Comparison of two retropubic tension-free vaginal tape procedures in women with stress urinary incontinence: a randomized controlled multicenter trial

Archives of Gynecology and Obstetrics
Juliane MarschkeMarkus Huebner

Abstract

Midurethral slings are a well-established treatment option in women suffering stress urinary incontinence. Various different products and methods are used, therefore, the aim of our study was to compare two inside-out retropubic slings (TVT exact® vs. RetroArc®) inserted in two different ways regarding perioperative and mid-term outcomes. In this prospective randomized controlled non-inferiority multicentre trial, primary endpoint was postoperative cure rate, both objective (negative cough test) and subjective (absence of leakage during physical activity using the UDI-6 questionnaire). Secondary endpoints were patients' satisfaction (Likert scale; ICIQ-UI-SF questionnaires). In addition, intra-and postoperative complications were evaluated. The TVT®-group was operated with an empty bladder, a 18 CH catheter was used with a straight inserter as instructed. Patients randomized into the RetroArc®-group were operated without inserter leading to a reduced catheter size (14 CH), bladder was filled (200 ml) during the procedure. Of the 303 women, 152 were randomized to the TVT® and 151 to the RetroArc® operation. At 3 months, n = 288 (95.0%) and at 12 months n = 229 (75.6%) were assessed. In postoperative objective cure the RetroArc®-...Continue Reading

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