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

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.