Juliane Marschke1, Christl Reisenauer2, Tomi S Mikkola3, Frank Schwab4, Ralf Tunn5, Markus Huebner2,6. 1. Department of Urogynecology, German Pelvic Floor Centre, St. Hedwig Hospital, Große Hamburger Strasse 5-11, 10115, Berlin, Germany. j.marschke@alexianer.de. 2. Department of Women's Health, University Hospital of Tuebingen, Tüebingen, Germany. 3. Department of Obstetrics and Gynecology, Helsinki University Hospital, Helsinki, Finland. 4. Department of Hygiene and Environmental Medicine, Charité, Universitätsmedizin Berlin, Berlin, Germany. 5. Department of Urogynecology, German Pelvic Floor Centre, St. Hedwig Hospital, Große Hamburger Strasse 5-11, 10115, Berlin, Germany. 6. Women´s Center Bern, Lindenhofgruppe, Bern, Switzerland.
Abstract
PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: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.
RCT Entities:
PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.