Bruce L Jacobs1, Stephanie Daignault2, Cheryl T Lee2, Khaled S Hafez2, Jeffrey S Montgomery2, James E Montie3, Jean E Humrich2, Brent K Hollenbeck3, David P Wood4, Alon Z Weizer5. 1. Department of Urology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania. 2. Divisions of Oncology and Health Services Research, University of Michigan, Ann Arbor, Michigan. 3. Department of Urology, University of Michigan, Ann Arbor, Michigan. 4. Department of Urology, William Beaumont School of Medicine, Royal Oak, Michigan. 5. Divisions of Oncology and Health Services Research, University of Michigan, Ann Arbor, Michigan. Electronic address: aweizer@umich.edu.
Abstract
PURPOSE:Prostate capsule sparing and nerve sparing cystectomies are alternative procedures for bladder cancer that may decrease morbidity while achieving cancer control. However, to our knowledge the comparative effectiveness of these approaches has not been established. We evaluated functional and oncologic outcomes in patients undergoing these procedures. MATERIALS AND METHODS: We performed a single institution trial in patients with bladder cancer in whomtransurethral prostatic urethral biopsy and transrectal prostate biopsy were negative. Men were randomized to prostate capsule sparing or nerve sparing cystectomy with neobladder creation and stratified by Sexual Health Inventory for Men score (greater than 21 vs 21 or less). Our primary end point was 12-month overall urinary function as measured by Bladder Cancer Index. Secondary end points included sexual function, cancer control and complications. RESULTS: A total of 40 patients were enrolled in the study with 20 patients in each arm. Urinary function at 12 months decreased by 13 and 28 points in the prostate capsule and nerve sparing groups, respectively (p = 0.10). Sexual function followed a similar pattern (p = 0.06). There was no difference in recurrence-free, metastasis-free or overall survival (each p >0.05). The rate of incidentally detected prostate cancer was similar (p = 0.15). CONCLUSIONS: Our study provides a randomized comparison of prostate capsule sparing and nerve sparing cystectomy techniques. We found no difference in functional or oncologic outcomes between the 2 approaches, although our study was underpowered due to a lack of patient accrual.
RCT Entities:
PURPOSE: Prostate capsule sparing and nerve sparing cystectomies are alternative procedures for bladder cancer that may decrease morbidity while achieving cancer control. However, to our knowledge the comparative effectiveness of these approaches has not been established. We evaluated functional and oncologic outcomes in patients undergoing these procedures. MATERIALS AND METHODS: We performed a single institution trial in patients with bladder cancer in whom transurethral prostatic urethral biopsy and transrectal prostate biopsy were negative. Men were randomized to prostate capsule sparing or nerve sparing cystectomy with neobladder creation and stratified by Sexual Health Inventory for Men score (greater than 21 vs 21 or less). Our primary end point was 12-month overall urinary function as measured by Bladder Cancer Index. Secondary end points included sexual function, cancer control and complications. RESULTS: A total of 40 patients were enrolled in the study with 20 patients in each arm. Urinary function at 12 months decreased by 13 and 28 points in the prostate capsule and nerve sparing groups, respectively (p = 0.10). Sexual function followed a similar pattern (p = 0.06). There was no difference in recurrence-free, metastasis-free or overall survival (each p >0.05). The rate of incidentally detected prostate cancer was similar (p = 0.15). CONCLUSIONS: Our study provides a randomized comparison of prostate capsule sparing and nerve sparing cystectomy techniques. We found no difference in functional or oncologic outcomes between the 2 approaches, although our study was underpowered due to a lack of patient accrual.
Authors: James E Montie; Peter E Clark; Mario A Eisenberger; Rizk El-Galley; Richard E Greenberg; Harry W Herr; Gary R Hudes; Deborah A Kuban; Timothy M Kuzel; Paul H Lange; Subodh M Lele; Jeffrey Michalski; Anthony Patterson; Kamal S Pohar; Jerome P Richie; Wade J Sexton; William U Shipley; Eric J Small; Donald L Trump; Phillip J Walther; Timothy G Wilson Journal: J Natl Compr Canc Netw Date: 2009-01 Impact factor: 11.908
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