Long-term outcomes of transobturator tapes in women with stress urinary incontinence

E-TOT randomised controlled trial

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Abstract

Objectives
To assess the long-term (LT) patient-reported outcomes and adverse events(AE) following transobturator tension-free vaginal tape(TO-TVT).
Design
Postal follow-up of the E-TOT randomised controlled trial(RCT).
Setting
A tertiary urogynaecology center in the UK; all procedures took place in 2005 to2007.
Population
341 Women were randomised to undergo either “inside-out” TVT-O (Ethicon Inc.,Somerville,NJ,USA) or “outside-in” TOT-ARIS (Coloplast Corp., Minneapolis,MN,USA).
Methods
Long-term (median 9-years) follow-up, using validated symptom severity and Qol questionnaires. Statistical analysis was performed using SPSS v22.0(IBM Corp.,Armonk, NY,USA) and GraphPad Statistics-2014.
Main Outcome Measures
Primary outcome was patient-reported success rate defined as “Very Much/Much Improved” on the Patient's Global Impression of Improvement (PGI-I) scale. Secondary outcomes included impact on women's QoL and sexual function; adverse events and re-operations for SUI.
Results
The adjusted-response rate was 67.8%; median follow-up was 9.2-years. The overall patient-reported success rate was 71.6% with further 14% reporting “improvement”; and no significant difference between inside-out and outside-in groups (p=0.76,OR:0.8676, 95%CI:0.4744,1.5865). The success rate showed significant reduction compared to 1-year results (71.6%vs.80%; p=0.004) but clinically insignificant reduction when compared to the 3-years (71.6%vs.73.1%). A total of 7.96% underwent further continence surgery; tape extrusion/ erosion rate was 4.5%; groin pain/discomfort was reported in 4.32% with only 1.4% requiring treatment.
Conclusions
This is the largest and longest follow-up randomized trial of TO-TVT. TO-TVT is associated with 71.6% patient-reported success rate, 4% groin pain/discomfort and 8% continence re-operation rate at median of 9-years follow-up. The success rate is almost stable after 3-years.
Original languageEnglish
Pages (from-to)973-981
Number of pages9
JournalBJOG-An International Journal of Obstetrics and Gynaecology
Volume124
Issue number6
Early online date21 Apr 2017
DOIs
Publication statusPublished - May 2017

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Suburethral Slings
Stress Urinary Incontinence
Randomized Controlled Trials
Groin
Pain
Patient Reported Outcome Measures
Therapeutics

Keywords

  • ARIS
  • tension-free vaginal tapes
  • transobturator tape
  • TVT-O
  • stress urinary incontinence

Cite this

@article{705b26e97ebd4da4aad49191ed47a92e,
title = "Long-term outcomes of transobturator tapes in women with stress urinary incontinence: E-TOT randomised controlled trial",
abstract = "ObjectivesTo assess the long-term (LT) patient-reported outcomes and adverse events(AE) following transobturator tension-free vaginal tape(TO-TVT).DesignPostal follow-up of the E-TOT randomised controlled trial(RCT).SettingA tertiary urogynaecology center in the UK; all procedures took place in 2005 to2007.Population341 Women were randomised to undergo either “inside-out” TVT-O (Ethicon Inc.,Somerville,NJ,USA) or “outside-in” TOT-ARIS (Coloplast Corp., Minneapolis,MN,USA).MethodsLong-term (median 9-years) follow-up, using validated symptom severity and Qol questionnaires. Statistical analysis was performed using SPSS v22.0(IBM Corp.,Armonk, NY,USA) and GraphPad Statistics-2014.Main Outcome MeasuresPrimary outcome was patient-reported success rate defined as “Very Much/Much Improved” on the Patient's Global Impression of Improvement (PGI-I) scale. Secondary outcomes included impact on women's QoL and sexual function; adverse events and re-operations for SUI.ResultsThe adjusted-response rate was 67.8{\%}; median follow-up was 9.2-years. The overall patient-reported success rate was 71.6{\%} with further 14{\%} reporting “improvement”; and no significant difference between inside-out and outside-in groups (p=0.76,OR:0.8676, 95{\%}CI:0.4744,1.5865). The success rate showed significant reduction compared to 1-year results (71.6{\%}vs.80{\%}; p=0.004) but clinically insignificant reduction when compared to the 3-years (71.6{\%}vs.73.1{\%}). A total of 7.96{\%} underwent further continence surgery; tape extrusion/ erosion rate was 4.5{\%}; groin pain/discomfort was reported in 4.32{\%} with only 1.4{\%} requiring treatment.ConclusionsThis is the largest and longest follow-up randomized trial of TO-TVT. TO-TVT is associated with 71.6{\%} patient-reported success rate, 4{\%} groin pain/discomfort and 8{\%} continence re-operation rate at median of 9-years follow-up. The success rate is almost stable after 3-years.",
keywords = "ARIS, tension-free vaginal tapes, transobturator tape, TVT-O, stress urinary incontinence",
author = "D Karmakar and A Mostafa and M Abdel-Fattah",
note = "FUNDING/SUPPORT AND ROLE OF THE SPONSOR: The initial phase of this study (up-to 3 years follow-up) was funded by a grant from the Henry Smith Charity (Address: 6th Floor, 65 Leadenhall Street,London EC3A2AD). Registered Charity Number – 230102. D. Karmakar was funded by IUGA Clinical Fellowship Grant 2014.",
year = "2017",
month = "5",
doi = "10.1111/1471-0528.14561",
language = "English",
volume = "124",
pages = "973--981",
journal = "BJOG-An International Journal of Obstetrics and Gynaecology",
issn = "1470-0328",
publisher = "John Wiley & Sons, Ltd (10.1111)",
number = "6",

}

TY - JOUR

T1 - Long-term outcomes of transobturator tapes in women with stress urinary incontinence

T2 - E-TOT randomised controlled trial

AU - Karmakar, D

AU - Mostafa, A

AU - Abdel-Fattah, M

N1 - FUNDING/SUPPORT AND ROLE OF THE SPONSOR: The initial phase of this study (up-to 3 years follow-up) was funded by a grant from the Henry Smith Charity (Address: 6th Floor, 65 Leadenhall Street,London EC3A2AD). Registered Charity Number – 230102. D. Karmakar was funded by IUGA Clinical Fellowship Grant 2014.

PY - 2017/5

Y1 - 2017/5

N2 - ObjectivesTo assess the long-term (LT) patient-reported outcomes and adverse events(AE) following transobturator tension-free vaginal tape(TO-TVT).DesignPostal follow-up of the E-TOT randomised controlled trial(RCT).SettingA tertiary urogynaecology center in the UK; all procedures took place in 2005 to2007.Population341 Women were randomised to undergo either “inside-out” TVT-O (Ethicon Inc.,Somerville,NJ,USA) or “outside-in” TOT-ARIS (Coloplast Corp., Minneapolis,MN,USA).MethodsLong-term (median 9-years) follow-up, using validated symptom severity and Qol questionnaires. Statistical analysis was performed using SPSS v22.0(IBM Corp.,Armonk, NY,USA) and GraphPad Statistics-2014.Main Outcome MeasuresPrimary outcome was patient-reported success rate defined as “Very Much/Much Improved” on the Patient's Global Impression of Improvement (PGI-I) scale. Secondary outcomes included impact on women's QoL and sexual function; adverse events and re-operations for SUI.ResultsThe adjusted-response rate was 67.8%; median follow-up was 9.2-years. The overall patient-reported success rate was 71.6% with further 14% reporting “improvement”; and no significant difference between inside-out and outside-in groups (p=0.76,OR:0.8676, 95%CI:0.4744,1.5865). The success rate showed significant reduction compared to 1-year results (71.6%vs.80%; p=0.004) but clinically insignificant reduction when compared to the 3-years (71.6%vs.73.1%). A total of 7.96% underwent further continence surgery; tape extrusion/ erosion rate was 4.5%; groin pain/discomfort was reported in 4.32% with only 1.4% requiring treatment.ConclusionsThis is the largest and longest follow-up randomized trial of TO-TVT. TO-TVT is associated with 71.6% patient-reported success rate, 4% groin pain/discomfort and 8% continence re-operation rate at median of 9-years follow-up. The success rate is almost stable after 3-years.

AB - ObjectivesTo assess the long-term (LT) patient-reported outcomes and adverse events(AE) following transobturator tension-free vaginal tape(TO-TVT).DesignPostal follow-up of the E-TOT randomised controlled trial(RCT).SettingA tertiary urogynaecology center in the UK; all procedures took place in 2005 to2007.Population341 Women were randomised to undergo either “inside-out” TVT-O (Ethicon Inc.,Somerville,NJ,USA) or “outside-in” TOT-ARIS (Coloplast Corp., Minneapolis,MN,USA).MethodsLong-term (median 9-years) follow-up, using validated symptom severity and Qol questionnaires. Statistical analysis was performed using SPSS v22.0(IBM Corp.,Armonk, NY,USA) and GraphPad Statistics-2014.Main Outcome MeasuresPrimary outcome was patient-reported success rate defined as “Very Much/Much Improved” on the Patient's Global Impression of Improvement (PGI-I) scale. Secondary outcomes included impact on women's QoL and sexual function; adverse events and re-operations for SUI.ResultsThe adjusted-response rate was 67.8%; median follow-up was 9.2-years. The overall patient-reported success rate was 71.6% with further 14% reporting “improvement”; and no significant difference between inside-out and outside-in groups (p=0.76,OR:0.8676, 95%CI:0.4744,1.5865). The success rate showed significant reduction compared to 1-year results (71.6%vs.80%; p=0.004) but clinically insignificant reduction when compared to the 3-years (71.6%vs.73.1%). A total of 7.96% underwent further continence surgery; tape extrusion/ erosion rate was 4.5%; groin pain/discomfort was reported in 4.32% with only 1.4% requiring treatment.ConclusionsThis is the largest and longest follow-up randomized trial of TO-TVT. TO-TVT is associated with 71.6% patient-reported success rate, 4% groin pain/discomfort and 8% continence re-operation rate at median of 9-years follow-up. The success rate is almost stable after 3-years.

KW - ARIS

KW - tension-free vaginal tapes

KW - transobturator tape

KW - TVT-O

KW - stress urinary incontinence

U2 - 10.1111/1471-0528.14561

DO - 10.1111/1471-0528.14561

M3 - Article

VL - 124

SP - 973

EP - 981

JO - BJOG-An International Journal of Obstetrics and Gynaecology

JF - BJOG-An International Journal of Obstetrics and Gynaecology

SN - 1470-0328

IS - 6

ER -