A Clinical Evaluation of the Tension-Free Vaginal Tape Obturator System For Treatment of Stress Urinary Incontinence (Urinary Leakage)
NCT ID: NCT00196521
Last Updated: 2007-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2005-01-31
2007-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
NONE
Interventions
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Tension-free vaginal tape obturator system
Eligibility Criteria
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Inclusion Criteria
* Patient is age 18 or older.
* Patient had a hysterectomy, tubal ligation or is otherwise incapable of pregnancy, or had a negative pregnancy test prior to study entry and has decided to cease childbearing.
* Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the IRB/EC-approved informed consent.
Exclusion Criteria
* Patient is on anti-coagulation therapy.
* Patient has received an investigational drug or device in the past 60 days.
For patients having URP measurements at selected sites:
* Patient has an active lesion or present injury to perineum or urethra.Patient has a urethral obstruction.
* Patient has an unreduced cystocele \> Stage 1. (Reduction of prolapse prior to URP testing is required.) Reduction of Cystocele (if applicable). Patients should be seated in a semi-fowler's position with head of bed at 40-60 degrees.
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.
* The subject has active infection upon urine dipstick analysis, defined as ≥+1 leukocytes or ≥+1 nitrates (Must reschedule appointment after UTI resolves.)
18 Years
FEMALE
No
Sponsors
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Ethicon, Inc.
INDUSTRY
Principal Investigators
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Martin Weisberg, MD
Role: STUDY_DIRECTOR
Ethicon, Inc.
Locations
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Urogynecology Associates of CO
Denver, Colorado, United States
Bladder Control Center
Norwalk, Connecticut, United States
Urogynecology Specialists of Kenuckiana
Louisville, Kentucky, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Oakwood Hospital
Dearborn, Michigan, United States
Sheldon Freedman, MD
Las Vegas, Nevada, United States
St. Peter's University Hospital
New Brunswick, New Jersey, United States
The Institute for Female Pelvic Medicine & Reconstructive Surgery
Allentown, Pennsylvania, United States
University Urology
Knoxville, Tennessee, United States
McDonlad Murrmann Women's Clinic
Memphis, Tennessee, United States
Sound Urology Ambulatory Surgery Center
Edmonds, Washington, United States
Sunnybrook & Women's College Health Sciences Center
Toronto, Ontario, Canada
Service d'Urologie
Marseille, , France
Hopital Des Diaconesses
Paris, , France
Klinikum der Eberhard-Karls-Universität
Tübingen, , Germany
Women's and Children's Hospital
Singapore, , Singapore
Samsung Medical Center
Seoul, , South Korea
University of Ulsan College of Medicine and Asan Medical Center
Seoul, , South Korea
Southport District General Hospital
Southport, , United Kingdom
Countries
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Other Identifiers
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300-04-004
Identifier Type: -
Identifier Source: org_study_id