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The Outcome of the Transobturator Tape (TOT) Procedure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01532583
First received: November 29, 2011
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Stress Urinary Incontinence
 Other: Gynaecological examination, a supine stress test, questionnaires

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: The Outcome of the Transobturator Tape (TOT) Procedure During the Follow-up of 6.5 Years

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • Objective outcome of the TOT operation, which was evaluated with stress test and need for reoperation for urinary incontinence. [ Time Frame: 8 years ]

Secondary Outcome Measures:
  • Subjective outcome of the TOT operation which was assessed with evaluated questionnaires. [ Time Frame: 8 years ]

Enrollment: 139
Study Start Date: January 2009
Study Completion Date: October 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients operated on with the TOT Other: Gynaecological examination, a supine stress test, questionnaires
Gynaecological examination, a supine stress test, questionnaires

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

191 female patients with genuine or recurrent stress urinary incontinence or mixed incontinence operated on with the TOT procedure at the mean of 6.5 years ago

Criteria

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:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01532583

Locations
Finland
Turku university hospital
Turku, Finland, 20521
Sponsors and Collaborators
Turku University Hospital
  More Information

No publications provided

Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT01532583     History of Changes
Other Study ID Numbers: 13/2005, 15.2.2005
Study First Received: November 29, 2011
Last Updated: December 12, 2012
Health Authority: Finland: Ethics Committee

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013