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The Outcome of the Transobturator Tape (TOT) Procedure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01532583
First Posted: February 14, 2012
Last Update Posted: December 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Turku University Hospital
  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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01532583


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

Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT01532583     History of Changes
Other Study ID Numbers: 13/2005, 15.2.2005
First Submitted: November 29, 2011
First Posted: February 14, 2012
Last Update Posted: December 13, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders