This study is looking at the long-term effects of the ProACT Adjustable Continence Therapy for Men device. This device uses two small, adjustable silicone balloons placed surgically to help men with stress urinary incontinence (leaking urine when you cough, sneeze, or exercise). You may be able to join if you are a man at least 50 years old, have stress urinary incontinence, and have had prostate surgery. The study wants to see how often problems like urethral strictures (narrowing of the urethra) or device erosions (when the device wears away tissue) occur over 5 years. It also measures how the device affects your quality of life. The current recruitment status is unclear.

Study design

This is a 5-year, open-label study across multiple centers, planning to enroll 145 participants.

What's involved

You would undergo surgical implantation of the ProACT devices and be followed for 5 years.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed for 5 years after the ProACT implantation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.