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Sponsored by: |
Ullevaal University Hospital |
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Information provided by: | Ullevaal University Hospital |
ClinicalTrials.gov Identifier: | NCT00308009 |
It is unknown whether it is best to do the TVT( procedure for urinary stress incontinence in women) at the time of prolapse surgery or at a later date. Women with both conditions were randomized to both procedures together or the TVT 3 months after the prolapse surgery. Any or no leakage when couching was the main end-point, evaluated 1 year after the last surgery
Condition | Intervention |
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Pelvic Organ Prolapse Urinary Stress Incontinence |
Procedure: Vaginal Repair for prolapse, TVT procedure Procedure: TVT and Prolapse surgery |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Multicenter Prospective Randomized Trial Comparing to Strategies When Incontinence Surgery is Needed in Addition to Prolapse Surgery |
Enrollment: | 194 |
Study Start Date: | February 2002 |
Study Completion Date: | September 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Group I
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Procedure: Vaginal Repair for prolapse, TVT procedure
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2: Active Comparator
Group II
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Procedure: Vaginal Repair for prolapse, TVT procedure
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All women were evaluated by the POP-Q (pelvic Organ Prolapse Quantification) prior to surgery and 1 year after.
Examination for urinary leakage was done prior to surgery and 1 year after. Group 2 was also examined after prolapse surgery to see if TVT was still needed.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: Pelvic Organ Prolapse that needs surgical repair and objectively proven urinary stress incontinence -
Exclusion Criteria: Not agreed to participate in randomization
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Responsible Party: | Ullevaal University Hospital ( Ellen Borstad, MD ) |
Study ID Numbers: | TVT Prolapse study |
Study First Received: | March 27, 2006 |
Last Updated: | January 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00308009 |
Health Authority: | Norway: The National Committees for Research Ethics in Norway |
Pelvic Organ Prolapse Urinary stress incontinence Surgery |
Pathological Conditions, Anatomical Urination Disorders Gastrointestinal Diseases Stress Intestinal Diseases Prolapse Rectal Diseases |
Signs and Symptoms Urinary Incontinence, Stress Digestive System Diseases Urologic Diseases Urinary Incontinence Rectal Prolapse |
Urological Manifestations |