Transperineal Implantation of a Permanent Adjustable Balloon Continence Device

This policy addresses transperineal implantation of a permanent adjustable balloon continence device (e.g., ProACT/ACT) for treatment of urinary incontinence and states the procedure is considered experimental, investigational, and/or unproven and therefore not a covered indication. Indications discussed are limited to adult stress urinary incontinence from intrinsic sphincter deficiency (not urge/mixed), typically adult men ≥12 months post‑radical prostatectomy or TURP who have failed conservative therapy and select women with ISD or prior failed repair, with major caveats including FDA approval only for the male ProACT device, limited and low‑quality evidence, high complication/revision rates, and an inactive policy status.

"Transperineal implantation of a permanent adjustable balloon continence device for treatment of urinary incontinence is considered experimental, investigational, and/or unproven and is not a covere..."