PURPOSE:Posterior rhabdosphincter reconstruction following radical prostatectomy was designed to improve early urinary continence. We executed a randomized clinical trial to test this conjecture in men undergoing robotic radical prostatectomy. MATERIALS AND METHODS: We conducted a phase II randomized clinical trial intended to detect a 25% difference in 3-month continence outcomes defined by a patient response of 0 or 1 to question 5 of the Expanded Prostate Cancer Index Composite questionnaire urinary domain, comparing standard running vesicourethral anastomosis (controls) to posterior rhabdosphincter reconstruction followed by standard running vesicourethral anastomosis (posterior rhabdosphincter reconstruction treated). Patients had clinically localized prostate cancer and were blinded. Surgeons were notified of computer randomization after prostate excision. Further continence outcomes were assessed by analysis of Expanded Prostate Cancer Index Composite questionnaire questions 1 and 12, International Prostate Symptom Score and 24-hour pad weights. Statistical significance was defined as p <0.05 RESULTS: A total of 94 patients were randomized, 47 to each arm. Preoperative clinical and functional variables were equivalent between study arms. There were no complications associated with either anastomotic technique. Of the 87 evaluable patients 62 (71.3%) met our 3-month continence definition. The null hypothesis was not rejected as 33 (81%) controls and 29 (63%) posterior rhabdosphincter reconstruction treated patients were continent at 3 months (chi-square p = 0.07, Fisher exact p = 0.1). Likewise there was no significant difference between arms in 24-hour pad weights (p = 0.14), International Prostate Symptom Score (p = 0.4), absence of daily leaks (p = 0.4) or perception of urinary function (p = 0.4). CONCLUSIONS: In this randomized clinical trial posterior rhabdosphincter reconstruction offered no advantage for return of early continence after robotic assisted radical prostatectomy.
RCT Entities:
PURPOSE: Posterior rhabdosphincter reconstruction following radical prostatectomy was designed to improve early urinary continence. We executed a randomized clinical trial to test this conjecture in men undergoing robotic radical prostatectomy. MATERIALS AND METHODS: We conducted a phase II randomized clinical trial intended to detect a 25% difference in 3-month continence outcomes defined by a patient response of 0 or 1 to question 5 of the Expanded Prostate Cancer Index Composite questionnaire urinary domain, comparing standard running vesicourethral anastomosis (controls) to posterior rhabdosphincter reconstruction followed by standard running vesicourethral anastomosis (posterior rhabdosphincter reconstruction treated). Patients had clinically localized prostate cancer and were blinded. Surgeons were notified of computer randomization after prostate excision. Further continence outcomes were assessed by analysis of Expanded Prostate Cancer Index Composite questionnaire questions 1 and 12, International Prostate Symptom Score and 24-hour pad weights. Statistical significance was defined as p <0.05 RESULTS: A total of 94 patients were randomized, 47 to each arm. Preoperative clinical and functional variables were equivalent between study arms. There were no complications associated with either anastomotic technique. Of the 87 evaluable patients 62 (71.3%) met our 3-month continence definition. The null hypothesis was not rejected as 33 (81%) controls and 29 (63%) posterior rhabdosphincter reconstruction treated patients were continent at 3 months (chi-square p = 0.07, Fisher exact p = 0.1). Likewise there was no significant difference between arms in 24-hour pad weights (p = 0.14), International Prostate Symptom Score (p = 0.4), absence of daily leaks (p = 0.4) or perception of urinary function (p = 0.4). CONCLUSIONS: In this randomized clinical trial posterior rhabdosphincter reconstruction offered no advantage for return of early continence after robotic assisted radical prostatectomy.
Authors: Quoc-Dien Trinh; Jesse Sammon; Jay Jhaveri; Maxine Sun; Khurshid R Ghani; Jan Schmitges; Wooju Jeong; James O Peabody; Pierre I Karakiewicz; Mani Menon Journal: Ther Adv Urol Date: 2012-04
Authors: Keith J Kowalczyk; Andy C Huang; Nathanael D Hevelone; Stuart R Lipsitz; Hua-yin Yu; John H Lynch; Jim C Hu Journal: World J Urol Date: 2012-11-08 Impact factor: 4.226