The Outcome of the Transobturator Tape (TOT) Procedure

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01532583
• Other study ID #: 13/2005, 15.2.2005
• Status: Completed
• Phase: N/A
• First received: November 29, 2011
• Last updated: December 12, 2012
• Start date: January 2009
• Est. completion date: October 2011

Study information

• Verified date: December 2012
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: October 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Other:
• Gynaecological examination, a supine stress test, questionnaires
Gynaecological examination, a supine stress test, questionnaires

Locations

Country	Name	City	State
Finland	Turku university hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective outcome of the TOT operation, which was evaluated with stress test and need for reoperation for urinary incontinence.		8 years
Secondary	Subjective outcome of the TOT operation which was assessed with evaluated questionnaires.		8 years