Post Approval Study of the ProACT™ Adjustable Continence Therapy for Men
Uromedica
Summary
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.
Eligibility
- Age range
- 50+ years
- Sex
- Male
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Subject is a male of at least 50 years of age. 2. Subject demonstrates stress urinary incontinence. 3. Subject has undergone a radical prostatectomy, transurethral resection of the prostate, or other prostate surgery. 4. Subject is willing and able to undergo surgical implantation of ProACT devices. 5. 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 a…
Interventions
- DeviceProACT Adjustable Continence Therapy for Men
The ProACT therapy consists of two small, adjustable silicone balloons connected with tubing to a port. During a minimally invasive outpatient procedure, the balloons are surgically placed in the area where the prostate was removed or resected.
Locations (6)
- University of ColoradoDenver, Colorado
- University of FloridaGainesville, Florida
- Emory UniversityAtlanta, Georgia
- University of Kansas Medical CenterKansas City, Kansas
- University of MichiganAnn Arbor, Michigan
- CentraCare- St. CloudSaint Cloud, Minnesota