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

M Abdel-Fattah, I Ramsay, S Pringle, C Hardwick, H Ali, D Young, A Mostafa

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69 Citations (Scopus)

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.
Original languageEnglish
Pages (from-to)870-878
Number of pages9
JournalBJOG-An International Journal of Obstetrics and Gynaecology
Volume117
Issue number7
Early online date12 Apr 2010
DOIs
Publication statusPublished - Jun 2010

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Suburethral Slings
Urodynamics
Quality of Life
Outcome Assessment (Health Care)
Surveys and Questionnaires
Health

Keywords

  • ARIS®
  • tension-free vaginal tapes
  • transobturator tape
  • TVT-O™
  • urodynamic stress incontinence

Cite this

@article{876dd2e9db2545b79752f7bcdace471f,
title = "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",
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{\circledR} 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{\circledR}) 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.",
keywords = "ARIS{\circledR}, tension-free vaginal tapes, transobturator tape, TVT-O™, urodynamic stress incontinence",
author = "M Abdel-Fattah and I Ramsay and S Pringle and C Hardwick and H Ali and D Young and A Mostafa",
year = "2010",
month = "6",
doi = "10.1111/j.1471-0528.2010.02544.x",
language = "English",
volume = "117",
pages = "870--878",
journal = "BJOG-An International Journal of Obstetrics and Gynaecology",
issn = "1470-0328",
publisher = "John Wiley & Sons, Ltd (10.1111)",
number = "7",

}

TY - JOUR

T1 - Randomised prospective single-blinded study comparing 'inside-out' versus 'outside-in' transobturator tapes in the management of urodynamic stress incontinence

T2 - 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

PY - 2010/6

Y1 - 2010/6

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.

AB - 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.

KW - ARIS®

KW - tension-free vaginal tapes

KW - transobturator tape

KW - TVT-O™

KW - urodynamic stress incontinence

U2 - 10.1111/j.1471-0528.2010.02544.x

DO - 10.1111/j.1471-0528.2010.02544.x

M3 - Article

C2 - 20394610

VL - 117

SP - 870

EP - 878

JO - BJOG-An International Journal of Obstetrics and Gynaecology

JF - BJOG-An International Journal of Obstetrics and Gynaecology

SN - 1470-0328

IS - 7

ER -