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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
123
Implantable device to reduce urinary stress incontinence
University of Arizona
Tucson, Arizona, United States
Kaiser Permanente-Los Angeles
Los Angeles, California, United States
The Pelvic Clinic
Pembroke Pines, Florida, United States
Indian River Urology
Vero Beach, Florida, United States
Urological Surgeons
Kankakee, Illinois, United States
Metro Urology
Saint Paul, Minnesota, United States
Kansas City Urology Care
Kansas City, Missouri, United States
Can-Med Clinical Research Inc.
Victoria, British Columbia, Canada
CHUS-Fleurimont
Fleurimont, Quebec, Canada
Urology Bay of Plenty (formerly Promed Urology)
Tauranga, New Zealand
Primary Efficacy: Demonstrate the Efficacy of the ProACT Device in Reducing Incontinence as Measured by the 24-hour Pad Weight at 18 Months Compared to Baseline. A Subject is a Success if he Demonstrates a 50% Reduction.
The percentage of participants with 50% reduction in pad weight.
Time frame: 18 month follow-up
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