A Parallel Randomized Clinical Trial Examining the Return of Urinary Continence After Robot-Assisted Radical Prostatectomy with or without a Small Intestinal Submucosa Bladder Neck Sling

PURPOSE - Urinary continence is a driver of quality of life after radical prostatectomy. The purpose of this study was to evaluate the impact of a biologic bladder neck sling on postoperative return of urinary continence after robot-assisted radical prostatectomy (RARP).

MATERIALS AND METHODS - This study compared early continence in patients undergoing RARP with a sling and without a sling in a two group, 1:1, parallel, randomized controlled trial. Patients were blinded to group assignment. The primary outcome was defined as urinary continence (0-1 pads per day) at 1 month postoperative. Inclusion criteria included organ-confined prostate cancer and a prostate-specific antigen <15. Exclusion criteria included any prior surgery on the prostate, history of neurogenic bladder, and history of prior pelvic radiation. A chi-squared test was used for the primary outcome.

RESULTS - A total of 147 patients were randomized (control=74, sling=73), and 92% were available for primary endpoint analysis at 1 month. There were no significant differences in baseline or perioperative data except that operating room time was 20. 1 minutes longer for the sling group (P=0. 04). The continence rate was similar between control and sling groups at both 1 month (47. 1% vs. 55. 2%, P=0. 34) and 12 months (86. 7% vs. 94. 5%, P=0. 15), respectively. Adverse events were similar between control and sling groups (10. 8% vs. 13. 7%, P=0. 59).

CONCLUSIONS - The application of an absorbable urethral sling at the time of RARP was well tolerated with no increase in obstructive symptoms in this randomized trial. However, the sling failed to show a significant improvement in continence.

The Journal of urology. 2016 Jan 16 [Epub ahead of print]

Clinton D Bahler, Chandru P Sundaram, Naveen Kella, Steven M Lucas, Michelle A Boger, Thomas A Gardner, Michael O Koch

Indiana University, Department of Urology, Indianapolis, IN. , Indiana University, Department of Urology, Indianapolis, IN. , The Urology Place, San Antonio, TX. , Indiana University, Department of Urology, Indianapolis, IN. , Indiana University, Department of Urology, Indianapolis, IN. , Indiana University, Department of Urology, Indianapolis, IN. , Indiana University, Department of Urology, Indianapolis, IN. 

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