A Randomized Study of Intraoperative Autologous Retropubic Urethral Sling on Urinary Control after Robotic Assisted Radical Prostatectomy

摘要

PURPOSE: We evaluated whether placement of a retropubic urethral sling fashioned from autologous vas deferens during robotic assisted radical prostatectomy would improve recovery of continence. MATERIALS AND METHODS: In a phase 2, single blind trial age stratified patients were randomized to undergo robotic assisted radical prostatectomy by multiple surgeons with or without sling placement. The outcomes were complete continence (0 urinary pads of any type) and near continence (0, an occasional or 1 pad per day) at 6 months, which was assessed by the Fisher exact test and logistic regression. The Kaplan-Meier method and the log rank test were used to evaluate time to continence. EPIC-UIN (Expanded Prostate Cancer Index Composite-Urinary Inventory) and I-PSS (International Prostate Symptom Score) 1, 3 and 6 months after catheter removal were evaluated by mixed models for repeated measures. RESULTS: Of 203 patients who were recruited 95 and 100 were randomized to undergo sling and no sling placement, respectively, and completed postoperative interviews. Six months after surgery the proportions reporting complete and near continence (66% and 87%, respectively) and times to complete and near continence were similar in the groups. Younger age was associated with a 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 (OR 2.18 per decreasing 5-year interval, 95% CI 1.21-3.92, p <0.01) adjusting for clinical, urinary and surgical factors. Adjusted EPIC-UIN and I-PSS scores changed with time but did not differ between the groups. No serious adverse events were observed. CONCLUSIONS: This trial failed to demonstrate a benefit of autologous urethral sling placement at robotic assisted radical prostatectomy on early return of continence at 6 months. Continence was related to patient age in adjusted models.