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Urogynaecology
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
Article first published online: 12 APR 2010
DOI: 10.1111/j.1471-0528.2010.02544.x
© 2010 The Authors Journal compilation © RCOG 2010 BJOG An International Journal of Obstetrics and Gynaecology
Issue
BJOG: An International Journal of Obstetrics & Gynaecology
Volume 117, Issue 7, pages 870–878, June 2010
Additional Information
How to Cite
Abdel-fattah, M., Ramsay, I., Pringle, S., Hardwick, C., Ali, H., 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 & Gynaecology, 117: 870–878. doi: 10.1111/j.1471-0528.2010.02544.x
Publication History
- Issue published online: 10 MAY 2010
- Article first published online: 12 APR 2010
- Accepted 10 February 2010. Published Online 12 April 2010.
Keywords:
- ARIS®;
- tension-free vaginal tapes;
- transobturator tape;
- TVT-O™;
- urodynamic stress incontinence
Please cite this paper as: Abdel-fattah M, Ramsay I, Pringle S, Hardwick C, Ali H, Young D, Mostafa A. 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 2010;117:870–878.
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.