We evaluated whether placement of a retropubic urethral sling fashioned from autologous vas deferens during robotic-assisted radical prostatectomy (RARP) improved recovery of continence.
In a phase-2, single-blinded trial, age-stratified patients were randomized to undergo RARP by multiple surgeons with or without sling placement. Outcomes were complete continence (0 urinary pads of any type) and near continence (0, occasional or 1 pad per day) at 6 months, assessed with Fisher's exact test and logistic regression. Kaplan-Meier method and log-rank were used to evaluate time to continence. EPIC Urinary Inventory (UIN) and IPSS scores at 1, 3, and 6 months after catheter removal were evaluated with mixed models for repeated measures.
Among 203 patients who were recruited, 195 patients were randomized to undergo sling (n=95) or no sling (n=100) placement and completed post-surgical interviews. Six months after surgery, proportions reporting complete continence (66%) and near continence (87%), and times to complete continence and to near continence, were similar between groups. Younger age was associated with higher likelihood of complete continence (OR 1.74 per decreasing 5 year interval (95%CI 1.23-2.48) p<0.01) and near continence (2.18 (1.21-3.92) p<0.01), adjusting for clinical, urinary, and surgical factors. Adjusted EPIC UIN and IPSS scores changed over time but did not differ between groups. No serious adverse events were observed.
This trial failed to demonstrate a benefit of autologous urethral sling placement at RARP on early return of continence at 6 months. Continence was related to patient age in adjusted models.
The Journal of urology. 2016 [Epub ahead of print]
Hao G Nguyen, Sanoj Punnen, Janet E Cowan, Michael Leapman, Clint Cary, Christopher Welty, Vivian Weinberg, Matthew R Cooperberg, Maxwell V Meng, Kirsten L Greene, Maurice Garcia, Peter R Carroll
Department of Urology, University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, California, USA. Electronic address: ., Department of Urology, University of Miami Miller School of Medicine and Sylvester Cancer Center, Miami, Florida, USA., Department of Urology, University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, California, USA., Department of Urology, Indiana University, Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, USA.