoms
than have chronic prostatitis/chronic pelvic
pain syndrome (CP/CPPS) symptoms. These
surprising findings from the RAND Interstitial Cystitis Epidemiology (RICE) male study
provoked plenty of surprise and controversy at
the AUA annual meeting in Atlanta.
The new estimate puts the prevalence of
those symptoms in men at 1.9% for a highspecificity case definition and 4.2% for a
high-sensitivity definition. That translates
to a range of 1.8 to 4.2 million U.S. men.
The prevalence of CP/CPPS symptoms was
pegged at 1.8% of U.S. men, or 2.1 million.
The degree of overlap between the two was
“not very large” at 17%, noted first author
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Anne Suskind, MD, a urology fellow at the University
“We should not ignore the possibility
of Michigan, Ann Arbor.
When Dr. Suskind finthat IC exists in men, and if a man
ished her presentation,
attendees jumped to the
has bladder pain symptoms, we should
microphone immediately
treat him analogous to how we treat
to question the survey
methods. One pointed out
women.”
that nonresponders to a
health survey usually have J. QUenTin CLeMenS, MD
about half the symptoms of
responders, so that if two-thirds did not take screening questions were collected as part of
part in the survey, as Dr. Suskind reported, a general cross-sectional survey about politithen the number would be far overestimated. cal opinions across the United States. Most
It would be too big a leap from the 149 patients people who were willing to answer the survey
who completed the full interview about symp- were also willing to answer the questions about
toms. “Ridiculous,” said one urologist about the whether someone in the household had bladder
estimate in a later CP/CPPS session.
or pelvic pain symptoms, so the nonresponse
But the estimate may not be ridiculous. As rate would not have nearly as much impact on
senior author J. Quentin Clemens, MD, point- the estimate as it would have if this had been a
please see iC in Men, page 16
ed out, this was not a health survey only. The
ES119505_UT0912_014.pgs 08.28.2012 10:07
ADV
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ES120129_UT0912_015_FP.pgs 08.29.2012 07:40
ADV
16
Prostate
health month
m a ri jua n a
continued from page 14
side effects, reasons for stopping, use and frequency, or dose smoked. Among those taking
in marijuana in food, pain users tended to use
more, with 24% reporting consuming more
than 1 gram per dose compared with 9% of
recreational users consuming this amount.
Importantly, the survey asked whether the
cannabis was of any benefit in treating or relieving symptoms.
“At this point in time, with the limited data
we have on the matter, the answer for the
majority of users is ‘yes,’ ” said Dr. Tripp, who
worked on the study with the psychology, urology, and anesthesia departments at Queen’s
University.
Of the 58 pain users who answered that
UTSTAT
of the 58 pain users who answered
a question about using marijuana for
treating or relieving pain, 67% said it
offered pain relief.
ic in me n
continued from page 14
health survey only. Moreover, added Dr. Suskind, the interviewers quickly asked for some
demographic information for those who did not
want to respond in order to weight the nonresponders.
Still, there is survey work to do to confirm
whether these numbers indeed reflect the prevalence of IC/BPS in men, Dr. Clemens told Urology Times. In the RICE study of women, IC
experts confirmed the IC/BPS diagnosis in a
subgroup of women reporting symptoms, helping to confirm the prevalence, but this has yet
to be done in the men.
The prevalence in women based on the RICE
data also seemed high when they were first
reported, Dr. Clemens pointed out. But further
RICE data also showed that most of the women
reporting symptoms still had symptoms a year
later, that 90% had sought care for these symptoms, and that their quality of life was similar
to that of women who have IC diagnosed in
the clinic.
“In men, we don’t have that yet because
we’re just analyzing the data. So, it’s possible that this is an overestimate because we
may be identifying more mild symptoms, but
only time will tell,” said Dr. Clemens, asso-
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September 2012
∣
Urology Times
Prostatitis
difficult, since staff at a particular
medical marijuana dispensary may
“With the limited data we have on the matter, serve patients with urologic pelvic
who all use a particular strain.
the answer [to whether marijuana is beneficial pain
In the age of medical use, marijuana is definitely not one thing. Breeders
for treating or relieving symptoms] for the
for the medical market have developed
majority of users is ‘yes.’ ”
strains with lower levels of tetrahydrocannabinol (THC)—the major psyDean Tripp, phD
chotropic cannabinoid—and higher
question, a sizable majority—67%—said that
levels of cannabidiol (CBD), which
it did indeed offer pain relief. Very few rec- has anti-inflammatory and other therapeutic
reational users answered this question, but effects. Just this July, an Israeli company garof the nine who did, three (33%) said it was nered media attention when it announced it had
beneficial for pain, whereas six (67%) said developed a THC-less strain.
it wasn’t. Compared with many treatments
Marijuana may address more than pain in
tried in the urologic pelvic pain syndromes, urologic pelvic pain as well, since marijuana
effectiveness in 33% isn’t bad, and in 67%, or isolated cannabinoids have demonstrated
it’s remarkable.
potential in moderating autoimmune disorSurvey studies including more patients ders, such as multiple sclerosis, rheumatoid
would be needed to confirm that figure.
arthritis, and inflammatory bowel disease
and neurologic disorders such as Alzheimer’s
Type of strain may be important
disease, amyotrophic lateral sclerosis, and
Population size isn’t the only refinement that epilepsy. Research in urologic pelvic pain
would make survey studies more revealing. has pointed to immune dysregulation as well
Where medical use is legal, surveys may also as neuropathies and central sensitization as
need to ask about the strain of marijuana possible etiologies.
being used or limit surveys to users of a parThe survey study was supported by a grant
ticular strain. Doing such studies may not be from Valeant Pharmaceuticals International. UT
ciate professor of urology at the University
of Michigan. In the women, he pointed out,
these methods identify a group that’s pretty
symptomatic, and although it’s not certain that
they have IC/BPS, “Whatever they have, you
don’t want.”
Results highlight unmet need for treatment
For a long time, prevalence estimates for these
conditions were based on diagnosis in the office,
and that reflected only patients who sought care
and, often, only patients who went to urologists.
The RICE estimates based on population surveys highlight that there’s a great unmet need
in the community for diagnosis and treatment.
That’s likely the case for men, too. Although the
prevalence estimates in men seem high, possibly because of different definitions, “These
estimates suggest that these conditions in men
are widespread and that they may be underdiagnosed and undertreated by physicians,” said
Dr. Suskind.
If these men reporting bladder pain symptoms were seen in the clinic, speculated Dr.
Clemens, they might be told they have CP/
CPPS if they have pelvic pain in other areas
that are more dominant or in areas that the clinician might focus on. CP/CPPS is a common
diagnosis, with population surveys showing
that 5% to as much as 9% of men have “prostatitis-like” symptoms, but there is probably
UTSTAT
The new estimate puts the
prevalence of IC/BPS symptoms
in men at 1.9% for a highspecificity case definition and 4.2%
for a high-sensitivity definition.
overlap, with a substantial number of these
men having bladder pain symptoms as well,
he said.
“I think [this study] means that we should
not ignore the possibility that IC exists in
men, and if a man has bladder pain symptoms, we should treat him analogous to how
we treat women,” Dr. Clemens said. “So it’s
something to at least think about when you’re
seeing patients and you think they have BPH
at first, you may want to ask if they have some
pain, too. It may turn out that if this patient
were a woman presenting with the same symptoms, you’d say she has IC, but because it’s
a man, you’re saying he has BPH or chronic
prostatitis.”
At the very least, this study shows that bladder pain symptoms in men are not as rare as
previously thought, Dr. Clemens concluded. UT
ES119504_UT0912_016.pgs 08.28.2012 10:06
ADV
UrologyTimes.com
∣
Prostate
September 2012
17
BPH health month
TURP associated with lower risk of repeat procedures
but procedure has higher complication rate than minimally invasive modalities
Charles Bankhead
Ut CONtrIbUtING eDItOr
Atlanta—Repeat surgery occurs two to three
times as often after newer minimally invasive
interventions for BPH compared with transurethral resection of the prostate (TURP), a review
of Medicare claims data showed.
Overall, four different minimally invasive
interventions had repeat surgery rates of about
20%. In contrast, repeat surgery occurred after
8.3% of TURP procedures. In most cases,
TURP was the repeat procedure, even among
patients who had TURP as the initial treatment,
first author Sean Elliott, MD, reported at the
AUA annual meeting in Atlanta.
“Even though TURP might be declining
in frequency as the primary procedure for
benign prostatic hyperplasia, it still seems
to be the go-to procedure for primary treatment failure,” Dr. Elliott, associate professor
of urologic surgery at the University of Minnesota in Minneapolis, told Urology Times. “I
think that probably emphasizes the fact that
everyone, regardless of what they use as primary therapy, still recognizes TURP as the
gold standard.”
Traditionally the predominant intervention
for BPH, TURP now accounts for fewer than
50% of BPH surgeries performed in the United
States each year. Newer minimally invasive
procedures have displaced TURP as the primary intervention in many cases, including
transurethral microwave therapy (TUMT),
transurethral needle ablation (TUNA), laser
vaporization, and laser coagulation.
To examine the comparative long-term effectiveness of BPH procedures, Dr. Elliott and colleagues reviewed Medicare records to identify
men who underwent BPH surgeries from 2001
through 2007. Using CPT codes, they identified
616,735 patients ages 66 years and older at the
time of initial treatment. Duration of follow-up
averaged 3.6 years.
TURP accounted for 51.8% of all the procedures, followed by TUMT (21.4%), laser
vaporization (12.2%), laser coagulation (7.6%),
and TUNA (7.0%). TURP’s share of all procedures declined steadily over the study period,
from 19.0% in 2001 to 9.2% in 2007. During
the last year of the study period, laser vaporization was the most commonly performed
BPH procedure (31.3%), followed by TUMT
(17.1%), TUNA (15.2%), TURP, and laser
coagulation (8.9%).
The primary outcome was repeat surgery.
Investigators extended the review period to
2008 to capture repeat procedures. The sec-
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ondary outcome was urologic complications
associated with the BPH interventions.
Complications higher with TURP
The 5-year estimated incidence of repeat BPH
surgery ranged from 8.3% with TURP to 25.8%
after TUMT. After adjusting for patient and
hospital factors, retreatment was 2.1 to 3.5
times more likely with laser vaporization or
TUMT, respectively, than with TURP.
The most common postoperative compliplease see TURP, page 21
WE’RE
CHANGING
THE WAY
PROSTATE CANCER PATIENTS
ARE TREATED EVEN WHEN
THEY’RE NOT BEING TREATED
When it comes to treating prostate cancer,
we do not believe in a one-size-fits-all
approach. That’s why doctors at UPMC are
experts in both traditional methods of
urologic surgery and in cutting-edge
robotic surgery. But our doctors also
recognize when the best management is
not an operation, but careful observation.
We believe it is important to be well
versed in all options to ensure patients
receive the right treatment at the right
time. Because our job is not only to save
lives, but to preserve the quality of life
of every patient we treat. Learn more at
UPMCPhysicianResources.com/ProstateCancer.
UPMC is affiliated with the University of Pittsburgh School of Medicine.
ES119487_UT0912_017.pgs 08.28.2012 10:06
ADV
Indication1
AndroGel® (testosterone gel) 1.62% CIII is an androgen indicated for replacement therapy in adult males for conditions associated with
a deficiency or absence of endogenous testosterone:
• Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis,
vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.
• Hypogonadotropic hypogonadism (congenital or acquired): idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH)
deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.
Important limitations of use: Safety and efficacy of AndroGel 1.62% in males <18 years old have not been established.
Important Safety Information1
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
• Virilization has been reported in children who were secondarily exposed to testosterone gel.
• Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel.
• Healthcare providers should advise patients to strictly adhere to recommended instructions for use.
• AndroGel 1.62% is contraindicated in men with breast cancer or known or suspected prostate cancer, and in women who are or may
become pregnant, or are breastfeeding, as testosterone may cause fetal harm.
• Monitor patients with benign prostatic hyperplasia (BPH) treated with androgens due to an increased risk for worsening signs and
symptoms of BPH.
• Patients treated with androgens may be at increased risk for prostate cancer and should be evaluated prior to initiating and during
treatment with androgens as appropriate. Monitor prostate specific antigen (PSA) levels periodically.
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ES115767_UT0912_018_FP.pgs 08.23.2012 02:56
ADV
For patients with hypogonadism,
AndroGel 1.62% is designed
with a man in mind
™
• A clear, unscented, and quick-drying gel.
• Flexible dosing with familiar application sites of shoulders
and upper arms.1
• Restored testosterone levels in 82% of patients treated
with AndroGel 1.62% in the pivotal trial (compared to
37% of placebo patients, p<0.0001) on Day 112.1,2
Study Design: Multicenter, randomized, double-blind, parallel-group,
placebo-controlled study of 274 hypogonadal men with low testosterone
(<300 ng/dL). Patients were initially randomized to receive 40.5 mg of
AndroGel 1.62% or placebo. Patients returned to the clinic on Days 14,
28, and 42 for pre-dose serum total testosterone assessments, and
their daily dose was titrated up or down in 20.25-mg increments if
their level was outside the range of 350–750 ng/dL. Patients could
have received one of four AndroGel 1.62% doses (20.25 mg, 40.5 mg,
60.75 mg, or 81 mg daily) or placebo during the 182 day treatment period.
The primary endpoint was the percentage of patients with an average
serum testosterone level within the normal range (300–1000 ng/dL)
on Day 112.1,2
• Avoid unintentional exposure of women or children to AndroGel 1.62%. Secondary exposure to testosterone can produce signs of virilization
and should be brought to the attention of the healthcare provider. Exposure of a pregnant woman to AndroGel may result in potential hazard
to the fetus. AndroGel 1.62% should be promptly discontinued until the cause of virilization is identified.
• Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. Monitor
hematocrit prior to and periodically during treatment.
• AndroGel 1.62% is not indicated for use in women.
• Treatment with AndroGel 1.62% may lead to azoospermia; edema in patients with preexisting cardiac, renal, or hepatic disease or in
patients taking adrenocorticotropic hormone (ACTH) or corticosteroids; gynecomastia; sleep apnea, especially in those with risk factors;
changes in insulin sensitivity or glycemic control; and changes in anticoagulant activity.
• Treatment with androgens may lead to serious hepatic effects. AndroGel 1.62% is not known to cause these adverse effects. Monitor liver
function tests (LFTs) periodically.
• Changes in serum lipid profile may require dose adjustment or discontinuation of testosterone therapy. Monitor lipid levels periodically.
• Androgens should be used with caution in cancer patients at risk of
hypercalcemia (and associated hypercalciuria). Regular monitoring
of serum calcium concentrations is recommended in these patients.
• Most common adverse reaction of AndroGel 1.62% (incidence ≥5%)
is an increase in prostate specific antigen (PSA).
Please see adjacent pages for Brief Summary
of Full Prescribing Information.
References: 1. AndroGel 1.62% [package insert]. North Chicago, IL: Abbott Laboratories. 2. Kaufman
JM, Miller MG, Garwin JL, Fitzpatrick S, McWhirter C, Brennan JJ. Efficacy and safety study of 1.62%
testosterone gel for the treatment of hypogonadal men. J Sex Med. 2011;8:2079-2089.
©2012 Abbott Laboratories Abbott Park, IL 60064
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852-820257
May 2012
Printed in U.S.A.
ES115768_UT0912_019_FP.pgs 08.23.2012 02:56
ADV
ANDROGEL® (testosterone gel) 1.62% for topical use CIII
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
• Virilization has been reported in children who were secondarily exposed to
testosterone gel [see Warnings and Precautions and Adverse Reactions].
• Children should avoid contact with unwashed or unclothed application sites in
men using testosterone gel [see Warnings and Precautions].
• Healthcare providers should advise patients to strictly adhere to recommended
instructions for use [see Warnings and Precautions and Patient Counseling
Information].
AndroGel 1.62% is not interchangeable with other topical testosterone products.
INDICATIONS AND USAGE
AndroGel 1.62% is an androgen indicated for replacement therapy in adult males for
conditions associated with a deficiency or absence of endogenous testosterone:
• Primary hypogonadism (congenital or acquired): testicular failure due to conditions such
as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy,
Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.
These men usually have low serum testosterone concentrations and gonadotropins
(follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
• Hypogonadotropic hypogonadism (congenital or acquired): idiopathic gonadotropin or
luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic
injury from tumors, trauma, or radiation. These men have low testosterone serum
concentrations, but have gonadotropins in the normal or low range.
Important limitations of use: Safety and efficacy of AndroGel 1.62% in males <18 years old
have not been established [See Use in Specific Populations].
CONTRAINDICATIONS
• AndroGel 1.62% is contraindicated in men with carcinoma of the breast or known
or suspected carcinoma of the prostate [see Warnings and Precautions and Adverse
Reactions].
• AndroGel 1.62% is contraindicated in women who are or may become pregnant, or
who are breastfeeding. AndroGel 1.62% may cause fetal harm when administered to a
pregnant woman. AndroGel 1.62% may cause serious adverse reactions in nursing infants.
Exposure of a fetus or nursing infant to androgens may result in varying degrees of
virilization. Pregnant women or those who may become pregnant need to be aware of the
potential for transfer of testosterone from men treated with AndroGel 1.62%. If a pregnant
woman is exposed to AndroGel 1.62%, she should be apprised of the potential hazard to
the fetus [see Warnings and Precautions and Use in Specific Populations].
WARNINGS AND PRECAUTIONS
Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer
• Patients with BPH treated with androgens are at an increased risk for worsening of signs
and symptoms of BPH. Monitor patients with BPH for worsening signs and symptoms.
• Patients treated with androgens may be at increased risk for prostate cancer. Evaluation
of patients for prostate cancer prior to initiating and during treatment with androgens is
appropriate [see Contraindications].
Potential for Secondary Exposure to Testosterone
Cases of secondary exposure resulting in virilization of children have been reported in
postmarketing surveillance of testosterone gel products. Signs and symptoms have
included enlargement of the penis or clitoris, development of pubic hair, increased erections
and libido, aggressive behavior, and advanced bone age. In most cases, these signs and
symptoms regressed with removal of the exposure to testosterone gel. In a few cases,
however, enlarged genitalia did not fully return to age-appropriate normal size, and bone
age remained modestly greater than chronological age. The risk of transfer was increased
in some of these cases by not adhering to precautions for the appropriate use of the topical
testosterone product. Children and women should avoid contact with unwashed or unclothed
application sites in men using AndroGel 1.62% [see Use in Specific Populations].
Inappropriate changes in genital size or development of pubic hair or libido in children,
or changes in body hair distribution, significant increase in acne, or other signs of virilization
in adult women should be brought to the attention of a physician and the possibility
of secondary exposure to testosterone gel should also be brought to the attention of a
physician. Testosterone gel should be promptly discontinued until the cause of virilization
has been identified.
Polycythemia
Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering
or discontinuation of testosterone. Check hematocrit prior to initiating treatment. It would
also be appropriate to re-evaluate the hematocrit 3 to 6 months after starting treatment,
and then annually. If hematocrit becomes elevated, stop therapy until hematocrit decreases
to an acceptable concentration. An increase in red blood cell mass may increase the risk of
thromboembolic events.
Use in Women
Due to the lack of controlled evaluations in women and potential virilizing effects, AndroGel
1.62% is not indicated for use in women [see Contraindications and Use in Specific
Populations].
Potential for Adverse Effects on Spermatogenesis
With large doses of exogenous androgens, including AndroGel 1.62%, spermatogenesis
may be suppressed through feedback inhibition of pituitary FSH possibly leading to adverse
effects on semen parameters including sperm count.
Hepatic Adverse Effects
Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone)
has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms,
cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal
complication. Long-term therapy with intramuscular testosterone enanthate has produced
multiple hepatic adenomas. AndroGel 1.62% is not known to cause these adverse effects.
Edema
Androgens, including AndroGel 1.62%, may promote retention of sodium and water. Edema,
with or without congestive heart failure, may be a serious complication in patients with
preexisting cardiac, renal, or hepatic disease [see Adverse Reactions].
Gynecomastia
Gynecomastia may develop and persist in patients being treated with androgens, including
AndroGel 1.62%, for hypogonadism.
Sleep Apnea
The treatment of hypogonadal men with testosterone may potentiate sleep apnea in some
patients, especially those with risk factors such as obesity or chronic lung diseases.
Lipids
Changes in serum lipid profile may require dose adjustment or discontinuation of
testosterone therapy.
Hypercalcemia
Androgens, including AndroGel 1.62 %, should be used with caution in cancer patients at
risk of hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium
concentrations is recommended in these patients.
Decreased Thyroxine-binding globulin
Androgens, including AndroGel 1.62%, may decrease concentrations of thyroxin-binding
globulins, resulting in decreased total T4 serum concentrations and increased resin uptake of
T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no
clinical evidence of thyroid dysfunction.
Flammability
Alcohol based products, including AndroGel 1.62%, are flammable; therefore, patients
should be advised to avoid fire, flame or smoking until the AndroGel 1.62% has dried.
ADVERSE REACTIONS
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates
observed in the clinical trials of a drug cannot be directly compared to rates in the clinical
trials of another drug and may not reflect the rates observed in practice.
AndroGel 1.62% was evaluated in a two-phase, 364-day, controlled clinical study. The first
phase was a multi-center, randomized, double-blind, parallel-group, placebo-controlled
black
PROFESSIONAL BRIEF SUMMARY
CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION
period of 182 days, in which 234 hypogonadal men were treated with AndroGel 1.62%
and 40 received placebo. Patients could continue in an open-label, non-comparative,
maintenance period for an additional 182 days.
The most common adverse reaction reported in the double-blind period was increased
prostate specific antigen (PSA) reported in 26 AndroGel 1.62%-treated patients (11.1%).
In 17 patients, increased PSA was considered an adverse event by meeting one of the two
pre-specified criteria for abnormal PSA values, defined as (1) average serum PSA >4 ng/mL
based on two separate determinations, or (2) an average change from baseline in serum PSA
of greater than 0.75 ng/mL on two determinations.
During the 182-day, double-blind period of the clinical trial, the mean change in serum
PSA value was 0.14 ng/mL for patients receiving AndroGel 1.62% and -0.12 ng/mL for the
patients in the placebo group. During the double-blind period, seven patients had a PSA
value >4.0 ng/mL, four of these seven patients had PSA less than or equal to 4.0 ng/mL
upon repeat testing. The other three patients did not undergo repeat PSA testing.
During the 182-day, open-label period of the study, the mean change in serum PSA values
was 0.10 ng/mL for both patients continuing on active therapy and patients transitioning
onto active from placebo. During the open-label period, three patients had a serum PSA value
> 4.0 ng/mL, two of whom had a serum PSA less than or equal to 4.0 ng/mL upon repeated
testing. The other patient did not undergo repeat PSA testing. Among previous placebo
patients, 3 of 28 (10.7%), had increased PSA as an adverse event in the open-label period.
Table 1 shows adverse reactions reported by >2% of patients in the 182-day, double-blind
period of the AndroGel 1.62% clinical trial and more frequent in the AndroGel 1.62% treated
group versus placebo.
Table 1: Adverse Reactions Reported in >2% of Patients in the 182-Day,
Double-Blind Period of AndroGel 1.62% Clinical Trial
Number (%) of Patients
AndroGel 1.62 %
Placebo
N=234
N= 40
PSA increased*
26 (11.1%)
0%
Emotional lability**
6 (2.6%)
0%
Hypertension
5 (2.1%)
0%
Hematocrit or hemoglobin increased
5 (2.1%)
0%
Contact dermatitis***
5 (2.1%)
0%
* PSA increased includes: PSA values that met pre-specified criteria for abnormal PSA
values (an average change from baseline > 0.75 ng/mL and/or an average PSA value
>4.0 ng/mL based on two measurements) as well as those reported as adverse events.
** Emotional lability includes: mood swings, affective disorder, impatience, anger,
and aggression.
*** Contact dermatitis includes: 4 patients with dermatitis at non-application sites.
Adverse Reaction
Other adverse reactions occurring in less than or equal to 2% of AndroGel 1.62%-treated
patients and more frequently than placebo included: frequent urination, and hyperlipidemia.
In the open-label period of the study (N=191), the most commonly reported adverse
reaction (experienced by greater than 2% of patients) was increased PSA (n=13; 6.2%) and
sinusitis. Other adverse reactions reported by less than or equal to 2% of patients included
increased hemoglobin or hematocrit, hypertension, acne, libido decreased, insomnia, and
benign prostatic hypertrophy.
During the 182-day, double-blind period of the clinical trial, 25 AndroGel 1.62%-treated
patients (10.7%) discontinued treatment because of adverse reactions. These adverse
reactions included 17 patients with PSA increased and 1 report each of: hematocrit
increased, blood pressure increased, frequent urination, diarrhea, fatigue, pituitary tumor,
dizziness, skin erythema and skin nodule (same patient – neither at application site),
vasovagal syncope, and diabetes mellitus. During the 182-day, open-label period, 9 patients
discontinued treatment because of adverse reactions. These adverse reactions included 6
reports of PSA increased, 2 of hematocrit increased, and 1 each of triglycerides increased
and prostate cancer.
Application Site Reactions
In the 182-day double-blind period of the study, application site reactions were reported
in two (2/234; 0.9%) patients receiving AndroGel 1.62%, both of which resolved. Neither
of these patients discontinued the study due to application site adverse reactions. In the
open-label period of the study, application site reactions were reported in three
(3/219; 1.4%) additional patients that were treated with AndroGel 1.62%. None of these
subjects were discontinued from the study due to application site reactions.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of AndroGel
1%. Because the reactions are reported voluntarily from a population of uncertain size, it is
not always possible to reliably estimate their frequency or establish a causal relationship to
drug exposure (Table 2).
Table 2: Adverse Reactions from Post Approval Experience of
AndroGel 1% by System Organ Class
System Organ Class
Blood and lymphatic
system disorders:
Endocrine disorders:
Gastrointestinal disorders:
General disorders:
Genitourinary disorders:
Hepatobiliary disorders:
Investigations:
Adverse Reaction
Elevated hemoglobin or hematocrit, polycythemia, anemia
Hirsutism
Nausea
Asthenia, edema, malaise
Impaired urination*
Abnormal liver function tests
Lab test abnormal**, elevated PSA, electrolyte changes
(nitrogen, calcium, potassium [includes hypokalemia],
phosphorus, sodium), impaired glucose tolerance,
hyperlipidemia, HDL, fluctuating testosterone levels, weight
increase
Neoplasms:
Prostate cancer
Nervous system disorders: Dizziness, headache, insomnia, sleep apnea
Psychiatric disorders:
Amnesia, anxiety, depression, hostility, emotional lability,
decreased libido, nervousness
Reproductive system and Gynecomastia, mastodynia, oligospermia, priapism
breast disorders:
(frequent or prolonged erections), prostate enlargement,
BPH, testis disorder***
Respiratory disorders:
Dyspnea
Skin and subcutaneous
Acne, alopecia, application site reaction (discolored hair,
tissue disorders:
dry skin, erythema, paresthesia, pruritus, rash), skin dry,
pruritus, sweating
Vascular disorders:
Hypertension, vasodilation (hot flushes)
* Impaired urination includes nocturia, urinary hesitancy, urinary incontinence, urinary
retention, urinary urgency and weak urinary stream
** Lab test abnormal includes elevated AST, elevated ALT, elevated testosterone, elevated
hemoglobin or hematocrit, elevated cholesterol, elevated cholesterol/LDL ratio, elevated
triglycerides, or elevated serum creatinine
*** Testis disorder includes atrophy or non-palpable testis, varicocele, testis sensitivity
or tenderness
were reported to have regressed with removal of the testosterone gel exposure. In a few
cases, however, enlarged genitalia did not fully return to age appropriate normal size, and
bone age remained modestly greater than chronological age. In some of the cases, direct
contact with the sites of application on the skin of men using testosterone gel was reported.
In at least one reported case, the reporter considered the possibility of secondary exposure
from items such as the testosterone gel user’s shirts and/or other fabric, such as towels and
sheets [see Warnings and Precautions].
DRUG INTERACTIONS
Insulin
Changes in insulin sensitivity or glycemic control may occur in patients treated with
androgens. In diabetic patients, the metabolic effects of androgens may decrease blood
glucose and, therefore, may decrease insulin requirements.
Oral Anticoagulants
Changes in anticoagulant activity may be seen with androgens, therefore more frequent
monitoring of international normalized ratio (INR) and prothrombin time are recommended
in patients taking anticoagulants, especially at the initiation and termination of androgen
therapy.
Corticosteroids
The concurrent use of testosterone with adrenocorticotropic hormone (ACTH) or
corticosteroids may result in increased fluid retention and requires careful monitoring
particularly in patients with cardiac, renal or hepatic disease.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category X [see Contraindications]: AndroGel 1.62% is contraindicated during
pregnancy or in women who may become pregnant. Testosterone is teratogenic and
may cause fetal harm. Exposure of a fetus to androgens may result in varying degrees of
virilization. If this drug is used during pregnancy, or if the patient becomes pregnant while
taking this drug, the patient should be made aware of the potential hazard to the fetus.
Nursing Mothers
Although it is not known how much testosterone transfers into human milk, AndroGel 1.62%
is contraindicated in nursing women because of the potential for serious adverse reactions in
nursing infants. Testosterone and other androgens may adversely affect lactation
[see Contraindications].
Pediatric Use
The safety and effectiveness of AndroGel 1.62% in pediatric patients < 18 years old has
not been established. Improper use may result in acceleration of bone age and premature
closure of epiphyses.
Geriatric Use
There have not been sufficient numbers of geriatric patients involved in controlled clinical
studies utilizing AndroGel 1.62% to determine whether efficacy in those over 65 years of
age differs from younger subjects. Of the 234 patients enrolled in the clinical trial utilizing
AndroGel 1.62%, 21 were over 65 years of age. Additionally, there is insufficient long-term
safety data in geriatric patients to assess the potentially increased risks of cardiovascular
disease and prostate cancer.
Geriatric patients treated with androgens may also be at risk for worsening of signs and
symptoms of BPH.
Renal Impairment
No studies were conducted involving patients with renal impairment.
Hepatic Impairment
No studies were conducted in patients with hepatic impairment.
DRUG ABUSE AND DEPENDENCE
Controlled Substance
AndroGel 1.62% contains testosterone, a Schedule III controlled substance as defined under
the Anabolic Steroids Control Act.
Abuse
Anabolic steroids, such as testosterone, are abused. Abuse is often associated with adverse
physical and psychological effects.
Dependence
Although drug dependence is not documented in individuals using therapeutic doses of
anabolic steroids for approved indications, dependence is observed in some individuals
abusing high doses of anabolic steroids. In general, anabolic steroid dependence is
characterized by any three of the following:
• Taking more drug than intended
• Continued drug use despite medical and social problems
• Significant time spent in obtaining adequate amounts of drug
• Desire for anabolic steroids when supplies of the drugs are interrupted
• Difficulty in discontinuing use of the drug despite desires and attempts to do so
• Experience of a withdrawal syndrome upon discontinuation of anabolic steroid use
OVERDOSAGE
There is a single report of acute overdosage after parenteral administration of an approved
testosterone product in the literature. This subject had serum testosterone concentrations
of up to 11,400 ng/dL, which were implicated in a cerebrovascular accident. There were no
reports of overdosage in the AndroGel 1.62% clinical trial.
Treatment of overdosage would consist of discontinuation of AndroGel 1.62%, washing the
application site with soap and water, and appropriate symptomatic and supportive care.
Marketed by:
Abbott Laboratories
North Chicago, IL, 60064, U.S.A.
Ref: 1062416 - 4E
Rev: April, 2011
© 2011 Abbott Laboratories
852-596802 MASTER
852-820257
Secondary Exposure to Testosterone in Children
Cases of secondary exposure to testosterone resulting in virilization of children have been
reported in postmarketing surveillance of testosterone gel products. Signs and symptoms of
these reported cases have included enlargement of the clitoris (with surgical intervention) or
the penis, development of pubic hair, increased erections and libido, aggressive behavior,
and advanced bone age. In most cases with a reported outcome, these signs and symptoms
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September 2012
Prostate
BPH health month
21
Bipolar techniques show advantages in treating BPH
Vaporization, enucleation offer improved outcomes in average, large prostates
Cheryl Guttman Krader
Ut CONtrIbUtING eDItOr
AtlantaÑResults from a prospective, randomized controlled clinical trial suggest that bipolar
plasma vaporization of the prostate (BPVP) is a
promising advance in the surgical treatment of
BPH in men with average-size prostates.
Bogdan Geavlete, MD, PhD, the study’s
first author, reported that BPVP offered an
improved surgical efficiency when compared
with bipolar transurethral resection in saline
(TURis) and monopolar transurethral resection of the prostate (TURP) and was associated with a faster postoperative recovery and
better long-term outcomes. He attributed the
superiority of BPVP to the large vaporization
surface and excellent coagulation properties
of the “button” vapo-resection electrode (PlasmaButton, Olympus, Center Valley, PA). In a
separate study, he reported that those attributes provided a premise for using the device
during bipolar enucleation of the prostate
(BPEP), which showed promise as a safe,
efficient BPH endoscopic treatment modality
for large prostates.
Both studies were presented at the AUA
annual meeting in Atlanta.
Shorter mean operative time with BPVP
BPVP was compared with TURis and TURP
in a single-center study enrolling 510 men
with a prostate volume of 30 mL to 80 mL,
International Prostate Symptom Score (IPSS)
>19, and Qmax <10 mL/s. The analysis of
perioperative outcomes confirmed BPVP as
a significantly faster procedure than TURis
and TURP (mean operative times of 39.7 vs.
52.1 and 55.6 minutes). The technique was also
associated with reduced morbidity and more
rapid recovery.
The perioperative safety data showed the
BPVP study group benefited from significantly
lower mean hemoglobin level decrease compared with TURis and TURP (0.5 g/dL vs. 1.2
T URP
continued from page 17
cation was urethral stricture, occurring in
4.4% of patients overall, including 5.7% of
TURP procedures, 2.3% of TUMT procedures, and 2.6% of TUNA procedures
(p<.001).
Bladder-neck contraction occurred in
magenta
cyan
yellow
black
g/dL and 1.6 g/dL), as well
as lower rates of intraoperative bleeding (1.8% vs. 8.2%
and 13.5%) and capsular perforation (1.2% vs. 7.1% and
9.4%). Rates of postoperative
hematuria and blood transfusion were also reduced in
the BPVP group (2.9% and
1.2%) and significantly lowDuring bipolar enucleation of the prostate, the median lobe
er than after TURP (15.3%
is enucleated from the bladder neck up to the verumontanum
and 6.5%). Mean duration
through incisions at 5 and 7 o’clock. (Images courtesy of Bogdan Geavlete, MD, PhD)
of catheterization was 23.5
hours for BPVP and twofold
and threefold longer after
TURis and TURP, respectively. Mean hospi- 7 o’clock. Next, a deep 12 o’clock incision is
tal stay for the three groups was 1.9, 3.1, and made up to the prostatic capsule, resulting in
4.2 days.
complete separation of the two lateral lobes that
“Some of these differences between groups are then enucleated in a descendant direction,
may be explained by the excellent cauteriza- starting from the 1 and 11 o’clock positions.
tion properties of the bipolar technique, which BPEP is continued from the 5 and 7 o’clock
reduced bleeding and subsequently improved incisions in an ascendant direction. The lateral
visualization,” said Dr. Geavlete, assistant pro- lobes are gradually detached from the prostatic
fessor of urology at the St. John Emergency capsule and pushed back into the bladder. The
Clinical Hospital, Bucharest, Romania.
procedure concludes with a careful coagulation
There were no significant differences among of any residual hemorrhagic sources and BPH
the BPVP, TURis, and TURP groups concern- tissue morcellation.
ing rates of irritative symptoms after surgery
“The lack of bleeding allows morcellation to
(12.4%, 11.2%, and 10.6%). IPSS scores were be performed under a clear endoscopic control.
significantly reduced in all groups and rose The procedure results in a large prostatic fossa,
slightly over time. However, at all follow-ups, without irregularities, debris, or obstruction,”
IPSS scores in the BPVP series were signifi- Dr. Geavlete said.
cantly lower than in the comparator arms, and
BPEP and open transvesical prostatectomy
Qmax values were also consistently superior had similar mean operative times (~90 minutes)
after BPVP.
and BPH tissue removal capabilities (~90%
of the initial prostate volume). During the
Enucleation promising in large prostates
12-month follow-up, improvements in sympIn a separate study, Dr. Geavlete and colleagues toms, quality of life, and voiding characteristics
compared BPEP with open transvesical pros- were also similar in the two study groups. Howtatectomy for larger prostates (>80 mL). The ever, BPEP was associated with less surgical
randomized trial included 130 men.
trauma and morbidity.
BPEP begins with a urethrocystoscopic
Compared with open prostatectomy, BPEP
assessment of the prostatic bulk. The median was associated with a significantly shorter
lobe is enucleated from the bladder neck up to catheterization period (35.4 vs. 98.3 hours) and
the verumontanum through incisions at 5 and hospital stay (2.4 vs. 5.2 days), significantly less
hemoglobin reduction (2.0 vs. 3.3 g/dL), and
significantly lower rates of postoperative hema2.0% of patients overall, including 2.6% with
turia (3.1% vs. 15.4%) and blood transfusion
TURP, 2.3% with laser coagulation, 1.6%
(1.5% vs. 10.8%). More so, open prostatectomy
with vaporization, and <1% with TUMT and
alone was associated with early acute urinary
TUNA (p<.001).
retention (6.1%) and bladder neck contracture
“It’s nothing new to learn that the compli(4.6%). The rate of irritative symptoms was
cation rate is higher with TURP, although not
higher following BPEP than with open surgery
much higher than with the other two proce(12.3% vs. 9.2%), but the difference was not
dures,” said Dr. Elliott. “On the other hand,
statistically significant.
the reoperation rate is dramatically lower
Dr. Geavlete was involved as a speaker and
with TURP.” UT
presented lectures in Olympus-sponsored symposia. UT
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22
Prostate
health month
September 2012
∣
Urology Times
BPH
56% incidence of retrograde ejaculation
Sexual dysfunction seen with Thulium laser for BPH
Nancy Groves
Ut COrreSpONDeNt
Atlanta—Filling a gap in the knowledge of the
incidence of sexual dysfunction following Thulium YAG vaporesection (ThuVaRP), a recent
study found that the risk of erectile dysfunction
was 20%, while that of retrograde ejaculation
was 56% in a group of patients who had been
sexually active before the procedure.
First author Raj P. Pal, MBChB, said that
11 of 54 patients treated for bladder outflow
obstruction experienced worsening erectile
dysfunction following surgery, and retrograde
ejaculation occurred in 30 of the 54. In addition,
diabetes and preoperative catheterization were
found to be correlated comorbidities for retrograde ejaculation (p=.04 and p=.03, respec-
tively); no comorbidities were associated with
erectile dysfunction.
Dr. Pal presented these findings at the AUA
annual meeting in Atlanta, and they were
published in Urologia Internationalis (2012;
88:165-9). At the time of the presentation, he
was a urology resident at University Hospitals
of Leicester and Leicester General Hospital,
Leicester, United Kingdom, working with
Masood A. Khan, MD, and colleagues. Dr.
Pal is continuing his residency at Royal Derby
Hospital, Derby, United Kingdom.
He explained that although several studies
have demonstrated the feasibility and efficacy
of ThuVaRP, scant data on postoperative sexual
dysfunction have been reported. He and his coauthors conducted a retrospective study of patients
who underwent ThuVaRP at their institute from
UTSTAT
Diabetes and preoperative
catheterization were found to
be correlated comorbidities for
retrograde ejaculation (p=.04 and
p=.03, respectively); no comorbidities
were associated with erectile dysfunction.
January 2009 to June 2010. Of 113 patients, only
those who were able to sustain an erection for
the duration of sexual intercourse were included
in the analysis (54 men). Their mean age was 71
years, and all had benign pathology.
please see sexual dysfunction, page 23
TURP, PVP functional outcomes found equivalent
photoselective vaporization displays more favorable perioperative profile, however
Nancy Groves
Ut COrreSpONDeNt
Atlanta— Photoselective vaporization of the
prostate (PVP) and transurethral resection of
the prostate (TURP) have no difference overall in intermediate-term functional outcomes
for surgical treatment of lower urinary tract
symptoms secondary to BPH, according to the
results of a systematic review of studies with
meta-analysis comparing the two procedures.
Of nine randomized, controlled trials in
which PVP was the intervention and TURP
was the control, six found no difference in
functional outcomes, while two favored TURP
and one favored PVP, said first author Isaac
Thangasamy, MD, of Hornsby Ku-Ring-Gai
Hospital, Sydney, Australia.
The safety and efficacy review encompassed
biomedical databases from 2002 to 2012, combined with a search of the AUA and European
Association of Urology conference proceedings
from 2007 to 2011. The meta-analysis was performed with a random effects model; outcome
variables were perioperative data, short- and
long-term complications, and functional outcomes at 12 months.
The nine trials meeting the inclusion criteria
included 448 patients who had undergone PVP
with either an 80W or 120W laser and 441 who
had undergone TURP. Due to heterogeneous
data reporting, only three of the nine trials could
magenta
cyan
yellow
black
than TURP while still generating
similar functional results of maxi“The benefit of a shorter length of hospital
mum urinary flow rates, symptom scores, and postvoid residual
stay is further proof that PVP is a very suitable volumes. The benefit of a shorter
length of hospital stay is further
alternative.”
proof that PVP is a very suitable
alternative,” said Dr. Thangasamy,
isaac thangasamy, md
who worked on the study with Henbe suitably analyzed to generate a mean difry Woo, MD, and colleagues.
ference. However, six out of nine individually
Dr. Thangasamy also told Urology Times
reported no difference in functional outcomes. that further randomized trials analyzing PVP
Although the overall results suggest that the and TURP in certain high-risk patients, such
two procedures are equivalent in functional as those on anticoagulants and those with
outcomes, differences were found in several larger prostates, will shed further light on the
perioperative variables, said Dr. Thangasamy improved safety profile of PVP.
of the study, which was presented at the AUA
“Many nonrandomized trials have already
annual meeting in Atlanta and published in demonstrated this and, as such, obtaining ethiEuropean Urology (2012; 62:315-23).
cal approval for randomized trials may prove to
be difficult. We are also awaiting the results of
Differences seen in perioperative variables a number of international multicenter randomPVP had a more favorable perioperative profile. ized trials analyzing the latest 180-watt laser
The catheterization time and the length of the versus TURP.”
hospital stay were both significantly shorter in the
Dr. Thangasamy also noted that one of the
PVP group by 1.91 days and 2.13 days, respec- problems with most studies on PVP is that they
tively (both, p<.0001). The likelihood of blood have included procedures performed by surtransfusion was also lower in the PVP patients geons in their learning curve.
(p=.03). However, the operative time was shorter
“Now that PVP is a readily available technolin the TURP group by 19.64 minutes (p=.0003). ogy, future randomized controlled trials should
“We believe that PVP is a very acceptable be multicenter and involve surgeons who are
alternative to TURP,” Dr. Thangasamy said.
equally as experienced in performing PVP as sur“PVP is associated with far less morbidity geons are with performing TURP,” he said. UT
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September 2012
se x Ua l dy sf U nc T ion
continued from page 22
The incidence of erectile dysfunction and retrograde ejaculation was reported at 12 months
postoperatively. The effect of variables including cardiovascular disease risk factors, preoperative catheterization, and resection weight on
the patients’ postoperative sexual function was
also evaluated.
While 20% experienced worsening erectile
BPH health month
have an adverse impact on erectile function
as well as ejaculatory function,” he added.
“However, in a minority, sexual function may
improve.”
In addition to the association discovered
between two preoperative factors—diabetes
and preoperative catheterization—and the
outcome of the procedure, the investigators
found an increased trend of erectile dysfunction in men over the age of 70 years who were
diagnosed with hypertension and hypercholes-
23
terolemia; however, this was not statistically
significant.
While these findings may be helpful in
understanding the risk profile of ThuVaRP, the
study has several limitations, Dr. Pal said.
These include the retrospective design, small
size, and the lack of a standardized assessment
tool. A larger, prospective study is needed, and
the data from traditional transurethral resection
procedures, for which ThuVaRP is an alternative, require updating, Dr. Khan said. UT
“Patients will have to be fully
counseled preoperatively that
laser prostate surgery may have an
adverse impact on erectile function
as well as ejaculatory function.”
masood Khan, md
function and 56% had retrograde ejaculation,
the remainder of patients had either no change
or an improvement in their erectile function or
their ejaculate, Dr. Pal reported.
It’s time to turn OAB on its head.
Importance of problem depends on age
Discussing the significance of these findings,
Dr. Khan told Urology Times that their importance depends on the age and underlying sexual
activity of the individual patient.
“It appears that amongst the older population, only approximately 50% are sexually
active. Hence, erectile dysfunction is less likely
to be an issue in this age group,” said Dr. Khan.
“However, younger men will also require prostate surgery and are more likely to be sexually
active. In this younger age group, it is likely
to pose a greater problem. Retrograde ejaculation, although an irritation, is better tolerated
and accepted than erectile dysfunction and is
unlikely to have a major impact on the patient.”
“Patients will have to be fully counseled
preoperatively that laser prostate surgery may
Coming next month
Look for these articles in the October issue of Urology Times:
• NEW COLUMN: Attorney Dawn Collins, JD, discusses malpractice and risk management using a
case-based approach
• Q&A: Howard Goldman, MD, talks about the
ongoing scrutiny of transvaginal surgical mesh
as a treatment for pelvic organ prolapse and
stress incontinence and the possible effects of
FDA reclassification of mesh
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OAB remains a problem for many patients
As the number of patients diagnosed with overactive bladder (OAB) continues to grow,
so does the need for improved prevention, diagnosis, and management.1 For many Americans
now living with OAB, the disease can have a significant negative impact on their quality of life.2,3
Current OAB treatments may work well for some, but they are not for everyone.4
Why are many patients suffering despite current
therapeutic options?
One potential reason is lack of persistence with OAB therapy.5 While discontinuation of therapy
is a significant issue among patients with chronic conditions, OAB therapy has demonstrated a
higher rate of discontinuation compared with other drug classes.5 In a 2008 study investigating
discontinuation rates of OAB therapy in the UK,* the median time to discontinuation was
4.76 months, with 77% of patients discontinuing their OAB treatment by 1 year.6
*A national health record database of women under the care of general practitioners in the UK
(National Health Service).6
References: 1. Irwin DE, Kopp ZS, Agatep B, Milsom I, Abrams P. Worldwide prevalence
estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder
outlet obstruction. BJU Int. 2011;108:1132-1138. 2. Coyne KS, Sexton CC, Irwin DE, Kopp ZS,
Kelleher CJ, Milsom I. The impact of overactive bladder, incontinence and other lower urinary
tract symptoms on quality of life, work productivity, sexuality and emotional well-being in
men and women: results from the EPIC study. BJU Int. 2008;101:1388-1395. 3. Stewart WF,
Van Rooyen JB, Cundiff GW, et al. Prevalence and burden of overactive bladder in the United States.
World J Urol. 2003;20:327-336. 4. Benner JS, Nichol MB, Rovner ES, et al. Patient-reported
reasons for discontinuing overactive bladder medication. BJU Int. 2009;105:1276-1282. 5. Yeaw J,
Benner JS, Walt JG, Sian S, Smith DB. Comparing adherence and persistence across 6 chronic
medication classes. J Manag Care Pharm. 2009;15:728-740. 6. Gopal M, Haynes K, Bellamy SL,
Arya LA. Discontinuation rates of anticholinergic medications used for the treatment of lower
urinary tract symptoms. Obstet Gynecol. 2008;112:1311-1318.
© 2012 Astellas Pharma US, Inc.
Printed in USA
012F-500-5743
All rights reserved.
July 2012
ES119486_UT0912_023.pgs 08.28.2012 10:06
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24
❳What’s Your Experience?❲
E X AM I N I NG URO LOG ISTS’ O PI N IO NS
O N TO DAY’S CR ITIC AL ISSUES I N M E D ICI N E
SEPTEMBER 2012
∣
Urology Times
Focus on men’s health can
strengthen urology, patient care
Karen Nash | UT COLUMNIST
T
he AUA this summer published
the Men’s Health Checklist, a
new resource designed to support urologists and other physicians in strengthening their
role as a resource for male patients and
to better coordinate patient care among
all physicians. It lists
age-related symptoms and complaints
that are both specific
to urology and more
general in nature, the
latter involving care
being coordinated
with a primary care
physician.
Urology Times
wanted to know to
what extent uroloThomas Johnson, MD
gists see themselves
Los Angeles
as a resource for
Richard Pelman, MD
men’s health. Do
Bellevue, WA
you consider the
possibility that conMark Swofford, DO
ditions other than
Pikeville, KY
st r ictly u rologic
Murphy Townsend, MD
problems are causMarietta, GA
ing or contributing
Mark Ventura, MD
to symptoms? And
North Dartmouth, MA
how willing are you
to coordinate with
other physicians when patients’ conditions
suggest other care is needed?
Richard Pelman, MD, in Bellevue, WA,
was involved in the first committee that
began putting together an AUA men’s
health initiative 3 years ago. He says the
current effort will improve the visibility
of urology.
“Part of it is our need to become the
representative of male interests,” Dr. Pelman said. “Urology is a great specialty to
be that physician. We’re not trying to take
anything away from other specialties. In
fact, we want to enhance the opportunities for other specialists to intervene in
prevention.
“Too many men wait until their first
chest pain before they see a doctor or wait
until they have blood in the stool before
they have a colonoscopy.”
Question
How important is your
role as a coordinator of
care for male patients?
Respondents
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Osteopathic Medicine, has long dis“We’re not trying to take anything cussed the role obesity and smoking may
away from other specialties. In
play in urologic problems, such as erecfact, we want to enhance the
tile dysfunction. He
opportunities for other specialists points out that with
the Physician Qualto intervene in prevention.”
ity Reporting System
(PQRS), there are
RICHARD PELMAN, MD
now financial benBut Dr. Pelman says if a patient visefits for doing so.
its a urologist for erectile dysfunction or
“The PQRS has bonus points for talknocturia and the urologist can see that ing about smoking and obesity. We actuhypertension, smoking, or obesity may ally have a bariatric center here, so we are
be significant contributing risk factors, very adamant about the problems obesity
an appropriate referral for those issues causes. There is a 2% bonus from Medican be initiated.
care for having and documenting those
Dr. Pelman, also a clinical professor discussions,” he said.
at the University of Washington, says the
He likes the idea of the AUA checkMen’s Health Checklist comes at a per- list and says he doesn’t hesitate to contact
fect time when health care organizations the patient’s primary care physician if he
are working to develop coordinated care thinks non-urologic care is needed.
efforts.
“Health policy promotion makes us a
stronger specialty; it also helps our relationship with patients. If we look at the “The PQRS has bonus points
potential of accountable care organizations, this gives us a stronger base as care- for talking about smoking and
givers to be more involved in male care,” obesity.”
he said.
In Pikeville, KY, Mark Swofford, DO, MARK SWOFFORD, DO
says that as the only urologist in his community, coordinating care with primary
care physicians and other specialists is
“In fact, I even spend time finding prialready a way of life.
mary care doctors for patients who don’t
“If I see someone for a urologic prob- have one,” he noted.
lem, if they also have a cardiac problem, I
have the patient cleared before I do the sur- Urologists on the front lines
gery. Patients come in all the time from the Murphy Townsend, MD, in Marietta, GA,
ER with hematuria, retention, and things says it’s not uncommon for urologists in
that they could actually see their family his area to be the first clinician to see a
doctor about, but I think the ER docs can patient, and they need to be ready to assess
get them in quicker to see me than to pri- whether the patient needs non-urologic
mary care,” Dr. Swofford explained.
care.
“I’ll see them, then turn around and call
“I frequently find that patients don’t
the primary care doctor and send a letter always have a primary care physician, so
saying, ‘By the way, I talked your patient I may be the only one seeing them. I’m the
and this is what we need to do.’ ”
one who has to initiate them obtaining a priDr. Swofford, on the clinical faculty at mary care physician,” Dr. Townsend said.
the University of Pikeville’s College of
Please see MEN’S HEALTH, page 27
ES118968_UT0912_024.pgs 08.27.2012 10:40
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I am Bob’s CIS bladder cancer.
I have resisted both TURBTs and BCG.
I’m still here because Bob’s not
a candidate for cystectomy.
Move forward
to VALSTAR
®
It’s your move.
Clinically proven efficacy1,2
18%
of BCG-refractory CIS patients were
disease free at 6 months (n=16/90)1
• Efficacy was assessed every 3 months; patients with
a documented recurrence* were withdrawn from
the study 2
• Patients who were disease free had a complete response
(ie, no evidence of disease at 6 months as documented by
biopsy and cytology)1,2
Study design: Three-year, open-label, noncomparative study of 90 patients with pathologically proven CIS. Patients had
received at least 2 prior courses of intravesical therapy for CIS, including at least 1 course of BCG. Each patient received
800 mg of VALSTAR once a week for 6 weeks. Primary disease evaluation took place 6 weeks after the last instillation of
VALSTAR. Subsequent evaluations for disease response occurred at 3-month intervals. 2
*Recurrence was defined as either biopsy-confirmed bladder cancer or positive urine cytology on 2 consecutive evaluations. 2
Indication
VALSTAR® (valrubicin) is indicated for intravesical therapy of
BCG-refractory carcinoma in situ (CIS) of the urinary bladder in
patients for whom immediate cystectomy would be associated with
unacceptable morbidity or mortality.
Important Safety Information
• VALSTAR is contraindicated in patients with known hypersensitivity
to anthracyclines or polyoxyl castor oil. VALSTAR should not be
administered to patients with a perforated bladder, compromised
bladder mucosa integrity, concurrent urinary tract infections, or
small bladder capacity (unable to tolerate a 75 mL instillation).
The integrity of the bladder should be confirmed prior to instillation
of VALSTAR in those patients who have had procedures with the
potential to compromise the bladder wall.
• Patients should be informed that VALSTAR has been shown
to induce complete response in about 1 in 5 patients with
BCG-refractory CIS. Delaying cystectomy could lead to
development of metastatic bladder cancer. If there is not a
complete response of CIS to treatment after 3 months or
if CIS recurs, cystectomy must be reconsidered.
• VALSTAR should be administered using aseptic technique
under the supervision of a practitioner experienced in the use of
intravesical cancer chemotherapeutic agents. VALSTAR should
be used with caution in patients with severe irritable bladder
symptoms. Patients of reproductive age should be advised to use
an effective contraception method. Myelosuppression is possible if
VALSTAR is inadvertently administered systemically or if significant
systemic exposure occurs following intravesical administration
(e.g., in patients with bladder rupture/perforation). If VALSTAR is
administered when bladder rupture or perforation is suspected,
weekly monitoring of complete blood counts should be performed
for 3 weeks.
• In clinical trials, the most common local adverse events include
urinary frequency, urinary urgency and dysuria. The most common
systemic adverse events include urinary tract infection, abdominal
pain, nausea, asthenia, headache, malaise and urinary retention.
• Patients receiving VALSTAR must be closely monitored for disease
recurrence or progression. The recommended evaluation should
include cystoscopy, biopsy, and/or urine cytology every 3 months.
Please see brief summary of the full Prescribing Information on the adjacent page.
References: 1. VALSTAR Prescribing Information. Endo Pharmaceuticals. August 2011. 2. Steinberg G,
Bahnson R, Brosman S, et al; and the Valrubicin Study Group. Efficacy and safety of valrubicin for the
treatment of Bacillus Calmette-Guerin refractory carcinoma in situ of the bladder [published correction
appears in J Urol. 2008;178:386]. J Urol. 2000;163:761-767.
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ES115932_UT0912_025_FP.pgs 08.23.2012 03:33
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BRIEF SUMMARY for VALSTAR® (valrubicin)
Sterile Solution for Intravesical Instillation
For Intravesical Use Only
Not for IV or IM Use
This Brief Summary does not include all the information needed to
use VALSTAR safely and effectively. See full Prescribing Information
for VALSTAR available at www.valstarsolution.com.
INDICATIONS AND USAGE
VALSTAR is indicated for intravesical therapy of BCG-refractory
carcinoma in situ (CIS) of the urinary bladder in patients for whom
immediate cystectomy would be associated with unacceptable
morbidity or mortality.
CONTRAINDICATIONS
VALSTAR is contraindicated in patients with known hypersensitivity
to anthracyclines or polyoxyl castor oil.
Patients with concurrent urinary tract infections should not receive
VALSTAR.
VALSTAR should not be administered to patients with a small
bladder capacity, i.e., unable to tolerate a 75 mL instillation.
WARNINGS
Patients should be informed that VALSTAR has been shown
to induce complete response in only about 1 in 5 patients with
BCG-refractory CIS, and that delaying cystectomy could lead to
development of metastatic bladder cancer, which is lethal. The
exact risk of developing metastatic bladder cancer from such a
delay may be difficult to assess but increases the longer cystectomy
is delayed in the presence of persisting CIS. If there is not a
complete response of CIS to treatment after 3 months or if CIS
recurs, cystectomy must be reconsidered.
VALSTAR should not be administered to patients with a
perforated bladder or to those in whom the integrity of the bladder
mucosa has been compromised (see PRECAUTIONS and
CLINICAL PHARMACOLOGY, Pharmacokinetics Figure 2 in the full
Prescribing Information).
In order to avoid possible dangerous systemic exposure to
VALSTAR for the patients undergoing transurethral resection of the
bladder, the status of the bladder should be evaluated before the
intravesical instillation of drug. In case of bladder perforation, the
administration of VALSTAR should be delayed until bladder integrity
has been restored.
VALSTAR should be administered under the supervision of
a physician experienced in the use of intravesical cancer
chemotherapeutic agents.
PRECAUTIONS
General: Aseptic techniques must be used during administration
of intravesical VALSTAR to avoid introducing contaminants into the
urinary tract or traumatizing unduly the urinary mucosa.
Information for Patients: Patients should be informed that
VALSTAR has been shown to induce complete responses in only
about 1 in 5 patients, and that delaying cystectomy could lead to
development of metastatic bladder cancer, which is lethal. They
should discuss with their physician the relative risk of cystectomy
versus the risk of metastatic bladder cancer (see CLINICAL
TRIALS in the full Prescribing Information) and be aware that the
risk increases the longer cystectomy is delayed in the presence of
persisting CIS.
Patients should be informed that the major acute toxicities from
VALSTAR are related to irritable bladder symptoms that may occur
during instillation and retention of VALSTAR and for a limited period
following voiding. For the first 24 hours following administration,
red-tinged urine is typical. Patients should report prolonged irritable
bladder symptoms or prolonged passage of red-colored urine
immediately to their physician.
Women of childbearing potential should be advised not to become
pregnant during treatment. Men should be advised to refrain from
engaging in procreative activities while receiving therapy with
VALSTAR. All patients of reproductive age should be advised to
use an effective contraception method during the treatment period.
Irritable Bladder Symptoms: VALSTAR should be used with
caution in patients with severe irritable bladder symptoms. Bladder
spasm and spontaneous discharge of the intravesical instillate
may occur; clamping of the urinary catheter is not advised and,
if performed, should be executed under medical supervision and
with caution.
Drug Interactions: Because systemic exposure to VALSTAR is
negligible following intravesical administration, the potential for drug
interactions is low. No drug interaction studies were conducted.
Carcinogenesis, Mutagenesis, Impairment of Fertility: The
carcinogenic potential of VALSTAR has not been evaluated, but the
drug does cause damage to DNA in vitro. VALSTAR was mutagenic
in in vitro assays in Salmonella typhimurium and Escherichia coli.
VALSTAR was clastogenic in the chromosomal aberration assay in
CHO cells. Studies of the effects of VALSTAR on male or female
fertility have not been done.
Pregnancy: Pregnancy Category C. Valrubicin can cause fetal
harm if a pregnant woman is exposed to the drug systemically.
Such exposure could occur after perforation of the urinary
bladder during valrubicin therapy. Daily intravenous doses of
12 mg/kg (about one sixth of the recommended human intravesical
dose on a mg/m2 basis) given to rats during fetal development
caused fetal malformations. A dose of 24 mg/kg (about one third
the recommended human intravesical dose on a mg/m2 basis)
caused numerous, severe alterations in the skull and skeleton
of the developing fetuses. This dose also caused an increase in
fetal resorptions and a decrease in viable fetuses. Thus, valrubicin
is embryo-toxic and teratogenic. There are no preclinical studies
of the effects of intravesical valrubicin on fetal development and
no adequate and well controlled studies of valrubicin in pregnant
women. If valrubicin is used during pregnancy, or if the patient
becomes pregnant while receiving this drug, the patient should
be apprised of the potential hazard to the fetus. It should be used
during pregnancy only if the potential benefit justifies the potential
risk to the fetus. Women who might become pregnant should be
advised to avoid doing so during therapy with VALSTAR.
Nursing Mothers: It is not known whether VALSTAR is excreted
in human milk. Nevertheless, the drug is highly lipophilic and
any exposure of infants to VALSTAR could pose serious health
risks. Women should discontinue nursing before the initiation of
VALSTAR therapy.
Pediatric Use: Safety and effectiveness in pediatric patients have
not been established.
Geriatric Use: Because carcinoma in situ of the bladder generally
occurs in older individuals, 85% of the patients enrolled in the
clinical studies of VALSTAR were more than 60 years of age (49% of
the patients were more than 70 years of age). In the primary efficacy
studies, the mean age of the population was 69.5 years. There are
no specific precautions regarding use of VALSTAR in geriatric
patients who are otherwise in good health.
ADVERSE REACTIONS
Approximately 84% of patients who received intravesical VALSTAR in
clinical studies experienced local adverse events, but approximately
half of the patients reported irritable bladder symptoms prior to
treatment. The local adverse reactions associated with VALSTAR
usually occur during or shortly after instillation and resolve within
1 to 7 days after the instillate is removed from the bladder.
TABLE 1 displays the frequency of the local adverse experiences
at baseline and during treatment among 170 patients who received
800 mg doses of VALSTAR® (valrubicin) Sterile Solution for
Intravesical Instillation in a multiple-cycle treatment regimen. Only
7 of 143 patients who were scheduled to receive six doses failed to
receive all of the planned doses because of the occurrence of local
bladder symptoms.
TABLE 1
Occurrence of Local Adverse Reactions Before and During
Treatment with Intravesical VALSTAR (% of Patients)
Patients Who Received Multiple-Cycle
Treatment Regimen at 800 mg/dose
(N = 170)
Before
During 6-week
Reaction
Treatment Course of Treatment
ANY LOCAL
45%
88%
BLADDER SYMPTOM
Urinary Frequency
30%
61%
Dysuria
11%
56%
Urinary Urgency
27%
57%
Bladder Spasm
3%
31%
Hematuria
11%
29%
Bladder Pain
6%
28%
Urinary Incontinence
7%
22%
Cystitis
4%
15%
Nocturia
2%
7%
Local Burning Symptoms –
Procedure Related
0%
5%
Urethral Pain
0%
3%
Pelvic Pain
1%
1%
Hematuria (Gross)
0%
1%
Most systemic adverse events associated with use of VALSTAR
have been mild in nature and self-limited, resolving within 24 hours
after drug administration. TABLE 2 displays the adverse events
other than local bladder symptoms that occurred in 1% or more of
the 230 patients who received at least one dose of VALSTAR (200
to 900 mg) in a clinical trial. It cannot be determined whether these
events are drug-related.
TABLE 2
Most Commonly Reported Systemic Adverse Reactions
Following Intravesical Administration of VALSTAR
(% of Patients)
Body System
All Patients Who Received VALSTAR
Preferred Term
(N = 230)
Body as a Whole
Abdominal Pain
5%
Asthenia
4%
Back Pain
3%
Chest Pain
3%
Fever
2%
Headache
4%
Malaise
4%
Cardiovascular
Vasodilation
2%
Digestive
Diarrhea
3%
Flatulence
1%
Nausea
5%
Vomiting
2%
Hemic and Lymphatic
Anemia
2%
Metabolic and Nutritional
Hyperglycemia
1%
Peripheral Edema
1%
Musculoskeletal
Myalgia
1%
Nervous
Dizziness
3%
Respiratory
Pneumonia
1%
Skin and Appendages
Rash
3%
TABLE 2
Most Commonly Reported Systemic Adverse Reactions
Following Intravesical Administration of VALSTAR
(% of Patients)
Body System
All Patients Who Received VALSTAR
Preferred Term
(N = 230)
Urogenital
Hematuria (miscroscopic)
3%
Urinary Retention
4%
Urinary Tract Infection
15%
Adverse reactions other than local reactions that occurred in less
than 1% of the patients who received VALSTAR intravesically
in clinical trials are listed below. This list includes only adverse
reactions that were suspected of being related to treatment.
Digestive System: Tenesmus; Metabolic and Nutritional: Nonprotein
nitrogen increased; Skin and Appendages: Pruritus; Special Senses:
Taste loss; Urogenital System: Local skin irritation, poor urine flow,
and urethritis.
Inadvertent paravenous extravasation of VALSTAR was not
associated with skin ulceration or necrosis.
OVERDOSAGE
There is no known antidote for overdoses of VALSTAR. The
primary anticipated complications of overdosage associated
with intravesical administration would be consistent with irritable
bladder symptoms.
Myelosuppression is possible if VALSTAR is inadvertently
administered systemically or if significant systemic exposure occurs
following intravesical administration (e.g., in patients with bladder
rupture/perforation). The maximum tolerated dose in humans by
either intraperitoneal or intravenous administration is 600 mg/m2.
Dose limiting toxicities are leukopenia and neutropenia, beginning
within 1 week of dose administration, with nadirs by the second
week, and recovery generally by the third week. If VALSTAR is
administered when bladder rupture or perforation is suspected,
weekly monitoring of complete blood counts should be performed
for 3 weeks.
DOSAGE AND ADMINISTRATION
VALSTAR is recommended at a dose of 800 mg administered
intravesically once a week for six weeks. Administration should
be delayed at least two weeks after transurethral resection and/or
fulguration. For each instillation, four 5 mL vials (200 mg valrubicin/
5 mL vial) should be allowed to warm slowly to room temperature,
but should not be heated. Twenty milliliters of VALSTAR should
then be withdrawn from the four vials and diluted with 55 mL
0.9% Sodium Chloride Injection, USP providing 75 mL of a diluted
VALSTAR solution. A urethral catheter should then be inserted into
the patient’s bladder under aseptic conditions, the bladder drained,
and the diluted 75 mL VALSTAR solution instilled slowly via gravity
flow over a period of several minutes. The catheter should then be
withdrawn. The patient should retain the drug for two hours before
voiding. At the end of two hours, all patients should void. (Some
patients will be unable to retain the drug for the full two hours.)
Patients should be instructed to maintain adequate hydration
following treatment.
Patients receiving VALSTAR for refractory carcinoma in situ must
be monitored closely for disease recurrence or progression.
Recommended evaluations include cystoscopy, biopsy, and urine
cytology every 3 months.
Administration Precautions: As recommended with other
cytotoxic agents, caution should be exercised in handling and
preparing the solution of VALSTAR. Contact toxicity, common and
severe with other anthracyclines, is not typical with VALSTAR and,
when observed, has been mild. Skin reactions may occur with
accidental exposure. The use of goggles, gloves, and protective
gowns is recommended during preparation and administration of
the drug. Irritation of the eye has also been reported with accidental
exposure. If this happens, the eye should be flushed with water
immediately and thoroughly. Procedures for proper handling and
disposal of anticancer drugs should be used. Spills should be
cleaned up with undiluted chlorine bleach.
VALSTAR sterile solution contains polyoxyl castor oil, which has
been known to cause leaching of di(2-ethylhexyl) phthalate (DEHP)
a hepatotoxic plasticizer, from polyvinyl chloride (PVC) bags and
intravenous tubing. VALSTAR solutions should be prepared and
stored in glass, polypropylene, or polyolefin containers and tubing.
It is recommended that non-DEHP containing administration sets,
such as those that are polyethylene-lined, be used.
Preparation for Administration: VALSTAR Sterile Solution
for Intravesical Instillation is a clear red solution. It should be
visually inspected for particulate matter and discoloration prior to
administration. At temperatures below 4°C, polyoxyl castor oil may
begin to form a waxy precipitate. If this happens, the vial should be
warmed in the hand until the solution is clear. If particulate matter is
still seen, VALSTAR should not be administered.
Stability: Unopened vials of VALSTAR are stable until the date
indicated on the package when stored under refrigerated conditions
at 2°-8°C (36°-46°F). Vials should not be heated. VALSTAR diluted in
0.9% Sodium Chloride Injection, USP for administration is stable for
12 hours at temperatures up to 25°C (77°F). Since compatibility data
are not available, VALSTAR should not be mixed with other drugs.
For more information, call 1-800-462-3636
Manufactured for:
Endo Pharmaceuticals Solutions Inc.
Chadds Ford, PA 19317
By:
Ben Venue Laboratories, Inc.
Bedford, OH 44146
This brief summary is based on PI 111005
August 2011
VL-01987/January 2012
Rx Only
VALSTAR® is a registered trademark of Endo Pharmaceuticals Solutions Inc.
© 2012 Endo Pharmaceuticals Inc. All Rights Reserved. Chadds Ford, PA 19317
VL-00803b/April 2012 www.valstarsolution.com 1-800-462-ENDO (3636)
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ES115913_UT0912_026_FP.pgs 08.23.2012 03:31
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UrologyTimes.com
∣
27
SEPTEMBER 2012
ME N’S HE A LT H
how his primary care physician was handling the anemia, and he said, ‘Well, I
continued from page 24
“If you have a specialist in
don’t have a primary care doctor. You’re
the only doctor I see.’
[urologic] areas, patients
“They enter the health care arena through
“So I think it’s helpful to look at
the problem of voiding complaints or erectile other issues in men’s health and ask,
tend to be more open to
dysfunction, or they’ve heard about testosterone ‘You have ED; what is your primary
discussing their personal
replacement. So they will see me before they care physician doing about your cardiac
see anybody else.
workup?’ Or, ‘You have ED; are they
issues.”
“We’re a crucial link to get men into a pri- dealing with your blood pressure?’ Or,
mary care arena, which they definitely need. ‘You’re a smoker; do you realize this MARK VENTURA, MD
Obviously, they need to be followed by primary will give you ED?’
care doctors.”
“That’s certainly a major incentive for
medical issues. That will make us much stronthem to stop smoking.”
ger and more effective physicians.”
Dr. Townsend thinks the AUA initiative
is a good idea. In fact, he was already look- Patients’ comfort level important
“We’re a crucial link to get ing into starting a male health program at Mark Ventura, MD, in North Dartmouth, MA,
his own hospital.
has similar views.
men into a primary care
“I’m just getting things started on the
“The initiative is certainly a great idea in
idea
that
we
can
be
more
of
a
men’s
health
that
patients don’t always feel comfortable
arena, which they definitely
clinic and not just a urologist who deals discussing male issues with their primary
need.”
with prostates or stones or kidney can- care physicians, but if you have a specialist
cer. We can have more of a role, poten- in those areas, patients tend to be more open
MURPHY TOWNSEND, MD
tially partnering with cardiologists for to discussing their personal issues as regards
management of ED, partnering with the to sexual health or genitourinary health,” Dr.
Dr. Townsend says the need for urologists to bariatric surgeons because so many of their Ventura said.
take an active role in men’s health is especially patients are at risk for stone disease, partner“Hopefully, it will bring out a lot more
strong when patients don’t discuss ailments with ing with primary care physicians to alert them patients who otherwise might not be able to
a general practitioner first.
that androgen deprivation therapy may make express their concerns about very personal and
“You would think that most everyone in this a patient’s lipids problematic and may make private issues.”
area would have a primary care doctor, but him gain weight.
Dr. Ventura says that when patients do exhibit
Medicare patients don’t need a referral,” he
“We’re being forced, and we should be, to be non-urologic medical issues, he will turn to othpointed out. “I just had a patient who had awful involved with other physicians in coordinating er physicians, and being part of a large multianemia, which I noted preoperatively. I asked a patient’s care and being more in tune to more
Please see MEN’S HEALTH, page 28
Nearly half of U.S. population could be obese by 2030, researchers report
A recent forecasting study found that nearly half of the
U.S. population could be obese by 2030.
For the study, researchers forecast the cost savings
and rise in obesity prevalence over the next 2 decades.
“Keeping obesity rates level could yield a savings of
nearly $550 billion in medical expenditures over the next
2 decades,” according to lead author Eric Finkelstein, PhD,
of Duke Global Health Institute, Durham, NC, and DukeNUS Graduate Medical School in Singapore.
The researchers found that 42% of the U.S. population
could be obese by 2030.
The findings suggest the U.S. health care system could
be burdened with 32 million more obese people within 2
decades. Action is needed to keep rates from increasing
further, according to researchers from Duke University;
RTI International, Durham, NC; and the Centers for Disease Control and Prevention (CDC).
The study, based on data from the Behavioral Risk
Factor Surveillance System (BRFSS) and state-level
data from the Bureau of Labor Statistics and other
organizations, was published in the American Journal
of Preventive Medicine (2012; 42:563-70). It was also
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presented at the CDC’s Weight of the Nation conference in Washington.
The study also forecasts an increase in the number of
individuals with severe obesity, with rates rising to 11%
by 2030. Severe obesity is defined as a body mass index
over 40 kg/m2 or roughly 100 pounds overweight.
Severely obese individuals are at highest risk for the
health conditions caused by excess weight, resulting in
substantially greater medical expenditures and rates of
absenteeism.
“Should these forecasts prove accurate, the adverse
health and cost consequences of obesity are likely to
continue to escalate without a significant intervention,”
noted senior author Justin Trogdon, PhD, of RTI.
“We know more than ever about the most successful
strategies that will help Americans live healthier, more
active lives and reduce obesity rates and medical costs,”
said co-author William H. Dietz, MD, PhD, of the CDC.
“People need to make healthy choices, but the healthy
choices must first be available and accessible in order to
make them,” Dr. Dietz added.
The Weight of the Nation conference also saw the
release of The Institute of Medicine’s report, “Accelerating
Progress in Obesity Prevention: Solving the Weight of the
Nation,” which provides the results of a comprehensive
review of obesity prevention-related recommendations.
The report identifies strategies and action steps that have
the greatest potential to speed up progress in combating
the obesity crisis.
In related news, the CDC recently released a map
detailing adult obesity prevalence for all U.S. states based
on BRFSS data from 2011.
Obesity estimates ranged from 20.7% in Colorado to
34.9% in Mississippi. No state had a prevalence of adult
obesity less than 20%, and 12 states had a prevalence of
30% or more. The South had the highest prevalence of
adult obesity (29.5%), followed by the Midwest (29%),
the Northeast (25.3%), and the West (24.3%).
BRFSS is only one of several data sets that monitor
rates of obesity in the United States. When considering
these other data sets, including the National Health and
Nutrition Examination Survey, the obesity epidemic is
still a major public health problem, the CDC said in a press
release.
ES118967_UT0912_027.pgs 08.27.2012 10:41
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28
ME N’S HE A LT H
continued from page 27
specialty group makes it easy to provide that
level of coordinated care.
“I spend a lot of time taking care of the whole
patient here in my office,” he said. “We have a
large medical group with a lot of subspecialists,
and I can just pick up the phone if I need to and
call one of my associates. If I feel the patient
may have a vascular problem, or a cardiac issue,
or even psychiatric issues, I have resources I can
refer those patients to.
“And if it’s something a primary care physician needs to be involved with, they are the first
person I call.”
Level of coordinated care varies
Urology Times found, however, that different
practices may require varying levels of coordinated care. In Los Angeles, Thomas Johnson,
MD, says most of his patients are already under
the care of a primary care physician and don’t
want, or need, too much additional workup.
“We don’t get many patients off the street.
They usually are already attended. By and
large, 90% or more of our patients are referred
to us from primary care people,” Dr. Johnson
noted.
“Any time I recognize deficiencies in men’s
care, whether it’s self-imposed or economically
imposed, I always try to work within the per-
Speak Out
Do you use social
media to interact with
patients?
SEPTEMBER 2012
attention, such as the prostate cancer screening trials. Compared to Twitter—and Facebook
for that matter—rather than giving quick sound
bite-type comments, we can actually put a substantive article on the blog.
The other difficulty with social media is
that when I am at work, I’m at work; when
I’m not at work, I’d rather not be, and it’s just
time consuming to try to keep up with those
conversations.”
Manish Vira, MD
ur hospital uses Facebook and a couple
of our docs have Twitter accounts they
post on, but I don’t have
anything, certainly not
for patients or the outside
world.
We do keep a blog on
our departmental Web
site, as well as the health
system site, and we post
various things, sometimes
Dr. Vira
specific, topic-related articles. Most of the things I
post are commentaries on urologic oncology
articles that have generated a lot of media
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Urology Times
Dr. Johnson says he is a “fanatic” about addressing smoking,
obesity, and lifestyle-associated
“Any time I recognize deficiencies in men’s
but many of his patients
care… I always try to work within the personal illnesses,
wouldn’t take kindly to being
referred to other physicians.
framework of what’s important to them.”
“There’s a heavy amount
of
skepticism already in our
THOMAS JOHNSON, MD
community in terms of doctors
sonal framework of what’s important to them
being overzealous. You have to
and relevant to them.”
be careful because their first thought would be
Dr. Johnson says what he recommends or that ‘this guy is trying to send me to his buddy
feels is needed is influenced by his patient base to make money’,” he observed.
and their view of medicine.
“You have to temper enthusiasm about the
“I have sort of an inner-city practice; it’s not new science—metabolic syndrome and all of
a high-end practice. So a lot of times you have that—with the realities and practicalities of
to prioritize, and patients have to prioritize,” the individual’s life and what they’re expecting
he explained. “I try to help them by taking into from you.
account co-pays and associated illnesses.
Initiatives like the Men’s Health Checklist are
“For example, for the 76-year-old guy who’s a good idea as long as they’re practical, according
on multiple medications, has some ED, and to Dr. Johnson.
probably has a 5-year life expectancy, I would
“I want a commonsense approach to medicine
probably not be overly aggressive in terms rather than just a scientific approach. I hate to
of getting him to other doctors to work those see doctors tell a healthy 85-year-old to drink
things out because there are lots of financial more water, then want to give him pills because
considerations that are of paramount impor- he has to get up more often at night to urinate,”
tance to him.
he said.
“A lot of doctors don’t pay attention to that
nearly enough. Because we are financially comfortable, people assume that everybody else has
the same comfort level and a lot of times, especially if it’s economics, our patients are reluctant
Karen Nash is a medical reporter and media
consultant based in Sioux Falls, SD.
to let you know about those issues.”
New Hyde Park, NY
“O
∣
“I
live and practice in a rural area where it
just wouldn’t be used all that much.
I don’t even have a personal Facebook page.
I work in a community of 11,000 people who are
all related to each other. I’d have to have 11,000
friends.
I’ve thought about getting into LinkedIn
because people will use that to look for evaluations, but I haven’t gotten around to it.
The hospital has a Web page, but they’ve just
run the cables that give smartphones a signal in
the past couple months. We don’t even have a
pager system that works out here in southern
Illinois. Once that gets up and running, I may
start using social media, because that is the way
people communicate these days.”
Mary Waller, MD
Olney, IL
“O
f the 11 partners in
our practice, three
use Twitter. One uses it regularly, mostly about prostate
cancer issues. He’s younger
and very media savvy.
Dr. Danoff
I use it infrequently. I wrote
a book about men’s sexual
health, and I tweet primarily to promote my book.
My son actually does most of my tweeting for me.
I don’t know how effective it is, but if you want
to keep up with what’s out there, it’s another way
of getting your message out.
I’m much more active in blogging. If you’re promoting your practice, it’s all about name recognition. It’s important to get your name in front of the
public, potential patients, and potential referring
sources. So the more you tweet or blog, the more
likely someone will remember you name when it’s
time to go to the urologist or to refer a patient.”
Dudley Danoff, MD
Los Angeles
ES118969_UT0912_028.pgs 08.27.2012 10:41
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UrologyTimes.com
∣
GUIDE L INE S
continued from page 1
Q
A
33
SEPTEMBER 2012
Why are they necessary?
The volume of information that any urologic practitioner has to assimilate from
the literature is overwhelming, and every year it
increases. In addition to the huge volume of liter-
urologists and other stakeholders that often
leads to important revisions in the guideline.
Q
A
How are the guidelines updated?
We have a program called the Update Literature Review Program, where a threeperson panel looks at the new literature that has
been published since the last guideline. This is
usually done every 18 to 24 months. It
involves conducting a mini systematic
review of just that updated literature and
generating an evidence report based on
that review. The panel, upon reviewing
the report, decides one of three things:
that the guideline is current, that the
guideline needs to be amended with
STEPHEN Y. NAKADA, MD
one or two statements, or that the guideline needs to be completely revised. In
addition to that, per AUA protocol and
national guidelines, all clinical practice
guidelines need to be revised at a miniature, that literature can be difficult to interpret mum of every 8 years.
and is often contradictory. For the vast majorHow can a practicing urologist
ity of practitioners who are not in subspecialty
become versed in guidelines?
practice, we need help to make sense of it all.
Why are guidelines
necessary?
Q
A
Take us through the process of
creating a clinical guideline.
It’s a very rigorous nine-step process
that we’ve been instituting for about 2
years now. I won’t go through every step, but
let’s review a few highlights. We first very
carefully identify the topic, which is usually
nominated by an AUA member. The criteria
we look at when selecting a topic are the problem or condition being common, being pertinent to domestic practice, and one in which
there is significant variability in practice.
These criteria speak to the goals of the
guidelines, which are to assist as many practitioners and as many patients as possible and to
reduce variation of care. You and I know that
some variation in care is quite appropriate. If
a man presents with an unusual renal cancer
or if a woman has an unusual presentation of
a urinary tract infection, then such a patient
could be managed “outside standard practice.”
But we both also know that there’s a lot of
inappropriate variation in urologic care in this
country, and guidelines can help reduce that.
All of the steps in the process of guideline
creation are important, of course, but other
steps that should be highlighted include the
utilization of an objective systemic review and
explicit level-of-evidence rating to create the
evidence report, the panel’s creation of welldefined guidelines statements that are explicitly linked to the certainty of the evidence, and
the extensive review of the draft document by
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Q
A
The guidelines are easily available
to practicing urologists at the AUA’s
Web site, www.auanet.org. Clicking on the
Clinical Practice Guidance tab will give
you a list of all the guidelines products.
The list is arranged in the following order:
clinical practice guidelines, best practice
report that summarizes not only what is known
but how certain we are about what is known;
in other words, the level of evidence underlying this report. From that evidence report, a
multidisciplinary panel creates the guideline
statements. Clinical guidelines are our main
product and the most rigorously defined.
A best practice statement, by contrast, is a
much less rigorous review that uses a much less
rigorous process to create the statements. The
AUA, in fact, is no longer producing best practice statements. The last one was produced 2
years ago. Going forward, we will be producing
only guideline statements and the occasional
collaborative project with another group that
might not follow our full guideline process,
either because of a lack of evidence or owing to
the intentions of the collaborating organization.
Q
A
How are the guidelines tied to the
maintenance of certification process?
One of the great utilities of guidelines to
our membership is that they are playing
an increasingly important role in certification,
recertification, and maintenance of certification. That’s because they represent the best evidence we have and the most clear and concise
answers that we have in our literature. Whether
you’re coming out of residency to be certified,
recertifying, or maintaining your certification, what better place to go to than a list of the
absolute standards that have been established
by experts based upon evidence?
As such, we’re using the guidelines to write
In addition to the huge volume of literature,
that literature can be difficult to interpret and
is often contradictory. We need help to make
sense of it all.
J. STUART WOLF, JR, MD
statements, and a number of other collaborative works that might help the urology
practitioner.
Q
Let’s talk about the different types
of products a little more. What’s
the difference between a guideline and
a best practice statement?
A
A guideline is based upon an explicitly
created systematic review, which is analyzed by a methodologist and the panel chair and
from which is derived a very concise evidence
the questions for board exams and using them
to write the questions for recertification exams.
And for maintenance of certification, they’re
an explicit part of the questions that urologists
have to answer on the American Board of Urology Web site relating to practice assessment
protocol.
Q
You touched on this, but let’s
revisit the issue of exceptions
to the guidelines. How do you see
exceptions to the guidelines and how
Please see GUIDELINES, on page 37
ES120159_UT0912_033.pgs 08.29.2012 09:15
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In advanced prostate cancer
TREAT EARLY WITH
PROVENGE TO
PROVENGE
Activate
PROVENGEactivated T cells
Resting
T cell
T-cell
activation
Amplify
Activated T cell
attacks prostate cancer
Attack
Prostate
cancer
cell cell
Prostate
cancer
EXTEND SURVIVAL
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ES115921_UT0912_034_FP.pgs 08.23.2012 03:32
ADV
PROVENGE activates the immune system
to fight advanced prostate cancer
Routinely scan to identify patients early
OVER
30
%
>
2
• Over 30% of men thought to have nonmetastatic castrate
resistant prostate cancer (CRPC) were found to have metastatic
disease when screened via imaging for a recent clinical trial1
PROVENGE extends median survival beyond 2 years2
years
1.5
%
• PROVENGE reduced the risk of death by 22.5% vs the control
group (P=0.032)2
PROVENGE provides a safety profile you can manage
• Only 1.5% of patients treated with PROVENGE in the pivotal
trial discontinued treatment due to adverse events3
• The most common adverse events in PROVENGE trials were
chills, fatigue, fever, back pain, nausea, joint ache, and headache3
INDICATION: PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of
asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
IMPORTANT SAFETY INFORMATION: PROVENGE is intended solely for autologous use and is not routinely tested
for transmissible infectious diseases.
In controlled clinical trials, serious adverse events reported in the PROVENGE group included acute infusion reactions
(occurring within 1 day of infusion) and cerebrovascular events. Severe (Grade 3) acute infusion reactions were reported
in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia,
bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion
reactions were reported in patients in the PROVENGE group.
The most common adverse events (incidence ≥15%) reported in the PROVENGE group were chills, fatigue, fever, back pain,
nausea, joint ache, and headache.
For more information on PROVENGE, please see Brief Summary of Prescribing Information on adjacent page.
www.PROVENGE.com
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ES115922_UT0912_035_FP.pgs 08.23.2012 03:32
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PROVENGE® (sipuleucel-T)
Suspension for Intravenous Infusion
Rx Only
BRIEF SUMMARY — See full Prescribing Information for complete product information
INDICATIONS AND USAGE: PROVENGE® (sipuleucel-T) is an autologous cellular
immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic
metastatic castrate resistant (hormone refractory) prostate cancer.
DOSAGE AND ADMINISTRATION
•For Autologous Use Only.
•TherecommendedcourseoftherapyforPROVENGEis3completedoses,givenat
approximately2-weekintervals.
•Premedicatepatientswithoralacetaminophenandanantihistaminesuchas
diphenhydramine.
•Beforeinfusion,confirmthatthepatient’sidentitymatchesthepatientidentifierson
the infusion bag.
•Do Not Initiate Infusion of Expired Product.
•InfusePROVENGEintravenouslyoveraperiodofapproximately60minutes.
Do Not Use a Cell Filter.
•Interruptorslowinfusionasnecessaryforacuteinfusionreactions,dependingon
theseverityofthereaction.
(See Dosage and Administration [2] of full Prescribing Information.)
CONTRAINDICATIONS: None.
WARNINGS AND PRECAUTIONS
•PROVENGE is intended solely for autologous use.
•Acute infusion reactions(reportedwithin1dayofinfusion)included,butwerenot
limitedto,fever,chills,respiratoryevents(dyspnea,hypoxia,andbronchospasm),
nausea,vomiting,fatigue,hypertension,andtachycardia.Incontrolledclinicaltrials,
71.2%ofpatientsinthePROVENGEgroupdevelopedanacuteinfusionreaction.
Incontrolledclinicaltrials,severe(Grade3)acuteinfusionreactionswerereported
in3.5%ofpatientsinthePROVENGEgroup.Reactionsincludedchills,fever,fatigue,
asthenia,dyspnea,hypoxia,bronchospasm,dizziness,headache,hypertension,muscle
ache,nausea,andvomiting.Theincidenceofsevereeventswasgreaterfollowingthe
secondinfusion(2.1%vs0.8%followingthefirstinfusion),anddecreasedto1.3%
following the third infusion. Some (1.2%) patients in the PROVENGE group were
hospitalizedwithin1dayofinfusionformanagementofacuteinfusionreactions.
NoGrade4or5acuteinfusionreactionswerereportedinpatientsinthe
PROVENGE group.
Closelymonitorpatientswithcardiacorpulmonaryconditions.Intheeventofan
acuteinfusionreaction,theinfusionratemaybedecreased,ortheinfusionstopped,
dependingontheseverityofthereaction.Appropriatemedicaltherapyshouldbe
administered as needed.
•Handling Precautions for Control of Infectious Disease. PROVENGE is
notroutinelytestedfortransmissibleinfectiousdiseases.Therefore,patient
leukapheresis material and PROVENGE may carry the risk of transmitting infectious
diseasestohealthcareprofessionalshandlingtheproduct.Universalprecautions
should be followed.
•Concomitant Chemotherapy or Immunosuppressive Therapy. Use of either
chemotherapyorimmunosuppressiveagents(suchassystemiccorticosteroids)
givenconcurrentlywiththeleukapheresisprocedureorPROVENGEhasnotbeen
studied.PROVENGEisdesignedtostimulatetheimmunesystem,andconcurrent
useofimmunosuppressiveagentsmayaltertheefficacyand/orsafetyofPROVENGE.
Therefore,patientsshouldbecarefullyevaluatedtodeterminewhetheritismedically
appropriatetoreduceordiscontinueimmunosuppressiveagentspriortotreatment
with PROVENGE.
•Product Safety Testing. PROVENGE is released for infusion based on the microbial
andsterilityresultsfromseveraltests:microbialcontaminationdeterminationby
Gramstain,endotoxincontent,andin-processsterilitywitha2-dayincubationto
determineabsenceofmicrobialgrowth.Thefinal(7-dayincubation)sterilitytest
resultsarenotavailableatthetimeofinfusion.Ifthesterilityresultsbecomepositive
formicrobialcontaminationafterPROVENGEhasbeenapprovedforinfusion,
Dendreon will notify the treating physician. Dendreon will attempt to identify the
microorganism,performantibioticsensitivitytestingonrecoveredmicroorganisms,
and communicate the results to the treating physician. Dendreon may request
additional information from the physician in order to determine the source
of contamination.
(See Warnings and Precautions [5] of full Prescribing Information.)
ADVERSE REACTIONS
Becauseclinicaltrialsareconductedunderwidelyvaryingconditions,adversereactionrates
observedintheclinicaltrialsofadrugcannotbedirectlycomparedtoratesintheclinical
trialsofanotherdrugandmaynotreflecttheratesobservedinpractice.
black
ThesafetyevaluationofPROVENGEisbasedon601prostatecancerpatientsinthe
PROVENGEgroupwhounderwentatleast1leukapheresisprocedureinfourrandomized,
controlledclinicaltrials.Thecontrolwasnon-activatedautologousperipheralblood
mononuclear cells.
Themostcommonadverseevents,reportedinpatientsinthePROVENGEgroupatarate
≥15%,werechills,fatigue,fever,backpain,nausea,jointache,andheadache.Severe
(Grade3)andlife-threatening(Grade4)adverseeventswerereportedin23.6%and4.0%
ofpatientsinthePROVENGEgroupcomparedwith25.1%and3.3%ofpatientsinthe
controlgroup.Fatal(Grade5)adverseeventswerereportedin3.3%ofpatientsinthe
PROVENGEgroupcomparedwith3.6%ofpatientsinthecontrolgroup.
Seriousadverseeventswerereportedin24.0%ofpatientsinthePROVENGEgroupand
25.1%ofpatientsinthecontrolgroup.SeriousadverseeventsinthePROVENGEgroup
included acute infusion reactions (see Warnings and Precautions),cerebrovascularevents,
andsinglecasereportsofeosinophilia,rhabdomyolysis,myastheniagravis,myositis,and
tumor flare.
PROVENGEwasdiscontinuedin1.5%ofpatientsinStudy1(PROVENGEgroupn 341;
Controlgroupn 171)duetoadverseevents.Somepatientswhorequiredcentralvenous
cathetersfortreatmentwithPROVENGEdevelopedinfections,includingsepsis.Asmall
number of these patients discontinued treatment as a result. Monitoring for infectious
sequelaeinpatientswithcentralvenouscathetersisrecommended.
EachdoseofPROVENGErequiresastandardleukapheresisprocedureapproximately3days
priortotheinfusion.Adverseeventsthatwerereported≤1dayfollowingaleukapheresis
procedurein≥5%ofpatientsincontrolledclinicaltrialsincludedcitratetoxicity(14.2%),
oralparesthesia(12.6%),paresthesia(11.4%),andfatigue(8.3%).
Table1providesthefrequencyandseverityofadverseeventsreportedin≥5%ofpatients
inthePROVENGEgroupofrandomized,controlledtrialsofmenwithprostatecancer.
Thepopulationincluded485patientswithmetastaticcastrateresistantprostatecancer
and116patientswithnon-metastaticandrogendependentprostatecancerwhowere
scheduledtoreceive3infusionsofPROVENGEatapproximately2-weekintervals.The
populationwasage40to91years(median70years),and90.6%ofpatients
were Caucasian.
Table 1 Incidence of Adverse Events Occurring in ≥5% of Patients
Randomized to PROVENGE
PROVENGE (N = 601)
Any Adverse Event
Chills
Fatigue
Fever
Backpain
Nausea
Joint ache
Headache
Citrate toxicity
Paresthesia
Vomiting
Anemia
Constipation
Pain
Paresthesia oral
Pain in extremity
Dizziness
Muscle ache
Asthenia
Diarrhea
Influenza-likeillness
Musculoskeletal pain
Dyspnea
Edema peripheral
Hot flush
Hematuria
Muscle spasms
Control* (N = 303)
All Grades
n (%)
Grade 3-5
n (%)
All Grades
n (%)
591 (98.3)
319(53.1)
247 (41.1)
188(31.3)
178(29.6)
129(21.5)
118(19.6)
109(18.1)
89(14.8)
85(14.1)
80(13.3)
75(12.5)
74(12.3)
74(12.3)
74(12.3)
73(12.1)
71(11.8)
71(11.8)
65(10.8)
60(10.0)
58(9.7)
54(9.0)
52(8.7)
50(8.3)
49(8.2)
46(7.7)
46(7.7)
186 (30.9)
13(2.2)
6(1.0)
6(1.0)
18(3.0)
3(0.5)
11(1.8)
4(0.7)
0(0.0)
1(0.2)
2(0.3)
11(1.8)
1(0.2)
7 (1.2)
0(0.0)
5(0.8)
2(0.3)
3(0.5)
6(1.0)
1(0.2)
0(0.0)
3(0.5)
11(1.8)
1(0.2)
2(0.3)
6(1.0)
2(0.3)
291 (96.0)
33(10.9)
105(34.7)
29(9.6)
87(28.7)
45(14.9)
62(20.5)
20(6.6)
43(14.2)
43(14.2)
23(7.6)
34(11.2)
40(13.2)
20(6.6)
43(14.2)
40(13.2)
34(11.2)
17(5.6)
20(6.6)
34(11.2)
11(3.6)
31(10.2)
14(4.6)
31(10.2)
29(9.6)
18(5.9)
17(5.6)
Grade 3-5
n (%)
97 (32.0)
0(0.0)
4(1.3)
3(1.0)
9(3.0)
0(0.0)
5(1.7)
0(0.0)
0(0.0)
0(0.0)
0(0.0)
7(2.3)
3(1.0)
3(1.0)
0(0.0)
1(0.3)
0(0.0)
0(0.0)
2(0.7)
3(1.0)
0(0.0)
3(1.0)
3(1.0)
1(0.3)
1(0.3)
3(1.0)
0(0.0)
(Table 1 continued on next page.)
ES115912_UT0912_036_FP.pgs 08.23.2012 03:31
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UrologyTimes.com
∣
37
SEPTEMBER 2012
GUIDE L IN E S
continued from page 33
Table 1 Incidence of Adverse Events Occurring in ≥5% of Patients
Randomized to PROVENGE
PROVENGE (N = 601)
Hypertension
$QRUH[LD
%RQHSDLQ
Upper respiratory tract
infection
,QVRPQLD
Musculoskeletal chest
pain
Cough
Neck pain
Weight decreased
Urinary tract infection
Rash
Sweating
Tremor
Control* (N = 303)
All Grades
n (%)
Grade 3-5
n (%)
All Grades
n (%)
do you recommend that urologists handle a situation in which
guidelines are not being followed?
Grade 3-5
n (%)
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How are the guidelines tied
to the maintenance of
certification process?
STEPHEN Y. NAKADA, MD
A
To answer your question, I need to explain the three types of guideline statements. The main statements are a standard, a recommendation, and an option. A standard and a recommendation are actionable
statements. That means we’re advising urologists or health care practitioners to do or not do something. The third type of statement is an option,
which essentially lays out what would be reasonable for a given situation.
The level of evidence for a standard is of either high or moderate certainty.
In other words, when we write something as a standard, we’re pretty sure that’s
what a practitioner should do. The word “standard” can be confusing. Some
people confuse that term with “standard of care,” which is a medicolegal term. It
is not that at all; we use “standard” because it’s supported by high-level evidence.
If you are going to deviate from a standard, which in some situations might
be quite appropriate, we simply recommend that you document why you’re
deviating. If you deviate, then you should document. In the case of an option
or maybe even a recommendation, that is less critical because implicit in the
guidelines is that the level of evidence supporting that statement is less certain.
Q
Do you think patients should read the guidelines?
They’re an explicit part of the
questions that urologists have
to answer on the American
Board of Urology Web site
relating to practice
assessment protocol.
References: 1. Yu EY, Miller K, Nelson J, et al. Detection of previously
unidentified metastatic disease as a leading cause of screening failure
in a phase III trial of zibotentan versus placebo with nonmetastatic,
castration resistant prostate cancer. J Urol. 2012;188:103-109.
2. Kantoff PW, Higano CS, Shore ND, et al; for the IMPACT Study
Investigators. Sipuleucel-T immunotherapy for castration-resistant
prostate cancer. N Engl J Med. 2010;363:411-422. 3. PROVENGE
[package insert]. Dendreon Corporation; June 2011.
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A
I think a patient reading a guideline that is written for the health
care practitioner would probably be confused. Some of them can be
very technical. However, for most guidelines, we now have a patient guide
that goes along with it, and those can be really helpful in your office. We
certainly encourage members to take advantage of that resource.
Q
Along those same lines, should non-urologist physicians
read AUA guidelines?
Please see GUIDELINES, on page 38
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ES120156_UT0912_037.pgs 08.29.2012 09:14
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38
❳ Q&A ❲
AUA Guidelines
SEPTEMBER 2012
J. Stuart Wolf, Jr, MD
GUIDE L INE S
continued from page 37
A
That’s a good question. We are the
American Urological Association, so
we write our guidelines for American urolo-
fers from that of other practitioners. A great
example, of course, would be the detection of
prostate cancer, which we’re in the process of
writing a guideline on right now. There’s obviously a lot of controversy about prostate cancer
detection, and we felt it best to do that one on
our own. It is important to point out, however,
How do you recommend that
urologists handle a situation in which
guidelines are not being followed?
STEPHEN Y. NAKADA, MD
gists. That being said, we try to make our
guidelines useful to the range of health care
practitioners. We are very aware that some
guidelines are probably used quite a lot by physicians in primary care practice. For example,
we just came out with a guideline on overactive
bladder, and we took great pains to make sure
that this would be an appropriate guideline
for someone in primary care to use in his or
her practice. Nurse practitioners and physician
assistants can also benefit from the guidelines.
Q
Some of the guidelines have been
international collaborations with
the European Association of Urology.
Do you think all guidelines should be
international collaborations?
A
We are trying to partner with as many
organizations as possible on as many
guidelines as possible, in order to enhance
the acceptance and dissemination of our
guidelines. In addition to the one that you
mentioned, we currently have completed or
in-process partnerships on full guidelines
with the American Society of Nephrology,
the American Society for Radiation Oncology, and the Society of Urodynamics, Female
Pelvic Medicine and Urogenital Reconstruction. We have non-guideline publications
completed or in-process with the Society of
Urologic Nurses and Associates, the American Heart Association, the American Cancer
Society, the Wound Ostomy Continence Nurse
Society, the Endocrine Society, the Infectious
Diseases Society of America, and the International Consultation on Urological Diseases.
Finally, we are in the process of ironing out
new partnerships on full guidelines with four
additional organizations.
However, there are some issues in which
clearly the urologist’s central point of view dif-
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that even on that panel we have several disciplines besides urology represented on that panel,
including medical oncology, radiation oncology,
and public health. Even if we do not formally
involve the professional organization of another
specialty on a particular guideline, we always
have non-urologists on the panel to diversify and
strengthen the panel.
Q
A
How many AUA guidelines
are there right now?
There are currently 17 guidelines, four of
which came out at the 2012 AUA annual
meeting. Those guidelines are on vasectomy,
microscopic hematuria, overactive bladder,
and urodynamics. We also presented a clinical effectiveness protocol at the meeting on
imaging for ureteral calculi. In addition to that
one, we have 14 other best practice statements
and other documents posted on our Web site.
∣
Urology Times
per year, and we will probably stay at about that
rate. I think we have a very good product now.
The AUA is recognized as a leader among surgical specialties in the guidelines process. The
ECRI Institute, which coordinates guidelines
on a national level, recently gave the AUA a
very outstanding review of our processes.
However, like most organizations producing
guidelines, where we fall down is lack of dissemination and lack of implementation. Personally, my agenda for my 2 remaining years
as chair of the Practice Guidelines Committee is to really enhance the dissemination and
implementation of guidelines. To that end, we
are publishing the guidelines in a lot of different formats now. We have courses and lectures at the AUA annual meeting and sectional
meetings, we have apps for cell phones, we
have brochures and handouts, etc. I’m really
excited about some new initiatives we have
to incorporate guidelines into computerized
order entry systems. We’re convinced that
that’s where we can really make a difference
with guidelines.
Q
A
In your opinion, are there
too many guidelines?
No, I don’t think there are too many
guidelines. At present, I think we have
addressed the vast majority of topics that we
will address. There will be a few new ones
coming down the pike, but we might be close
to the point where we will be simply revising existing guidelines as opposed to adding
new ones.
I know there’s been a concern among urology practitioners that guidelines aren’t useful
and, in fact, can be harmful. They think that
they’re being told what to do. It’s important to
know that guidelines are not a cookbook.
If you are going to deviate from a standard,
which in some situations might be quite
appropriate, we simply recommend that you
document why you’re deviating.
J. STUART WOLF, JR, MD
Q
A
What does the future hold for
guidelines?
We are planning to introduce four guidelines at next year’s annual meeting. In general, we aim to produce three to four guidelines
They’re guidelines, not rules or laws. They’re
meant to assist you in your practice. If you, upon
a full appraisal of your patient’s situation, honestly feel that you should deviate from the
guidelines, by all means do so. The guidelines
are there to help you, not get in your way. UT
ES120158_UT0912_038.pgs 08.29.2012 09:14
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UrologyTimes.com
∣
❳ News ❲
SEPTEMBER 2012
ROBO T IC RP
continued from page 1
hospitals, of which 14 acquired robotic technology during the study period and 14 did not.
Excluded were data from one extremely highvolume hospital (Johns Hopkins, >100 RPs
per year), 16 extremely low-volume hospitals
(<1 RP per year), and others where no RP was
performed.
For the 14 hospitals that acquired robotic
technology during the study period, comparisons were made between the eight calendar
quarters before acquisition and the most recent
eight calendar quarters. The results showed a
statistically significant increase in median
quarterly RP volume (four to eight) and statistically significant decreases in the proportion of cases being performed by high-volume
surgeons (32.8% to 14.3%) and at high-volume
hospitals (64.9% to 60.0%).
Shorter length of stay observed with robot
The impact on patient outcomes was investigated by analyzing in-hospital mortality, intensive care unit admissions, length of stay, and
30-day readmissions, and the results showed
statistically significant decreases from the preto post-robotic technology acquisition periods
in both mean length of stay (2 to 1 day) and
30-day readmission rate (1.2% to 0.3%).
“We know that the introduction of robotic
technology has been associated with nationwide increases in post-RP hospital discharges,
and in this study, we have observed a similar
trend in Maryland hospitals,” said Dr. Mullins,
who worked on the study with Brian Matlaga,
MD, MPH, and colleagues.
“The impact of acquiring robotic technology on postsurgical morbidity has not been
fully defined, and although the Maryland
HSCRC lacks granular data on postoperative morbidity, our study shows reductions in
length of stay and 30-day readmissions in men
operated on at hospitals with robotic technology.
“These are important observations because
men who get out of the hospital faster and stay
out of the hospital are more likely to have a
smooth and accelerated recovery after surgery.
Furthermore, these endpoints have significant
health care cost implications that may begin
to justify the increased cost associated with
performing a robotic prostatectomy,” Dr. Mullins said.
A second analysis compared patient demographics and outcomes at robotic adopter and
non-adopter hospitals, but only including data
from procedures performed beginning in the
last quarter of 2008, which is when the ICD9 modifier for robotic surgery was first intro-
duced. The results showed that compared to
non-adopter hospitals, hospitals with robotic
technology were more likely to be high-volume
centers (63.8% vs. 0%) and had a higher proportion of high-volume surgeons (>40 cases per
year, 25.3% vs. 0%).
Compared with the non-adopting hospitals,
patients undergoing RP at hospitals with robotic
technology were again found to have a signifi-
cantly shorter length of stay (1 vs. 2 days) and
significantly lower 30-day readmission rate (0.2
vs. 6%).
Analyses of quarterly case volumes throughout the study period also showed an increase at
hospitals adopting robotic technology, from 8.9
to 10.7 cases (+20.5%), whereas there was a
52.8% decrease from three to 1.4 cases at hospitals that did not acquire a robot. UT
When bigger
is better.
BIGopsy is specifically designed to obtain larger samples
for pathological evaluation of tumors within the kidneys
and ureters. The device’s 4 mm3 cup provides a larger
sample than any other device on the market—enabling an
accurate diagnosis without costly repeated procedures.
Because of BIGopsy’s superior cup size, the device has
been designed to be backloaded through the working
channel of a ureteroscope before being used in a patient.
Cook Medical—Pioneering urological products for a
physician to use and a patient to trust.
www.cookmedical.com
© COOK 2012
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39
URO-BADV-BIGUT-EN-201208
ES120157_UT0912_039.pgs 08.29.2012 09:15
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40
❳Practice Management❲
SEPTEMBER 2012
∣
Urology Times
Avoid unbundling
instillation, in/out catheter
Be sure to code for instillation based on drug
being used and charge separately for drugs instilled
Q When instilling an agent into
Coding Q&A
the bladder via temporary catheter,
can one charge for the in-and-out
catheter (51701) as well as the
lavage (51700)? An example would
be giving a pentosan polysulfate
(Elmiron) cocktail for the treatment
of interstitial cystitis or administering
bacillus Calmette-Guérin (BCG
[TheraCys, TICE BCG]) for treatment
of bladder cancer.
Ray Painter, MD, Mark Painter
A
You have actually provided two
examples that require the use of different codes.
The first example of the pentosan
cocktail for IC is correctly coded using
51700—Bladder irrigation, simple, lavage,
and/or instillation. The simple answer to
your question about the 51701—Insertion
of non-indwelling bladder catheter (eg,
straight catheterization for residual urine)
is no; one cannot bill for the 51701 with the
51700. In fact, if you look at the bundling
matrix or the bundled codes for 51700
in AUACodingToday.com, code 51701
is included and can never be unbundled.
This is common for most of the urology
procedure codes.
Further, from a CPT perspective, you
cannot accomplish an instillation without
using some type of delivery device, so
it would be incorrect coding from
CPT’s perspective
to report the insertion of the catheter
unless you are using
THIS ISSUE
a separate catheter
to accomplish some
❯❯MONEY MATTERS
ot her me d ica l ly
Deciphering the alphabet
necessary service
soup of financial advisers
during the same
visit. Therefore, you
❯❯THE BOTTOM LINE
should not code the
Data-driven care: Who will
51701 with 51700 to
benefit, and how
any private payer
❯❯IN PRACTICE
unless it is clearly
a separate inserYour high-maintenance
tion for a separate
staffer: Worth the hassle?
reason.
Practice
Management
41
46
48
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Urologist Ray Painter, MD, is president of Physician Reimbursement Systems, Inc., in Denver and
is also publisher of Urology Coding and Reimbursement Sourcebook. Mark Painter is CEO of PRS
Urology SC in Denver.
In the second example you provide,
the BCG instillation should be coded as
51720—Bladder instillation of anticarcinogenic agent (including retention time).
Again, code 51701 is bundled into the
51720 and unbundling is never allowed.
Like code 51700, the CPT inference would
require the use of a catheter to instill the
anticarcenogenic agent.
In short, you should not bill the 51701
with either 51700 or 51720 to any payer
if the service you are providing that day
is solely the instillation of a substance in
the bladder. Make sure that you are coding correctly for the instillation based on
the type of drug you are using and charge
separately for the drugs that are instilled.
Q How would you code for
cystoscopy with instillation of
bupivacaine (Marcaine, Sensorcaine)
and gentamicin (Garamycin,
Gentak) into the bladder and trigger
point injection with a mixture of
triamcinolone (Kenalog), bupivacaine,
and onabotulinumtoxinA (Botox)?
(Editor’s note: This question is based
on an operative note and has been
edited for length.)
A
First, we will address the cystoscopy
with instillation of the bupivacaine and
gentamicin. The operative note indicates
that a complete diagnostic cystoscopy
with inspection of the bladder was performed. “After this was completed, a rigid
cystoscope was assembled, lubricated,
and placed through the urethra into the
urinary bladder in atraumatic fashion.
A survey of the entire bladder was performed. The patient’s old scar in the left
lateral wall of her bladder was identified.
There were no other abnormalities in her
bladder. Her bilateral ureteral orifices
were orthotopic position. The bladder
was then emptied.”
The operative note also indicates: “A
mixture of bupivacaine and gentamicin
was then instilled into the bladder through
the cystoscope.” Unfortunately, there is no
code that reflects both a cystoscopy and
instillation. Of course, a code for instillation, 51700, is available (see related
question above). The 51700 code does not
specify that the delivery device must be
a catheter, and code 52000—Cystourethroscopy (separate procedure) does not
include reference to an instillation of any
type. The operative note indicates that the
diagnostic and therapeutic portions of the
procedure were separate. Therefore, we
would recommend coding both the 52000
and the 51700−59 for this portion of the
procedure.
The other part of the procedure indicates injection of triamcinolone and bupivacaine into three separate injection sites:
at 4 o’clock and 7 o’clock of the levator
ani and into the left thigh. This was then
followed by injection of onabotulinumtoxinA into the same three areas.
Please see INSTILLATION, page 41
Send coding and reimbursement questions
to Ray Painter, MD, and Mark Painter c/o
Urology Times, at [email protected].
Questions of general interest will be
chosen for publication. The information in this column is designed to be
authoritative, and every effort has
been made to ensure its accuracy
at the time it was written. However,
readers are encouraged to check with
their individual carrier or private payers
for updates and to confirm that this
information conforms to their specific
rules.
ES116502_UT0912_040.pgs 08.23.2012 12:01
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UrologyTimes.com
∣
41
SEPTEMBER 2012
Deciphering the alphabet
soup of financial advisers
Different professional certifications come with different
qualifications, requirements
Q I am in the process of interviewing
various financial professionals to
determine whom I want to work with.
Many have designations, but what do they
represent and what was needed to obtain
them?
A
The relationship with one’s financial adviser
is a true partnership in which both parties are
working toward a common goal—your financial stability and independence. A financial
adviser may help manage your investments,
perform portfolio evaluations, and serve as an
educator to ensure a greater understanding of
the investment environment. In addition to registered investment advisers, there are a number
of other financial-based professionals who may
be in a position to assist you with many financial
planning areas.
The following list of professionals, as well
as their industry-focused professional designations and educational requirements, should
serve as a guide in your search for advice:
Accredited Asset Management Specialist (AAMS). These professionals complete a
12-module self-study course. Modules cover
asset management, investment policy, risk,
return, performance, asset allocation, investment strategies, tax issues, retirement planning,
Send us your questions
Send your questions about estate planning,
retirement, and investing to Joel M. Blau, CFP,
c/o Urology Times, at [email protected].
Questions of general interest will be chosen for publication.
The information in this column is designed to be authoritative. The publisher is not engaged in rendering legal advice.
INS T IL L AT ION
continued from page 40
The procedure description in the introduction of the operative notes lists the injections
as trigger point injections. However, the body
of the operative note references the location of
each injection. We would encourage any operative note to be clearly descriptive and match the
other parts of the operative note, such as findings and procedures performed in detail. In
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insurance products, estate planning, ethics, and
legal and regulatory issues.
Accredited Tax Preparer (ATP). The course
provides basic background on tax preparation
issues for individuals and sole proprietorships.
Chartered Financial Analyst (CFA). The 3-year
program is intensive, with three 6-hour exams.
Prerequisites for the designation include a bachelor’s degree or comparable work experience, and
3 years of investment management experience.
Word of mouth, through referrals
made by friends and colleagues, is
an excellent way to meet potential
financial advisers.
Certified Financial Planner (CFP). The Certified Financial Planner Board of Standards is a
regulatory organization for financial planners.
It awards the CFP designation to individuals
who meet its requirements. The curriculum
covers insurance, income taxation, retirement
planning, investments, and estate planning.
In addition to self-study programs, there are
classroom instruction programs offered at colleges and universities across the country.
Certified Investment Management Analyst
(CIMA). Three years of investment management
consulting experience, an interview, and a preliminary exam are prerequisites for the course.
The program covers due diligence, asset allocation, risk management, and other investment
management consulting concepts.
Money Matters
Joel M. Blau, CFP,
Ronald J. Paprocki,
JD, CFP, CHBC
Joel M. Blau, CFP, (top)
is president and Ronald J. Paprocki, JD, CFP, CHBC, is chief
executive officer of MEDIQUS
Asset Advisors, Inc. in Chicago.
They can be reached at 800-8838555 or [email protected] or
[email protected].
study course that covers investment management
consulting. It also addresses asset allocation, formalizing investment policy, and active versus
passive investment performance evaluation.
Certified Specialist in Tax Sheltered Accounts
(CSTSA). The CSTSA self-study program is for
advisers who work with 403(b) plans.
Chartered Life Underwriter (CLU). The CLU
self-study curriculum includes 10 courses—
eight required and two electives. Three years
of business experience and client service in the
financial field are prerequisites for the course.
Chartered Financial Consultant (CHFC). The
CHFC self-study program includes 10 courses—nine required and one elective. Three years
of business experience and client service in the
financial field are required.
Chartered Mutual Fund Counselor (CMFC). This
nine-module, self-study course is a primer on
mutual funds.
Chartered Retirement Planning Counselor
(CRPC). The CRPC program is an 11-module,
self-study program for advisers who provide
retirement planning for individuals.
Chartered Retirement Plans Specialist (CRPS).
The CRPS program is targeted at advisers who
work with qualified and non-qualified retirement plans.
Master of Science/Financial Planning Concentration. This graduate-level program focuses on
Certified Investment Management Consultant
(CIMC). CIMC certification is a two-level, self-
financial planning, wealth management, tax
other words, all introductory parts of the note
are considered a summary for which the body
of the note should provide matching detail.
As such, we would recommend the trigger
point injection code 20552 for all injections.
Trigger point injections are covered under
LCD restrictions for multiple jurisdictions and
should be reviewed prior to reporting, making
certain that supported diagnoses for muscle
spasms are clearly indicated in the patient’s
medical record.
Coverage of triamcinolone, bupivacaine,
and onabotulinumtoxinA in this instance is not
the concern of the office, as the service was
provided under general anesthesia in facility
that would be paid separately for the drugs
used. If provided in an office setting, triamcinolone and bupivacaine can be reported
under HCPCS codes if trigger point injections
are covered. OnabotulinumtoxinA is a separate
issue covered in many states for the treatment
of muscle spasms, but not in all areas. The LCD
for onabotulinumtoxinA will also need to
checked if billed in the office setting. UT
Please see ADVISERS, page 46
ES116504_UT0912_041.pgs 08.23.2012 12:01
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ADRENALS
PROSTATE
TUMOR TISSUE
TESTES
Important Safety Information
Contraindications—ZYTIGA® may cause fetal harm (Pregnancy
Category X) and is contraindicated in women who are or may
become pregnant.
Hypertension, Hypokalemia, and Fluid Retention Due to
Mineralocorticoid Excess—Use with caution in patients with a
history of cardiovascular disease or with medical conditions that
might be compromised by increases in hypertension, hypokalemia,
and fluid retention. ZYTIGA® may cause hypertension, hypokalemia,
and fluid retention as a consequence of increased mineralocorticoid
levels resulting from CYP17 inhibition. Safety has not been established
in patients with LVEF < 50% or New York Heart Association (NYHA)
Class III or IV heart failure because these patients were excluded
from the randomized clinical trial. Control hypertension and correct
hypokalemia before and during treatment. Monitor blood pressure,
serum potassium, and symptoms of fluid retention at least monthly.
Adrenocortical Insufficiency (AI)—AI has been reported
in clinical trials in patients receiving ZYTIGA® in combination
with prednisone, after an interruption of daily steroids, and/or
with concurrent infection or stress. Use caution and monitor for
symptoms and signs of AI if prednisone is stopped or withdrawn, if
prednisone dose is reduced, or if the patient experiences unusual
stress. Symptoms and signs of AI may be masked by adverse reactions
associated with mineralocorticoid excess seen in patients treated
with ZYTIGA®. Perform appropriate tests, if indicated, to confirm AI.
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Increased dosages of corticosteroids may be used before, during, and
after stressful situations.
Hepatotoxicity—Increases in liver enzymes have led to drug
interruption, dose modification, and/or discontinuation. Monitor
liver function and modify, withhold, or discontinue ZYTIGA® dosing
as recommended (see Prescribing Information for more information).
Measure serum transaminases [alanine aminotransferase (ALT) and
aspartate aminotransferase (AST)] and bilirubin levels prior to starting
treatment with ZYTIGA®, every two weeks for the first three months
of treatment, and monthly thereafter. Promptly measure serum
total bilirubin, AST, and ALT if clinical symptoms or signs suggestive
of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from
the patient’s baseline should prompt more frequent monitoring.
If at any time AST or ALT rise above five times the upper limit of
normal (ULN) or the bilirubin rises above three times the ULN, interrupt
ZYTIGA® treatment and closely monitor liver function.
Food Effect—ZYTIGA® must be taken on an empty stomach.
Exposure of abiraterone increases up to 10-fold when abiraterone
acetate is taken with meals. No food should be eaten for at least
two hours before the dose of ZYTIGA® is taken and for at least
one hour after the dose of ZYTIGA® is taken. Abiraterone C max and
AUC 0-∞ (exposure) were increased up to 17- and 10-fold higher,
respectively, when a single dose of abiraterone acetate was
administered with a meal compared to a fasted state.
ES115936_UT0912_042_FP.pgs 08.23.2012 03:37
ADV
Mechanism of action
ZYTIGA® is converted in vivo to abiraterone, an androgen biosynthesis inhibitor
(ABI) that directly affects the androgen biosynthesis pathway by inhibiting CYP17
(17a-hydroxylase/C17,20-lyase)
— Consequently, androgen biosynthesis is inhibited at 3 sources of testosterone
production: the testes, adrenal glands, and prostate tumor tissue
Androgen biosynthesis inhibition with ZYTIGA® results in decreased levels of serum
testosterone and other androgens
Proven survival benefit
Results of the interim analysis of the pivotal phase 3 study*† showed a statistically
significant improvement in overall survival (OS) in patients treated with ZYTIGA® plus
prednisone compared with patients who received placebo plus prednisone (median
OS: 14.8 months vs 10.9 months [hazard ratio (HR) = 0.646; 95% confidence interval
(CI): 0.543, 0.768; P < 0.0001])
— This represents a 3.9-month difference/improvement in median OS
In an updated analysis,‡ results were consistent with the interim analysis, with a
4.6-month difference/improvement in median OS with ZYTIGA® plus prednisone
compared with placebo plus prednisone (median OS: 15.8 months vs 11.2 months
[HR = 0.74; 95% CI: 0.638, 0.859])
ZYTIGA® (abiraterone acetate) in combination with prednisone is indicated for the treatment of patients with
metastatic castration-resistant prostate cancer (mCRPC) who have received prior chemotherapy containing docetaxel.
THERAPY
study in patients with metastatic castration-resistant prostate cancer
(mCRPC) who had received prior chemotherapy containing docetaxel
(N = 1,195). Patients were randomized 2:1 to receive ZYTIGA® 1,000 mg
orally once daily + prednisone 5 mg orally twice daily (n = 797) or
placebo orally once daily + prednisone 5 mg orally twice daily (n = 398).
Patients were using a gonadotropin-releasing hormone (GnRH) agonist
or were previously treated with orchiectomy and were at castration
levels of testosterone (serum testosterone ≤ 50 ng/dL).1 The primary
efficacy endpoint was overall survival.
†552 events.
‡775 events.
08Z11121R3
Adverse Reactions—The most common adverse reactions
(≥ 5%) are joint swelling or discomfort, hypokalemia, edema, muscle
discomfort, hot flush, diarrhea, urinary tract infection, cough,
hypertension, arrhythmia, urinary frequency, nocturia, dyspepsia,
fractures and upper respiratory tract infection.
Drug Interactions—ZYTIGA® is an inhibitor of the hepatic
drug-metabolizing enzyme CYP2D6. Avoid coadministration with
CYP2D6 substrates that have a narrow therapeutic index. If an
alternative cannot be used, exercise caution and consider a dose
reduction of the CYP2D6 substrate. Additionally, abiraterone is
a substrate of CYP3A4 in vitro. Strong inhibitors and inducers of
CYP3A4 should be avoided or used with caution.
Use in Specific Populations—The safety of ZYTIGA® in patients
with baseline severe hepatic impairment has not been studied.
These patients should not receive ZYTIGA®.
*Study Design: ZYTIGA®, in combination with prednisone, was evaluated
in a phase 3, randomized, double-blind, placebo-controlled, multicenter
ORAL
Reference: 1. de Bono JS, Logothetis CJ, Molina A, et al. Abiraterone and increased
survival in metastatic prostate cancer. N Engl J Med. 2011;364(21):1995-2005.
Please see adjacent pages for brief summary of full
Prescribing Information.
www.zytiga.com
Janssen Biotech, Inc.
© Janssen Biotech, Inc. 2012 3/12 08Z12069A
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ZYTIGA® (abiraterone acetate) Tablets
Brief Summary of Prescribing Information.
INDICATIONS AND USAGE
ZYTIGA in combination with prednisone is indicated for the treatment of patients
with metastatic castration-resistant prostate cancer (CRPC) who have received prior
chemotherapy containing docetaxel.
CONTRAINDICATIONS
Pregnancy: ZYTIGA may cause fetal harm when administered to a pregnant woman.
ZYTIGA is contraindicated in women who are or may become pregnant. If this drug is
used during pregnancy, or if the patient becomes pregnant while taking this drug, the
patient should be apprised of the potential hazard to the fetus.
WARNINGS AND PRECAUTIONS
Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess: Use
ZYTIGA with caution in patients with a history of cardiovascular disease. ZYTIGA may
cause hypertension, hypokalemia, and fluid retention as a consequence of increased
mineralocorticoid levels resulting from CYP17 inhibition [see Adverse Reactions and
Clinical Pharmacology (12.1) in full Prescribing Information]. Co-administration of a
corticosteroid suppresses adrenocorticotropic hormone (ACTH) drive, resulting in a
reduction in the incidence and severity of these adverse reactions. Use caution when
treating patients whose underlying medical conditions might be compromised by
increases in blood pressure, hypokalemia or fluid retention, e.g., those with heart failure,
recent myocardial infarction or ventricular arrhythmia. The safety of ZYTIGA in patients
with left ventricular ejection fraction <50% or NYHA Class III or IV heart failure has not
been established because these patients were excluded from the randomized clinical
trial. Monitor patients for hypertension, hypokalemia, and fluid retention at least once
a month. Control hypertension and correct hypokalemia before and during treatment
with ZYTIGA.
Adrenocortical Insufficiency: Adrenocortical insufficiency has been reported in
clinical trials in patients receiving ZYTIGA in combination with prednisone, following
interruption of daily steroids and/or with concurrent infection or stress. Use caution and
monitor for symptoms and signs of adrenocortical insufficiency, particularly if patients
are withdrawn from prednisone, have prednisone dose reductions, or experience
unusual stress. Symptoms and signs of adrenocortical insufficiency may be masked by
adverse reactions associated with mineralocorticoid excess seen in patients treated
with ZYTIGA. If clinically indicated, perform appropriate tests to confirm the diagnosis
of adrenocortical insufficiency. Increased dosage of corticosteroids may be indicated
before, during and after stressful situations [see Warnings and Precautions].
Hepatotoxicity: Marked increases in liver enzymes leading to drug discontinuation or dosage
modification have occurred [see Adverse Reactions]. Measure serum transaminases
(ALT and AST) and bilirubin levels prior to starting treatment with ZYTIGA, every two
weeks for the first three months of treatment and monthly thereafter. In patients with
baseline moderate hepatic impairment receiving a reduced ZYTIGA dose of 250 mg,
measure ALT, AST, and bilirubin prior to the start of treatment, every week for the
first month, every two weeks for the following two months of treatment and monthly
thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms
or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from
the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT
rise above five times the ULN, or the bilirubin rises above three times the ULN, interrupt
ZYTIGA treatment and closely monitor liver function. Re-treatment with ZYTIGA at a
reduced dose level may take place only after return of liver function tests to the patient’s
baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or
equal to 1.5X ULN [see Dosage and Administration (2.2) in full Prescribing Information].
The safety of ZYTIGA re-treatment of patients who develop AST or ALT greater than or
equal to 20X ULN and/or bilirubin greater than or equal to 10X ULN is unknown.
Food Effect: ZYTIGA must be taken on an empty stomach. No food should be consumed
for at least two hours before the dose of ZYTIGA is taken and for at least one hour after
the dose of ZYTIGA is taken. Abiraterone Cmax and AUC0-∞ (exposure) were increased
up to 17- and 10-fold higher, respectively, when a single dose of abiraterone acetate
was administered with a meal compared to a fasted state. The safety of these increased
exposures when multiple doses of abiraterone acetate are taken with food has not been
assessed [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full
Prescribing Information].
ADVERSE REACTIONS
The following are discussed in more detail in other sections of the labeling:
Hypertension, hypokalemia, and fluid retention due to mineralocorticoid excess [see
Warnings and Precautions].
Adrenocortical insufficiency [see Warnings and Precautions].
Hepatotoxicity [see Warnings and Precautions].
Food effect [see Warnings and Precautions].
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction
rates observed in the clinical trials of a drug cannot be directly compared to rates in the
clinical trials of another drug and may not reflect the rates observed in clinical practice.
In a placebo-controlled, multicenter phase 3 clinical trial of patients with metastatic
castration-resistant prostate cancer who were using a gonadotropin-releasing hormone
(GnRH) agonist or were previously treated with orchiectomy, ZYTIGA was administered
at a dose of 1,000 mg daily in combination with prednisone 5 mg twice daily in the active
treatment arm (N = 791). Placebo plus prednisone 5 mg twice daily was given to control
patients (N = 394). The median duration of treatment with ZYTIGA was 8 months.
The most common adverse drug reactions (≥5%) reported in clinical studies were joint
swelling or discomfort, hypokalemia, edema, muscle discomfort, hot flush, diarrhea,
urinary tract infection, cough, hypertension, arrhythmia, urinary frequency, nocturia,
dyspepsia, fractures and upper respiratory tract infection.
The most common adverse drug reactions that resulted in drug discontinuation were
aspartate aminotransferase increased, alanine aminotransferase increased, urosepsis
and cardiac failure (each in <1% of patients taking ZYTIGA).
Adverse reactions and laboratory abnormalities related to mineralocorticoid effects
were reported more commonly in patients treated with ZYTIGA than in patients
treated with placebo: hypokalemia 28% versus 20%, hypertension 9% versus 7% and
fluid retention (edema) 27% versus 18%, respectively (see Table 1). In patients treated
with ZYTIGA, grades 3 to 4 hypokalemia occurred in 5% of patients and grades 3 to 4
hypertension was reported in 1% of patients [see Warnings and Precautions].
black
ZYTIGA® (abiraterone acetate) Tablets
Table 1 shows adverse reactions due to ZYTIGA that occurred with either a ≥ 2%
absolute increase in frequency compared to placebo, or were events of special interest
(mineralocorticoid excess, cardiac adverse reactions, and liver toxicities).
Table 1: Adverse Reactions due to ZYTIGA in a Placebo-Controlled Phase 3 Trial
ZYTIGA with
Placebo with
Prednisone
Prednisone
(N=791)
(N=394)
System/Organ Class
All Grades1 Grade 3-4
All Grades Grade 3-4
Adverse reaction
%
%
%
%
Musculoskeletal and
connective tissue disorders
Joint swelling/discomfort2
29.5
4.2
23.4
4.1
Muscle discomfort3
26.2
3.0
23.1
2.3
General disorders
Edema4
26.7
1.9
18.3
0.8
Vascular disorders
Hot flush
19.0
0.3
16.8
0.3
Hypertension
8.5
1.3
6.9
0.3
Gastrointestinal disorders
Diarrhea
17.6
0.6
13.5
1.3
Dyspepsia
6.1
0
3.3
0
Infections and infestations
Urinary tract infection
11.5
2.1
7.1
0.5
Upper respiratory tract infection
5.4
0
2.5
0
Respiratory, thoracic and
mediastinal disorders
Cough
10.6
0
7.6
0
Renal and urinary disorders
Urinary frequency
7.2
0.3
5.1
0.3
Nocturia
6.2
0
4.1
0
Injury, poisoning and
procedural complications
Fractures5
5.9
1.4
2.3
0
Cardiac disorders
7.2
1.1
4.6
1.0
Arrhythmia6
3.8
0.5
2.8
0
Chest pain or chest discomfort 7
2.3
1.9
1.0
0.3
Cardiac failure8
1
Adverse events graded according to CTCAE version 3.0
Includes terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness
3 Includes terms Muscle spasms, Musculoskeletal pain, Myalgia, Musculoskeletal
discomfort, and Musculoskeletal stiffness
4 Includes terms Edema, Edema peripheral, Pitting edema, and Generalized edema
5 Includes all fractures with the exception of pathological fracture
6 Includes terms Arrhythmia, Tachycardia, Atrial fibrillation, Supraventricular
tachycardia, Atrial tachycardia, Ventricular tachycardia, Atrial flutter, Bradycardia,
Atrioventricular block complete, Conduction disorder, and Bradyarrhythmia
7 Includes terms Angina pectoris, Chest pain, and Angina unstable. Myocardial infarction
or ischemia occurred more commonly in the placebo arm than in the ZYTIGA arm (1.3%
vs. 1.1% respectively).
8 Includes terms Cardiac failure, Cardiac failure congestive, Left ventricular dysfunction,
Cardiogenic shock, Cardiomegaly, Cardiomyopathy, and Ejection fraction decreased
Cardiovascular Adverse Reactions: Cardiovascular adverse reactions in the phase
3 trial are shown in Table 1. The majority of arrhythmias were grade 1 or 2. Grade 3-4
arrhythmias occurred at similar rates in the two arms. There was one death associated
with arrhythmia and one patient with sudden death in the ZYTIGA arm. No patients had
sudden death or arrhythmia associated with death in the placebo arm. Cardiac ischemia
or myocardial infarction led to death in 2 patients in the placebo arm and 1 death in the
ZYTIGA arm. Cardiac failure resulting in death occurred in 1 patient on both arms.
Hepatotoxicity: Drug-associated hepatotoxicity with elevated ALT, AST, and total bilirubin
has been reported in patients treated with ZYTIGA. Across all clinical trials, liver function
test elevations (ALT or AST increases of > 5X ULN) were reported in 2.3% of patients
who received ZYTIGA, typically during the first 3 months after starting treatment. In the
phase 3 trial, patients whose baseline ALT or AST were elevated were more likely to
experience liver function test elevations than those beginning with normal values.
When elevations of either ALT or AST > 5X ULN, or elevations in bilirubin > 3X ULN were
observed, ZYTIGA was withheld or discontinued. In two instances marked increases in
liver function tests occurred [see Warnings and Precautions]. These two patients with
normal baseline hepatic function, experienced ALT or AST elevations 15 to 40X ULN and
bilirubin elevations 2 to 6 X ULN. Upon discontinuation of ZYTIGA, both patients had
normalization of their liver function tests and one patient was re-treated with ZYTIGA
without recurrence of the elevations.
In clinical trials, the following patients were excluded: patients with active hepatitis,
patients with baseline ALT and/or AST ≥ 2.5X ULN in the absence of liver metastases, and
patients with ALT and/or AST > 5X ULN in the presence of liver metastases. Abnormal
liver function tests developing in patients participating in clinical trials were managed
by treatment interruption, dose modification and/or discontinuation [see Dosage and
Administration (2.2) in full Prescribing Information and Warnings and Precautions].
Patients with elevations of ALT or AST > 20X ULN were not re-treated.
Other Adverse Reactions: Adrenal insufficiency occurred in two patients on the
abiraterone arm of the phase 3 clinical trial (< 1%).
Laboratory Abnormalities of Interest: Table 2 shows laboratory values of interest from
the phase 3 placebo-controlled clinical trial. Grade 3-4 low serum phosphate (7.2%) and
potassium (5.3%) occurred more frequently in the ZYTIGA arm.
2
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ZYTIGA® (abiraterone acetate) Tablets
Table 2: Laboratory Abnormalities of Interest in a Phase 3 Placebo-Controlled Clinical
Trial
Abiraterone (N=791)
Placebo (N=394)
All Grades
Grade 3-4
All Grades
Grade 3-4
Laboratory Abnormality
(%)
(%)
(%)
(%)
High Triglyceride
62.5
0.4
53.0
0
High AST
30.6
2.1
36.3
1.5
Low Potassium
28.3
5.3
19.8
1.0
Low Phosphorus
23.8
7.2
15.7
5.8
High ALT
11.1
1.4
10.4
0.8
High Total Bilirubin
6.6
0.1
4.6
0
DRUG INTERACTIONS
Effects of Abiraterone on Drug Metabolizing Enzymes: ZYTIGA is an inhibitor of the
hepatic drug-metabolizing enzyme CYP2D6. In a CYP2D6 drug-drug interaction trial, the
Cmax and AUC of dextromethorphan (CYP2D6 substrate) were increased 2.8- and 2.9-fold,
respectively, when dextromethorphan was given with abiraterone acetate 1,000 mg daily
and prednisone 5 mg twice daily. Avoid co-administration of abiraterone acetate with
substrates of CYP2D6 with a narrow therapeutic index (e.g., thioridazine). If alternative
treatments cannot be used, exercise caution and consider a dose reduction of the
concomitant CYP2D6 substrate drug [see Clinical Pharmacology (12.3) in full Prescribing
Information].
In vitro, ZYTIGA was shown to inhibit the hepatic drug-metabolizing enzyme CYP2C8.
There are no clinical data on the use of ZYTIGA with drugs that are substrates of CYP2C8.
Drugs that Inhibit or Induce CYP3A4 Enzymes: Based on in vitro data, ZYTIGA is a
substrate of CYP3A4. The effects of strong CYP3A4 inhibitors (e.g., ketoconazole,
itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir,
indinavir, nelfinavir, voriconazole) or inducers (e.g., phenytoin, carbamazepine, rifampin,
rifabutin, rifapentine, phenobarbital) on the pharmacokinetics of abiraterone have not
been evaluated, in vivo. Avoid or use with caution, strong inhibitors and inducers of
CYP3A4 during ZYTIGA treatment [see Clinical Pharmacology (12.3) in full Prescribing
Information].
USE IN SPECIFIC POPULATIONS
Pregnancy: Pregnancy Category X [see Contraindications]. ZYTIGA is contraindicated
in women who are or may become pregnant while receiving the drug. If this drug is
used during pregnancy, or if the patient becomes pregnant while taking this drug, the
patient should be apprised of the potential hazard to the fetus and the potential risk for
pregnancy loss. Women of childbearing potential should be advised to avoid becoming
pregnant during treatment with ZYTIGA.
Nursing Mothers: ZYTIGA is not indicated for use in women. It is not known if abiraterone
acetate is excreted in human milk. Because many drugs are excreted in human milk, and
because of the potential for serious adverse reactions in nursing infants from ZYTIGA,
a decision should be made to either discontinue nursing, or discontinue the drug taking
into account the importance of the drug to the mother.
Pediatric Use: ZYTIGA is not indicated in children.
Geriatric Use: Of the total number of patients in a phase 3 trial of ZYTIGA, 71% of patients
were 65 years and over and 28% were 75 years and over. No overall differences in safety
or effectiveness were observed between these elderly patients and younger patients.
Patients with Hepatic Impairment: The pharmacokinetics of abiraterone were examined
in subjects with baseline mild (n = 8) or moderate (n = 8) hepatic impairment (ChildPugh Class A and B, respectively) and in 8 healthy control subjects with normal hepatic
function. The systemic exposure (AUC) of abiraterone after a single oral 1,000 mg dose
of ZYTIGA increased by approximately 1.1-fold and 3.6-fold in subjects with mild and
moderate baseline hepatic impairment, respectively compared to subjects with normal
hepatic function.
No dosage adjustment is necessary for patients with baseline mild hepatic impairment.
In patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce
the recommended dose of ZYTIGA to 250 mg once daily. If elevations in ALT or AST
>5X ULN or total bilirubin >3X ULN occur in patients with baseline moderate hepatic
impairment, discontinue ZYTIGA treatment [see Dosage and Administration (2.1) and
Clinical Pharmacology (12.3) in full Prescribing Information].
The safety of ZYTIGA in patients with baseline severe hepatic impairment has not been
studied. These patients should not receive ZYTIGA.
For patients who develop hepatotoxicity during treatment, interruption of treatment
and dosage adjustment may be required [see Dosage and Administration (2.2) in full
Prescribing Information, Warnings and Precautions, and Clinical Pharmacology (12.3) in
full Prescribing Information].
Patients with Renal Impairment: In a dedicated renal impairment trial, the mean PK
parameters were comparable between healthy subjects with normal renal function
(N=8) and those with end stage renal disease (ESRD) on hemodialysis (N=8) after a
single oral 1,000 mg dose of ZYTIGA. No dosage adjustment is necessary for patients
with renal impairment [see Dosage and Administration (2.1) and Clinical Pharmacology
(12.3) in full Prescribing Information].
OVERDOSAGE: There have been no reports of overdose of ZYTIGA during clinical studies.
There is no specific antidote. In the event of an overdose, stop ZYTIGA, undertake
general supportive measures, including monitoring for arrhythmias and cardiac failure
and assess liver function.
Storage and Handling: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C
to 30°C (59°F to 86°F) [see USP controlled room temperature]. Based on its mechanism
of action, ZYTIGA may harm a developing fetus. Therefore, women who are pregnant or
women who may be pregnant should not handle ZYTIGA without protection, e.g., gloves
[see Use in Specific Populations].
Manufactured by:
Patheon Inc.
Mississauga, Canada
Manufactured for:
Janssen Biotech, Inc.
Horsham, PA 19044
Issued: May 2012
08Z12155B
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46
❳Practice Management❲
SEPTEMBER 2012
Data-driven care: Who
it will benefit, and how
E
Robert A. Dowling, MD
of data. Health care organizations are facing
narrower margins as revenues trend downward
and expenses increase. Rapid consolidation
of medical practices large and small is occurring to realize perceived advantages of scale,
sometimes by merger and often by acquisition.
The pace of regulations and oversight of health
care delivery is increasing. The complexity
associated with implementing systems and
managing large organizations is challenging
human and technical resources. The emergence of new payment models, some of them
based upon value and involving partnerships
with different stakeholders, is transforming
markets.
At the center of the transformation are the
information systems that house health care
data. The promise of data lies in the ability to
ask the right questions and use tools to organize
the data into accurate, actionable answers.
Four questions you need to ask
Quality and quality measures. The first question
The tectonic forces shaping health care today
may be the key to understanding the promise
for a health care organization might be, “Are
we delivering high-quality care and experience
to our patients in order to meet the challenges
of value-based payment reform?” Answering
this question requires a definition of quality,
ability to measure performance, benchmarks
and goals, and tools to present the information
to an audience who can effect change.
A DV ISE RS
Q Our accountant is recommending
Drivers of change and data
continued from page 41
planning, retirement planning, and estate planning. Participants must have a bachelor’s degree
to enroll and complete 12 courses for 36 credits.
As is the case with all professional designations, having one does not necessarily mean
that you are good at what you do. Word of
mouth, through referrals made by friends and
colleagues, is an excellent way to meet potential
advisers. Even though they may come highly
recommended, it is always a good idea to interview a number of advisers to determine compatibility. Only in this manner will you be able
to determine who you are most comfortable
partnering with in guiding you toward, reaching, and ultimately maintaining true financial
independence and long-term security.
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that we use a SIMPLE (Savings Incentive
Match Plan for Employees) IRA for our
small office retirement plan. Is it as
straightforward as the title implies?
A
Urology Times
The Bottom Line
Dr. Dowling is an independent
consultant and the former medical
director of a large metropolitan
urology practice. He resides in Fort
Worth, TX.
Your patients—and you—are the beneficiaries of unlocking
information stored in health care databases
arly adopters of health information technology have been creating
electronic health records for over
10 years. With the creation of the
Health Information Technology for
Economic and Clinical Health (HITECH) Act
and its incentives, the pace of clinical data accumulation is accelerating.
To be sure, some of the data is stored in
proprietary systems and is not easily accessible; interoperability standards are immature;
meaningful health information exchanges are
in their infancy; and much of the data is still
unstructured, especially as providers make the
disruptive transition from a narrative medical
record to one based in software. Nevertheless,
stakeholders in the health care marketplace are
beginning to demand access to “their data.”
Stage 2 of EHR meaningful use will likely
sharpen the focus on issues like data ownership,
consents, security, and privacy. But the larger
question looms: How will the data be used and by
whom? What exactly is the promise of unlocking
the information within health care databases,
and who will benefit? As this article discusses,
some early experience with use of data may
inform the answers to these and other questions.
∣
The name does say a lot, and while the plan
rules are quite simple, there are potential issues
with its limited flexibility relative to timing.
SIMPLE IRAs are required to operate on a
calendar year basis, and employer contributions
must be funded for the entire year. SIMPLE
IRA plan sponsors must provide all eligible
employees with a plan notice 60 days before the
beginning of each plan year. Once the notice is
provided, the SIMPLE IRA must run for the
entire year and cannot be terminated, unlike
traditional 401(k) plans that can be terminated
at any time.
Defining quality is probably the biggest
hurdle. While measurements of the patient
experience, such as patient satisfaction
instruments, are mature and available in
large datasets by commercial vendors, quality metrics for clinical care are neither widely
available nor widely adopted. The most common measures used for quality are process
measures: how often was an expected process, clinical guideline, or best practice followed based on straightforward definitions of
a numerator and denominator. The percentage of patients with newly diagnosed prostate
cancer who have documentation of T stage,
Gleason score, and PSA is an example of a
process measure.
Outcome measures concern the health
state of a patient impacted by clinical interventions, adjusted for risk. The risk-adjusted mortality rate following coronary artery
bypass grafting is a common outcome measure in large acute care facilities. Measures
are typically developed by stakeholders (eg,
specialty societies), endorsed by stewards of
quality (eg, the National Quality Forum), and
implemented by private and public entities
(eg, the Centers for Medicare & Medicaid
Services). Primary care, cardiology, and a
few other specialties have mature process and
Please see DATA-DRIVEN CARE, page 47
❳• Financial Tips ❲
•
•
•
In addition to registered investment advisers,
there are a number of other financial-based
professionals who may be able to assist in many
financial planning areas.
Even though they may come highly recommended, it is always a good idea to interview a number
of financial advisers to determine compatibility.
SIMPLE (Savings Incentive Match Plan for Employees) IRAs are required to operate on a calendar
year basis, and employer contributions must be
funded for the entire year.
Once notice is provided, a SIMPLE IRA must run for
an entire year and cannot be terminated, unlike
traditional 401(k) plans that can be terminated
at any time.
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UrologyTimes.com
∣
DATA - DRI V E N C A RE
continued from page 46
outcome measures; many surgical specialties
lack either.
Many clinical information systems (and
their users) today do not structure data in
a way that can directly answer the quality
questions. Federal incentives are beginning
to align the design of the products and the
“meaningful use” of the products by health
care providers, which in turn will lead to more
valuable clinical data. Clinical intelligence
tools (descriptive analytics) hold the promise
of accelerating the development of meaningful
and relevant measures, using data to measure
clinical quality and using the measurements
to improve care.
Productivity/efficiency. The second question
a health care entity might wish to answer to
confront the challenges of today and tomorrow is, “Are we productive and efficient in the
delivery of care?” Productivity in a health care
environment has traditionally been a measurement of units of work, where more is better.
Common measurements have included number
of patients seen, hours or days worked, charges
billed, or a system designed to accommodate
a fee-for-service business model called “work
relative value units.”
Future needs may require measuring information about the productivity and efficiency
of work differently, eg: How long does it take,
on average, for a provider to complete his
documentation? What is the mean number of
minutes elapsed between appointment time
and “seen by a nurse” time? How many outstanding tasks does a provider typically have
at measurement time, or how many lab results
can she process in a typical workday? Some
combination of clinical data and practice management data—now typically stored in different systems—will be necessary to complete the
answer to these questions.
The demand on the health care system is
outstripping the supply, and some measure
of efficiency will define how health care is
accessed and delivered in the future. Analytic
tools hold the promise of delivering meaningful
reports and improving efficiency in the health
care workplace.
Profitability. The third question any business
must ask and answer in the context of change is,
“How do we remain profitable?” New payment
models may require assembling financial data
in new ways (for the health care industry). For
example, it may become critically important
to associate not only revenues with a certain
patient or episode of care but also costs of goods
and services with that same patient, group of
patients, or episodes of care.
Cost accounting is familiar to insurers,
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47
SEPTEMBER 2012
often practiced in large hospitals, and largely
unheard of in independent medical practices. It may be de rigueur in accountable care
organizations, where populations of patients
are managed under a contract and/or global
payment. Physicians, ancillary services, and
others may morph from revenue centers to cost
centers. Business intelligence tools hold the
promise of looking at financial information
in new and dynamic ways in a changing payment model.
Patient satisfaction. Finally, the fourth question a health care business may wish to have
answered is, “Do we understand every aspect of
our business: our strengths, weaknesses, opportunities, and threats?” Knowing the demographic profile of “customers” is business 101 for most
enterprises but late to arrive in medicine. Monitoring customer satisfaction is an expense most
businesses don’t think twice about.
Responding to a product or device recall or
a security breach requires access to prescribing information, treatment data, and audit data.
Evaluating a proposal to participate in clinical
research demands real-time information about
the characteristics of patients. Business intelligence tools hold the promise of addressing
these cases and many others.
What the future holds
time comparison of a patient with a large
dataset of similar patients; comparing the
outcomes of different diagnostic and therapeutic interventions in similar patients could
prove invaluable to providers as they make
important decisions about individuals. Realtime evaluation of a patient’s candidacy for
clinical trials is another application of CDS.
Finally, observations of actual care outside of
traditional clinical trials may help advance an
understanding of treatment combinations and/
or treatment sequencing and the consequences
to patients.
In 10 years, we may look back on 2012 as the
stone age of data-driven health care. The promise of health care data is, inevitably, to benefit
patients. The benefit to providers, payers, and
other stakeholders in health care is ancillary
but equally inevitable. Information systems
continue to transform many industries, and
health care is no exception. Federal incentives
to speed the adoption of electronic health
records may expire, but data-driven health care
is likely here to stay. UT
Editor’s note: Dr. Dowling serves as a paid consultant to
HealthTronics Information Technology Solutions, a provider of
technology solutions for urologists. Portions of this article were
previously submitted for publication in The Physician’s Guide to
the HITECH Act and EHR Solutions (Blue Sky Media, 2012).
What is the promise
of health care data,
and who will benefit?
Ultimately, patients
will benefit from the
intelligent use of their
health care information. One example is
clinical decision suppor t (CDS) —using
information systems
to help cl i n icia ns
with decision-making
tasks—which is still in
its infancy. The most
common application
of CDS is real-time
dr ug-allergy, dr ugdrug, and drug-disease
checking, an important advance in patient
safety.
A na ly t ics offers
the potential to bring
the same analysis of
a patient in context to
decisions more complex than, “Is it safe?”
A future extension
of clinical analytics, applied to clinical decision support,
might involve real-
ES120410_UT0912_047.pgs 08.29.2012 14:32
ADV
48
❳Practice Management❲
SEPTEMBER 2012
Your high-maintenance
staffer: Worth the hassle?
∣
Urology Times
In Practice
Joe Capko, Judy Capko
Constant complaints may indicate problems
with your practice—or the difficult employee
E
very urology practice faces this situation eventually: a difficult employee
who demands disproportionate time
and attention from management.
Over time, your high-maintenance
employee’s ability to shift the focus to himself will inevitably make you wonder, is this
employee worth the hassle?
In this article, we’ll discuss the different
types of high-maintenance employees and how
to manage them.
Difficult or misunderstood?
In the equine world, thoroughbreds stand out
for their beauty and athleticism, as well as their
high-strung personalities and special health
needs. Own one and you have to be prepared
to provide it special attention and incur extra
A lack of clearly defined staff roles is
one of the most common operational
problems we see in urology
practices.
headsets for her and the other receptionists, and
was repeatedly offended by the shoddy work
of the practice’s cleaning service. Instead of
being annoyed with these requests, though, the
manager should have been listening. Every one
of the employee’s complaints involved an issue
that would diminish productivity, adversely
affect patient service, and could explode into a
bigger problem if not addressed.
Clarity of staff roles key
For thoroughbreds and workhorses alike,
clarity of roles and a clear path to providing
feedback to management are essential to top
performance.
A lack of clearly defined staff roles is one of
the most common operational problems we see
in urology practices. Knowing exactly what is
required to do a good job is essential for employee
morale, especially for highly motivated or perfectionistic thoroughbreds. Clarity of roles is also
essential to creating accountabilityÑto ensure
everything that needs to get done gets done. If
you’ve been repeatedly bothered by a squeaky
wheel or wheels, be sure your own internal communication and HR systems are up to snuff.
‘The cockatoo’: A bad fit for your practice
costs. For the occasional rider, the extra care
and feeding a thoroughbred requires may not be
worth the aggravation, especially since they’re
often temperamental to boot. But, for winning
races, there’s no better breed.
ÒProblemÓ employees can sometimes be
misunderstood thoroughbreds. They have the
best interests of the practice in mind, but may
need more clarity or more support to do their
best. Often, a thoroughbred’s complaints can
illuminate trouble spots that are brewing with
the practiceÑissues that your team’s easygoing
workhorses are suffering without complaint,
but that really should be fixed. Sometimes the
thoroughbred’s extra sensitivity to minor workflow issues is a gift to the practice that allows
management to head off problems while they’re
still minor.
Is your complainer a thoroughbred in disguise? The type of complaints you’re hearing
provides a clue. Recently, we worked with a
practice with a ÒproblemÓ employee who was
driving the practice manager crazy with her
ÒissuesÓ and requests. She was frustrated that
the office network was frequently down, wanted
magenta
cyan
yellow
black
Of course, not every high-maintenance employee is a thoroughbred eager to run at top speed as
soon as you clear the track. Sometimes they’re
more akin to another high-maintenance pet: a
cockatoo.
People who meet baby cockatoos are often
charmed by their sweet, child-like nature, but
what they don’t realize is that the adult cockatoo
is almost always a poor fit as a pet. Unhappy
cockatoos express their displeasure and almost
unlimited need for attention by constant screaming (reportedly just a few decibels softer than a
jet engine). Keeping an unhappy cockatoo in a
home is unbearable for all involved; many of
these poor birds end up in rescue situations.
When a high-maintenance employee needs
constant attention because he’s just a bad fit
for your practice, your dedication to listening
and attempting to fix the problems he puts at
your feet might only make things worse for your
practice. Like a cockatoo expressing its need to
live in a more appropriate environment, your
employee’s attention-grabbing behavior will
make everyone working with him miserable
and less productive.
Joe Capko is a senior health care consultant with
Capko & Co. who specializes in research, marketing, social media, business development, and
strategic planning. Judy Capko is a health care
consultant and the author of Take Back Time—
Bringing Time Management to Medicine. They can
be reached at [email protected] or [email protected].
Is your high-maintenance employee frequently at the center of conflicts with other staff members? Does he make the same mistakes again
and again? Does he require continual retraining
in his job, despite having a clearly defined role?
Does he complain aboutÑor want to ÒfixÓÑ
aspects of the job that are immutable, like your
hours or dealing with patients? If so, he’s likely
a cockatooÑa bad fit for your practiceÑand
needs a new home in another type of work.
When you discover you’ve got a cockatoo
on your hands, addressing performance issues
quickly, professionally, and compassionately
is essential to protecting the productivity and
morale of your team. When one employee’s
poor performance drains management’s attention or leaves others to pick up the slack, the
effect on others can be powerfully negative.
Don’t forget that downplaying the situation
When one employee’s poor
performance drains management’s
attention or leaves others to pick up
the slack, the effect on others can
be powerfully negative.
because you want to be nice to the troublesome
employee comes at the cost of putting the rest
of the team’s needs second. Addressing performance issues promptly gives your employee the
chance to consider whether her personality is
a better fit for a different role: perhaps outside
your practice, but maybe even within it. For
example, if the front desk is a poor fit, maybe
a strictly clerical role would be more suitable.
Above all, be sure your practice is equipped
with clear policies for evaluating performance,
delivering written warnings, allowing for
improvement or reassignment, and terminating
when that’s clearly the only suitable option.
ES110234_UT0912_048.pgs 08.17.2012 14:08
ADV
UrologyTimes.com
∣
September 2012
FDA approves first beta-3 adrenergic
agonist for treatment of OAB
Northbrook, IL—Astellas pharma US, Inc.
announced that the FDA has approved mirabegron (myrbetriq) extended-release tablets
for the treatment of overactive bladder with
symptoms of urge urinary incontinence,
urgency, and urinary frequency. the first
once-daily oral beta-3 adrenergic agonist,
it relaxes the detrusor smooth muscle during the storage phase of the urinary bladder
fill-void cycle, increasing bladder capacity.
Starting dose is 25 mg but may be increased
to 50 mg based on efficacy and tolerability.
mirabegron will be available in the fourth
quarter of 2012, according to Astellas.
For more information, visit www.myrbetriq.com.
Surgical shears with adaptive tissue
technology receive FDA clearance
Cincinnati—ethicon endo-Surgery, Inc. has
received FDA 510(k) clearance for the HArmONIC ACe+ Shears with Adaptive tissue
technology, an ultrasonic surgical device that
performs multiple jobs, including dissection,
sealing, transection, and otomy creation. the
Adaptive tissue technology allows the shears
to respond to varying tissue conditions by
regulating energy delivery and providing surgeons with audible feedback, allowing for
23% less thermal spread while delivering 21%
shorter transection times compared to the
current HArmONIC ACe. the shears also feature a tapered, coated blade for multi-functionality with precise grasping and dissection.
For more information, visit www.ees.com.
Twin-balloon, zero-tip urinary
catheter reduces bladder trauma
Tequesta, FL—poiesis
medical has launched
a twin-balloon, zero-tip
urinary catheter called
Duette designed to
address the risks associated with urinary catheterization and to help
eliminate bladder
trauma caused by
traditional Foley catheters. by utilizing a
second balloon that subsumes its tip, the Duette
cushions the bladder wall during drainage
and protects the bladder’s mucosal lining, its
magenta
cyan
yellow
black
New Products & Services
natural bacterial defense. the Duette offers
patients a non-traumatic alternative for catheterization, poiesis says.
For more information, visit www.poiesismedical.com.
Web site offers providers free CAUTI
prevention educational materials
Bothell, WA—Verathon Inc. has announced
a new Web site offering free educational
materials on catheter-associated urinary
49
tract infection (CAUtI) prevention. Designed
for health care providers, materials include
a bundle poster and animated checklist,
instructional videos with urinary expert
Diane Newman, DNp, CrNp, an interactive
timeline with facts and figures, and downloadable information for reducing CAUtI—
the most common health care-associated
infection.
For more information, visit
www.verathon.com/products/bladderscan/cauti-zero.
PRS Advanced Coding, Billing
and Reimbursement National Seminars
What: Two identical seminars for you to choose from
When / Where:
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Register at: IUUQXXXSFHPOMJOFDPNBVDSMW
We look forward to seeing you at the Advanced Coding
and Billing Seminars. We know you will take home
valuable information that will help you run your practice.
Sincerely,
Mark Painter, CEO
PRS Urology Services Corp.
Ray Painter, President
Physician Reimbursement Systems
Leading the industry since 1989 with coding, reimbursement and
practice management tools tailored to unique medical specialties.
ES116795_UT0912_049.pgs 08.23.2012 14:34
ADV
50
Meeting Calendar
September
2012
21-22
22-23
American Association of Clinical Urologists State
Society Network Advocacy Conference
AUA Renal Oncology
MiaMi
Tel: 800-908-9414
E-mail: [email protected]
www.auanet.org
ChiCago
Tel: 847-517-1050
Fax: 847-517-7229
E-mail: [email protected]
www.aacuweb.org
21-22
Illinois Urological Society Annual Meeting
C h a M pa i g n , i l
Tel: 847-517-7225
E-mail: [email protected]
www.wjweiser.com
29-30
30-Oct. 4
American College of Surgeons Clinical Congress
ChiCago
Tel: 800-621-4111
7-12
Product
Page #
Web site/E-Mail
Abbott Laboratories
Androgel
18-20
www.androgel.com
Greenlight
5
www.americanmedicalsystems.com
XGEVA
29-32
www.amgen.com
Astellas
Myrbetriq
23
www.myrbetriq.com
Astellas
Corporate
CV4
http://www.astellas.us/
Cook Medical
BIGopsy
39
www.cookmedical.com
Dendreon Corp.
Provenge
34-37
www.dendreon.com
Valstar
25-26
www.endo.com
Roth Grip-Tip
15
www.greenwaldsurgical.com
—
47
www.inclinix.com
Janssen Pharmaceuticals
Inc.
ZYTIGA
42-45
www.zytigahcp.com
Laclede Inc.
Luvena
11-12
www.laclede.com
PlasmaButton
7
www.olympussurgical.com
Toviaz
CV2-3
www.toviaz.com
—
49
www.prsnetwork.com
Corporate
17
www.upmc.com
Olympus America Inc.
ChiCago
Tel: 202-367-1167
Fax: 202-367-2167
E-mail: [email protected]
www.augs.org
boston
Tel: 800-908-9414
E-mail: [email protected]
www.auanet.org
Advertiser
Inclinix Inc.
2012
AUA Primary Cases in Urology - Topics in Women’s
Health
To obtain additional information about products advertised in this issue, use the contact
information below. This index is provided as an additional service. The publisher does not
assume any liability for errors or omissions.
Greenwald Surgical
Company Inc.
October
6
Companies featured in this issue
Endo Pharmaceuticals Inc.
f U k U o k a , j a pa n
Tel: 514-875-5665
E-mail: [email protected]
www.siucongress.org
American Urogynecologic Society Annual
Scientific Meeting
Advertisers Index
Amgen Inc.
Fax: 312-202-5001
E-mail: [email protected]
www.facs.org
3-6
AUA Primary Cases in Urology - Topics in Women’s
Health
American Medical Systems
Urology Times
2012 Congress of the Société Internationale
d’Urologie
hoUston
Tel: 800-908-9414
E-mail: [email protected]
www.auanet.org
philadelphia
Tel: 800-908-9414
E-mail: [email protected]
www.auanet.org
∣
30-Oct. 4
AUA Mentored Renal Laparoscopy: A Skills and
Problem-Solving Approach
22
September 2012
... for a full listing of meetings through 2012
and beyond, visit UrologyTimes.com
Western Section of the AUA Annual Meeting
b i g i s l a n d, h i
Tel: 714-550-9155
Fax: 714-550-9234
E-mail: [email protected]
www.wsaua.org/hawaii2012/2012.htm
7-13
New York Section of the AUA Annual Meeting
s i C i ly, i ta ly
Tel: 516-520-1226
Fax: 516-520-1225
E-mail: [email protected]
www.nysauasicily2012.com
10-13
North Central Section of the AUA Annual Meeting
ChiCago
Tel: 847-517-1544
Fax: 847-517-7229
E-mail: [email protected]
www.ncsaua.org
11-14
Mid-Atlantic Section of the AUA Annual Meeting
Pfizer Inc.
Physician Reimbursement
Systems Inc.
UPMC
magenta
cyan
yellow
black
philadelphia
Tel: 978-927-8330
Fax: 978-524-8890
E-mail: [email protected]
www.maaua.org
ES115381_UT0912_050.pgs 08.22.2012 11:52
ADV
|
www.urologytimes.com
51
september 2012
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❳ News ❲
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Marketplace
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UrologyTimes.com
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Marketplace
september, 2012
53
Recruitment
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54
Marketplace
september, 2012
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Urology Times
Recruitment
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ES115954_ut0912_054_CL.pgs 08.23.2012 04:19
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UrologyTimes.com
∣
❳Washington and You❲
SEPTEMBER 2012
Election Day holds many
keys to docs’ future
Critical issues include replacing IPAB, sustainable growth rate
Washington—With the presidential and con-
gressional campaigns now in high gear, government and politics are in the forefront of thought
for many. In fact, they’re hard to avoid, given
the blizzard of ads that bombard us day in and
day out.
But urologists are being urged to become
more involved than simply to vote on Election Day, because the decisions by the men
and women who are elected can directly affect
the way medicine is practiced and health care
provided.
Those decisions will determine whether
physicians who treat Medicare are fairly reimbursed; whether the Independent Payment
Advisory Board (IPAB) is allowed to continue;
and even how government agencies, task forces,
and advisory boards that make recommendations on specific testing and treatment protocols
are allowed to function.
That’s why David F. Penson, MD, MPH,
the AUA’s health policy chair, urges urologists
to support AUA’s political action committee,
UROPAC, and to actively back candidates for
office who understand urology’s concerns.
“We are working together to get elected officials who will support legislation to replace
the IPAB,” he said. “We are optimistic that we
may be able to succeed, particularly if there is
a change in the White House in November.”
But jettisoning that board, which is to be
established under the Affordable Care Act
and charged with holding down Medicare
costs in a way that largely targets physician
reimbursement, is just one of the key objectives of many physician groups heading into
the election.
Fast Facts
The USPSTF Transparency and
Accountability Act of 2012:
❯❯ would require a “balanced representation of
primary and specialty care providers”... to be
involved in the development and review of
USPSTF recommendations
❯❯ would establish a Preventive Services Task
Force Board that would suggest evidence for
consideration when a particular service is
proposed for review
❯❯ is not considered likely to be enacted
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A second goal, of course, is gaining support
in Congress for reform of the hated sustainable
growth rate formula that is responsible for the
annual havoc faced by physicians who serve
Medicare patients. For example, the Centers
for Medicare & Medicaid Services recently
released its fee schedule for 2013, and it contains a 27% average reduction for physicians
effective Jan. 1, 2013.
However, Congress has never allowed such
cuts to be imposed and each year it acts at the
last minute, or sometimes after the last minute,
to prevent them from taking place.
“We are working together to get
elected officials who will support
legislation to replace the IPAB.”
DAVID F. PENSON, MD, MPH
So, most observers assume Congress will
jump in, probably in a lame-duck session
around Christmas, and enact another temporary fix. But then what will the new Congress
do? Will there be even more lawmakers who
will insist on cutting elsewhere to pay for the
cost of reform no matter what? Or will there be
an increased number of lawmakers who recognize the seriousness of the problem and work
to develop some sort of practical and effective
solution?
A third key issue for urologists is the U.S.
Preventive Services Task Force (USPSTF)
and the process by which it makes formal
recommendations regarding preventive care
services.
It was the USPSTF that recommended in
May against performing PSA-based screening for prostate cancer in asymptomatic men, a
recommendation that prompted organizations
representing urology, as well as many prostate
cancer advocacy groups, to criticize the manner
in which the decision was reached as well as the
conclusion itself.
Legislation directed at task force
As a result, Reps. Marsha Blackburn (R-TN)
and John Barrow (D-GA), along with Reps.
Donna Christensen (D-VA) and Lee Terry
(R-NE) introduced the USPSTF Transparency
and Accountability Act of 2012 in late June.
55
Bob Gatty
UT Washington
Correspondent
Bob Gatty, a former
congressional aide, covers
news from Washington
for Urology Times.
That measure calls for significant changes in
the task force and its decision-making process.
Supported by the AUA, the American Association of Clinical Urologists, and the Large
Urology Group Practice Association, the bill
would require a “balanced representation of
primary and specialty care providers” and
other health care community representatives
to be involved in the development and review
of recommendations. It also would establish
a Preventive Services Task Force Board that
would include providers, patient groups, and
federal agency representatives, which would
suggest evidence for consideration when a
particular service is proposed for review and
provide feedback on draft and final recommendations.
“Allowing independent bodies to make
broad, population-based decisions regarding
which tests or diagnostics are appropriate without consultation from the specialists who treat
these diseases is inappropriate,” Blackburn said
in introducing her bill, adding that she worked
with the AUA on the legislation. “Patients and
their physicians have the right to choose which
tests are best for them.”
The fact that this bill was introduced in the
U.S. House of Representatives is significant, but
there is virtually no chance it will be approved
by Congress this year, given lawmakers’ focus
on their campaigns, the remaining congressional workload, and the few actual remaining
workdays on Capitol Hill. Even if that were
not the case, the Web site www.Govtrack.us
gives the legislation only a 5% chance of being
enacted.
What if more lawmakers who agreed with
the idea were elected in November? That could
change the outlook, especially if more representatives from the party in power could be
convinced to join as co-sponsors.
“This is a great example of how urology
should use its influence in Washington,” said
Dr. Penson, “working closely with other groups
to make this happen. That will be our modus
operandi—collaboration to effect change that
will allow the specialty to provide high-quality
care to our patients.”
Feedback
Send your comments to
Bob Gatty c/o Urology Times, at [email protected]
ES108329_UT0912_055.pgs 08.16.2012 08:35
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56
In the Public Eye
What your patients are reading in consumer
magazines, newspapers, and on web sites
SEPTEMBER 2012
∣
Urology Times
WebMD
Recreational ED med use may lead to psychogenic ED
MedPage Today
Scripps Howard News Service
Early-stage prostate Ca dropped after
2008 task force statement
Investigators question legitimacy
of vacuum device payments
A swift drop in incidence of early-stage
prostate cancer in older men may be
related to a 2008 U.S. Preventive Services Task
Force recommendation against prostate cancer
screening for men age 75 years and older,
according to a research letter published online
in Archives of Internal Medicine (July 23, 2012).
Author David H. Howard, PhD, of Emory
University in Atlanta, reviewed data from the
Surveillance, Epidemiology, and End Results
(SEER) registry, which included 254,184
cases of prostate cancer, 53,263 of which
occurred in men age 75 or older.
Rates for stage T1 or T2 prostate cancer in
this age group declined by 25.4%, while there
was a 14.3% decline in stages T3 and T4 cancer. Additionally, there was a 16.8% reduction
in unknown-stage tumors.
While Medicare reimbursements for vacuum erection devices have skyrocketed
500% in the last 10 years, federal investigators are considering the possibility of fraud
among payments for thousands of the devices,
according to a Scripps Howard News Service
article.
The Centers for Medicare & Medicaid Services reported that annual spending on the
devices climbed from $7.2 million in 2000 to
$36 million-plus in 2011. Meanwhile, investigators are questioning at least $8 million in
Medicare payments made for the devices over
the past 4 years.
New York Times
FDA: Bisphenol A officially banned
in baby bottles, toddler cups
The FDA has officially banned bisphenol
A (BPA) use in the manufacture of baby
bottles and children’s drink cups, the New York
Times reported (July 18, 2012).
Manufacturers had already halted BPA use
in the above-mentioned products; however,
the FDA says its decision is in response to an
appeal from the American Chemistry Council
that rules permitting BPA in such products be
phased out. In a statement, the council said it
urged the FDA to respond due to public confusion as to whether baby bottles and cups for
toddlers still contained BPA.
The ban does not affect BPA use in other
products. The FDA had declared BPA safe in
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2008, but alluded to potential health risks
in 2010, when it said it had “some concern
about the potential effects of BPA on the
brain, behavior, and prostate gland of fetuses,
infants, and children.”
Reuters
Screening for VUR may be
ineffective in some children
For children with low-grade hydronephrosis and normal-functioning kidneys and
bladder, vesicoureteral reflux screening may
be ineffective, according to a study in the
Journal of Urology (2012; 188:576-81).
Researchers from McGill University, Montreal
reviewed data on 206 children with hydronephrosis but without renal or bladder anomalies.
A total of 148 children had grade I or II hydronephrosis. Voiding cystourethrography was conducted in 66.2% of the low-grade group and in
all but one child with grade III or IV disease.
Rate of urinary tract infection was 3.52 per
100 patient-years in children with low-grade
hydronephrosis and 11.1 per 100 patientyears in those with high-grade hydronephrosis. No difference was found in incidence of
UTIs between those with low-grade hydronephrosis who were screened and those who
were not, reported the authors.
As an example, two Florida entrepreneurs
collected $28,000-plus for 75 vacuum
erection devices that were never shipped,
government sources say. Medicare pays for
vacuum erection devices as durable medical equipment if the devices are deemed
medically necessary for treatment of erectile
dysfunction.
ES108630_UT0912_056.pgs 08.16.2012 10:53
Getty Images/Photodisc/Geoff Manasse (top); Getty Images/Flickr/McDonald P. Mirabile (second column); Getty Images/Stockbyte (third column)
Risk of developing psychogenic erectile dysfunction may be elevated in men who use ED drugs
recreationally, according to a recent study.
“Among young, healthy men who used ED medicines recreationally, the more frequent
ED medicine use was associated with lower confidence in achieving and maintaining
erections, which in turn was associated with lower erectile function,” said co-author
Christopher Harte, PhD, of the VA Boston Healthcare System.
For the study, which was published in the Journal of Sexual Medicine (2012;
9:1852-9), Dr. Harte evaluated 1,207 men via online survey: 72 were recreational
users with no physician-reported ED diagnosis; 1,111 were non-users of ED
drugs; and 24 were prescribed the drugs and used them.
Compared to non-users, recreational users reported lower erectile confidence
and overall satisfaction. The decreased confidence, in turn, was linked negatively
with erectile functioning, Dr. Harte said.
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ES120136_UT0912_CV3_FP.pgs 08.29.2012 07:40
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Throughout the course of castration-resistant prostate cancer (CRPC)
T H E RO OT O F
T U M O R GRO W T H
A N D R O G E N R E C E P TO R S I G N A L I N G
Despite low or undetectable levels of testosterone, androgen
receptor signaling persists.
1,2
Androgen receptor signaling promotes tumor growth and drives
prostate cancer progression.
1,3,4
Visit www.TargetAR.com to learn more.
REFERENCES:
1. Harris WP, Mostaghel EA, Nelson PS, Montgomery B. Nat Clin Pract Urol. 2009;6:76-85. 2. Chen Y, Clegg NJ, Scher HI. Lancet Oncol. 2009;10:981-991.
3. Knudsen KE, Scher HI. Clin Cancer Res. 2009;15:4792-4798. 4. Sawyers CJ, Tran C, Wongvipat J, et al. Poster presented at: ASCO 2007 Prostate Cancer
Symposium; February 22-24, 2007; Miami, FL.
© 2012 Astellas Pharma US, Inc. All rights reserved. Printed in USA. 012D-075-5384 5/12
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