A randomised trial of transvaginal tape (TVT) versus transvaginal obturator tape (TVTO): a pilot study

Not Applicable

Completed

• Conditions: Stress urinary incontinence; Urological and Genital Diseases; Urinary incontinence

• Registration Number: ISRCTN86612493
• Lead Sponsor: niversity of Aberdeen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2006-01-31
• Study Start: 2010-10-21
• Last Update Posted: 6 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1. Women aged over 18 years
2. Urodynamic stress incontinence
3. Failed conservative treatment
4. Being offered surgery

Exclusion Criteria

1. Not prepared to accept surgery
2. Requiring additional prolapse surgery
3. Undergone previous surgery for stress urinary incontinence
4. Not completed their families, i.e., will still want children
5. Unable or unwilling to give informed consent
6. Unwilling to participate in follow-up

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Changes in International Consultation on Incontinence Questionnaire (ICIQ), assessed at baseline<br> 2. Differences in quality adjusted life years (QALYs) estimated from responses to the EQ-5D, measured at baseline and 12 months<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Subjective cure rate<br> 2. Changes in the King's Health questionnaire (KHQ) scores<br> 3. Difference in EQ-5D scores at three and twelve months follow-up<br> 4. Operative data<br> 5. Self-reported acceptability<br> 6. Usage recommendation to a friend<br><br> All measured at baseline, two weeks (except for the EQ-5D), three months and twelve months.<br>