Artificial Urinary Sphincters and Adjustable Dual-Balloon Continence Therapy in Men

Guidelines from the American Urological Association (AUA) indicate that patients with persistent or severe urinary incontinence may benefit from surgical intervention. Continence surgery should only be offered if the urinary incontinence is sufficiently bothersome despite conservative therapy. Post-prostatectomy incontinence is the most common cause of severe, intractable urinary leakage in men, with a reported occurrence of 4% to 69%, depending on the definition used. The primary etiology of post-prostatectomy urinary incontinence is damage or injury to the external urethral sphincter with resulting intrinsic sphincteric deficiency. Incontinence symptoms can improve with postoperative pelvic floor physical therapy and lifestyle changes; most improvements are seen within 1 to 2 years following surgery. A study reported that 8.4% of men still experienced severe incontinence 18 months after surgery. The current surgical standard for post-prostatectomy urinary incontinence is an artificial urinary sphincter (AUS), but other options, such as a urethral sling or dual-balloon adjustable continence therapy (DBACT), are available. Surgical intervention may be considered as early as 6 months after prostatectomy if the incontinence is severe and should be offered no sooner than 1 year after prostate surgery if the incontinence is moderate.  The artificial urinary sphincter (AUS) has been considered the gold standard treatment for stress urinary incontinence since it was first approved in the United States in 1972. The AUS is an active system comprising an occlusive constricting cuff, a control pump, and a pressure-regulating balloon reservoir. These parts are connected by kink-resistant tubing, creating a closed system. The AUS promotes urinary continence via circumferential compression of the urethra. A fluid-filled silicone-elastomer cuff achieves dryness through urethral constriction, permitting micturition through a manually operated scrotal implanted pump that transfers fluid from the compression cuff into the pressure-regulating balloon reservoir. After voiding, the compression cuff automatically refills within 3 to 5 minutes to restore cuff compression and continence. The AUS is available worldwide to treat severe, intractable urinary incontinence in women and is approved for that purpose in the United States; that discussion is beyond the scope of this activity. AUS placement for severe, intractable intrinsic sphincter deficiency in women is infrequently performed in the US but more commonly so in Europe. The surgical approach is usually transabdominal, and the cuff is placed at the bladder neck; good long-term success rates are reported. The average life expectancy of an AUS is 10 years. AUS devices are compatible with magnetic resonance imaging (MRI); image quality around the device may be compromised. Currently, AUS devices are made and marketed by only one manufacturer in the United States: Boston Scientific Corp., formerly American Medical Systems. AUS devices sold in the United States and most Western countries have an antibiotic coating of rifampicin and minocycline, offering substantial gram-positive bactericidal activity. Dual-balloon adjustable continence therapy(DBACT) utilizes 2 periurethral silicon balloons implanted percutaneously on either side of the urethra just distal to the bladder neck. These balloons increase passive urethral compression and improve bladder outlet resistance. A titanium port connected to the balloons via a silicon conduit in the scrotum allows office-based volume adjustments to the implanted balloons as needed.  DBACT placement is considered minimally invasive surgery and is easily reversible; the devices can be removed in the clinic with simple surgical instruments using only a local anesthetic. DBACT is MRI-compatible and is currently made by one manufacturer in the United States: UroMedica, Inc. While DBACT is available in Europe and South America for the treatment of stress urinary incontinence in women and men, the device is not approved for use in women in the United States.