A Randomized Comparison of a Single-incision Midurethral Sling and a Transobturator Midurethral Sling in Women with Stress Urinary Incontinence: Results of 12-mo Follow-up

Background

Midurethral sling procedures have become the prime surgical treatment for women with stress urinary incontinence (SUI). Single-incision mini-slings (SIMS) potentially offer similar efficacy with reduced morbidity. This international multicenter trial compared the efficacy and morbidity of a SIMS (MiniArc) and a transobturator standard midurethral sling (SMUS) (Monarc).

Objective

To compare subjective and objective cure, morbidity, and surgery-related discomfort following SIMS and transobturator SMUS.

Design, setting, and participants

Prospective randomized controlled trial with an initial follow-up period of 12 mo. Women with symptomatic SUI were eligible.

Outcome measurements and statistical analysis

Primary outcome was subjective cure, defined as an improvement on the Patient Global Impression of Improvement (PGI-I). Coprimary outcome was the mean visual analog scale (VAS) pain score (0–100) during 3 d after surgery. Secondary outcomes were objective cure based on the cough stress test (CST), disease-specific quality of life determined by the Urogenital Distress Inventory (UDI-6) score, surgical parameters, and physical performance during recovery. Analysis was by intent to treat. Differences between the MiniArc and Monarc groups on dichotomous variables were chi-square tested and presented as relative risks (RR) with corresponding 95% confidence intervals. We hypothesized that MiniArc was noninferior to Monarc concerning subjective cure and superior concerning postoperative pain.

Results and limitations

We randomized 97 women to MiniArc and 96 to Monarc. At 12-mo follow-up, subjective cure was 83% following MiniArc and 86% following Monarc (p = 0.46). Objective cure was 89% following MiniArc and 91% following Monarc (p = 0.65). The mean pain VAS score during the first three postoperative days was 9 following MiniArc and 22 following Monarc (Mann-Whitney U test, p < 0.01).

Conclusions

At 1-yr follow-up, MiniArc was noninferior to Monarc with respect to subjective and objective cure and superior with respect to postoperative pain.

Patient summary

This 1-yr randomized clinical trial showed that MiniArc, a single-incision midurethral sling, is noninferior to Monarc, a transobturator sling, with respect to cure and superior with respect to pain and recovery.