Midurethral slings techniques achieve high cure rates in women with stress urinary incontinence (SUI) and have become the criterion standard surgical treatment for women with SUI. However, use of the retropubic or transobturator approach with these invasive techniques is associated with a number of complications (including vascular or visceral injuries and thigh pain). In an attempt to avoid such adverse events, minislings were developed as a minimally invasive approach to midurethral sling placement. Use of the minisling method may be associated with shorter operation time and fewer complications.
The primary aim of this single-center randomized controlled trial was to compare the efficacy and safety of a single-incision minisling compared with a transobturator midurethral sling for SUI treatment. A total of 130 women with SUI were randomized to a minisling or a transobturator midurethral tape. The primary study outcomes were the objective and subjective cure rates 1 year after surgery, satisfaction rates, and improvements in quality of life. Objective cure of SUI was defined as absence of urinary leakage in the cough stress test and in the 20-minute pad test; subjective cure was the satisfaction rate. Quality of life was assessed using the Incontinence Quality of Life Questionnaire and the Urogenital Distress Inventory Short Form. Operation time, complications, and reoperation rates were also compared. A noninferiority test with a margin of 15% was used to compare efficacy of the 2 techniques, with P > 0.05 indicating that the minisling procedure was not inferior to the transobturator technique.
At the 1-year follow-up, 120 of the 130 randomized patients were available for analysis (64 in the minisling group and 56 in the transobturator midurethral tape group). The objective cure rate was 68.1% with the minisling versus 81.9% with the transobturator sling for an absolute difference of 13.8 (90% confidence interval [CI], 1.5–26.1; P = 0.439). Subjective cure rates were 81.1% and 88.5%, respectively (absolute difference, 7.4%; 90% CI, 2.8–17.6; P = 0.110). Both procedures significantly improved quality of life. Mean operative time was not significantly different, but the transobturator sling caused thigh pain for 7.1% of patients versus zero for the minisling (P = 0.045). Surgical reintervention for persistent SUI was required in 5 patients (7.8%) in the minisling group and 1 patient (1.8%) in the transobturator group (P = 0.213). The few complications occurring with either method were successfully managed.
This study found that the minisling procedure was not inferior to the transobturator sling at the1-year follow-up, although there was a trend toward lower continence rates in the minisling group by both subjective and objective criteria.