The ProACT Post-Approval Study is a research project that will last 5 years. It looks at men who have a condition called stress urinary incontinence (SUI), which means they might leak urine when they cough or laugh. The study is about an implant called ProACT, which helps stop these leaks. The study will check for problems like urethral stricture (a narrowing of the tube that carries urine out of the body) and device erosion (when the implant wears away surrounding tissue) after the device is put in. It will also see how well the ProACT works if the person needs more treatment later on.
- The study needs men aged 50 or older who have had prostate surgery.
- Participants must be willing to have the ProACT implant and follow-up for 5 years.
- Exclusions include recent prostate surgery, bladder cancer, and certain health conditions.
Participants will have to attend regular check-ups and answer questions over the phone once a year. This study helps doctors understand how well the ProACT works long-term and if it affects other treatments later.