Introduction

Open and robotic radical prostatectomy have substantial effects on post-operative quality of life through resultant urinary incontinence and erectile dysfunction. Retzius-Sparing Robotic Assisted Radical Prostatectomy (RS-RARP) has emerged as a technique to improve early return of continence. Alternative strategies including transvesical approaches have shown promise in achieving similar continence outcomes. This study aims to evaluate a novel hybrid technique, Transvesical Retzius-Sparing Robotic Assisted Radical Prostatectomy (TRS-RARP).

Methods

This is a single-arm prospective phase II clinical trial utilizing Simon's two-stage design (NCT06237114). The 1ry objective is the rate of urinary continence, defined as 0-1 pad/day, at 3 mo post-operatively. 2ry objectives include continence rates at 1 and 6 mo, quality of life using EQ-5D-5L and EPIC-CP questionnaires. The study is powered to detect a 65% continence rate (H1) vs 40% (H0) at 3-mo with planned 30 patient enrollment. Patients undergoing TRS-RARP are evaluated with baseline demographic data collection, surgical outcomes and pathology results. Post-operative assessments are conducted at 4 wks, 3 and 6 mo.

Results

As of time of submission, data from initial 17 enrolled patients are available for analysis. Median patient age is 63.5 years. 15 patients completed a 1-mo follow-up, and 3-mo follow-up data is expected shortly. Baseline urinary incontinence according to EPIC-CP questionnaire average was 0-1, and 4 at 1-mo. The average number of pads/day was 0 at baseline, and 1-2 pads/day at 1 mo. Quality of life as measured by EQ-5D showed 66% of patients had a normal baseline score of 11111, with 50% maintaining this score at 1-mo.

Conclusion

TRS-RARP represents a novel technique to potentially enhance early urinary continence recovery following radical prostatectomy. Early results suggest promising trends towards achieving the study's 1ry endpoint of improved early continence rates.