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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.
Eur Urol. 2012 Nov; 62(5):843-51.EU

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.

Authors+Show Affiliations

Division of Applied Health Sciences, University of Aberdeen, Aberdeen, Scotland, UK. m.abdelfattah@abdn.ac.ukNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22534058

Citation

Abdel-Fattah, Mohamed, et al. "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." European Urology, vol. 62, no. 5, 2012, pp. 843-51.
Abdel-Fattah M, Mostafa A, Familusi A, et al. 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. Eur Urol. 2012;62(5):843-51.
Abdel-Fattah, M., Mostafa, A., Familusi, A., Ramsay, I., & N'dow, J. (2012). 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. European Urology, 62(5), 843-51. https://doi.org/10.1016/j.eururo.2012.04.021
Abdel-Fattah M, et al. 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. Eur Urol. 2012;62(5):843-51. PubMed PMID: 22534058.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Abdel-Fattah,Mohamed, AU - Mostafa,Alyaa, AU - Familusi,Akinbowale, AU - Ramsay,Ian, AU - N'dow,James, Y1 - 2012/04/14/ PY - 2012/02/10/received PY - 2012/04/03/accepted PY - 2012/4/27/entrez PY - 2012/4/27/pubmed PY - 2013/3/7/medline SP - 843 EP - 51 JF - European urology JO - Eur Urol VL - 62 IS - 5 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. SN - 1873-7560 UR - https://www.unboundmedicine.com/medline/citation/22534058/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0302-2838(12)00487-3 DB - PRIME DP - Unbound Medicine ER -