Abstract
INTRODUCTION AND OBJECTIVES: Urinary incontinence post radical prostatectomy is a common complication regardless of approach, with significant negative impact on health-related quality of life. Although 12-month continence rates range from 85-95% in established studies, few patients are continent in the early postoperative period. The posterior reconstruction of Denonvilliers’ musculofascial plate (PRDMP) may improve the early return to urinary continence, though reports in the literature have been mixed, warranting further study. Weaknesses in previous studies of PRDMP included varied definitions of continence, differing surgeon experience, lack of randomization, and insufficient statistical power. We compared the PRDMP versus standard urethrovesical anastomosis during robotassisted radical prostatectomy (RARP) in a randomized controlled trial (RCT). METHODS: Patients with clinically localized prostate cancer scheduled for RARP were prospectively recruited in clinic and randomly allocated to PRDMP or conventional anastomosis. Patients were blinded to allocation status and the surgeon was informed immediately before the case to minimize bias. All cases were performed by a highvolume surgeon at a tertiary healthcare center. Our primary outcome was assessed by using the Expanded Prostate Cancer Index Composite Short Form (EPIC-26) survey at baseline and 2, 3, 4, 6, 8, and 12-months postoperatively. Continence was defined as an answer of 0-1 safety pad per day. The trial is powered to detect a significant improvement in continence of 40-75% at 3 months with an a level of 0.05 at 80%, requiring 65 patients per group for power. We have oversampled to account for attrition. Follow-up interviews were done via telephone. RESULTS: Recruitment occurred from April 2014 to July 2015, with a total N1⁄4164. We currently have 6-month follow-up data available on 55 patients in the PRDMP group and 42 in the control group. At months 2, 3, 4, and 6, use of pads for the intervention group and the control group at 0-1 per day (measured continence) was 36.5% and 37.5%, 60.7% and 60.5%, 72.6% and 65.7%, and 83% and 76.5%, respectively CONCLUSIONS: Interim analysis of this RCT suggests a trend toward the PRPMD being more effective than conventional anastomosis in terms of early return to continence following RARP, but more so as the data reached the fourth month. The two groups were also not equal in size. Final analysis at the completion of this RCT is required to establish statistical significance of these findings.
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