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Sponsored by: |
Uromedica |
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Information provided by: | Uromedica |
ClinicalTrials.gov Identifier: | NCT00277095 |
The purpose of the study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 109 male patients. The ProACT device is designed to treat men who have stress urinary incontinence arising from intrinsic sphincter deficiency following an operation performed on the prostate for cancer or for benign prostatic hyperplasia. Two adjustable balloons (one on each side of the urethra) are implanted to treat urinary stress incontinence.
The results will be analyzed to demonstrate the effects of the device as well as its associated risks. Therapeutic success will be based on whether patients demonstrate at least a 50% reduction in pad weight at 18 months follow-up compared to the pad weight results at baseline.
Condition | Intervention | Phase |
---|---|---|
Urinary Incontinence |
Device: ProACT (Adjustable Continence Therapy) |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Clinical Investigation of the ProACT Adjustable Continence Therapy for Treatment of Post-Prostatectomy Stress Urinary Incontinence |
Estimated Enrollment: | 109 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
The study is a prospective, non-randomized multi-center investigation. Multiple measurements using 24 hour pad weight and pad count, validated questionnaires, voiding diaries will be used to evaluate the achievement of the study objectives. Subjects will be followed for a minimum of 18 months following implantation. Subjects will be requested to continue annual follow-ups through the FDA approval.
The purpose of the study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 109 male patients. The ProACT device is designed to treat men who have stress urinary incontinence arising from intrinsic sphincter deficiency following an operation performed on the prostate for cancer or for benign prostatic hyperplasia. Two adjustable balloons (one on each side of the urethra) are implanted to treat urinary stress incontinence.
The results will be analyzed to demonstrate the effects of the device as well as its associated risks. Therapeutic success will be based on whether patients demonstrate at least a 50% reduction in pad weight at 18 months follow-up compared to the pad weight results at baseline.
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
University of Arizona | |
Tucson, Arizona, United States, 85724 | |
United States, California | |
Kaiser Permanente-Los Angeles | |
Los Angeles, California, United States, 90027 | |
United States, Florida | |
The Pelvic Clinic | |
Pembroke Pines, Florida, United States, 33028 | |
Indian River Urology | |
Vero Beach, Florida, United States, 32960 | |
United States, Illinois | |
Urological Surgeons | |
Kankakee, Illinois, United States, 60901 | |
United States, Minnesota | |
Metro Urology | |
St. Paul, Minnesota, United States, 55102 | |
United States, Missouri | |
Kansas City Urology Care | |
Kansas City, Missouri, United States, 64123 | |
Canada, British Columbia | |
Can-Med Clinical Research Inc. | |
Victoria, British Columbia, Canada, V8T5G1 | |
Canada, Quebec | |
CHUS-Fleurimont | |
Fleurimont, Quebec, Canada, J1H5N4 | |
New Zealand | |
ProMed Urology | |
Tauranga, New Zealand |
Study Director: | Tim Cook, PHD | Uromedica, Inc. |
Responsible Party: | Uromedica Inc. ( Diane Burnside, Clinical Director ) |
Study ID Numbers: | UM02 |
Study First Received: | January 11, 2006 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00277095 |
Health Authority: | United States: Food and Drug Administration |
Urinary Incontinence |
Signs and Symptoms Urinary Incontinence, Stress Urologic Diseases |
Urination Disorders Stress Urinary Incontinence |
Urological Manifestations |