A Clinical Evaluation of the Tension-Free Vaginal Tape Obturator System For Treatment of Stress Urinary Incontinence (Urinary Leakage)
- Conditions
- Stress Urinary Incontinence
- Registration Number
- NCT00196521
- Lead Sponsor
- Ethicon, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 300
- Patient has objective demonstrable signs of stress urinary incontinence (SUI), including patients with ISD. Objective testing includes: standing stress test, urodynamics evaluation, or pad test.
- 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.
- Patient has an associated or suspected neurological disease.
- 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.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Overall incidence of treatment success.
- Secondary Outcome Measures
Name Time Method Patient satisfaction Assessment of unresolved de novo urgency post-treatment. No additional surgery required to correct SUI post-treatment Intraoperative and postoperative complications Quality-of-life measurements Return to usual activity
Trial Locations
- Locations (19)
Greater Baltimore Medical Center
🇺🇸Baltimore, Maryland, United States
Bladder Control Center
🇺🇸Norwalk, Connecticut, United States
St. Peter's University Hospital
🇺🇸New Brunswick, New Jersey, United States
Service d'Urologie
🇫🇷Marseille, France
Klinikum der Eberhard-Karls-Universität
🇩🇪Tubingen, Germany
Urogynecology Associates of CO
🇺🇸Denver, Colorado, United States
University Urology
🇺🇸Knoxville, Tennessee, United States
Oakwood Hospital
🇺🇸Dearborn, Michigan, United States
Urogynecology Specialists of Kenuckiana
🇺🇸Louisville, Kentucky, United States
Sunnybrook & Women's College Health Sciences Center
🇨🇦Toronto, Ontario, Canada
Hopital Des Diaconesses
🇫🇷Paris, France
The Institute for Female Pelvic Medicine & Reconstructive Surgery
🇺🇸Allentown, Pennsylvania, United States
Sheldon Freedman, MD
🇺🇸Las Vegas, Nevada, United States
McDonlad Murrmann Women's Clinic
🇺🇸Memphis, Tennessee, United States
Sound Urology Ambulatory Surgery Center
🇺🇸Edmonds, Washington, United States
University of Ulsan College of Medicine and Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Women's and Children's Hospital
🇸🇬Singapore, Singapore
Southport District General Hospital
🇬🇧Southport, United Kingdom