Safety and Efficacy of Single Incision Sling Versus Midurethral Sling in the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial.

Importance: This study compares the long-term efficacy and safety of an innovative single-incision sling (SIS) with the inside-out transobturator tape (TOT) sling in the treatment of female stress urinary incontinence. Objectives: Women with urodynamic stress urinary incontinence were randomized to either SIS or TOT groups and followed up for 4 years. The primary outcome was objective cure defined with a negative cough stress test result. Secondary outcomes involved subjective cure reported via patient's satisfaction scale, surgery complications, postoperative de novo urgency, and patient's life quality. Study

Design: This is a randomized noninferiority controlled trial.

Results: A total of 168 women were randomized (84 in both groups). After 4-year follow-up, 130 patients were analyzed (66 in the SIS group and 64 in the TOT group). The objective (86.4% vs 84.4%; risk difference [95% confidence interval], 0.020 [-0.101 to 0.141]; P = 0.807) and subjective cure rates (83.3% vs 81.3%; risk difference [95% confidence interval], 0.020 [-0.111 to 0.151]; P = 0.821) were similar with the SIS and TOT groups. Both procedures were associated with low complication rates. Repeated surgery rates were 7.6% in the SIS group and 6.3% in the TOT groups. The mesh exposure rate was 1.5% for the SIS group and 3.1% for the TOT group. Incidence of de novo urgency did not vary between TOT and SIS patients. Both groups registered significant life quality improvement.

Conclusion: After long-term follow-up, anti-incontinence SIS surgery proved noninferior to the inside-out TOT procedure in terms of objective and subjective cure rates.