Artificial Urinary Sphincter Placement Treatment & Management
- Author: Kamran P Sajadi, MD; Chief Editor: Edward David Kim, MD, FACS more...
No known reliable medical therapy exists for postprostatectomy male stress incontinence. Alpha agonists have not been demonstrated to be helpful in correcting male intrinsic sphincteric dysfunction. Periurethral bulking agents, including collagen injections, have a long history of use in incontinence. They have been effective in improving stress incontinence symptoms, but problems with agent migration or absorption have limited their long-term efficacy. Overall improvement varies from 35-70%, and multiple injections are often required. Nonetheless, collagen injections present a less-invasive alternative for patients who are wary of an implanted device or are poor candidates for the artificial urinary sphincter.
For women with intrinsic sphincteric dysfunction, estrogen therapy, alpha agonists, or both have provided some improvement in symptoms. Periurethral collagen injections are most effective for women with intrinsic sphincteric dysfunction, producing cure rates that last as long as 1 or 2 years. Although the efficacy of periurethral injection therapy is better in women than in men, the treatment does not produce lasting cure, for the same reasons.
Duloxetine is a serotonin and norepinephrine reuptake inhibitor that is indicated for depression and has been shown to increase resting urethral pressure and may, therefore, decrease stress incontinence in women. Clinical trials for use of duloxetine in postprostatectomy patients are currently in progress. Duloxetine is not yet approved by the US Food and Drug Administration for treatment of incontinence in men or women.
Other noninvasive options include Kegel exercises, which should be taught to all women with genuine stress incontinence and men with postprostatectomy incontinence. In addition, for men with incontinence, there are external continence clamps that are applied to the penile urethra; however, although these clamps are noninvasive and easily discontinued, they demonstrate limited efficacy and are uncomfortable for many men to wear.
In short, all noninvasive interventions for stress incontinence caused by intrinsic sphincteric dysfunction are less effective than surgical interventions.
Male Suburethral Slings
Male suburethral slings are discussed below.
InVance male sling
In 2000, American Medical Systems (AMS) launched the InVance male suburethral sling, a surgical option for men with intrinsic sphincteric dysfunction (which usually occurs after radical or transurethral prostatectomy).
The male sling is not as effective as the artificial urinary sphincter and is therefore indicated only for patients with mild-to-moderate stress incontinence due to intrinsic sphincteric dysfunction and patients with significant incontinence who are not candidates for the artificial urinary sphincter.
Patients who continue to have significant incontinence after placement of the suburethral sling may still be candidates for an artificial urinary sphincter (ie, prior placement of a sling is not a contraindication to placement of the artificial urinary sphincter).
AdVance male sling
In 2004, AMS launched the AdVance male suburethral sling, which is a transobturator suburethral sling placed perineally. The AdVance sling is indicated for men with mild to moderate stress incontinence, as is the InVance male sling.
In establishing candidacy for the AdVance sling, demonstration of residual sphincter function is necessary preoperatively. Urethroscopy can be used to evaluate function. In this study, the patient is asked to voluntarily coapt his sphincter under direct vision. Alternatively, the ability for the patient to voluntarily stop and start their urinary stream demonstrates residual sphincter function.
The AdVance sling has shown excellent short-term results. As with the InVance, patients in whom AdVance sling placement fails are still candidates for the artificial urinary sphincter.
Coloplast launched the Virtue Male Sling in Summer 2009. Also placed through a perineal approach, the Virtue has four arms, two of which are passed prepubic, and two through the obturator foramen. It has been described as a hybrid device, offering urethral mobilization through the transobturator arms, and urethral compression through the prepubic arms.
The AMS 800 device
The AMS 800 artificial urinary sphincter is the most commonly used device and is the criterion standard for the treatment of incontinence caused by intrinsic sphincteric dysfunction. It is composed of a pressure-regulating balloon, an inflatable cuff, and a control pump (see image below). The balloon has a dual function as a pressure regulator and a fluid reservoir.
Balloon reservoirs come in 5 preset pressures—41-50, 51-60, 61-70, 71-80, and 81-90 cm water. The lowest pressure required to close the urethra is used. Balloon reservoirs are typically placed in the lower abdomen. For uncomplicated bulbar urethral cuffs, the most commonly chosen balloon reservoirs are the ones with preset pressures of 51-60 and 61-70 cm water. For bladder neck cuffs, the balloon reservoir with pressures of 71-80 cm water is chosen because higher pressures are necessary to occlude the bladder neck. Patients with prior radiation or surgical changes that present a higher risk of erosion may benefit from a 51-60 cm water reservoir. In addition to a lower pressure reservoir, some advocate transcorporal cuff placement in patients with a history of radiation therapy.
The inflatable cuff has a variable length that compresses the urethra or the bladder neck circumferentially. Cuff sizes range from 3.5-11 cm, in 0.5-cm increments. The cuff is placed around the bulbar urethra in adult males. For women and children, the bladder neck is the only site that should be used. The cuff size is based on the circumference of the bladder neck or the bulbar urethra. A properly sized cuff for the bulbar urethra ranges from 4.5-5.5 cm in length. Most commonly, a 4.0-cm cuff is chosen for adult males. For the bladder neck, a 6- to 8-cm cuff is selected in women.
The control pump contains unidirectional valves, a delayed-fill resistor, a locking mechanism, and a deflate pump. The control pump is small and easily concealed within a subcutaneous or dartos pouch in the scrotum or the labia. The delayed-fill resistor is responsible for automatic cuff refilling. The cuff inflation takes 3-5 minutes, although bladder emptying takes less time. A unique feature of this model is the locking mechanism that can keep the cuff deflated for a prolonged period. The locking mechanism is a small button located on the side of the control pump.
Mechanics of the AMS 800
The AMS 800 artificial urinary sphincter works on the basis of hydraulic mechanics. The isotonic fluid within the sphincter is transferred from the reservoir to the cuff and vice versa in a unidirectional fashion. When the sphincter is first activated (unlocked), the fluid from the reservoir travels down the pressure gradient to the cuff. The cuff gradually inflates to effectively close the urethra. The inflated cuff causes urine to be stored in the bladder and prevents urine loss. The device works in a semiautomatic fashion, with the cuff remaining closed at all times except when the patient opens the cuff for voiding.
To void, the patient must open the artificial sphincter. The patient manually squeezes the control pump that is located in the scrotum or the labia. When the control pump is squeezed, the fluid in the control pump is sent up to the balloon reservoir. The control pump then automatically reexpands; as it reexpands, it pulls the fluid out from the cuff, which causes the sphincter cuff to deflate. The patient repeats this maneuver 3-4 times until the pump remains flat, which indicates that the cuff is completely empty. At this point, the urine flows freely from the bladder. Urination continues until the bladder is empty. After 3-5 minutes, the fluid from the balloon reservoir automatically flows through a delayed-fill resistor within the pump and down back to the cuff. When the cuff reinflates, the urethra becomes effectively closed and the patient becomes dry.
The locking mechanism (button on the side of the control pump) allows the physician to lock the cuff in an open or closed position. Typically, the AMS 800 device is left locked (deactivated) in an open position at the time of surgical implantation to allow for adequate tissue healing and is unlocked in the physician's office 6-8 weeks after operation. If the patient inadvertently locks the button when the cuff is closed, urinary retention occurs. Conversely, if the button is locked when the cuff is open, persistent incontinence occurs. Patients should be instructed on the locking mechanism to understand and be able to respond to these problems.
Limitations of the AMS 800
Although the AMS 800 artificial urinary sphincter is an extremely reliable prosthesis that is easy to place and the patient satisfaction rate is high after successful implantation, certain limitations exist with this device despite advances in mechanical design. Mechanical malfunctions (ie, cuff leak, defective pump) and surgical problems (ie, pump migration, cuff migration, improper cuff size) require reoperation and sphincter revision. Urinary incontinence may arise from improper usage, fluid leakage, pressure atrophy, or cuff erosion. Urinary retention may occur as a result of particle obstruction or a tube kink in the system.
Silicone composition: The AMS 800 is composed of permeable silicone elastomer. Although relatively inert and resistant to body fluids, silicone deteriorates and loses tensile strength over time. Because the cuff is permeable, fluid escapes over time, with a resultant decrease in closing cuff pressure. The constant rubbing together of the 2 silicone components can lead to thinning of the silicone elastomer and exacerbate fluid leakage.
The hydraulic system: The balloon, cuff, pump, and connecting tubings are filled with iso-osmotic solution. Either isotonic sodium chloride solution or radiocontrast is used. The tonicity of the contrast is approximately 290-310 mOsm/L, which is similar to that of human intracellular and extracellular fluid. The use of hypo-osmolar or hyperosmolar fluid causes sphincter malfunction from osmotic fluid shifts.
Pressure-regulating balloon: The fluid volume of the pressure-regulating balloon regulates the cuff pressure. A typical balloon reservoir holds 20-22 mL of iso-osmotic fluid. The pressure-volume relationship of the AMS 800 device is very narrow and sigmoid-curve shaped. Small volume changes (eg, 2 mL) decrease the pressure characteristics; when the volume decreases to below 14 mL, the pressure decrease is precipitous. A common cause of postactivation incontinence is fluid loss from the pressure-regulating balloon. The patient notices that the number of squeezes to deactivate the pump has decreased or the pump does not refill and remains flat. The incidence of balloon leak responsible for sphincter malfunction has been reported to be as high as 13% in some series.
Inflatable cuff: A common problem leading to delayed or persistent incontinence is fluid loss caused by a wear defect in the cuff. The most common site of fluid leak is the lower surface of the cuff. In 1983, the inner surface of the cuff was reinforced with a layer of fluorosilicone gel to prevent friction between 2 leaflets. With this modification, the cuff leak rate decreased from 56% to 1.3%.
Connecting tubing: A short tube length may disrupt connecting junctions, causing a fluid leak or pulling up the control pump into the inguinal area, making device manipulation difficult. Excess tube length may lead to kinks, obstructing the system and causing urinary retention. Kinks are rare after 3 months of device implantation. In the past, tube kinks were the most common mechanical cause for surgical revision. With the advent of reinforced kinkproof tubing, no mechanical failures have been reported. However, tube kinks still may occur from tailoring connecting tubes to an improper length during the implant procedure.
Control pump: The control pump is cosmetically appealing because of its small size. Its small size can be a handicap, however, because some patients may have difficulty manipulating the pump. Labial or scrotal hematomas may displace the pump into an unfamiliar location. The pump may rotate upon itself and become kinked. Migration of the pump into the inguinal region may cause failure to deflate the cuff.
Locking mechanism: A major technological advancement of the AMS 800 is its locking mechanism. The disadvantage is that activating and deactivating the cuff using the locking mechanism is not always easy. The locking mechanism lacks a tactile feedback mechanism, making it difficult to tell if locking has occurred. Before locking the cuff, one must be sure that some fluid remains in the pump chamber. If the pump chamber is totally flat and empty, unlocking (activating) the cuff in the standard fashion is impossible. If this occurs, squeezing the sides of the locking button (located immediately above the pump chamber) allows the fluid to return to the pump chamber by circumventing the delayed-fill resistor.
During the informed consent, potential complications unique to placement of the AMS 800 should be discussed. Potential complications include urethral injury, bladder injury, rectal injury, mechanical failure, labial or scrotal hematoma, device infection, urinary retention, tissue atrophy, and persistent stress incontinence. The relative risk of these complications is described under Complications. Many of these complications require reoperation, and the possibility of surgical revision at a future date should therefore be discussed. In addition, patients should be cautioned that the procedure will be terminated in the event of a urethral, bladder, or rectal injury because of the risk of infection. Finally, patients should understand that they will remain incontinent during the healing process, until the device is activated 4-8 weeks after operation.
The operating room staff and surgeon should be familiar with the device, the equipment needed, and the surgical steps of the procedure. The surgeon and/or the operating room staff should observe the AMS 800 prosthesis implantation procedure before surgery.
Prophylactic broad-spectrum antibiotics (usually an aminoglycoside [eg, gentamicin] and vancomycin) should be administered. An alcohol-based preparation is preferred because it offers better control of the typical offending bacteria. Magera et al reported that patients who scrubbed preoperatively with 4% chlorhexidine were 4 times less likely to experience perineal colonization during surgery. More recently, chlorhexidine-alcohol preparation has been shown to reduce the presence of coagulase-negative Staphylococci from the surgical site better than povidine-iodine in a randomized trial.
Once the patient is in the operating room, the abdomen and genitalia are shaved. Following the shave, the area is scrubbed for 10-15 minutes. For bulbar urethra cuff placement, the patient is placed in the dorsal lithotomy position. The patient is draped for both a perineal and an abdominal incision. The use of barrier drapes reduces the risk of contamination with skin flora.
A plastic-draped Mayo stand is used as a station for handling and filling of prosthetic components. The surgical setup should include a broad-spectrum antibiotic solution for irrigation. The antibiotic solution and the filling solution should be kept separate from each other. Components should not have contact with paper or cloth drapes. Submerge the filled components in a storage basin containing sterile sodium chloride solution until they are ready for implantation.
Silicone components actively attract dust and lint. Glove powder that enters the tubing may block the pump valves. Surgeons should wash their gloves before making the tubing connections. The operative technique of placing the urethral cuff is described below (see images).
See the list below:
Balloon reservoir placement: Make a suprapubic incision. A midline or transverse incision is made. Divide the rectus fascia. Spread the linea alba to reach the prevesical space. Use blunt dissection to create a space for the balloon. Fill the balloon with 22 mL iso-osmotic filling solution, aspirate the air, and evacuate the fluid from the balloon. Clamp the tubing and position the balloon in the prevesical space. Route the tubing through the rectus fascia to the abdominal incision.
Bulbous cuff placement
- Place a 12F or 14F Foley catheter. Make a midline perineal incision. Identify the bulbocavernosus muscle. The bulbocavernosus muscle is either split in the midline or left intact according to surgeon preference. Use a combination of scissor dissection and a right-angle clamp to dissect around the bulbar urethra under direct vision. Dissect out a 2-cm plane posteriorly around the urethra to accommodate the cuff. The most common site of urethral injury during artificial urinary sphincter placement is at the 12-o'clock position, where the urethra is adherent to the septum of the corpora cavernosa. Encircle a Penrose drain around the urethra and use it as a retractor to facilitate urethral dissection. Exchange the Penrose drain for a measuring tape. The urethral measuring tape is placed around the urethra at the site where the cuff is to be implanted. The measuring tape must fit snugly but without constricting the urethra. Remove the urethral catheter before measuring the urethra.
- Select the cuff size that corresponds to the measured length. The cuff is prepared for implantation by injecting the filling solution into the cuff, aspirating all of the air, and then evacuating the fluid from the cuff. Place the cuff around the urethra. Pass the cuff, tab first, under the urethra. Snap the cuff into place. Route the cuff tubing suprapubically through a subcutaneous tunnel to the abdominal incision. If it was divided, reapproximate the bulbocavernosus muscle over the cuff followed by Colles fascia. Close the perineal incision.
- A transverse scrotal, single-incision approach has been described, with results comparable to those of the classic two-incision approach. In this operation, the transversalis fascia is pierced to place the reservoir in the paravesical space. Alternatively, an approach through the inguinal ring has been described that does not pierce the fascia, but this approach poses a risk of iatrogenic hernia. Other authors have corroborated the success of this procedure. However, in a recent comparative study, Henry et al (2008) found better overall continence rates and a lower risk of revision surgery with the classic perineal approach.
Pressurizing the system
- To pressurize the cuff, the cuff tubing and the balloon tubing are temporarily connected with a straight connector. Remove the catheter. Flush the tubing ends to remove all debris. Fill the balloon with 22 mL of iso-osmotic filling solution. Temporarily connect the cuff tubing and the balloon tubing by using a straight connector. This allows the cuff to pressurize. Wait 10-30 seconds. Clamp the cuff tubing and the balloon tubing with silicone-shod hemostats and remove the connector. Remove the hemostat and aspirate all of the remaining fluid from the balloon. Refill it with 20 mL of filling solution. Clamp the tubing with silicone-shod hemostat until the final connection is made. This 2-step filling compensates for the potential pressure atrophy.
- Some surgeons feel that pressurizing the cuff and the balloon reservoir before making the final connection is optional rather than truly necessary. Many surgeons instead opt to fill the pressure reservoir with 23 mL of isotonic sodium chloride solution (ie, 22 mL for the balloon and 1 mL for the cuff = 23 mL total) and connect the tubing after all components (ie, balloon, cuff, pump) have been implanted. By not pressurizing the cuff, the operation is simplified without compromising the efficacy of the sphincter function.
Pump implantation: To implant the control pump in the scrotum, use blunt dissection to create a dependent subdartos pouch. The control pump should be placed on the patient's hand-dominant side. From the abdominal incision, dissect out the chosen hemiscrotum for pump placement. After filling the pump with filling solution, replace it in the scrotum. Place the pump in the most dependent part of the scrotal pouch, making sure that it is palpable and the locking button faces outward. The pump tubing should be above the rectus muscle and fascia in the abdominal incision.
Connections: After the components are placed, trim the excess tubing. Connect the ends of the tubing by using the sutureless Quick connectors. Suture-tie connectors are used for revision surgeries. Connecting tubings should lie above the rectus fascia.
Checking the device: After the connections, the sphincter is cycled. The device should be cycled 2 or 3 times to ensure good mechanical function. Adequate urethral coaptation may be evaluated via retrograde perfusion sphincterometry or flexible cystoscopy, but this is optional. After confirming that the sphincter is working properly, the cuff is locked in an open position (deactivated). To deactivate the device, the pump is squeezed and released several times to empty the cuff. When the cuff has refilled so that a slight dimple is palpable, the deactivation button is pushed to lock the cuff open. Be careful not to leave the pump completely empty, as this can greatly complicate activating the device later. During the healing process, the cuff must remain locked in an open position. The abdominal incision is closed. A small Foley catheter (14F) is optional but recommended for the immediate postoperative period.
Intravenous antibiotics are continued until discharge. The Foley catheter is removed the day of or the day after the surgery according to surgeon preference. Postoperative antibiotics are prescribed at the surgeon's discretion.
Immediately after implantation, a 4- to 8-week deactivation period allows healing. The cuff is left open in a locked state. Postoperatively, the patient experiences no change in stress incontinence until the sphincter is activated. Thus, some protection must be used in the form of pads, external condom drainage, or intermittent catheterization during the healing phase.
Intermittent catheterization is not a contraindication to an artificial urinary sphincter as long as the cuff remains deflated. Those with bladder-neck cuff placement may perform self-catheterization without risk to the cuff and the underlying tissue. However, patients with bulbous urethral cuffs are at higher risk of injury from prolonged indwelling, rather than intermittent, catheterization.
The patient is instructed not to manipulate the sphincter for 6 weeks. The first postoperative clinic visit is in 1-2 weeks, at which time the abdominal and perineal incisions are inspected for skin integrity and wound infection. At 6-week follow-up, the sphincter is activated by applying a firm, forceful squeeze to the control pump. The patient is instructed on the proper use of this device by the physician, and, if available, a video presentation is shown to the patient.
All patients require direct visual demonstration of sphincter use after activation. Some patients are more adept than others in learning how to operate the pump. Improper cuff use is the most common cause of postactivation urinary incontinence. Patients experience incomplete emptying and overflow incontinence if the cuff is not opened properly. Difficulty manipulating the pump leads to inadequate cuff deflation and sphincter malfunction.
If these patients are treated in the emergency department or if they require hospitalization for a medical problem, they are instructed to inform their treating physician that they have an artificial urinary sphincter. Passage of a catheter or any other instrument through the urethra without deflating the cuff and deactivating the device first may result in sphincter injury. Many physicians and health care providers are not familiar with the artificial urinary sphincter; therefore, educating patients on how to deactivate the sphincter can be invaluable. AMS provides patients a card to carry in their wallets that identifies them as having an implanted artificial urinary sphincter.
Some surgeons advocate nighttime deactivation of the sphincter. For patients willing to wear pads or a diaper at bedtime, deactivating the sphincter overnight provides a daily period when there is no cuff pressure on the urethra. These patients may therefore reduce the risk of or delay the onset of urethral atrophy and recurrent incontinence. Other surgeons believe this approach to be ineffective and to impose unnecessary nighttime incontinence on the patient. One study comparing the two approaches demonstrated a trend toward decreased atrophy with nighttime deactivation, but the study lacked sufficient power and did not achieve statistical significance.
For excellent patient education resources, see eMedicineHealth's patient education article Cystoscopy.
See Limitations of the AMS 800 for a discussion of device-related complications.
See the list below:
Pressure-regulating balloon: The balloon reservoir is placed intra-abdominally or in an extraperitoneal prevesical space (space of Retzius). For patients with prior pelvic surgery, scars and adhesions increase the risk of bladder perforation. The intraoperative use of a catheter keeps the bladder decompressed and greatly reduces the risk of bladder injury. Iatrogenic peritoneotomy and bowel injury have been reported. If bowel injury occurs, the implantation must be abandoned.
- Inflation cuff
- Urethral injuries result from direct perforation or tissue necrosis due to thermal injury. Most urethral injuries occur at the 12-o'clock position, where the urethra is adherent to the corpus cavernosa. This is the most difficult site of dissection. Unrecognized urethral injuries result in early cuff erosion and incontinence. Bulbar placement in a prepubescent male should not be performed, because the tissues are thin and the risk of erosion is high. Cuff implantation at the bladder neck is more difficult than at the bulbar urethra. Bladder neck implantation of AUS via a robotic-assisted laparoscopic approach has been performed in a small series of adult men. This avoids the morbidity of open abdominal surgery, although long-term success rates are as of yet unclear.
- In females, a correct plane between the bladder neck and the vagina must be identified to avoid injury to the urethra, vagina, and rectum. To aid in the cuff placement, the use of a Cutter clamp and cystoscopy have been used. Some surgeons open the bladder before dissection to visualize ureteral orifices and the bladder neck. Vaginal injuries are closed primarily. If a rectal injury occurs, the procedure must be abandoned.
- Connecting tubing: The presence of particulate matter in the tubing increases the risk of sphincter malfunction. A few air bubbles entering the system are harmless because they are absorbed; however, aggregation of air bubbles into an air lock can obstruct the pump. Blood clots can also obstruct the connecting tube or the valves in the pump. Care is therefore taken to prevent entry of particulate matter into the system by flushing the air bubble or blood clot out of tubing during surgery.
- Inflation cuff
Postoperative complications can be described as mechanical or nonmechanical. The reported reoperation rate for the artificial urinary sphincter is 17-35%, with about 50% of these cases caused by mechanical complications and 50% by nonmechanical complications. Despite these reoperation rates, the success rate for secondary artificial urinary sphincter operations is high and patient satisfaction excellent.
Mechanical failure of the artificial urinary sphincter is most commonly caused by loss of fluid from the system. It can also occur because of obstruction of flow due to debris, airlock, blood, or crystallized material. Care at the time of device filling and implantation to avoid air entrapment and presence of debris can reduce the risk of several of these problems. Obstruction due to kinking is now rare because of the introduction of kink-resistant tubing in the late 1980s.
The overall life expectancy of the artificial urinary sphincter is 10 years, with a 5-year device survival rate of 75%.
See the list below:
- Because the artificial urinary sphincter is a synthetic device, it is a risk factor for bacterial infection. The overall risk of infection is reported to be 2-3% for initial artificial urinary sphincter placement.
- The most common infecting organisms are Staphylococcus epidermidis and Staphylococcus aureus. Gram-positive infections most commonly occur because of intraoperative contamination, and the gram-positive organisms are the most likely causative agents of early device infection. Late infections are more likely to be caused by gram-negative uropathogens, including Proteus species, Pseudomonas species, Escherichia coli, Serratia species, Corynebacterium, and Enterobacter species.
- Meticulous aseptic techniques must be exercised during sphincter implantation. Perioperative broad-spectrum antibiotic coverage is imperative. The use of barrier drapes reduces potential operative exposure to skin flora. Traffic in the operating room must be minimized.
- As with all implanted devices, patients should be advised that prophylactic antibiotic coverage is required for dental or other nonsterile procedures.
- The initial presenting sign of infection is usually pain, often located at the scrotal pump. Later manifestations include fluctuance, warmth, fever, and, eventually, septicemia.
- Treatment for an infected prosthesis consists of intravenous antibiotics and removal of the device.
- A rest period of 3-6 months is recommended before proceeding with a new artificial urinary sphincter placement. That said, Mulcahy and colleagues have reported a salvage procedure for a noneroded infected artificial urinary sphincter that is similar to the procedure for an infected penile prosthesis, with a reported success rate of 87%.
- A common cause of recurrent stress incontinence is loss of cuff compression due to tissue atrophy. Tissue atrophy is the most common cause of nonmechanical failure and has been reported to be the most common cause of surgical revision.
- Tissue atrophy results from local tissue ischemia around the cuff. Tissue atrophy, in turn, causes poor mucosal coaptation and incomplete urethral occlusion. Patients who were initially continent with the device complain of gradually increasing incontinence over months or even years and report having to squeeze the pump more often to deflate the cuff and void. If the cuff inflates and deflates normally but the patient remains incontinent, tissue atrophy should be suspected.
- In 1987, a narrow-backed cuff was introduced to decrease the incidence of tissue atrophy. By decreasing the width of the outer leaflet from 2 cm to 1.5 cm while maintaining the inner-leaflet dimension at 2 cm, cuff pressure transmission to the urethra was improved. This modification allowed the inner-cuff leaflet to compress a wider surface area without increasing the occlusive pressure. This new innovative design decreased the reoperation rate from 33-39% in the 1980s to 3-9% in recent series.
- Another method of retarding tissue atrophy is nocturnal deactivation of the cuff. The cuff is locked in an open position during the night when the patient is asleep. Nocturnal deactivation of the device has been reported to reduce tissue atrophy by decreasing the potential ischemia time. As previously mentioned, however, nocturnal deactivation has critics and proponents, and its benefits have not been conclusively demonstrated.
- If tissue atrophy occurs, balloon pressure can be increased to the next higher pressure (eg, from 61-70 cm water to 71-80 cm water) to increase the urethral closing pressure. Of course, a higher-pressure balloon will eventually lead to further pressure atrophy of the urethra, and most patients will eventually have some recurrent incontinence. If this fails, the cuff can be downsized to the next smaller size. Unfortunately, most men have the smallest-size cuff placed initially, so cuff-size reduction is not an option. Alternatively, the cuff site may be changed to a different area with better tissue integrity.
- A well-described approach to recurrent incontinence due to atrophy is the placement of a tandem cuff. The two cuffs are connected with a Y-connector to the remainder of the device. The tandem cuff provides 2 resistors in series and often restores continence and prolongs the life of the device. The tandem cuff is usually placed distal to the original cuff, but it can be placed proximally. The tandem cuff has had excellent results in restoring continence. Some surgeons offer double cuffs at the initial artificial urinary sphincter placement. This has been shown to improve continence rates over the single cuff, but disadvantages include increased cost, longer operative time, and, possibly, increased risk of urethral injury. In a comparison series, O'Connor et al (2008) found no statistically significant benefit between initial single-cuff and double-cuff placement but did find a higher complication rate with the latter.
- Transcorporal placement can be an effective way to manage urethral atrophy, similar to its use for cuff erosion.
- Urethral buttressing: A series of 17 men underwent AUS revision for urethral atrophy, in which the atrophied urethra was buttressed with a fibrin-coated collagen fleece to provide "bulking," with a 75% subjective success rate.
- Overactive bladder syndrome: De novo symptoms of OAB, such as urgency, frequency, nocturia, and urgency incontinence, may develop in up to 23% of patients who did not have these symptoms preoperatively. Those with preoperative OAB will have persistent symptoms in 71% of cases.
- One of the most feared complications of the artificial urinary sphincter is cuff erosion. Cuff erosion most commonly occurs within 3-4 months after surgery. Early cuff erosion suggests unrecognized injury to the bladder neck or urethra at the time of surgery. Later causes of erosion are frequently related to catheterization, but erosion may also result from periprosthetic infection or pressure necrosis. The site of erosion can be localized by urethroscopy; cuff protrusion through the urethral mucosa is unmistakably visible. The incidence of cuff erosion has been reported to be 1-3%, which has decreased since the introduction of delayed postoperative activation.
- Risk factors for cuff erosion include pelvic radiation, excessive cuff pressure, undersized cuff, and retrograde instrumentation (eg, cystoscopy, urethral catheterization) without deactivating the device. Patients who have undergone radiation have a reported erosion rate of 10-20%. The risk of erosion in patients undergoing instrumentation underscores the need for patients to inform emergency department and other physicians that they have an artificial urinary sphincter. In a retrospective study, Diokno (2006) found increased rates of erosion in patients with a history of hypertension, coronary artery disease, radiation, or a prior incidence of cuff erosion. In that study, patients undergoing revision for cuff erosion tended to have good outcomes but were at higher risk for repeat erosion.
- Efforts to minimize the incidence of cuff erosion include delayed activation, nocturnal deactivation, and use of a low-pressure reservoir. Using a balloon with a pressure of less than 71-80 cm water decreases the risk.
- Early signs of erosion include gross hematuria, burning perineal pain, perineal or scrotal swelling, swelling at the cuff site, pain at the head of the penis, or even urine leakage from the surgical wound. Erosion may also present simply as recurrent incontinence. Erosion is easily confirmed by urethroscopy. If the erosion is clean and uncomplicated, only the cuff may be removed. If purulent drainage is obvious, removal of all sphincter units is mandatory.
- Following removal of the cuff or entire device, the urethra should be stented with a catheter for 3-4 weeks to allow healing. A new cuff may be placed 3-6 months later.
- Women of childbearing age should be warned of the danger of cuff erosion during vaginal delivery. As the baby crowns through the vaginal introitus, the baby's head may compress the cuff against the pubic symphysis, risking cuff erosion. Elective cesarean delivery is advocated by some. Deactivation of the artificial urinary sphincter in the final trimester is recommended to minimize the risk of cuff erosion in this situation, and deactivation during labor is imperative.
- Transcorporal cuff placement is a relatively recent approach for managing urethral erosion. In this procedure, the cuff is placed not only around the urethra but also through a portion of the corpora cavernosa. This can be done during the initial placement in patients at high risk for cuff erosion (eg, patients who have undergone radiation therapy). Otherwise, this approach should be reserved as a salvage technique in case of erosion, impending erosion, or infection.
- A study by Bates et al conducted a systematic review and meta-analysis of artificial urinary sphincter placement after radical prostatectomy and external beam radiotherapy. The study found that men receiving radical prostatectomy and external beam radiotherapy appear at increased risk of infection/erosion and urethral atrophy, resulting in a greater risk of surgical revision compared with radical prostatectomy alone.
Troubleshooting the AMS 800
One of the most common complaints associated with the AMS 800 is persistent or recurrent stress incontinence following placement of the device. A careful history and evaluation can often reveal the problem.
History and physical examination
- A history of recent instrumentation, such as catheterization, without prior deactivation of the device suggests cuff erosion.
- If the number of pump cycles required to void increases, tissue atrophy or fluid leak should be suspected.
- Difficulty pumping the device may indicate it has been accidentally deactivated.
- If the patient never achieves continence after activation, the most common problem is too large a cuff or too small a reservoir.
- Radiographic evaluation is an important means of troubleshooting a malfunctioning sphincter if contrast is used as a filling medium. Radiography of the lower abdomen is the single most important test to obtain if contrast is used. If isotonic sodium chloride solution is used as fluid medium, radiographic evaluation does not help because silicone components are not radiopaque.
- Inflate-deflate radiographs are needed to assess the function of the sphincter. When the cuff is open, the pump and the balloon reservoir should contain some contrast, and the cuff should have none. When the cuff is closed, a doughnut-like circumferential ring of contrast should be visible at the cuff site. If the radiographic contrast is absent, a leak has occurred.
Urethral pressure profilometry: Urethral pressure profilometry is a nonradiologic test of sphincter function. Withdrawal urethral pressure profilometry should be conducted with the cuff in both inflated and deflated modes. Minimal pressure differential between 2 modes suggests sphincter malfunction.
Perfusion sphincterometry: Retrograde perfusion sphincterometry with cystoscopy is a useful test to assess the integrity of the sphincter unit. If time to inflate the cuff is longer than usual or the urethra remains open, either cuff malfunction or tissue atrophy has occurred. At the authors' institution, retrograde perfusion sphincterometry with a flexible cystoscope is performed routinely at the time of sphincter implantation.
Electrical conductance testing: Reoperation is often required to service the malfunctioning device. At the time of operation, the use of electrical conductance testing (ohmmeter) aids in identifying the faulty component and the site of the leak. Leaks at connector sites and the balloon stem are excluded first. If the ohmmeter cannot be used to identify the leak site, the pressure in the balloon reservoir can be measured by connecting the tubing to a pressure transducer or by aspirating and measuring the volume in the balloon.
Outcome and Prognosis
American Medical Systems (AMS, the manufacturer of the artificial urinary sphincter) reports the placement of over 94,000 artificial urinary sphincters in men and women. Social continence (1 pad or fewer a day) at 3-year follow-up is achieved in 75-95% of patients. The largest study of artificial urinary sphincter in the literature reports that 90% of patients have a functional artificial urinary sphincter in place at a mean follow-up of 5 years, with a 28% revision rate. The efficacy in women compares with that in men, although there are fewer studies of the efficacy of artificial urinary sphincter in women, largely because women are more often treated with bladder neck suspension and suburethral sling procedures.
A review of 344 women with intrinsic sphincter deficiency treated with an artificial urinary sphincter, followed for a mean of nearly 10 years, demonstrated complete continence in 85.6% and social continence (drops but no pad) in an additional 8.8% of patients. Revision rates and mechanical complications were similar to historical data for men.
The largest single-institution series in children demonstrates a total continence rate of 86% and a revision rate of 25%. Multiple series have supported the safety of concomitant augmentation cystoplasty in patients with intrinsic sphincteric dysfunction and small-capacity or poorly compliant bladders. Another review showed better clinical outcomes in children when the artificial urinary sphincter was implanted before puberty and when preoperative or concomitant augmentation cystoplasty was performed. However, most of these patients still require long-term clean intermittent catheterization.
In patients with neuropathic bladder dysfunction, close urodynamic follow-up is advised after artificial urinary sphincter placement, as urodynamic parameters can change profoundly over time.
The patient satisfaction rate is reported to be 85-95% and depends more on the degree of improvement than on the achievement of total continence. Success is likely in large part influenced by proper patient selection and careful patient education regarding expectations and the possible, even eventual, need for operative revisions.
Future and Controversies
Placement of the AMS 800 is an excellent surgical treatment for men, women, and children with type III stress urinary incontinence. Extremely reliable and durable, the AMS 800 has greatly improved the quality of life in patients with stress urinary incontinence.
Despite recent advances in mechanical design, certain limitations exist with this device. When mechanical malfunctions and surgical problems arise, repeat surgery is often diagnostic and therapeutic. With continued advances in biomechanical engineering, an even better artificial urinary sphincter—one that approaches the function of a biological urinary sphincter—should be forthcoming.
The presence of recurrent bladder neck contracture in combination with postprostatectomy stress incontinence is a difficult problem to treat. Recurrent bladder neck contractures are often treated with incision (direct-vision internal urethrotomy [DVIU]) or transurethral incision of the bladder neck contracture (TUIBNC) followed by implantation of an artificial urinary sphincter. Alternatively, intermittent catheterization is advocated to allow the contracture to "soften up" and stabilize over time. After the contracture has stabilized, an artificial urinary sphincter may be placed. The exact timing of sphincter placement is tailored to each individual, but at least 3 months of patency since the last procedure is generally recommended. Some encouraging results have been reported of concomitant or staged artificial urinary sphincter with stenting (UroLume stent [AMS] of the bladder neck contracture in patients with recurrent, difficult-to-treat stricture).
Ziegelmann MJ, Linder BJ, Rivera ME, Viers BR, Rangel LJ, Elliott DS. Outcomes of artificial urinary sphincter placement in octogenarians. Int J Urol. 2016 May. 23 (5):419-23. [Medline].
Lai HH, Boone TB. Implantation of artificial urinary sphincter in patients with post-prostatectomy incontinence, and preoperative overactive bladder and mixed symptoms. J Urol. 2011 Jun. 185(6):2254-9. [Medline].
Rapp DE, Reynolds WS, Lucioni A, Bales GT. Surgical technique using AdVance sling placement in the treatment of post-prostatectomy urinary incontinence. Int Braz J Urol. 2007. 33:231 - 5. [Medline].
Stoffel JT, Barrett DM. The artificial genitourinary sphincter. BJU Int. 2008 Aug 5. 102(5):644-58. [Medline].
Magera JS Jr, Inman BA, Elliott DS. Does preoperative topical antimicrobial scrub reduce positive surgical site culture rates in men undergoing artificial urinary sphincter placement?. J Urol. 2007 Oct. 178(4 Pt 1):1328-32; discussion 1332. [Medline].
Yeung LL, Grewal S, Bullock A, Lai HH, Brandes SB. A comparison of chlorhexidine-alcohol versus povidone-iodine for eliminating skin flora before genitourinary prosthetic surgery: a randomized controlled trial. J Urol. 2013 Jan. 189(1):136-40. [Medline].
Wilson SK, Delk JR 2nd. Ectopic placement of AMS 800 urinary control system pressure-regulating balloon. Urology. 2005 Jan. 65(1):167-70. [Medline].
Sotelo TM, Westney OL. Outcomes related to placing an artificial urinary sphincter using a single-incision, transverse-scrotal technique in high-risk patients. BJU Int. 2008 May. 101(9):1124-7. [Medline].
Henry GD, Graham SM, Cleves MA, Simmons CJ, Flynn B. Perineal approach for artificial urinary sphincter implantation appears to control male stress incontinence better than the transscrotal approach. J Urol. 2008 Apr. 179(4):1475-9; discussion 1479. [Medline].
Elliott DS, Boone TB. Combined stent and artificial urinary sphincter for management of severe recurrent bladder neck contracture and stress incontinence after prostatectomy: a long-term evaluation. J Urol. 2001 Feb. 165(2):413-5. [Medline].
Yates DR, Phé V, Rouprêt M, Vaessen C, Parra J, Mozer P. Robot-assisted laparoscopic artificial urinary sphincter insertion in men with neurogenic stress urinary incontinence. BJU Int. 2013 Jun. 111(7):1175-9. [Medline].
Bryan DE, Mulcahy JJ, Simmons GR. Salvage procedure for infected noneroded artificial urinary sphincters. J Urol. 2002 Dec. 168(6):2464-6. [Medline].
Elliott DS, Barrett DM, Gohma M, Boone TB. Does nocturnal deactivation of the artificial urinary sphincter lessen the risk of urethral atrophy?. Urology. 2001 Jun. 57(6):1051-4. [Medline].
Kowalczyk JJ, Spicer DL, Mulcahy JJ. Long-term experience with the double-cuff AMS 800 artificial urinary sphincter. Urology. 1996 Jun. 47(6):895-7. [Medline].
O'Connor RC, Lyon MB, Guralnick ML, Bales GT. Long-term follow-up of single versus double cuff artificial urinary sphincter insertion for the treatment of severe postprostatectomy stress urinary incontinence. Urology. 2008 Jan. 71(1):90-3. [Medline].
Margreiter M, Farr A, Sharma V, Schauer I, Klingler HC. Urethral buttressing in patients undergoing artificial urinary sphincter surgery. J Urol. 2013 May. 189(5):1777-81. [Medline].
Diokno AC. Erosions of the artificial urinary sphincter: risk factors, outcomes and management. Nat Clin Pract Urol. 2006 Nov. 3(11):580-1. [Medline].
Magera JS Jr, Elliott DS. Tandem transcorporal artificial urinary sphincter cuff salvage technique: surgical description and results. J Urol. 2007 Mar. 177(3):1015-9; discussion 1019-20. [Medline].
Bates AS, Martin RM, Terry TR. Complications following artificial urinary sphincter placement after radical prostatectomy and radiotherapy: a meta-analysis. BJU Int. 2015 Oct. 116 (4):623-33. [Medline].
Elliott DS, Barrett DM. Mayo Clinic long-term analysis of the functional durability of the AMS 800 artificial urinary sphincter: a review of 323 cases. J Urol. 1998 Apr. 159(4):1206-8. [Medline].
Thomas K, Venn SN, Mundy AR. Outcome of the artificial urinary sphincter in female patients. J Urol. 2002 Apr. 167(4):1720-2. [Medline].
Costa P, Poinas G, Ben Naoum K, Bouzoubaa K, Wagner L, Soustelle L, et al. Long-Term Results of Artificial Urinary Sphincter for Women with Type III Stress Urinary Incontinence. Eur Urol. 2012 Mar 16. [Medline].
Herndon CD, Rink RC, Shaw MB, Simmons GR, Cain MP, Kaefer M. The Indiana experience with artificial urinary sphincters in children and young adults. J Urol. 2003 Feb. 169(2):650-4; discussion 654. [Medline].
Catti M, Lortat-Jacob S, Morineau M, Lottman H. Artificial urinary sphincter in children -- voiding or emptying? An evaluation of functional results in 44 patients. J Urol. 2008. 180:690 - 3. [Medline].
Barrett DM, Furlow WL. Incontinence, intermittent self-catheterization and the artificial genitourinary sphincter. J Urol. 1984 Aug. 132(2):268-9. [Medline].
Barrett DM, O'Sullivan DC, Malizia AA, Reiman HM, Abell-Aleff PC. Particle shedding and migration from silicone genitourinary prosthetic devices. J Urol. 1991 Aug. 146(2):319-22. [Medline].
Choe JM. Freedom Regained: Female Urinary Incontinence Can Be Overcome. Columbus, Ohio: Anadem Publishing; 1999. 199-201.
Choe JM, Staskin DR. Artificial urinary sphincter: evolution and development. J Long Term Eff Med Implants. 1997. 7(1):75-100. [Medline].
DiMarco DS, Elliott DS. Tandem cuff artificial urinary sphincter as a salvage procedure following failed primary sphincter placement for the treatment of post-prostatectomy incontinence. J Urol. 2003 Oct. 170(4 Pt 1):1252-4. [Medline].
Diokno AC, Hollander JB, Alderson TP. Artificial urinary sphincter for recurrent female urinary incontinence: indications and results. J Urol. 1987 Oct. 138(4):778-80. [Medline].
Fishman IJ, Shabsigh R, Scott FB. Experience with the artificial urinary sphincter model AS800 in 148 patients. J Urol. 1989 Feb. 141(2):307-10. [Medline].
Furlow WL, Barrett DM. Recurrent or persistent urinary incontinence in patients with the artificial urinary sphincter: diagnostic considerations and management. J Urol. 1985 May. 133(5):792-5. [Medline].
Goldwasser B, Furlow WL, Barrett DM. The model AS 800 artificial urinary sphincter: Mayo Clinic experience. J Urol. 1987 Apr. 137(4):668-71. [Medline].
Gundian JC, Barrett DM, Parulkar BG. Mayo Clinic experience with use of the AMS800 artificial urinary sphincter for urinary incontinence following radical prostatectomy. J Urol. 1989 Dec. 142(6):1459-61. [Medline].
Heitz M, Olianas R, Schreiter F. [Therapy of female urinary incontinence with the AMS 800 artificial sphincter. Indications, outcome, complications and risk factors]. Urologe A. 1997 Sep. 36(5):426-31. [Medline].
Kreder KJ, Webster GD. Evaluation and management of incontinence after implantation of the artificial urinary sphincter. Urol Clin North Am. 1991 May. 18(2):375-81. [Medline].
Leo ME, Barrett DM. Success of the narrow-backed cuff design of the AMS800 artificial urinary sphincter: analysis of 144 patients. J Urol. 1993 Nov. 150(5 Pt 1):1412-4. [Medline].
Light JK, Reynolds JC. Impact of the new cuff design on reliability of the AS800 artificial urinary sphincter. J Urol. 1992 Mar. 147(3):609-11. [Medline].
Light JK, Scott FB. The artificial urinary sphincter in children. Br J Urol. 1984 Feb. 56(1):54-7. [Medline].
Marques Queimadelos A, Abascal Garcia R, Muruamendiaraz Fernandez V. [Artificial sphincter implantation in women with urinary incontinence using a combined abdomino-vaginal approach]. Arch Esp Urol. 1999 Oct. 52(8):877-80. [Medline].
Martins FE, Boyd SD. Artificial urinary sphincter in patients following major pelvic surgery and/or radiotherapy: are they less favorable candidates?. J Urol. 1995 Apr. 153(4):1188-93. [Medline].
Meulen T, Zambon JV, Janknegt RA. Treatment of anastomotic strictures and urinary incontinence after radical prostatectomy with urolume wallstent and AMS 800 artificial sphincter. J Endourol. 1999 Sep. 13(7):517-20. [Medline].
Montague DK, Angermeier KW. Artificial urinary sphincter troubleshooting. Urology. 2001 Nov. 58(5):779-82. [Medline].
O'Connor RC, Gerber GS, Avila D, Chen AA, Bales GT. Comparison of outcomes after single or DOUBLE-CUFF artificial urinary sphincter insertion. Urology. 2003 Oct. 62(4):723-6. [Medline].
Petero VG Jr, Diokno AC. Comparison of the long-term outcomes between incontinent men and women treated with artificial urinary sphincter. J Urol. 2006 Feb. 175(2):605-9. [Medline].
Raj GV, Peterson AC, Toh KL, Webster GD. Outcomes following revisions and secondary implantation of the artificial urinary sphincter. J Urol. 2005 Apr. 173(4):1242-5. [Medline].
Rose SC, Hansen ME, Webster GD. Artificial urinary sphincters: plain radiography of malfunction and complications. Radiology. 1988 Aug. 168(2):403-8. [Medline].
Saffarian A, Walsh K, Walsh IK, Stone AR. Urethral atrophy after artificial urinary sphincter placement: is cuff downsizing effective?. J Urol. 2003 Feb. 169(2):567-9. [Medline].
Salisz JA, Diokno AC. The management of injuries to the urethra, bladder or vagina encountered during difficult placement of the artificial urinary sphincter in the female patient. J Urol. 1992 Nov. 148(5):1528-30. [Medline].
Scott FB, Bradley WE, Timm GW. Treatment of urinary incontinence by implantable prosthetic sphincter. Urology. 1973 Mar. 1(3):252-9. [Medline].
Shires GT, Canizaro PC. Fluid, Electrolyte, and Nutritional Management of the Surgical Patient. Schwartz SI, Lillehei RC, Shires GT, et al, eds. Principles of Surgery. 2nd ed. New York, NY: McGraw-Hill; 1974. 65.
Smith JJ, Barrett DM. Implantation of the artificial genitourinary sphincter. Walsh PC, ed. Campbell's Urology. 8th ed. Philadelphia, Pa: Elsevier Science; 2002. 1187-94.
Tse V, Stone AR. Incontinence after prostatectomy: the artificial urinary sphincter. BJU Int. 2003 Dec. 92(9):886-9. [Medline].
Webster GD, Guralnick ML. The neurourologic evaluation. Walsh PC, ed. Campbell's Urology. 8th ed. Philadelphia, Pa: Elsevier Science; 2002. 900-30.
Webster GD, Sherman ND. Management of male incontinence following artificial urinary sphincter failure. Curr Opin Urol. 2005 Nov. 15(6):386-90. [Medline].
Webster GD, Sihelnik SA. Troubleshooting the malfunctioning Scott artificial urinary sphincter. J Urol. 1984 Feb. 131(2):269-72. [Medline].