Aim To assess the efficacy and safety of tension-free vaginal tape-obturator (TVT-O) 13 years after implantation for the treatment of female pure stress urinary incontinence (SUI). This is the longest-term evaluation available of TVT-O outcomes.Methods 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. 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 and multivariate analyses was performed to investigate outcomes.Results One hundred sixty-eight women had TVT-O implantation. At 13 year after surgery, 150 of 157 patients (95%) declared themselves cured (P = .8). Similarly, at 10-year evaluation, 148 of 160 patients (92%) were objectively cured. No significant deterioration of objective cure rates was observed over time (P = .1). The multivariate analysis showed that previous anti-incontinence procedures and obesity independently predicted the subjective (odd ratio [OR]: 6.2 [95% confidence interval [CI], 1.8-13.6]; P = .02 and OR, 1.8 [95% CI, 1.3-3.0]; P = .03, respectively) and objective failure of TVT-O (OR, 5.8 [95% CI, 1.6-13.2]; P = .02 and OR, 1.6 [95% CI, 1.2-3.2]; P = .03, respectively). We found four cases of sling exposure; all of them occurred after the 10-year follow-up.Conclusions The 13-year results of this study showed that TVT-O is a highly effective and safe option for the treatment of SUI. We found that there is a significantly higher risk of having a sling exposure over 10 years after the procedure; however, the incidence is very low.
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