Clinical Investigation of the ProACT Adjustable Continence Therapy for Treatment of Post-Prostatectomy Stress Urinary Incontinence
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
24 hour pad weight
6wk, 6 mo, 12 mo, 18 mo, 2 yr, annually after
No
Tim Cook, Ph.D
Study Director
Uromedica, Inc.
United States: Food and Drug Administration
UM02
NCT00277095
August 2005
March 2013
Name | Location |
---|---|
University of Arizona | Tucson, Arizona 85724 |
Kansas City Urology Care | Kansas City, Missouri 64131 |
Kaiser Permanente-Los Angeles | Los Angeles, California 90027 |
The Pelvic Clinic | Pembroke Pines, Florida 33028 |
Indian River Urology | Vero Beach, Florida 32960 |
Urological Surgeons | Kankakee, Illinois 60901 |
Metro Urology | St. Paul, Minnesota 55102 |