Transobturator Tension-Free Vaginal Flap Operation versus Synthetic Transobturator Tape for Treatment of Female Stress Urinary Incontinence: A Prospective Randomized Study.

INTRODUCTION: Synthetic mid-urethral slings (MUSs) are the gold standard treatment for female stress urinary incontinence (SUI). Recently, there have been reports of serious adverse events with synthetic tapes such as urethral erosion, vaginal erosion, and mesh infection. Tension-free vaginal flap (TVF) operation has been proven to be successful as a natural alternative to synthetic slings. We propose our novel technique, the transobturator tension-free vaginal flap (TO-TVF), utilizing native vaginal tissue and being suspended via transobturator route. METHODS: This prospective study was conducted on 72 female patients with SUI, presenting at Alexandria University Hospital. Patients were randomized into 2 groups, group 1: 37 patients subjected to TO-TVF and group 2: 35 patients to conventional transobturator tape (TOT). In TO-TVF, a rectangular vaginal wall flap is created. A polypropylene monofilament mesh is sutured to each edge of the vaginal flap. This is inserted like conventional outside-in TOT. Patients were subjected to PGI and UDI-6 questionnaires and urodynamic study before and 6 months postoperatively. RESULTS: Both groups showed comparable and significant improvements in questionnaires. Mean operative time for TO-TVF and conventional TOT was 26.31 ± 5.2 min and 21.8 ± 3.1 min, respectively. Cure rate was 89% in group 1 and 91.4% in group 2, which was not statistically significant. No significant intraoperative complications were encountered. We had no cases of vaginal or urethral erosion in both groups. CONCLUSIONS: TO-TVF is a cost-effective, feasible, safe, and effective surgical alternative to synthetic MUS. Synthetic mesh tissue anchoring properties are maintained for better adjustment of tension. However, long-term follow-up on a large cohort of patients is still needed.