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Also known as
ProACT™ Adjustable Continence Therapy for Men, ProACT system, ProACT balloons, Adjustable Continence Therapy, ACT device
Definition
The Pro-ACT (Adjustable Continence Therapy) Device is a minimally invasive implantable medical device designed to treat male stress urinary incontinence. It consists of two small, adjustable silicone balloons connected via tubing to titanium ports.1 Each balloon is surgically placed on either side of the bladder neck or urethra where the prostate was removed or resected.2 The fluid-filled balloons apply pressure to support the bladder neck, which helps prevent accidental urine leakage during physical activity, coughing, or sneezing.3 The titanium ports are placed subcutaneously in the scrotum, allowing for post-operative adjustment of balloon volume to achieve optimal continence based on individual patient needs.4
Clinical Context
The Pro-ACT Device is clinically indicated for the treatment of adult men who have stress urinary incontinence arising from intrinsic sphincter deficiency.3 It is specifically designed for patients who have undergone radical prostatectomy or transurethral resection of the prostate (TURP) and are experiencing incontinence at least twelve months following their procedure.3 The device is recommended for patients who have failed to respond adequately to conservative therapy options such as pelvic floor exercises and behavioral modifications.1
Patient selection criteria include men with confirmed stress urinary incontinence, adequate manual dexterity for potential self-catheterization if needed, and absence of contraindications such as active urinary tract infections, detrusor instability, reduced bladder compliance, or significant residual volume greater than 100 cc after voiding.3 The device is also contraindicated in patients currently receiving radiotherapy or planning to receive it within 6 months.3
The surgical implantation procedure is minimally invasive, taking approximately 30 minutes to complete.2 The balloons are placed via a perineal approach, with the ports positioned subcutaneously in the scrotum for future adjustments.2 Post-operatively, adjustments typically begin 4-6 weeks after placement, with optimal results usually achieved after 3-4 adjustment visits.4
Clinical outcomes from a systematic review and meta-analysis of 19 studies with 1264 patients showed significant improvement in quality of life scores (30.8 points improvement from baseline) and reduction in pad usage from an average of 4.0 pads per day to 1.1 pads per day.1 Approximately 60.2% of patients achieved complete dryness, while 81.9% experienced either complete dryness or greater than 50% improvement in their condition.1 The mean follow-up time in these studies was 3.6 years, demonstrating the long-term efficacy of the device.1