Evaluation of transobturator tapes (E-TOT) study: randomised prospective single-blinded study comparing inside-out vs. outside-in transobturator tapes in management of urodynamic stress incontinence: short term outcomes

Mohamed Abdel-Fattah, Iain Ramsay, Stewart Pringle, Chris Hardwick, Hassan Ali

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

Objectives
To compare the “inside-out (TVT-O)” vs. “outside-in (ARIS)” transobturator tapes in the management of female urodynamic stress incontinence (USI) and to identify independent risk factors of failure of transobturator tapes.

Study design
A prospective, single blinded, randomised trial. Women undergoing transobturator tapes as sole procedure in the period April 2005 and April 2007 were randomised to TVT-O™ for the inside-out approach and TOT–ARIS for the outside-in approach. The primary outcome measure at 6 months was the absence of USI on urodynamics. Secondary outcomes included; patient-reported success rates, overall patient satisfaction and peri-operative complications.

Results
341 women were recruited: 171 in the outside-in group and 170 in the inside-out. Severe post-operative thigh pain was twice as common in the inside-out group but this was not statistically significant (6.7% vs. 3.5%, p = 0.19). 317 women completed the 6 months follow-up; objective cure rates and patient-reported success rates were 85.4 and 80.5%, respectively, with no significant difference between the groups (p = 0.28 and p = 0.138, respectively). On multivariate analysis: low maximum urethral closure pressure (MUCP) (<30 cm H2O) and previous incontinence surgery were confirmed as independent risk factors for objective failure of transobturator tape with increased odds of failure of 7.06 (2.85–17.48) and 6.22 (2.34–16.52), respectively.

Conclusion
This study shows no significant differences in the objective cure rates and patient-reported success rates between the “inside-out (TVT-O™)” and “outside-in (ARIS)” transobturator tape procedures in the management of female USI at 6 months follow-up. Previous incontinence surgery and low MUCP were significant risk factors for failure of transobturator tapes.
Original languageEnglish
Pages (from-to)106-111
Number of pages6
JournalEuropean Journal of Obstetrics & Gynecology and Reproductive Biology
Volume149
Issue number1
Early online date24 Dec 2009
DOIs
Publication statusPublished - Mar 2010

Fingerprint

Suburethral Slings
Urodynamics
Prospective Studies
Pressure
Thigh
Patient Satisfaction
Multivariate Analysis
Outcome Assessment (Health Care)
Pain

Keywords

  • female
  • humans
  • multivariate analysis
  • patient satisfaction
  • prospective studies
  • prosthesis implantation
  • quality of life
  • questionnaires
  • severity of illness index
  • single-blind method
  • suburethral slings
  • treatment outcome
  • urinary incontinence, stress
  • urodynamics

Cite this

@article{5e1a30d32c934ee9a219ea4e0e6176ce,
title = "Evaluation of transobturator tapes (E-TOT) study: randomised prospective single-blinded study comparing inside-out vs. outside-in transobturator tapes in management of urodynamic stress incontinence: short term outcomes",
abstract = "ObjectivesTo compare the “inside-out (TVT-O)” vs. “outside-in (ARIS)” transobturator tapes in the management of female urodynamic stress incontinence (USI) and to identify independent risk factors of failure of transobturator tapes.Study designA prospective, single blinded, randomised trial. Women undergoing transobturator tapes as sole procedure in the period April 2005 and April 2007 were randomised to TVT-O™ for the inside-out approach and TOT–ARIS for the outside-in approach. The primary outcome measure at 6 months was the absence of USI on urodynamics. Secondary outcomes included; patient-reported success rates, overall patient satisfaction and peri-operative complications.Results341 women were recruited: 171 in the outside-in group and 170 in the inside-out. Severe post-operative thigh pain was twice as common in the inside-out group but this was not statistically significant (6.7{\%} vs. 3.5{\%}, p = 0.19). 317 women completed the 6 months follow-up; objective cure rates and patient-reported success rates were 85.4 and 80.5{\%}, respectively, with no significant difference between the groups (p = 0.28 and p = 0.138, respectively). On multivariate analysis: low maximum urethral closure pressure (MUCP) (<30 cm H2O) and previous incontinence surgery were confirmed as independent risk factors for objective failure of transobturator tape with increased odds of failure of 7.06 (2.85–17.48) and 6.22 (2.34–16.52), respectively.ConclusionThis study shows no significant differences in the objective cure rates and patient-reported success rates between the “inside-out (TVT-O™)” and “outside-in (ARIS)” transobturator tape procedures in the management of female USI at 6 months follow-up. Previous incontinence surgery and low MUCP were significant risk factors for failure of transobturator tapes.",
keywords = "female, humans, multivariate analysis, patient satisfaction, prospective studies, prosthesis implantation, quality of life, questionnaires, severity of illness index, single-blind method, suburethral slings, treatment outcome, urinary incontinence, stress, urodynamics",
author = "Mohamed Abdel-Fattah and Iain Ramsay and Stewart Pringle and Chris Hardwick and Hassan Ali",
note = "Copyright 2009 Elsevier Ireland Ltd. All rights reserved.",
year = "2010",
month = "3",
doi = "10.1016/j.ejogrb.2009.11.023",
language = "English",
volume = "149",
pages = "106--111",
journal = "European Journal of Obstetrics & Gynecology and Reproductive Biology",
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publisher = "Elsevier Ireland Ltd",
number = "1",

}

TY - JOUR

T1 - Evaluation of transobturator tapes (E-TOT) study

T2 - randomised prospective single-blinded study comparing inside-out vs. outside-in transobturator tapes in management of urodynamic stress incontinence: short term outcomes

AU - Abdel-Fattah, Mohamed

AU - Ramsay, Iain

AU - Pringle, Stewart

AU - Hardwick, Chris

AU - Ali, Hassan

N1 - Copyright 2009 Elsevier Ireland Ltd. All rights reserved.

PY - 2010/3

Y1 - 2010/3

N2 - ObjectivesTo compare the “inside-out (TVT-O)” vs. “outside-in (ARIS)” transobturator tapes in the management of female urodynamic stress incontinence (USI) and to identify independent risk factors of failure of transobturator tapes.Study designA prospective, single blinded, randomised trial. Women undergoing transobturator tapes as sole procedure in the period April 2005 and April 2007 were randomised to TVT-O™ for the inside-out approach and TOT–ARIS for the outside-in approach. The primary outcome measure at 6 months was the absence of USI on urodynamics. Secondary outcomes included; patient-reported success rates, overall patient satisfaction and peri-operative complications.Results341 women were recruited: 171 in the outside-in group and 170 in the inside-out. Severe post-operative thigh pain was twice as common in the inside-out group but this was not statistically significant (6.7% vs. 3.5%, p = 0.19). 317 women completed the 6 months follow-up; objective cure rates and patient-reported success rates were 85.4 and 80.5%, respectively, with no significant difference between the groups (p = 0.28 and p = 0.138, respectively). On multivariate analysis: low maximum urethral closure pressure (MUCP) (<30 cm H2O) and previous incontinence surgery were confirmed as independent risk factors for objective failure of transobturator tape with increased odds of failure of 7.06 (2.85–17.48) and 6.22 (2.34–16.52), respectively.ConclusionThis study shows no significant differences in the objective cure rates and patient-reported success rates between the “inside-out (TVT-O™)” and “outside-in (ARIS)” transobturator tape procedures in the management of female USI at 6 months follow-up. Previous incontinence surgery and low MUCP were significant risk factors for failure of transobturator tapes.

AB - ObjectivesTo compare the “inside-out (TVT-O)” vs. “outside-in (ARIS)” transobturator tapes in the management of female urodynamic stress incontinence (USI) and to identify independent risk factors of failure of transobturator tapes.Study designA prospective, single blinded, randomised trial. Women undergoing transobturator tapes as sole procedure in the period April 2005 and April 2007 were randomised to TVT-O™ for the inside-out approach and TOT–ARIS for the outside-in approach. The primary outcome measure at 6 months was the absence of USI on urodynamics. Secondary outcomes included; patient-reported success rates, overall patient satisfaction and peri-operative complications.Results341 women were recruited: 171 in the outside-in group and 170 in the inside-out. Severe post-operative thigh pain was twice as common in the inside-out group but this was not statistically significant (6.7% vs. 3.5%, p = 0.19). 317 women completed the 6 months follow-up; objective cure rates and patient-reported success rates were 85.4 and 80.5%, respectively, with no significant difference between the groups (p = 0.28 and p = 0.138, respectively). On multivariate analysis: low maximum urethral closure pressure (MUCP) (<30 cm H2O) and previous incontinence surgery were confirmed as independent risk factors for objective failure of transobturator tape with increased odds of failure of 7.06 (2.85–17.48) and 6.22 (2.34–16.52), respectively.ConclusionThis study shows no significant differences in the objective cure rates and patient-reported success rates between the “inside-out (TVT-O™)” and “outside-in (ARIS)” transobturator tape procedures in the management of female USI at 6 months follow-up. Previous incontinence surgery and low MUCP were significant risk factors for failure of transobturator tapes.

KW - female

KW - humans

KW - multivariate analysis

KW - patient satisfaction

KW - prospective studies

KW - prosthesis implantation

KW - quality of life

KW - questionnaires

KW - severity of illness index

KW - single-blind method

KW - suburethral slings

KW - treatment outcome

KW - urinary incontinence, stress

KW - urodynamics

U2 - 10.1016/j.ejogrb.2009.11.023

DO - 10.1016/j.ejogrb.2009.11.023

M3 - Article

C2 - 20036048

VL - 149

SP - 106

EP - 111

JO - European Journal of Obstetrics & Gynecology and Reproductive Biology

JF - European Journal of Obstetrics & Gynecology and Reproductive Biology

SN - 0301-2115

IS - 1

ER -