Treatment with an adjustable long‐term implant for post‐prostatectomy stress incontinence: The ProACT™ pivotal trial

Abstract

These results demonstrate the safety and efficacy of this newly FDA-approved therapy, showing significant improvements in objective and subjective measures of SUI in mild, moderate, and severely incontinent male patients. The duration of the implant procedure is short, and complications are mild and easily resolvable.

Adjustable continence therapy (ProACT) for the treatment of male stress urinary incontinence: A systematic review and meta‐analysis

“…The overall revision rate of ProACT for any reason was 22.2%. Studies highlight the brevity and minimally invasiveness of the explant procedure which can be done in the office using topical anesthesia . After explant of the ProACT device, patients can either be reimplanted or continue on to a more invasive treatment option .…”

“…Studies highlight the brevity and minimally invasiveness of the explant procedure which can be done in the office using topical anesthesia. 18 After explant of the ProACT device, patients can either be reimplanted or continue on to a more invasive treatment option. 14 Rates of explantation for fixed and adjustable slings are estimated at 5% (95% CI: 3%-9%) and 14% (95% CI: 10%-18%), respectively, 26 while the AUS revision rate was 26.0%.…”

“…28 The severity of incontinence was not stratified in the majority of selected studies, but in recently published studies, ProACT was not limited to a specific severity indication and showed similar functional results in mild, moderate, and severe patients. 18,20 ProACT is a passive system requiring no patient manipulation. When given a choice of surgery, patients have been reported to overwhelmingly choose a passive therapy for SUI than active treatments.…”

Systematic review and meta-analysis comparing Adjustable Transobturator Male System (ATOMS) and Adjustable Continence Therapy (ProACT) for male stress incontinence

“…ProACT has been implanted for two decades in Europe and more recently in the United States, often in outpatient basis under X-ray or transrectal ultrasound guidance. Based on this minimally invasiveness it has been recommended as first-line treatment in non-irradiated patients with mild-to-moderate incontinence [6,54,56], although revision and explantation rates are high [18,27,29,30] because a correct positioning of the balloons is mandatory to achieve good results [21]. Based on our findings, ProACT does not appear to be an ideal device for durable continence or patient satisfaction.…”

Secondary placement of adjustable continence therapy (ProACT™) using open perineal technique: Case report of ProACT placement in a man with a devastated urethra following pelvic trauma and multiple AUS erosions

“…Each balloon is attached to an adjustment port which is placed in the inferior scrotum for percutaneous access. 4 We describe placement of ProACT device using an open perineal approach in a patient with a devastated urethra due to pelvic trauma and history of multiple AUS erosion who previously failed a tunneled approach. 5…”