Injury Due to Sling-shot Clinical Trial
Official title:
Transobturator Sling Compared With Single-incision Mini-sling for the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment