Document Detail


Randomised prospective single-blinded study comparing 'inside-out' versus 'outside-in' transobturator tapes in the management of urodynamic stress incontinence: 1-year outcomes from the E-TOT study.
MedLine Citation:
PMID:  20394610     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To compare the 'inside-out' versus 'outside-in' routes for transobturator tape insertion for urodynamic stress incontinence, and to identify independent risk factors for failure at 1 year. DESIGN: Prospective single-blinded randomised trial. SETTING: Tertiary urogynaecology centre. POPULATION: A cohort of 341 women undergoing transobturator tape procedures between April 2005 and April 2007. METHODS: Women were randomised to tension-free vaginal tape-obturator (TVT)-O for the 'inside-out' route (n = 170) and transobturator tape (TOT)-ARIS for the 'outside-in' route (n = 171). Participants completed validated symptom-severity, quality-of-life and sexual-function questionnaires before and after surgery. In addition, they completed the patient global impression of improvement questionnaire (PGI-I) and standard 1-hour pad test postoperatively. MAIN OUTCOME MEASURES: The primary outcome was the patient-reported success rate reported on the PGI-I scale. Secondary outcomes included objective cure rate and improvement in King's Health Questionnaire scores. RESULTS: A total of 341 women were recruited: 171 women to the 'outside-in' (TOT-ARIS) group and 170 to the 'inside-out' (TVT-O) group; 299 completed the 1-year follow up. The patient-reported success rate was 80% with no statistically significant differences between the groups ('outside-in' 77.6% versus 'inside-out' 81.2%; OR 1.25; 95% CI 0.71, 2.20; P = 0.54). The objective cure rate was 91% with no statistically significant difference between the groups ('outside-in' 88% versus 'inside-out' 94%; OR 2.21; 95% CI 0.85, 5.75; P = 0.157). Previous incontinence surgery (OR 1.41; 95% CI 1.18, 1.91; P = 0.029) and preoperative urgency incontinence (OR 1.78; 95% CI 1.21, 3.91, P = 0.048) were significant risk factors for failure of transobturator tape at the 1-year follow up. CONCLUSIONS: There are no significant differences in patient reported and objective cure rates between 'inside-out' and 'outside-in' transobturator tapes. Quality of life and sexual function significantly improved following surgery. Both previous incontinence surgery and preoperative urgency incontinence are associated with significantly lower patient-reported cure rates.
Authors:
M Abdel-Fattah; I Ramsay; S Pringle; C Hardwick; H Ali; D Young; A Mostafa
Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-04-12
Journal Detail:
Title:  BJOG : an international journal of obstetrics and gynaecology     Volume:  117     ISSN:  1471-0528     ISO Abbreviation:  BJOG     Publication Date:  2010 Jun 
Date Detail:
Created Date:  2010-05-20     Completed Date:  2010-08-17     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100935741     Medline TA:  BJOG     Country:  England    
Other Details:
Languages:  eng     Pagination:  870-8     Citation Subset:  AIM; IM    
Affiliation:
Division of Applied Health Science, University of Aberdeen, Aberdeen, UK. m.abdelfattah@abdn.ac.uk
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MeSH Terms
Descriptor/Qualifier:
Female
Humans
Intraoperative Complications / etiology
Middle Aged
Prospective Studies
Quality of Life
Risk Factors
Sexual Dysfunction, Physiological / etiology
Single-Blind Method
Suburethral Slings*
Treatment Outcome
Urinary Incontinence, Stress / surgery*

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