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Open Access research with a European policy impact...

The Strathprints institutional repository is a digital archive of University of Strathclyde's Open Access research outputs. Strathprints provides access to thousands of Open Access research papers by Strathclyde researchers, including by researchers from the European Policies Research Centre (EPRC).

EPRC is a leading institute in Europe for comparative research on public policy, with a particular focus on regional development policies. Spanning 30 European countries, EPRC research programmes have a strong emphasis on applied research and knowledge exchange, including the provision of policy advice to EU institutions and national and sub-national government authorities throughout Europe.

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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

Abdel-fattah, M. and Ramsay, I. and Pringle, S. and Hardwick, C. and Ali, H. and Young, D. and Mostafa, A. (2010) 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. BJOG: An International Journal of Obstetrics and Gynaecology, 117 (7). pp. 870-878. ISSN 1470-0328

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Abstract

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.