Tension-free Vaginal Tape–Obturator for Treatment of Pure Urodynamic Stress Urinary Incontinence: Efficacy and Adverse Effects at 10-year Follow-up

Background Inside-out transobturator tape (tension-free vaginal tape–obturator [TVT-O]) is currently one of the most effective and popular procedures for the surgical treatment of female stress urinary incontinence (SUI). However, data reporting long-term outcomes are lacking. Objective To assess the efficacy and safety of TVT-O 10 yr after implantation for the treatment of female pure SUI. Design, setting, and participants A multicenter, prospective study was conducted in five tertiary referral centers in three countries. All consecutive women with urodynamically proven pure SUI treated by TVT-O were included. Patients with mixed incontinence and/or anatomic evidence of pelvic organ prolapse were excluded. Intervention TVT-O implantation. Outcome measurements and statistical analysis Data regarding subjective outcomes (International Consultation on Incontinence Questionnaire–Short Form, Patient Global Impression of Improvement, and patient satisfaction scores), objective cure (stress test) rates, and adverse events were collected during follow-up. Univariable analysis was performed to investigate outcomes. Results and limitations One hundred sixty-eight women had TVT-O implantation. At 10-yr follow-up, 160 patients (95%) were available for the evaluation. We did not find any significant change of the surgical outcomes during this time. At 10 yr after surgery, 155 of 160 patients (97%) declared themselves cured (p = 0.7). Similarly, at 10-yr evaluation, 148 of 160 patients (92%) were objectively cured. No significant deterioration of objective cure rates was observed over time (p = 0.4). The history of failure of previous anti-incontinence procedures (hazard ratio: 5.34; 95% CI, 2.61–11.9; p = 0.009) was the only predictor of recurrence of SUI. The onset of de novo overactive bladder was reported by 23 of 160 patients (14%) at 10-yr follow-up. No other late complications were reported. Conclusions The 10-yr results of this study showed that TVT-O is a highly effective and safe option for the treatment of SUI. Patient summary At long-term follow up, tension-free vaginal tape-obturator is highly effective and safe for the treatment of stress urinary incontinence. © 2016 European Association of Urology