Male Stress Urinary Incontinence Clinical Study
Control Starts with ProACT™, Adjustable Continence Therapy for Men
If you are struggling with incontinence after your prostate surgery and have not responded to conservative treatments such as pelvic floor exercises (Kegels), you may qualify for the ProACT Post-Approval Study. The study is being run to evaluate the long-term safety of the FDA-approved ProACT Therapy. The ProACT Therapy is designed to reduce or eliminate bladder leakage caused by stress urinary incontinence.
The ProACT Post-Approval Study may be right for you if:
+ You've been diagnosed with stress urinary incontinence for at least 12 months following your prostate surgery
+ You've failed conservative treatments, such as pelvic floor muscle exercises
+ You are able to visit your local study center approximately 4 times over a 1-year period and willing to complete 4 annual telephonic follow-ups.
+ You are not currently undergoing radiotherapy, have not received radiotherapy treatments within the last six months, and do not plan to receive radiotherapy within the next six months
+ You do not have suspected bladder cancer
+ You do not have unsuccessfully treated bladder stones
+ You do not have a bleeding disorder
+ You do not have significant urge incontinence symptoms
WHAT IS STRESS URINARY INCONTINENCE (SUI)?
Stress urinary incontinence is the involuntary loss of urine due to physical strain such as coughing, sneezing, or heavy lifting. After prostate surgery, you may not be able to prevent the flow of urine during times of strain.
WHAT IS PROACT?
ProACT, Adjustable Continence Therapy for Men consists of two small, adjustable, silicone balloons each connected with tubing to a port. The balloons are placed where the prostate was removed or resected.
The fluid-filled balloons apply pressure to and support the bladder neck, which helps prevent accidental leakage of urine.
KEY DEVICE ELEMENTS:
Adjustable to meet individual and changing incontinence needs.
No patient manipulation required.
Minimally invasive day case that takes on average 30 minutes to complete.