The Outcome of the Transobturator Tape (TOT) Procedure

Completed

• Conditions: Stress Urinary Incontinence

• Registration Number: NCT01532583
• Lead Sponsor: Turku University Hospital

Brief Summary

The aim of our study is to report the subjective and objective outcome of outside-in transobturator technique (TOT) (Monarc®) in long-term follow-up.

This is a follow-up study concerning 191 patients operated on in Turku University Hospital between May 2003 and December 2004 by using TOT. SUI was diagnosed with a positive stress test, the Urinary Incontinence Severity Score (UISS) and the Detrusor Instability Score (DIS). After a mean of 6.5 years evaluation included a gynecological examination and a supine stress test. Subjective outcome was evaluated with UISS, DIS, a visual analogue scale (VAS), a questionnaire of subjective evaluation of continence, EuroQoL-5D, EQ-5D VAS and short versions of IIQ-7 and UDI-6. Objective cure was defined as negative stress test and an absence of reoperation for SUI during the follow-up period.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2011-07
• Study Completion: 2011-10
• Study First Submitted: 2011-11-29
• Study First Submitted QC: 2012-02-09
• Study First Posted: 2012-02-14
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-12
• Last Update Posted: 2012-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 139

Inclusion Criteria

• 191 patients operated on with the TOT procedure between May 2003 and December 2004 at the Department of Obstetrics and Gynecology in the Turku University Hospital.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective outcome of the TOT operation, which was evaluated with stress test and need for reoperation for urinary incontinence.	8 years

Secondary Outcome Measures

Name	Time	Method
Subjective outcome of the TOT operation which was assessed with evaluated questionnaires.	8 years

Trial Locations

Locations (1)

Turku university hospital; 🇫🇮 Turku, Finland