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Injury Due to Sling-shot clinical trials

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NCT ID: NCT02540525 Completed - Clinical trials for Injury Due to Sling-shot

Transobturator Sling Compared With Single-incision Mini-sling for the Treatment of Stress Urinary Incontinence

Start date: January 2013
Phase: N/A
Study type: Interventional

1. 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. 2. METHODS: This prospective single-center randomized controlled trial will involve 100 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.