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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.
BJOG. 2010 Jun; 117(7):870-8.BJOG

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.

Authors+Show Affiliations

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

20394610

Citation

Abdel-Fattah, M, et al. "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, vol. 117, no. 7, 2010, pp. 870-8.
Abdel-Fattah M, Ramsay I, Pringle S, et al. 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(7):870-8.
Abdel-Fattah, M., Ramsay, I., Pringle, S., Hardwick, C., Ali, H., Young, D., & 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), 870-8. https://doi.org/10.1111/j.1471-0528.2010.02544.x
Abdel-Fattah M, et al. 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(7):870-8. PubMed PMID: 20394610.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Abdel-Fattah,M, AU - Ramsay,I, AU - Pringle,S, AU - Hardwick,C, AU - Ali,H, AU - Young,D, AU - Mostafa,A, Y1 - 2010/04/12/ PY - 2010/4/17/entrez PY - 2010/4/17/pubmed PY - 2010/8/18/medline SP - 870 EP - 8 JF - BJOG : an international journal of obstetrics and gynaecology JO - BJOG VL - 117 IS - 7 N2 - 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. SN - 1471-0528 UR - https://www.unboundmedicine.com/medline/citation/20394610/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_ L2 - https://doi.org/10.1111/j.1471-0528.2010.02544.x DB - PRIME DP - Unbound Medicine ER -