Introduction: Posterior rhabdosphincter reconstruction (PRRS) following radical prostatectomy
was designed to improve early urinary continence. We executed a randomized
clinical trial comparing early continence rates in patients undergoing urethrovesical anastomosis with or without periprostatic reconstruction.
Methods: We conducted a randomized clinical trial (NCT03302169) intended to detect a 20% difference in 1-month continence defined by a patient response of 0 to question 3 of the EPIC26 questionnaire urinary domain, comparing standard running vesicourethral anastomosis (controls) to PRRS followed by standard running vesicourethral anastomosis (PRRS treated). Further continence outcomes were assessed by time to have no leakage (dry pad first date), 24-hour pad weights and time until stop using pad/any protection (Pad 0 first date), ICIQ-SF and IPSS questionnaires. Patients had clinically localized prostate cancer and were blinded. Surgeons were notified of computer randomization (random.org) after prostate excision. Patients and data gatherers were blinded to treatment allocation.
Results: A total of 158 patients were randomized between January 2017 and September 2018. 153 patients completed the 6 months study first analysis. Preoperative clinical and functional variables were equivalent between study arms. 50th percentile of patients with dry pad and patients without any protection in the PRRS group was 23 and 34 days, respectively. While 49 and 81 were the equivalent distribution of the control group. Univariate analyses showed that the type of reconstruction was related with absence of any protection 1 month after the surgery (p=0.012) but it wasn’t associate with the dry pad status. No differences were found at 6 months or using the questionnaires specific domains . We performed a multivariate analysis including PSA, BMI, age, prostate volume, lymphadenectomy, nerve-sparing technique and the reconstruction type. PRRS was the only independent predictor of dry pad status and use of any protection at 1 month (Pad 0). The Kaplan-Meier curve demonstrated the statistically significant difference between both techniques in time to recovery early urinary continence.
Conclusions: In this randomized clinical trial posterior rhabdosphincter showed a clear benefit in early urinary continence. To determine the date of dry pad and Pad 0 seems to be more reliable than apply validated questionnaires in established timeframes in order to assess continence status after radical prostatectomy. Source of