Posterior Rhabdosphincter Reconstruction During Robotic Assisted Radical Prostatectomy: Results From a Phase II Randomized Clinical Trial

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...