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The Outcome of the Transobturator Tape (TOT) Procedure

NCT ID: NCT01532583

Last Updated: 2012-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

139 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-10-31

Brief Summary

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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

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Conditions

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Stress Urinary Incontinence

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients operated on with the TOT

Gynaecological examination, a supine stress test, questionnaires

Intervention Type OTHER

Gynaecological examination, a supine stress test, questionnaires

Interventions

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Gynaecological examination, a supine stress test, questionnaires

Gynaecological examination, a supine stress test, questionnaires

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Turku university hospital

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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13/2005, 15.2.2005

Identifier Type: -

Identifier Source: org_study_id