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.