This trial is evaluating an implanted device, ProACT, for the treatment of stress urinary incontinence (SUI) in men. The main outcome to be measured is an improvement of patient quality of life and the device remaining in good condition long term. This trial is being carried out in Georgia and Michigan, the United States.
Stress incontinence is urine leakage when there is pressure on the bladder. It is often observed when a patient coughs, sneezes or exercises. It happens as a result of weak muscles around the bladder that help hold urine in. It can be treated by pelvic floor exercises, drug therapy, pessaries (to support the walls of the bladder) or nerve stimulation. Surgery can also be an option when these treatments do not work.
ProACT is an implanted device which squeezes the neck of the bladder to stop urine from leaking. This trial is evaluating the long-term safety and effectiveness of the ProACT device. The main outcome to be measured is an improvement of patient quality of life and the device remaining in good condition long term.
Who are they looking for?
145 patients are needed for this trial. To be included in this trial, patients must be willing and able to have surgery to implant the device and be able to comply with trial instructions and follow-up activities for 5 years. Patients must have 2 positive 24-hour pad tests and should not have a urinary infection or active urinary or genital cancers, other than treated prostate cancer. Patients must be determined as a suitable candidate for surgery by a doctor.
Patients will not be included in the trial if they have a narrow urethra (the tube where urine comes out from the bladder) or if it was removed. Patients cannot have an artificial urinary sphincter or any components of it still in their body. Patients who have bladder stones, a bleeding disorder or uncontrolled diabetes will no be included in the trial.
How will it work
All patients will receive the ProACT device. Patients will be followed for 5 years after implantation. Patients will be assessed for quality of life, urinary symptoms and the condition the device is in.