Urinary Incontinence Clinical Trial
Official title:
Clinical Investigation of the ProACT Adjustable Continence Therapy for Treatment of Post-Prostatectomy Stress Urinary Incontinence
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.
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