Single-Incision Mini-Slings for Stress Urinary Incontinence in Women
Abstract
This multicenter, noninferiority randomized trial compared single-incision mini-slings (SIMS) with standard midurethral slings (SMUS) in 600 women with stress urinary incontinence (SUI) over 36 months. The primary outcome patient reported success (PGI-I score of "very much" or "much improved") at 15 months was similar between groups (79.1% SIMS vs. 75.6% SMUS; adjusted risk difference 4.6%, 95% CI: -2.7 to 11.8; P<0.001 for noninferiority). Results remained comparable at 36 months (72.0% vThis multicenter, noninferiority randomized trial compared single incision mini-slings (SIMS) with standard midurethral slings (SMUS) in 600 women with stress urinary incontinence (SUI) over 36 months. The primary outcome patient reported success (PGI-I score of "very much" or "much improved") at 15 months was similar between groups (79.1% SIMS vs. 75.6% SMUS; adjusted risk difference 4.6%, 95% CI: -2.7 to 11.8; P<0.001 for noninferiority). Results remained comparable at 36 months (72.0% vs. 66.8%). SIMS procedures were more often performed under local anesthesia, with less postoperative pain (mean pain score 19.8 vs. 28.1, P<0.001). However, SIMS were associated with higher rates of dyspareunia (11.7% vs. 4.8% at 36 months, P=0.01) and mesh exposure (3.3% vs. 1.9%). Further surgery for SUI was rare but more frequent with SIMS (2.5% vs. 1.1%). The trial supports SIMS as noninferior to SMUS for SUI treatment but highlights trade offs in postoperative recovery and sexual function.s. 66.8%). SIMS procedures were more often performed under local anesthesia, with less postoperative pain (mean pain score 19.8 vs. 28.1, P<0.001). However, SIMS were associated with higher rates of dyspareunia (11.7% vs. 4.8% at 36 months, P=0.01) and mesh exposure (3.3% vs. 1.9%). Further surgery for SUI was rare but more frequent with SIMS (2.5% vs. 1.1%). The trial supports SIMS as noninferior to SMUS for SUI treatment but highlights trade-offs in postoperative recovery and sexual function.