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- Title
Comparison of two retropubic tension-free vaginal tape procedures in women with stress urinary incontinence: a randomized controlled multicenter trial.
- Authors
Marschke, Juliane; Reisenauer, Christl; Mikkola, Tomi S.; Schwab, Frank; Tunn, Ralf; Huebner, Markus
- Abstract
<bold>Purpose: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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®-procedure was not inferior to TVT® (p = 0.144). In subjective cure, however, the TVT exact® procedure achieved significant better results (TVT® 76.1%, RetroArc® 54.3%, p = 0.002). Perioperative complications were in majority voiding difficulties and lower after the TVT exact®-procedure.<bold>Conclusions: </bold>Retropubic sling procedures are safe and successful to treat female stress urinary incontinence. However, different materials and techniques result in differences between outcomes also experienced surgeons should be aware of.
- Subjects
URINARY stress incontinence; TAPING &; strapping; URINARY incontinence in women; SUBURETHRAL slings; RANDOMIZED controlled trials; LIKERT scale; PATIENT satisfaction
- Publication
Archives of Gynecology & Obstetrics, 2019, Vol 299, Issue 4, p1015
- ISSN
0932-0067
- Publication type
journal article
- DOI
10.1007/s00404-019-05077-0