INTRODUCTION AND HYPOTHESIS: The aim of this study is to compare a modified inside-out transobturator procedure with its original counterpart [inside-out transobturator (TVT-O)] for the treatment of female stress urinary incontinence (SUI). METHODS: A prospective, randomized trial in women suffering from SUI was used. The modified procedure consisted of a shorter tape whilst the scissors or guide no longer perforated the obturator membrane. The primary outcome was the resolution of subjective and objective SUI at 1 year. Secondary outcome measures included adverse events, quality of life measures, and groin pain. RESULTS:One hundred seventy-five patients were randomized. No intraoperative complications were recorded. The SUI cure rate was 91.7% versus 90.7% (original versus modified, respectively; p = 0.824). Incidence and intensity of groin pain was higher in the original TVT-O group on day 0 and 1 (p < 0.05), requiring more analgesics (p = 0.015) but not thereafter. CONCLUSIONS: At 1 year follow-up, the modified inside-out transobturator tape procedure was as efficient and safe as the original technique but associated with less immediate postoperative groin pain.
RCT Entities:
INTRODUCTION AND HYPOTHESIS: The aim of this study is to compare a modified inside-out transobturator procedure with its original counterpart [inside-out transobturator (TVT-O)] for the treatment of female stress urinary incontinence (SUI). METHODS: A prospective, randomized trial in women suffering from SUI was used. The modified procedure consisted of a shorter tape whilst the scissors or guide no longer perforated the obturator membrane. The primary outcome was the resolution of subjective and objective SUI at 1 year. Secondary outcome measures included adverse events, quality of life measures, and groin pain. RESULTS: One hundred seventy-five patients were randomized. No intraoperative complications were recorded. The SUI cure rate was 91.7% versus 90.7% (original versus modified, respectively; p = 0.824). Incidence and intensity of groin pain was higher in the original TVT-O group on day 0 and 1 (p < 0.05), requiring more analgesics (p = 0.015) but not thereafter. CONCLUSIONS: At 1 year follow-up, the modified inside-out transobturator tape procedure was as efficient and safe as the original technique but associated with less immediate postoperative groin pain.
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