The TVT Worldwide Observational Registry for Long-Term Data: Safety and Efficacy of Suburethral Sling Insertion Approaches for Stress Urinary Incontinence in Women

Abstract

We examined the clinical effectiveness of a single incision sling in women with stress urinary incontinence and obtained comparative perioperative and postoperative data on retropubic and transobturator slings. Women who underwent a cough stress test were treated with surgery using a single incision, retropubic or obturator sling (Gynecare® TVT SECUR™, TVT™ or TVT Obturator System, respectively) with the choice of sling based on surgeon preference. Objective cure was assessed by the standing cough stress test at 1 year. Subjective outcomes were assessed by the Incontinence Quality of Life Questionnaire and EQ-5D™. Perioperative data and return to normal activity were recorded. Of the 1,398 women who underwent surgery there were postoperative data on 1,334, including 32.8%, 17.8% and 49.4% who received a tension free vaginal tape, obturator tension free vaginal tape and SECUR, respectively. After obturator tension free vaginal tape surgery fewer women had a positive cough stress test than after TVT and SECUR surgery (4 of 110 or 3.6% vs 24 of 187 or 12.8% and 59 of 374 or 15.8%, respectively). Incontinence Quality of Life Questionnaire effect size was 1.87, 1.42 and 1.56, respectively, indicating a large treatment effect. Using our Incontinence Quality of Life Questionnaire response definition 85.4%, 79.0% and 85.2% of the TVT, TVT outside-in obturator system and SECUR cohorts, respectively, were treatment responders (p = 0.11).The SECUR cohort had the shortest operative time, the lowest proportion of women who required an overnight stay and the most women who underwent surgery under local anesthesia. Median time to return to employment, housework, sex life and hobbies was most rapid for SECUR. This registry demonstrates the high effectiveness of all 3 approaches. The single incision sling appeared to have objective and subjective efficacy similar to that of the retropubic sling and it can be performed under local anesthesia in an office environment.