Anastasios D Asimakopoulos1,2, Luca Topazio3, Michele De Angelis3, Enrico Finazzi Agrò4, Antonio Luigi Pastore5, Andrea Fuschi3,5, Filippo Annino3. 1. Department of Urology, Usl Toscana Sud Est, San Donato Hospital, Arezzo, Italy. tasospao2003@yahoo.com. 2. Department of Experimental Medicine and Surgery, UOC of Urology, University of Rome Tor Vergata, Rome, Italy. tasospao2003@yahoo.com. 3. Department of Urology, Usl Toscana Sud Est, San Donato Hospital, Arezzo, Italy. 4. Department of Experimental Medicine and Surgery, UOC of Urology, University of Rome Tor Vergata, Rome, Italy. 5. Department of Medico-Surgical Sciences and Biotechnologies, Urology Unit, Sapienza University of Rome, Latina, Italy.
Abstract
BACKGROUND: Post-prostatectomy urinary incontinence is an adverse event leading to significant distress. Our aim was to evaluate immediate urinary continence (UC) recovery in a single-surgeon prospective randomized comparative study between the traditional robot-assisted laparoscopic radical prostatectomy (TR-RALP) and the Retzius-sparing RALP (RS-RALP), for the treatment of the clinically localized prostate cancer (PCa). METHODS:102 consecutive PCa patients were prospectively randomized to TR-RALP (57) or RS-RALP (45). Postoperative continence was defined as patient-reported absence of leakage or use of 0 pads/day. The immediate continence rate and 95% confidence interval (CI 95%) were calculated for each treatment. Univariable and multivariate logistic regressions were used to assess predictors of immediate continence following RALP. Continence rates from 1 to 6 months were calculated by Kaplan-Meier curves; log-rank test was used for the curve comparison. Two analyses were performed, considering a per-protocol (PP) population regarding all randomized patients that received nerve-sparing RALP and an Intention-To-Treat (ITT) population regarding all randomized patients that received RALP. RESULTS: In the PP analysis, the rates of immediate continence were 12/40 (30%) (CI 95% 17-47%) for the TR-RALP and 20/39 (51.3%) (CI 95% 35-68%) for the RS-RALP (p = 0.05). In the ITT analysis, the corresponding rates were 12/57 (21%) (CI 95% 11-34%) for the TR-RALP and 23/45 (51%) (CI 95% 36-66%) for the RS-RALP (p = 0.001). Median time to continence was 21 days for the TR-RALP and 1 day for RS-RALP, respectively (p = 0.02). The relative Kaplan-Meier curves regarding continence resulted statistically different when compared with the log rank test (p = 0.02). In the multivariate analysis, lower age and the Retzius-sparing approach were significantly associated to earlier continence recovery. CONCLUSIONS: The Retzius-sparing approach significantly reduces time to continence following RALP. Further studies are required to confirm the reproducibility of our results and investigate the role of the RS-RALP as an additional "protective" factor for postoperative continence in the elderly population.
RCT Entities:
BACKGROUND: Post-prostatectomy urinary incontinence is an adverse event leading to significant distress. Our aim was to evaluate immediate urinary continence (UC) recovery in a single-surgeon prospective randomized comparative study between the traditional robot-assisted laparoscopic radical prostatectomy (TR-RALP) and the Retzius-sparing RALP (RS-RALP), for the treatment of the clinically localized prostate cancer (PCa). METHODS: 102 consecutive PCa patients were prospectively randomized to TR-RALP (57) or RS-RALP (45). Postoperative continence was defined as patient-reported absence of leakage or use of 0 pads/day. The immediate continence rate and 95% confidence interval (CI 95%) were calculated for each treatment. Univariable and multivariate logistic regressions were used to assess predictors of immediate continence following RALP. Continence rates from 1 to 6 months were calculated by Kaplan-Meier curves; log-rank test was used for the curve comparison. Two analyses were performed, considering a per-protocol (PP) population regarding all randomized patients that received nerve-sparing RALP and an Intention-To-Treat (ITT) population regarding all randomized patients that received RALP. RESULTS: In the PP analysis, the rates of immediate continence were 12/40 (30%) (CI 95% 17-47%) for the TR-RALP and 20/39 (51.3%) (CI 95% 35-68%) for the RS-RALP (p = 0.05). In the ITT analysis, the corresponding rates were 12/57 (21%) (CI 95% 11-34%) for the TR-RALP and 23/45 (51%) (CI 95% 36-66%) for the RS-RALP (p = 0.001). Median time to continence was 21 days for the TR-RALP and 1 day for RS-RALP, respectively (p = 0.02). The relative Kaplan-Meier curves regarding continence resulted statistically different when compared with the log rank test (p = 0.02). In the multivariate analysis, lower age and the Retzius-sparing approach were significantly associated to earlier continence recovery. CONCLUSIONS: The Retzius-sparing approach significantly reduces time to continence following RALP. Further studies are required to confirm the reproducibility of our results and investigate the role of the RS-RALP as an additional "protective" factor for postoperative continence in the elderly population.
Authors: Vincenzo Ficarra; Giacomo Novara; Walter Artibani; Andrea Cestari; Antonio Galfano; Markus Graefen; Giorgio Guazzoni; Bertrand Guillonneau; Mani Menon; Francesco Montorsi; Vipul Patel; Jens Rassweiler; Hendrik Van Poppel Journal: Eur Urol Date: 2009-01-25 Impact factor: 20.096
Authors: Stefano Tappero; Paolo Dell'Oglio; Mattia Longoni; Carlo Buratto; Erika Palagonia; Pietro Scilipoti; Enrico Vecchio; Marco Martiriggiano; Silvia Secco; Alberto Olivero; Michele Barbieri; Giancarlo Napoli; Elena Strada; Giovanni Petralia; Dario Di Trapani; Aldo Massimo Bocciardi; Antonio Galfano Journal: World J Urol Date: 2022-06-30 Impact factor: 3.661