1. Prospective randomised controlled trial of transobturator tapes in management of urodynamic stress incontinence in women: 3-year outcomes from the Evaluation of Transobturator Tapes study.
- Author
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Abdel-Fattah M, Mostafa A, Familusi A, Ramsay I, and N'dow J
- Subjects
- Chi-Square Distribution, Female, Humans, Logistic Models, Middle Aged, Multivariate Analysis, Odds Ratio, Postoperative Complications etiology, Postoperative Complications surgery, Prospective Studies, Quality of Life, Reoperation, Risk Assessment, Risk Factors, Scotland, Single-Blind Method, Surveys and Questionnaires, Time Factors, Treatment Outcome, Urinary Bladder physiopathology, Urinary Incontinence, Stress physiopathology, Urinary Incontinence, Stress psychology, Urologic Surgical Procedures adverse effects, Urologic Surgical Procedures methods, Suburethral Slings, Urinary Bladder surgery, Urinary Incontinence, Stress surgery, Urodynamics, Urologic Surgical Procedures instrumentation
- Abstract
Background: There is a lack of information on the long-term outcomes of transobturator tension-free vaginal tape (TO-TVT) in the surgical treatment of female stress urinary incontinence (SUI)., Objectives: To assess the 3-yr outcomes following TO-TVT and to compare the effectiveness of inside-out versus outside-in approaches., Design, Setting, and Participants: A 3-yr follow-up study of the Evaluation of Transobturator Tapes (E-TOT) trial, a randomised controlled trial (RCT) conducted with women undergoing TO-TVT as a sole procedure between April 2005 and April 2007 in a tertiary urogynaecology centre in the United Kingdom., Intervention: Patients (n=341) were randomised to undergo either TVT-O (Ethicon Inc., Somerville, NJ, USA) for the inside-out approach or TOT-Aris (Coloplast Corp., Minneapolis, MN, USA) for the outside-in approach., Outcome Measurements and Statistical Analysis: The primary outcome was patient-reported success rate. Secondary outcomes included further treatment for SUI, improvement in quality of life, late complications, and risk factors for late failures. Categorical variables were compared using the chi-square or Fisher exact test. Within-group comparison was undertaken using Wilcoxon and Mann-Whitney tests. Risk factors for late failures were assessed in a multivariate regression model. All statistical analysis was performed using SPSS v.18.0 (IBM Corp., Armonk, NY, USA)., Results and Limitations: The 3-yr follow-up was completed by 238 of the 341 women (70%). The overall success rate, based on Patient's Global Impression of Improvement response, was 73.1%, with no significant difference between the inside-out and the outside-in TO-TVT (73.18% vs 72.3%; odds ratio: 0.927; 95% confidence interval, 0.552-1.645; p=0.796). Compared with the 1-yr follow-up, there was a significant reduction in the patient-reported success rate (p=0.005); however, no independent risk factors were identified. A clinically significant improvement (≥10 points) was seen in 80% (n=191) of women, with no significant difference between both groups (p=0.113). Twenty-two women (6%) underwent further surgical treatment within 3 yr. The lack of an objective outcome assessment is a potential limitation of this RCT., Conclusions: The E-TOT RCT showed a 73% patient-reported success rate for TO-TVT at 3-yr follow-up, with no significant differences between inside-out and outside-in approaches. There was a significant drop in patient-reported success rates between 1 and 3 yr., (Copyright © 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.)
- Published
- 2012
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