OBJECTIVE: To determine the efficacy and safety of a single-incision mini-sling compared with a transobturator midurethral sling for stress urinary incontinence (SUI) treatment.
METHODS: This prospective single-center randomized controlled trial involved 130 women with a diagnosis of SUI. Primary outcomes were the objective and subjective cure rates, defined as negative cough stress and pad tests, and satisfaction rates. Quality of life assessed by the Incontinence Quality of Life Questionnaire and the Urogenital Distress Inventory Short Form, operation time, complications, and reoperation rates were also recorded. The efficacy was analyzed using a noninferiority test with a margin of 15%. For the noninferiority test, a P value >.05 rejects the noninferiority hypothesis of the mini-sling.
RESULTS: Sixty-four patients in the mini-sling group and 56 in the transobturator group completed the 12-month follow-up. The objective cure rates for the mini-sling and the transobturator sling were 68.1% and 81.9% (absolute difference 13.8; 90% confidence interval [CI] 1.5–26.1; P=.439) and the subjective cure rates were 81.1% and 88.5% (absolute difference 7.4%; 90% CI 2.8–17.6; P=.110), respectively. There was a significant improvement in quality of life in both groups. Thigh pain was greater after the transobturator sling, four patients (7.1%) compared with zero (P=.045). The mean operation time was 5 minutes shorter for the mini-sling procedure (P=.000). Five patients (7.8%) in the mini-sling group and one patient (1.8%) in the transobturator group underwent surgical reintervention for persistent SUI (P=.213).
CONCLUSION: The noninferiority of the mini-sling could not be demonstrated in this study at the 12-month follow-up. The mini-sling was associated with shorter operative time and less postoperative thigh pain.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01094353.
LEVEL OF EVIDENCE: I