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The Outcome of the Transobturator Tape (TOT) Procedure

NCT01532583 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 139

Last updated 2012-12-13

No results posted yet for this study

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

OTHER

Gynaecological examination, a supine stress test, questionnaires

Gynaecological examination, a supine stress test, questionnaires

Sponsors & Collaborators

  • Turku University Hospital

    lead OTHER_GOV

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-07-31
Completion
2011-10-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01532583 on ClinicalTrials.gov