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The Outcome of the Transobturator Tape (TOT) Procedure

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ClinicalTrials.gov Identifier: NCT01532583
Recruitment Status : Completed
First Posted : February 14, 2012
Last Update Posted : December 13, 2012
Sponsor:
Information provided by (Responsible Party):
Turku University Hospital

Brief 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.


Condition or disease Intervention/treatment
Stress Urinary Incontinence Other: Gynaecological examination, a supine stress test, questionnaires

Study Type : Observational
Actual Enrollment : 139 participants
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
Study Start Date : January 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : October 2011

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U.S. FDA Resources

Group/Cohort Intervention/treatment
Patients operated on with the TOT Other: Gynaecological examination, a supine stress test, questionnaires
Gynaecological examination, a supine stress test, questionnaires



Primary Outcome Measures :
  1. 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 :
  1. Subjective outcome of the TOT operation which was assessed with evaluated questionnaires. [ Time Frame: 8 years ]


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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:


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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

Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT01532583     History of Changes
Other Study ID Numbers: 13/2005, 15.2.2005
First Posted: February 14, 2012    Key Record Dates
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