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

Mohamed Abdel-fattah, Alyaa Mostafa, Akinbowale Familusi, Ian Ramsay, James N'Dow

Research output: Contribution to journalArticle

42 Citations (Scopus)

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.
Original languageEnglish
Pages (from-to)843-851
Number of pages9
JournalEuropean Urology
Volume62
Issue number5
Early online date13 Apr 2012
DOIs
Publication statusPublished - Nov 2012

Fingerprint

Suburethral Slings
Urodynamics
Randomized Controlled Trials
Stress Urinary Incontinence
Therapeutics
Odds Ratio
Quality of Life
Outcome Assessment (Health Care)
Confidence Intervals

Keywords

  • transobturator tapes
  • tension-free vaginal tapes
  • stress urinary incontinence

Cite this

@article{154a6b7a843847e9ad469fdbb3d1b01b,
title = "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",
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.",
keywords = "transobturator tapes, tension-free vaginal tapes, stress urinary incontinence",
author = "Mohamed Abdel-fattah and Alyaa Mostafa and Akinbowale Familusi and Ian Ramsay and James N'Dow",
note = "Copyright {\circledC} 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.",
year = "2012",
month = "11",
doi = "10.1016/j.eururo.2012.04.021",
language = "English",
volume = "62",
pages = "843--851",
journal = "European Urology",
issn = "0302-2838",
publisher = "Elsevier",
number = "5",

}

TY - JOUR

T1 - Prospective randomised controlled trial of transobturator tapes in management of urodynamic stress incontinence in women

T2 - 3-year outcomes from the Evaluation of Transobturator Tapes study

AU - Abdel-fattah, Mohamed

AU - Mostafa, Alyaa

AU - Familusi, Akinbowale

AU - Ramsay, Ian

AU - N'Dow, James

N1 - Copyright © 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.

PY - 2012/11

Y1 - 2012/11

N2 - 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.

AB - 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.

KW - transobturator tapes

KW - tension-free vaginal tapes

KW - stress urinary incontinence

U2 - 10.1016/j.eururo.2012.04.021

DO - 10.1016/j.eururo.2012.04.021

M3 - Article

C2 - 22534058

VL - 62

SP - 843

EP - 851

JO - European Urology

JF - European Urology

SN - 0302-2838

IS - 5

ER -