All Products
Also known as
ProACT, ProACT™ Adjustable Continence Therapy, Dual Balloon Adjustable Continence Therapy (DBACT), Periurethral Balloon System, Adjustable Periurethral Balloons, Male Sling Alternative
Definition
Adjustable Continence Therapy (ACT) is a minimally invasive implantable medical device designed to treat stress urinary incontinence in men, particularly following prostate surgery.1 The system consists of two small, adjustable silicone balloons that are surgically placed on either side of the proximal urethra, just distal to the bladder neck.2 Each balloon is connected via tubing to a titanium port that is implanted under the skin of the scrotum.3 The balloons provide gentle pressure on the urethra, increasing bladder outlet resistance and thereby preventing involuntary urine leakage during physical activities that increase abdominal pressure, such as coughing, sneezing, or exercise.4 A key feature of this therapy is its adjustability—the volume of fluid in each balloon can be modified through the subcutaneous ports during office visits, allowing physicians to customize the pressure to meet individual patient needs without requiring additional surgery.5
Clinical Context
Adjustable Continence Therapy is primarily indicated for the treatment of adult men with stress urinary incontinence (SUI) arising from intrinsic sphincter deficiency, most commonly following radical prostatectomy or transurethral resection of the prostate.1 The therapy is typically considered for patients who have failed conservative treatments such as pelvic floor exercises and behavioral modifications, and who have experienced symptoms for at least 12 months post-prostate surgery.2
The implantation procedure is performed under general or spinal anesthesia and takes approximately 30 minutes.3 Using fluoroscopic or ultrasound guidance, the surgeon places two balloons on either side of the proximal urethra through small perineal incisions. The connected titanium ports are positioned in the scrotum for future adjustments.4
Post-operative adjustments typically begin 2-4 weeks after implantation, with incremental increases in balloon volume (0.5-1.0 cc per side) to achieve optimal continence while maintaining normal urination.5 These adjustments are performed in an outpatient setting using local anesthesia.
Clinical outcomes from meta-analyses demonstrate that approximately 60.2% of patients achieve complete dryness, while 81.9% experience at least a 50% improvement in their incontinence symptoms.1 Quality of life scores show significant improvement, with an average increase of 30.8 points from baseline.1 The therapy has shown durable results, with studies reporting sustained efficacy over follow-up periods averaging 3.6 years.1
Complications are generally minor and include temporary perineal pain (15%), balloon migration (5-10%), urinary retention (3-5%), and infection (2-3%).3 If necessary, the device can be removed or replaced in a minimally invasive procedure, making it a reversible treatment option.4
ACT offers several advantages over alternative treatments such as the artificial urinary sphincter, including less invasiveness, no need for manual activation, and lower infection rates.2 It is considered a viable first-line surgical option for appropriate candidates, particularly those who are not ideal candidates for more invasive procedures.1