The Outcome of the Transobturator Tape (TOT) Procedure During the Follow-up of 6.5 Years
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Turku University Hospital
- Enrollment
- 139
- Locations
- 1
- Primary Endpoint
- Objective outcome of the TOT operation, which was evaluated with stress test and need for reoperation for urinary incontinence.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Objective outcome of the TOT operation, which was evaluated with stress test and need for reoperation for urinary incontinence.
Time Frame: 8 years
Secondary Outcomes
- Subjective outcome of the TOT operation which was assessed with evaluated questionnaires.(8 years)