Long-term Effectiveness and Complications Comparing Tension-free Vaginal Tape versus Tension-free Vaginal Tape Obturator for Female Stress Urinary Incontinence: A 15-year Extended Follow-up of a Randomized Clinical Trial

Objective: To compare long-term effectiveness and safety outcomes of a randomized trial of tension-free vaginal tape (TVT) versus tension-free vaginal tape obturator (TVT-O) in women with stress urinary incontinence (SUI). Methods: : From February 2004 to December 2007, 315 were randomized into TVT (N=160) or TVT-O (N=155) groups and were followed up through clinic visits, telephone or postal survey. Primary outcome was subjective success, defined as very much and much improved on Patient Global Impression of Improvement (PGI-I). Secondary outcomes included SUI subjective satisfaction, defined as 70% score reduction measured by the Question 3 on the Urogenital Distress Inventory-6 (UDI-6) questionnaire. Results: : During a median of 15.9 years of follow-up (IQR: 14.3 to 17.2), 187 (59.4%) completed follow-up assessments beyond 15 years after randomization. Compared with TVT-O, TVT was associated with higher odds of improved response in PGI-I (81.2% in the TVT group, 79.1% in the TVT-O group, odd ratio [OR] 0.87, 95% confidence interval [CI] 0.43-1.80). Absence of SUI symptoms was 79.2% and 84.6%, and subjective satisfaction was 71.9% and 65.9% in the TVT and TVT-O groups, respectively. In the TVT group, 28.1% had at least one complication, while in the TVT-O group, the incidence was 33.0%. More patients reported mild groin/thigh pain in TVT-O group than in TVT group (11.0% vs 3.1%). Mesh erosion/exposure, voiding function, de novo overactive bladder, recurrent urinary tract infections and dyspareunia were similar between procedures. Conclusions: : There were no significant differences in patient-reported outcomes or long-term complications between TVT and TVT-O groups at 15-year follow-up. More patients in TVT-O group reported mild groin/thigh pain.