Post Approval Study of the ProACT™ Adjustable Continence Therapy for Men
The ProACT Post Approval Study is a 5-year prospective, open-label, multi-center study designed to evaluate the long-term incidence of urethral stricture and device erosion after ProACT implantation. In addition, the study will evaluate whether treatment with ProACT affects clinical outcomes after subsequent SUI therapies.
• Subject is a male of at least 50 years of age.
• Subject demonstrates stress urinary incontinence.
• Subject has undergone a radical prostatectomy, transurethral resection of the prostate, or other prostate surgery.
• Subject is willing and able to undergo surgical implantation of ProACT devices.
• Subject is willing and able to comply with study-required
• follow-up activities, including annual telephonic follow -up interviews, for a period of 5 years from their date of initial implantation. This includes compliance even after possible explant of ProACT devices and/or possible implantation of subsequent therapies.
• Subject is willing and able to sign the approved informed consent.
• Subject has two positive 24-hour pad weight tests (greater than or equal to 8 gram pad weight increase demonstrated in two 24-hour pad weight tests).
• Subject has a negative urine culture.
• Subject has no known urogenital malignancy, other than previously treated prostate cancer.
⁃ Subject meets ONE of the following criteria:
∙ Baseline Prostate-Specific Antigen (PSA) of less than or equal to 2.5ng/mL;
‣ Baseline PSA \> 2.5ng/mL and less than or equal to 10 ng/mL AND free PSA greater than or equal to 25% of total PSA;
⁃ Physician determines subject to be a suitable surgical candidate.