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Sponsors and Collaborators: |
University of Calgary Calgary Health Region Boston Scientific Corporation |
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Information provided by: | University of Calgary |
ClinicalTrials.gov Identifier: | NCT00234754 |
Stress urinary incontinence is a health concern for many women. The transvaginal tape surgery has become a common procedure to address the problem. Another surgery is now available, tran-obturator tape. We will compare these 2 approaches to dealing with SUI and follow the women for 1 year.
Condition | Intervention |
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Stress Urinary Incontinence |
Procedure: TVT Surgery TOT Surgery |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Surgical Management of Stress Urinary Incontinence in Women: An RCT of TOT vs TVT |
Enrollment: | 201 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Trans-vaginal tape Surgery
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Procedure: TVT Surgery TOT Surgery
TVT surgery and TOT surgery
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2: Experimental
Trans-obturator tape surgery
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Procedure: TVT Surgery TOT Surgery
TVT surgery and TOT surgery
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This study is a randomized trial in which women with stress incontinence will be allocated to receive either TOT or TVT procedures. Women who elect surgical management of their type II stress incontinence are eligible to participate in the trial. Baseline data, including a patient questionnaire, will be collected. Hospital outcomes, including length of stay and surgical complications will be documented from hospital charts. All women attend a 6-week follow-up visit as standard of care: a structured data collection form will be used by surgeons to collect information and another patient questionnaire will be administered. At 12 months postoperatively women will attend clinic for objective measurement of incontinence, a full exam and to complete a questionnaire. The main outcome is effectiveness of the procedure determined using a 1-hour pad test. Secondary research questions include:
How effective is TOT compared to TVT in terms of:
Subjective cure at 12 months postoperatively? Incontinence-specific quality of life at 6 weeks and 12 months postoperatively? Satisfaction with surgery at 12 months postoperatively? Return to usual activities and usual sex life after surgery? The prevalence of voiding dysfunction at 12 months postoperatively? Surgical complications, both short term and long term? Utility and cost? (an economic evaluation) The study will be carried out according to the ICH Good Clinical Practice Guidelines.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Alberta | |
Calgary Health Region | |
Calgary, Alberta, Canada, T2N 2T9 |
Study Director: | Sue J Ross, PhD | University of Calgary |
Principal Investigator: | Magali Robert, MD | Univerty of Calgary, Calgary Health Region |
Responsible Party: | University of Calgary ( Dr. Magali Robert ) |
Study ID Numbers: | 18421, 200400964 |
Study First Received: | October 5, 2005 |
Last Updated: | June 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00234754 |
Health Authority: | Canada: Health Canada |
Incontinence Surgery Trans-vaginal tape Trans-obturator tape |
Signs and Symptoms Urinary Incontinence, Stress Urologic Diseases |
Urination Disorders Stress Urinary Incontinence |
Urological Manifestations Pathologic Processes |