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Sponsored by: |
Ethicon, Inc. |
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Information provided by: | Ethicon, Inc. |
ClinicalTrials.gov Identifier: | NCT00196521 |
Stress urinary incontinence affects nearly 30 million women worldwide and the main goal of surgical treatment is to stop urinary incontinence (urinary leakage) that occurs with physical activity, coughing, sneezing, etc.Patients in the study will have an operation to improve urinary incontinence symptoms. This will involve inserting a mesh sling to help support the urethra (tube leading into your bladder). During the operation, the study doctor will use tension-free vaginal obturator system. The study will include women diagnosed with Stress Urinary Incontinence who have completed their families.
Condition | Intervention |
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Stress Urinary Incontinence |
Device: Tension-free vaginal tape obturator system |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Clinical Evaluation of the Tension-Free Vaginal Tape Obturator System For Treatment of Stress Urinary Incontinence |
Estimated Enrollment: | 300 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | March 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Objective testing includes: standing stress test, urodynamics evaluation, or pad test.
Exclusion Criteria:
For patients having URP measurements at selected sites:
Carefully place a half of a speculum into the vagina, reducing prolapse to less than stage 1. Be careful not to over extend or elongate the vaginal length. The half of a speculum must be placed with pressure emphasis on the posterior and apical areas. Anterior wall pressure or urethral pressure must be avoided at all times.
Study Director: | Martin Weisberg, MD | Ethicon, Inc. |
Responsible Party: | ( Ethicon, Inc. ) |
Study ID Numbers: | 300-04-004 |
Study First Received: | September 13, 2005 |
Last Updated: | December 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00196521 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Signs and Symptoms Urinary Incontinence, Stress Urologic Diseases |
Urination Disorders Stress Urinary Incontinence |
Signs and Symptoms Urological Manifestations Pathologic Processes Urinary Incontinence, Stress |
Urologic Diseases Urination Disorders Stress Urinary Incontinence |