NCT01532583

The Outcome of the Transobturator Tape (TOT) Procedure

The Outcome of the Transobturator Tape (TOT) Procedure During the Follow-up of 6.5 Years

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 139 (actual)
• Sponsor: Turku University Hospital · Other Government
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
OTHER	Gynaecological examination, a supine stress test, questionnaires	Gynaecological examination, a supine stress test, questionnaires

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-07-01
• Completion: 2011-10-01
• First posted: 2012-02-14
• Last updated: 2012-12-13

Locations

1 site across 1 country: Finland