The TVT Worldwide Observational Registry for Long-Term Data: Safety and Efficacy of Suburethral Sling Insertion Approaches for Stress Urinary Incontinence in Women Douglas G. Tincello,* Theunis Botha, Douglas Grier, Peter Jones, Dhinagar Subramanian, Colin Urquhart, Aaron Kirkemo and Salil Khandwala for the TVT Worldwide Registry Investigators From the University of Leicester and Leicester General Hospital (DGT), Leicester and Clinical Development (PJ, CU) and Health Economics and Reimbursement (DS), Evidence Based Medicine, Ethicon, Livingston, United Kingdom, Arwyp Medical Centre (TB), Kempton Park, South Africa, Sound Urology (DG), Edmonds, Washington, Medical Affairs, Evidence Based Medicine (AK), Ethicon, Somerville, New Jersey, and Division of Urogynecology, Oakwood Hospital (SK), Dearborn, Michigan Abbreviations and Acronyms BMI = body mass index CST = standing cough stress test EQ-5D = EuroQol FAS = full analysis set I-QOL = Incontinence Quality of Life Questionnaire TVT = tension free vaginal tape TVT-O = TVT outside-in obturator system VAS = visual analog scale Submitted for publication March 14, 2011. Study received ethics committee/institutional review board approval at all 29 centers. Supported by Ethicon. Supplementary material for this article can be obtained at http://swww2.le.ac.uk/departments/ csmm/research/prolapse-and-incontinence-group. * Correspondence: Department of Obstetrics and Gynaecology, University of Leicester, Robert Kilpatrick Clinical Sciences Building, Leicester Royal Infirmary, P. O. Box 65, Leicester LE27LX, United Kingdom (telephone: +44 (0) 116 252 5813; FAX: +44 (0) 116 252 5846; e-mail: dgt4@ leicester.ac.uk). Purpose: 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. Materials and Methods: 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 Question- naire and EQ-5D™. Perioperative data and return to normal activity were recorded. Results: 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 ten- sion 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, respec- tively, 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. Conclusion: This registry demonstrates the high effectiveness of all 3 ap- proaches. 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. Key Words: urethra; urinary incontinence, stress; slings; pelvic organ prolapse; quality of life RETROPUBIC TVTs 1 and transobturator tapes 2 are alternative surgical de- vices for stress incontinence surgery. Single incision slings were developed to explore the potential of a device with short insertion trocars to mini- 2310 www.jurology.com 0022-5347/11/1866-2310/0 Vol. 186, 2310-2315, December 2011 THE JOURNAL OF UROLOGY ® Printed in U.S.A. © 2011 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION AND RESEARCH,INC. DOI:10.1016/j.juro.2011.07.078