Andrew Siegel MD 4/25/20
Charley Morgan, our beautiful English Springer spaniel. She is on steroids for an autoimmune disease that affects her chewing muscles and therefore has severe urinary incontinence, which hopefully will improve as the steroids are tapered.
This is the final entry in the series of entries about urinary incontinence following prostate cancer treatments. The Artificial Urinary Sphincter (AUS) is the “gold standard” for the rare patient who has persistent and significant post-prostatectomy incontinence that has failed to respond to lesser measures. The AUS can be as gratifying and life-changing to a patient incapacitated by incontinence as is a total knee replacement be to a patient crippled with arthritis. Although the lion’s share of AUS implantation surgeries are done in males with incontinence following prostate surgery, an occasional procedure is done in females.
HISTORICAL PERSPECTIVE
Dr F. Brantley Scott performed the first AUS implant in 1972 on a 36-year-old woman. Dr. Scott was a urologist and surgical pioneer who also developed and refined the inflatable penile prosthesis. Sadly, he died at age 61 when a plane he was piloting crashed while trying to land near his vacation home in Texas. He is the father of urological prosthetic surgery and a surgical retractor that he developed–the Scott retractor–is still widely used in most female and male pelvic reconstructive procedures and prosthetic device implantations.
EVALUATION
Before embarking on surgery, it is imperative for the significantly incontinent patient to undergo a comprehensive evaluation to determine the most appropriate treatment option. Evaluation typically involves a cystoscopy to visually inspect the urethra, sphincters and urinary bladder and urodynamics to provide important information about bladder function. The type of surgical management is tailored to the extent of the urinary incontinence as well as other factors, including the ability of the bladder to contract properly. The degree of incontinence is best quantified by pad usage, particularly by determining the weight of pads used in 24 hours.
EFFECTIVE, SAFE AND RELIABLE
The artificial urinary sphincter (AUS) is an effective, safe and reliable implantable medical prosthesis to restore urinary control in men with severe stress urinary incontinence that has not been suitably treated by other means. Although there is no way to totally replace one’s natural sphincter system, the AUS is the only device that simulates normal sphincter function by opening and closing the urethra at the will of the patient. It provides consistent results in the treatment of incontinence following prostatectomy and is considered to be the “gold standard” in the management of this problem.
HISTORY OF AUS
The AUS, first developed in 1972, has been used successfully for almost 50 years and has been implanted in more than 150,000 men. Over the years, biomedical engineering refinements have further improved the device. The AUS can be “life changing,” converting bladder “cripples” back to normal function. About two-thirds of men will be completely continent after an AUS implant, and the other one-third will experience only minor incontinence, requiring 1-2 small pads per day. The overall patient satisfaction rate exceeds 90%.
The AUS does not directly treat the damaged sphincter, but functions to mechanically compress the urethra. The device is under the patient’s command, providing simple and discreet control over bladder storage and emptying. Implanted entirely within the body, the device mimics the function of a healthy sphincter muscle by keeping the urethra closed until the patient desires to urinate.
AUS COMPONENTS
The AUS is a hydraulic, saline fluid-filled device composed of solid silicone elastomer. It consists of three interconnected components: a cuff implanted around the urethra, a pressure-regulating balloon reservoir implanted behind the pubic bone adjacent to the bladder, and a control pump implanted in the scrotum. The cuff gently squeezes the urethra closed, preventing urine from passing. When one desires to urinate, he simply squeezes and releases the control pump that is situated in the scrotum, temporarily transferring saline fluid from the cuff to the pressure regulating balloon. The cuff opens, allowing urine to flow through the urethra and the bladder to be emptied. Within several minutes, the pressure regulating balloon automatically returns the saline fluid to the cuff to once again pinch the urethra closed.
Blausen.com staff (2014). “Medical gallery of Blausen Medical 2014“. WikiJournal of Medicine 1 (2). DOI:10.15347/wjm/2014.010. ISSN 2002-4436.
INDICATIONS FOR AUS
An appropriate candidate for the AUS has incontinence caused by a weakened or damaged sphincter and not due to bladder over-activity. Additionally, bladder capacity needs to be adequate and urinary flow rate sufficient to empty the bladder. The incontinence should be present for a minimum of 6 months before considering the AUS since spontaneous improvement occurs for some time after prostatectomy. One needs to be sufficiently motivated to receive an implant, and its use demands manual dexterity in order to operate the control pump.
IMPLANTATION OF THE AUS
Implantation of the AUS is an approximately one-hour outpatient surgical procedure done under anesthesia. The conventional operation is performed with legs in stirrups and requires one incision in the abdomen and another in the perineum (area between scrotum and anus). In 2003, Drs. Steve Wilson, John Delk, Gerard Henry and I devised an innovative technique for AUS implantation via a single scrotal incision. The advantages of the scrotal technique are a single incision (versus two incisions), the fact that it can be done supine, which is an easier position to work with (versus legs up in stirrups), faster operative time, ease of doing the procedure and decreased patient discomfort. In either case, the control pump is one-size fits all, but the cuff is precisely measured to one’s anatomy and the pressure-regulating balloon reservoir is usually chosen to be 61-70 cm water pressure.
It is important to know that following implantation the AUS is not activated–and thus will not be functional– for about a 6-week period of time to allow for healing of tissues. Activation is a simple office process involving minimal discomfort. It is advisable to order and wear a MedicAlert bracelet (www.medicalert.org) to inform health care personnel that you have an AUS implant in the event of a medical emergency. If you were rendered unconscious or unable to communicate, this bracelet will inform emergency medical staff that you have an AUS, because if there is ever a need for placement of a urethral catheter, it is imperative that the AUS be deactivated prior to catheter placement in order to avoid damaging the urethra.
Frequently Asked Questions
Who manufactures the AUS?
American Medical Systems Men’s Health Division of Boston Scientific, Inc.
Will insurance cover the AUS?
Medicare has a coverage policy for incontinence control devices, which includes the AUS. Most commercial health insurers also cover the AUS when deemed medically necessary for the patient.
How effective is the AUS?
More than 90% of patients with the AUS have greatly improved continence, many of whom achieve complete urinary control with no need for pads and the remainder of whom have occasional, minor stress incontinence with vigorous activities, typically requiring 1-2 pads per day. The commonly implanted pressure regulating balloon provides 61-70 cm of pressure around the urethra, which is sufficient closure for most of the activities of daily living.
Does the AUS need to be measured to my body?
The control pump is one-size-fits-all, but the cuff is sized to the circumference of your urethra to achieve a proper fit. The reservoir comes in a variety of pressures. The higher the pressure of the reservoir, the tighter the closure of the urethra. The tighter the closure of the urethra, the better the continence, but also the greater the chance of urethral damage from the higher pressures. A balance must be achieved in order to achieve the necessary pressure to achieve continence while minimizing potential damage to the urethra. In practical terms, this translates into a 61-70 cm pressure reservoir for most men.
Can I have an AUS if I underwent surgery followed by radiation therapy?
Yes, but radiation therapy increases the potential risk for complications because of tissue damage, scarring, decreased blood flow and less optimal wound healing.
Who should not have an AUS?
The AUS is not appropriate for a man with an obstructed lower urinary tract. It also should not be used for men with bladder-related incontinence (overactive bladder or a small-capacity, scarred bladder) as it is indicated only for those with sphincter-related incontinence. It cannot be effectively used in those with compromised dexterity or mental acuity.
What are the potential risks and complications of AUS implantation?
Infection As with any prosthetic implant surgery, an infection can develop after an AUS implant. Every step is taken to reduce the likelihood of an infection, including use of intravenous antibiotics, an antiseptic scrub of the surgical site followed by the application of a chlorhexidine and alcohol skin antiseptic immediately prior to the operation, double-gloving, meticulous surgical technique with the procedure done in the least amount of time as feasible, topical antibiotics to flush the surgical site, and minimizing operating room traffic. Antibiotic ointment is placed on the surgical incision prior to placing the surgical dressing. Patients are sent home on oral antibiotics. Two of the three components of the AUS–the cuff and pump–are coated with an antibiotic combination called InhibiZone, which consists of rifampin and minocycline. If an infection occurs and does not respond to antibiotics, it may be necessary to remove the AUS, an extremely rare occurrence.
Erosion This is a breakdown of the urethral tissues that lie beneath the cuff. It is generally treated with cuff removal to allow for urethral healing prior to consideration for cuff replacement at a later date. Erosion can occur when a catheter is placed into the urinary bladder by health care personnel uninformed that the AUS device is in place. The delicate urethra, pinched closed by the inflated cuff surrounding it, is traumatized and damaged by catheter placement. This situation can be avoided by deactivating the AUS prior to catheterization. This is one of the reasons that a MedicAlert card and bracelet are useful considerations. Erosion of the other AUS components can also occur on a rare basis. The control pump can potentially erode through the scrotal skin and the pressure-regulating balloon reservoir into the urinary bladder.
Mechanical Malfunction The AUS is effective and reliable, but like any mechanical device, it can ultimately malfunction. It is not possible to predict how long an AUS will function in an individual patient. As with any biomedical prosthesis, the device is subject to wear, component disconnection, component leakage, and other mechanical problems that may lead to the device not functioning as intended and that may ultimately require additional surgery to replace the device. The median durability of the device is about 7.5 years, although I have patients who still have a functional AUS twenty years following implantation.
Urethral Tissue Atrophy This may result from the long-term pressure effect of the cuff on the urethra. Essentially, the urethra shrinks down from being squeezed by the cuff, resulting in gradual worsening of urinary control. When this happens, it generally requires repositioning of the cuff to a new urethral location or the use of a smaller cuff or, on rare occasions, placement of a second cuff (tandem cuff).
Pain Discomfort in the groin, penis, scrotum and perineum is expected immediately after surgery and during the period when the device is first used. It is very rare to experience chronic pain from an AUS implantation.
Migration and Extrusion Migration is movement or displacement of AUS components within the body space in which they were originally implanted. Extrusion occurs when a component moves to an abnormal location outside of the body. These are both extremely rare occurrences.
Wishing you the best of health,
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Dr. Andrew Siegel is a physician and urological surgeon who is board-certified in urology as well as in female pelvic medicine and reconstructive surgery. He is an Assistant Clinical Professor of Surgery at the Rutgers-New Jersey Medical School and is a Castle Connolly Top Doctor New York Metro Area, Inside Jersey Top Doctor and Inside Jersey Top Doctor for Women’s Health. His mission is to “bridge the gap” between the public and the medical community. He is a urologist at New Jersey Urology, the largest urology practice in the United States.
The content of this entry is excerpted from his new book, PROSTATE CANCER 20/20: A Practical Guide to Understanding Management Options for Patients and Their Families
Video trailer for Prostate Cancer 20/20
Preview of Prostate Cancer 20/20
Andrew Siegel MD Amazon author page
Prostate Cancer 20/20 on Apple iBooks
PROSTATE CANCER 20/20: A Practical Guide to Understanding Management Options for Patients and Their Families is now on sale at Audible, iTunes and Amazon as an audiobook read by the author (just over 6 hours).
Dr. Siegel’s other books:
PROMISCUOUS EATING— Understanding and Ending Our Self-Destructive Relationship with Food
MALE PELVIC FITNESS: Optimizing Sexual and Urinary Health
THE KEGEL FIX: Recharging Female Pelvic, Sexual, and Urinary Health
Our Greatest Wealth Is Health 