Urology Times
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Urology Times
® The Leading News Source for Urologists Robotic RP raises surgical volume, lowers morbidity ROBOTIC RP: BEFORE & AFTER facebook.com/urologytimes twitter.com/urologytimes 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 magenta cyan yellow black 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 magenta cyan yellow black © 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 magenta cyan yellow black 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 24950 Country Club Blvd., Suite 200, North Olmsted, OH 44070 800-225-4569 | E-mail: [email protected] Benjamin P. Saylor Content Specialist Julia Brown, Miranda Hester Content Coordinators Lecia Landis Art Director Bob Gatty UT Washington Correspondent Ray Painter, MD/Mark Painter Coding/Reimbursement Columnists Contributing Editors: Charles Bankhead, Cheryl Guttman Krader, Mac Overmyer Richard R. 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ES108330_UT0912_004.pgs 08.16.2012 08:35 ADV THE TIME IS RIGHT FOR GREENLIGHT ™ GreenLight XPS®, with the NEW 650kJ MoXy® Liquid-Cooled Fiber, is now applicable for a wider range of gland sizes by delivering over 50% more energy. The NEW MoXy Fiber Ability to treat larger glands • Increases cost efficiency • More energy with one fiber When you think BPH, think GreenLight.™ The time is right. For more information, contact your local AMS Representative. www.AMSGreenLight.com The GreenLight™ laser system is intended for incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue, including photoselective vaporization of the prostate for benign prostatic hyperplasia (BPH). The laser system is contraindicated for patients who: are contraindicated for surgery, have calcified tissue, require hemostasis in >2 mm vessels, have uncontrolled bleeding disorders, have prostate cancer, have acute urinary tract infection (UTI) or severe urethral stricture. Possible adverse events include, but are not limited to, irritative symptoms (dysuria, urgency, frequency), retrograde ejaculation, hematuria, urinary incontinence, erectile dysfunction, hematuria - gross, UTI, bladder neck contracture/outlet obstruct, urinary retention, perforation - prostate, urethral stricture. Prior to using these devices, please review the Operator’s Manual and any accompanying instructions for use for a complete listing of indications, contraindications, warnings, precautions and potential adverse events. Rx Only GreenLight™ is a trademark of and GreenLight XPS® and MoXy® are registered trademarks of American Medical Systems, Inc. © 2012 American Medical Systems, Inc. All Rights Reserved. Minnetonka, MN 55343 AMSUS/GL-00063/August 2012 www.AmericanMedicalSystems.com 1-800-328-3881 Global Use magenta cyan yellow black ES120128_UT0912_005_FP.pgs 08.29.2012 07:40 ADV 6 SEPTEMBER 2012 ∣ Urology Times Part of the Your guide to what’s happening online at UrologyTimes.com Urology Times is part of the ModernMedicine Network, a Web-based portal for health professionals offering best-in-class content and tools in a rewarding and easy-to-use environment for knowledge sharing among members of our community. urologytimes.com/addicts urologytimes.com/handlebars LEARN WHAT YOU’RE MISSING: EHR implementations shatter CMS estimates Our new online digital editions let you flip through the pages of your favorite Advanstar Communications publications from any computer. Sign up for free at the following Web sites. Like Us! Follow Us! Contemporary Pediatrics: contemporarypediatrics.com/digital Contemporary OB/GYN: contemporaryobgyn.modernmedicine.com facebook.com/urologytimes Medical Economics: twitter.com/urologytimes memag.com/subscribedigital Formulary: formularyjournal.modernmedicine.com/digital Drug Topics: drugtopics.com/digital More than 110,000 medical providers have attested to meaningful use after implementing electronic health record systems, shattering Centers for Medicare & Medicaid Services estimates. For details, see: Getty Images/Stockbyte Bicycle setup may be related to genital numbness in female cyclists, according to a study in the Journal of Sexual Medicine (2012; 9:1367-73). Bike handlebars positioned lower than the saddle were associated with decreased genital sensation. The authors noted that low handlebars cause a rider to lean forward and increase pelvic tilt; this may put more weight on the perineal region. The study suggests that modifying bicycle setup may help decrease risk of genital neuropathy. See: Getty Images/Comstock Images/Comstock In the Southeast, a group known as Project Prevention is making a controversial offer to male and female addicts: Get sterilized and earn $300. Community-based groups oppose the group’s tactics more often than not, but Project Prevention’s transitory nature has thus far kept policymakers from prohibiting incentivized sterilization Read more at: Getty Images/Stockbyte Low handlebars may impair Sterilization for addicts gets pass from lawmakers female genital sensation urologytimes.com/EHR 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: urologytimes.com/PSApoem Thomas Collins/ Photographer’s Choice RF/Getty Images magenta cyan yellow black ES116503_UT0912_006.pgs 08.23.2012 12:01 ADV One Urology Partner Infinite Solutions PlasmaButton™ Vaporization Electrode Plasma Vaporization Therapy Performed Safely in Saline The PlasmaButtonª Vaporization Electrode utilizes a plasma corona created by a controlled pulsing, ultra-low voltage and high current energy, reducing energy penetration and resulting in well-coagulated, smooth tissue. Scan here to visit www.PlasmaButton.com for more information The revolutionary, optimized spherical shape of the PlasmaButtonª Vaporization Electrode combined with the easy-to-learn technique provides a safe and simple solution to tissue management challenges. For more information contact your local Olympus representative or call 888-524-7266 or visit www.PlasmaButton.com. © 2012 Olympus America, Inc. Trademark or Registered Trademark of Olympus and its affiliate entities in the U.S. and/or other countries of the world. All patents apply. AD199-0512 magenta cyan yellow black ES115749_UT0912_007_FP.pgs 08.23.2012 02:55 ADV 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. magenta cyan yellow black 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 ADV 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- magenta cyan yellow black 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 ADV 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) ❳ magenta cyan yellow black ❲ “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 ADV magenta cyan yellow black ES109570_UT0912_LACLEDE1_FP.pgs 08.17.2012 10:11 ADV magenta cyan yellow black ES109574_UT0912_LACLEDE2_FP.pgs 08.17.2012 10:11 ADV 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 magenta cyan yellow black 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 ADV 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 magenta cyan yellow black 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 GREENWALD ROTH GRIP-TIP™ SUTURE GUIDES: “…incorporate an expanding tip which grips and fixates the cut end of the urethra to the guide…easing reanastomosis during radical prostatectomy.” Catalog number: U515 Often it is difficult to grasp and hold enough In many radical of the transected urethra to perform prostatectomy procedures, a clean bladder neck reanastomosis. simply inserting the 28 Fr. The GREENWALD ROTH GRIP-TIP™ stainless steel GRIP-TIP™ suture guide incorporates three completely guide will push enough of retractable stainless steel rods with the urethra into view to allow non-slip ends which “grip and precise suture placement. fixate…the urethra to the Occasionally, however, the urethra guide,” providing excellent will partially retract again or will not exposure of the transected have extended far enough for suturing. urethra and three sets of This is exactly the situation for which paired suture guide the GRIP-TIP™ was developed. Twisting the grooves, arranged at proximal knurled end of the guide extends the 120° intervals, three rods anywhere from “just showing” all the offering the surgeon way out to the equivalent of 45 Fr., sufficient to numerous suture firmly grip any urethra, preventing further unnecessary placement exposure trauma. The smooth extend-retract action possibilities is minutely controllable and, once set, the GRIP-TIP™ without will hold the exact degree of extension desired. having to New GRIP-TIP™ guides are fabricated of the finest readjust surgical grade mirror-finish stainless steel. GRIP-TIP™ the guide Guides carry GREENWALD’s famous guarantee. within the Call GREENWALD today for prices and to place your order: urethra. 1-888-962-1829, 219/962-1604, FAX: 219/962-4009 or write: Actual size Now available in 24 Fr.! Greenwald Surgical Company, Inc. 2688 DeKalb Street Lake Station, IN 46405-1519 © Greenwald Surgical Company, Inc. 2012 magenta cyan yellow black 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- magenta cyan yellow black 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- magenta cyan yellow black 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. magenta cyan yellow black 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 magenta cyan yellow black 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 ES115747_UT0912_020_FP.pgs 08.23.2012 02:55 ADV UrologyTimes.com ∣ 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 ES119490_UT0912_021.pgs 08.28.2012 10:06 ADV 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 ES119485_UT0912_022.pgs 08.28.2012 10:06 ADV UrologyTimes.com ∣ Prostate 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 magenta cyan yellow black 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 ADV 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 magenta cyan yellow black 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 ADV 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. magenta cyan yellow black ES115932_UT0912_025_FP.pgs 08.23.2012 03:33 ADV 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) black ES115913_UT0912_026_FP.pgs 08.23.2012 03:31 ADV 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 magenta cyan yellow black 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 ADV 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 magenta cyan yellow black 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 ADV 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 magenta cyan yellow black 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 ADV 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 magenta cyan yellow black 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 magenta cyan yellow black ES115922_UT0912_035_FP.pgs 08.23.2012 03:32 ADV 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 ADV 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 (%) &RQWUROZDVQRQDFWLYDWHGDXWRORJRXVSHULSKHUDOEORRGPRQRQXFOHDUFHOOV Cerebrovascular Events.,QFRQWUROOHGFOLQLFDOWULDOVFHUHEURYDVFXODUHYHQWV LQFOXGLQJKHPRUUKDJLFDQGLVFKHPLFVWURNHVZHUHUHSRUWHGLQRISDWLHQWVLQ WKH3529(1*(JURXSFRPSDUHGZLWKRISDWLHQWVLQWKHFRQWUROJURXS (See Adverse Reactions [6] of full Prescribing Information.) To report SUSPECTED ADVERSE REACTIONS, contact Dendreon Corporation at 1-877-336-3736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Dendreon Corporation Seattle, Washington 98101 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. J. STUART WOLF, JR, MD k'HQGUHRQ&RUSRUDWLRQ $OOULJKWVUHVHUYHG-XO\ 3ULQWHGLQWKH86$ 'HQGUHRQWKH'HQGUHRQORJRDQG PROVENGE are registered trademarks of Dendreon Corporation. P-A-07.12-221.00 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 magenta cyan yellow black ES120156_UT0912_037.pgs 08.29.2012 09:14 ADV 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- magenta cyan yellow black 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 ADV 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 magenta cyan yellow black 39 URO-BADV-BIGUT-EN-201208 ES120157_UT0912_039.pgs 08.29.2012 09:15 ADV 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 magenta cyan yellow black 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 ADV 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 magenta cyan yellow black 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 ADV 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. magenta cyan yellow black 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 magenta cyan yellow black ES115938_UT0912_043_FP.pgs 08.23.2012 03:37 ADV 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 ES115972_UT0912_044_FP.pgs 08.23.2012 04:22 ADV 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 black ES115961_UT0912_045_FP.pgs 08.23.2012 04:19 ADV 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. magenta cyan yellow black 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. ES116513_UT0912_046.pgs 08.23.2012 12:02 ADV 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, magenta cyan yellow black 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: t-BT7FHBT/FWBEB'SJEBZ/PWo4BUVSEBZ%FD t"UMBOUB(FPSHJB'SJEBZ'FCo4BUVSEBZ'FC For: &YQFSJFODFEDPEFSTCJMMFSTPóDFNBOBHFSTBOE QIZTJDJBOT%FTJHOBUFETQFDJBMTFDUJPOTGPSFBDIHSPVQ Seminar Topics Will Include: &.3BOE0*(DPODFSOT 5IF1IZTJDJBOTSPMFJODPEJOH &òFDUJWFVTFPGQSPGFTTJPOBMUJNFGPSCFUUFSQSPEVDUJWJUZ $PWFSBHFGPSOFXUFTUTBOEOFXESVHT 0UIFS$PEJOHBOE#JMMJOHJTTVFTFUDo&.DPEJOHCVOEMJOH NPEJöFSTHMPCBMQSPDFEVSBMDPEJOH 8IBUTOFXGPS Cost: POFEBZUXPEBZTGPSPOFQFSTPO POFEBZUXPEBZTBEEJUJPOBMBUUFOEFFT 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 Go to: Products & Service SHOWCASE products.modernmedicine.com CME WORKSHOP AMERICAN_ACADEMY_OF ANTI-AGING_MEDICINE Search NOw iNTRODuciNg ThE SExuAL hEALTh cERTificATiON MODuLE A: fEMALE SExuAL DYSfuNcTiON NOV 2-3, 2012 ENROLL TODAY! 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Smart marketing. 16 ❳ News ❲ ® 5-ARIs sho w Wayne Kuznar UT CORRESP ONDENT imes.com San Francisc www.urologyt o—Althoug for ves ADT impro RT plusadvanced locally tcomes PCa ou s The some diff erences in sexual JUNE 2010 ∣ Urology Times side effe cts the combina umes less tion, or placebo the relief h similarl MTOPS than 31 grams, , had prostate fewer sexual of lower urinary y effectiv volDr. Kaplan is represen tract symptom e men side finaster noted. If with symptom tative of the for ide (Proscaeffects were observe s, mance (Avodar atic BPH, population r) compar News Source d with of of t) in a retrospe then the ed to dutaster Leading formally dutaster ide has BPH, Steven perforctive not in UE ide this conditio a sizable proport been evaluate ofISS AUA annual A. 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As by Protox ut0810 urologi Urolog ists Inside outcome survival bination Better com seen withdata indicate therapy, 8 At a Glan ce News Management Practice 42 Columns 4 40 PRO T OX 53 Department s orge Baquero ❳ UT by the Cover illustration/Ge IN ists must ent: Urolog n AUA presid ir positio protect the ❲ Numbers UTSTAT Q * A ut0610 _016.p gs 05.19.2 ta magen yellow cyan black 010 11:08 ADVAN STAR_ PDF/X 1a Have you been featured in Urology Times? For instant credibility, put a reprint into your prospect’s hands. Now, that’s smart. THE YGS GROUP | 800-290-5460 x100 | [email protected] The YGS Group is the authorized provider of custom reprints for Urology Times. 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Psyche’s solutions are designed to make laboratories of all sizes more efficient. Don’t just keep up with innovation – stay on top of it! Pre-Owned Flexible Scopes with 18 month Warranty Sales | Repair Contact us today. 800.345.1514 Pre-Owned Video Camera Systems Bovie Units | Light Sources Bladder Fulgration System www.psychesystems.com GE Ultrasound Systems Probe Repair E.C. MEDICAL PRODUCTS B R E N T W O O D, T N 800-825-2708 • 615-373-3240 [email protected] ASK FOR FRITZ PRACTICE FOR SALE PENNSYLVANIA FOR SALE LARGE SOLO UROLOGICAL PRACTICE SW OF PHILADELPHIA. Near 3 hospitals • Reasonable • Ready to retire [email protected] Get Fast Action with the Dynamics of Marketplace Advertising! magenta cyan yellow black CLASSIFIEDS CAN WORK FOR YOU! REACH HIGHLY-TARGETED, MARKET-SPECIFIC BUSINESS PROFESSIONALS, INDUSTRY EXPERTS AND PROSPECTS BY PLACING YOUR AD HERE! PLEASE CONTACT: JOAN MALEY 1-800-225-4569 EXT. 2722 ES115948_ut0912_052_CL.pgs 08.23.2012 04:19 ADV UrologyTimes.com | Marketplace september, 2012 53 Recruitment NATIONAL UROLOGY POSITIONS LocumTenens.com is exhibiting hundreds of urology jobs available now, nationwide. SEATTLE AREA: Hospital employed 45 minutes to Seattle on Puget Sound. 1-5 call. MICHIGAN: Hospital employed solo 45 minutes to Lansing-Ann Arbor with daVinci Robotics. PENNSYLVANIA: Hospital employed with 450 bed health system. 1-4 call. VERMONT: Hospital employed with 188 bed hospital in great area and city. 1-4 call. Excellent salary,bonus and benefit packages SURGICAL SEARCH 800-831-5475 E/M: [email protected] DELAWARE Our gallery of services includes paid travel and housing with personalized arrangements, paid malpractice insurance, and licensing and credentialing assistance. Log on to locumtenens.com/uro or call 888.223.7950 to speak with our urology recruiting specialists today. 888.223.7950 | 2655 Northwinds Parkway | Alpharetta GA, 30009 | locumtenens.com/uro ILLINOIS “COME LIVE, WORK AND PLAY IN ILLINOIS” Live near several metropolitan cities including Chicago (3 hours) and St. Louis and Indianapolis (2 hours). • Join a dynamic health system that recently completed a $31 million modernization project. • Modern 385-bed fully accredited health care facility situated on an attractive 21-acre campus overlooking a picturesque lake. • Live in a vibrant community ranked #1 Best Small Metro Area in America by Forbes Magazine. • Numerous universities and colleges in the area. Illinois offers diverse geography, a climate with four distinct seasons and a wide variety of lifestyle opportunities. We want YOU to become part of our team of physicians. Call George Ivekich (800) 243-4353 or [email protected]. STRELCHECK & ASSOCIATES, INC. Urology Associates of Dover, PA Established five-man private practice urology group, located in the capital city of Dover, Delaware (pop: 45,000). For nearly 50 years, the practice has functioned as the only group urological practice in Kent County, servicing a single hospital with a surrounding population of 150,000. On-call responsibility shared equally (1:6 nights). Dover is within easy reach of DE/MD beaches and the major cities of Philadelphia, Baltimore and Washington D.C. Email: [email protected] [email protected] PLACE YOUR RECRUITMENT AD TODAY! Call Jacqueline Moran TO SEE THE L ATEST ADS VISIT US AT ht tp://careers.modernmedicine.com magenta cyan yellow black 1-800-225-4569 Ext. 2762 or 440-891-2762 Email: [email protected] ES115949_ut0912_053_CL.pgs 08.23.2012 04:19 ADV 54 Marketplace september, 2012 | Urology Times Recruitment NORTH DAKOTA PENNSYLVANIA UROLOGY POSITION NORTH DAKOTA’S ECONOMIC “MIRACLE” Forget the Texas Miracle. Let’s instead take a look at North Dakota, which has the lowest unemployment rate and the fastest job growth rate in the country. North Dakota has had the lowest unemployment in the country every single month since July 2008. North Dakota is the only state to be in continuous budget surplus since the banking crisis of 2008. Nicknamed the “magic city” because of its phenomenal growth during the early years of the 20th Century, Minot has become a regional powerhouse. As a major center for commerce, health care, finance, agribusiness, education, industry, transportation and recreation, Minot enjoys the finest in technology and quality services while maintaining its “small town” flair. • HOSPITAL EMPLOYED • SIGNING BONUS – “Up To” $100,000 • DA VINCI SURGICAL SYSTEM • STUDENT LOAN FORGIVENESS • BASE SALARY – “Up To” $550,000 • LEVEL II TRAUMA CENTER If you’re looking for great quality of life within a city with excellent family values, the “magic city” has it all. Please call ROBERT OVERFIELD at 800-839-4728 or email your CV to overfield@beck-field.com CONNECT with qualified leads and career professionals POST A JOB TODAY Jacqueline Moran RECRUITMENT MARKETING ADVISOR (800) 225-4569, ext. 2762 [email protected] BC/BE UROLOGIST Very busy, highly respected Urology group is seeking a Urologist proficient in Laparoscopy and Robotics. This is a Private Practice in an Academic setting with excellent coverage and an opportunity to develop a Robotics and Laparoscopic program at one of our hospitals. We have a fully integrated office with Electronic Medical Records and state of the art Urologic equipment located in the heart of Center City Philadelphia. Offering an excellent package with a partnership track. reply to: [email protected] VERMONT Engaging minds that change the world Assistant Professor/Associate Professor (Clinical Scholar Pathway) #014007 Department of Surgery, Division of Urology The Division of Urology at the University of Vermont College of Medicine in alliance with Fletcher Allen Health Care, is seeking a board certified/board eligible Urologist. The successful applicant must have completed a board approved urology residency, be eligible for medical licensure in the State of Vermont and eligible to work in the United States. Advanced training in female urology, neuro-urology and reconstructive urology is preferred. Duties will include general urologic patient care opportunities aligned with the teaching of medical students and urology residents. Candidates should have broad experience in all aspects of Urology. This is a full-time, 12month, salaried position with attending staff privileges at Fletcher Allen Health Care. The academic appointment at the University of Vermont will be at the Assistant Professor or Associate Professor rank (Clinical Scholar Pathway) and will be determined by the candidate’s background and experience. The University is especially interested in candidates who can contribute to the diversity and excellence of the academic community through their research, teaching, and/or service. Applicants are requested to include in their cover letter information about how they will further this goal. Applications will be accepted until the position is filled. Interested individuals should submit electronically their curriculum vitae with a cover letter and contact information for four references to: Mark K. Plante, MD, University of Vermont, Division of Urology, 320FL4 – MC Campus, 111 Colchester Avenue, Burlington, VT 05401, Email: [email protected], or apply on-line at: https://www.uvmjobs.com The University of Vermont is an Equal Opportunity/Affirmative Action Employer. Applications from women and people from diverse racial, ethnic, and cultural backgrounds are encouraged. magenta cyan yellow black ES115954_ut0912_054_CL.pgs 08.23.2012 04:19 ADV 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 magenta cyan yellow black 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 ADV 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 magenta cyan yellow black 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. ADV Connect with Urology Times on Facebook and Twitter Join your colleagues in conversation, respond to hot-topic questions, and stay up to date on breaking news. Like and follow us today! facebook.com/UrologyTimes @UrologyTimes Visit online at www.urologytimes.com magenta cyan yellow black ES120136_UT0912_CV3_FP.pgs 08.29.2012 07:40 ADV 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 magenta cyan yellow black ES115748_UT0912_CV4_FP.pgs 08.23.2012 02:55 ADV