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continuing_education_activitystatpearls· Continuing Education Activity· item NBK597382

Urinary incontinence after radical prostatectomy for prostate cancer is a common occurrence that can significantly increase patient distress and decrease their quality of life. The most significant contributing factor to postoperative stress incontinence is damage to the external urethral sphincter. While initial treatment of urinary continence comprises pelvic floor physical therapy, lifestyle changes, and medication, surgical intervention may be the best option for patients with refractory, severe, or debilitating urinary incontinence. The two most commonly performed surgical procedures for post-prostatectomy urinary incontinence are the placement of an artificial urinary sphincter (AUS) or a dual-balloon adjustable continence therapy (DBACT) device. This activity reviews the pertinent guidelines, relevant anatomy and physiology, indications, contraindications, complications, and surgical techniques used in placing these devices and highlights the role of the interprofessional team in caring for patients with post-prostatectomy urinary incontinence. Objectives: Assess patients for clinical factors that increase the risk of developing urinary incontinence following prostate surgery and apply management strategies to mitigate these factors. Identify patients who may benefit from surgical treatment of urinary incontinence with a prosthetic device based on their clinical history and physical examination. Apply best practices when surgically treating urinary incontinence with a prosthetic device. Develop and effectively implement interprofessional team strategies to improve functional outcomes for patients with urinary incontinence following prostate surgery. Access free multiple choice questions on this topic.

introductionstatpearls· Introduction· item NBK597382

Guidelines from the American Urological Association (AUA) indicate that patients with persistent or severe urinary incontinence may benefit from surgical intervention.[1] 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.[2] The primary etiology of post-prostatectomy urinary incontinence is damage or injury to the external urethral sphincter with resulting intrinsic sphincteric deficiency.[3] Incontinence symptoms can improve with postoperative pelvic floor physical therapy and lifestyle changes; most improvements are seen within 1 to 2 years following surgery.[4][5][6] A study reported that 8.4% of men still experienced severe incontinence 18 months after surgery.[7] 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.[1] Artificial Urinary Sphincter 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.[8][9][10] The AUS is an active system comprising an occlusive constricting cuff, a control pump, and a pressure-regulating balloon reservoir.[9][10] 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.[11] After voiding, the compression cuff automatically refills within 3 to 5 minutes to restore cuff compression and continence.

introductionstatpearls· Introduction· item NBK597382

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.[11] 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 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.[12] These balloons increase passive urethral compression and improve bladder outlet resistance.[11] 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.[12] 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.

complicationsstatpearls· Complications· item NBK597382

Artificial Urinary Sphincter The most common intraoperative complication of AUS placement is urethral injury. While some surgeons choose to repair the injury and proceed with AUS placement immediately, it is generally recommended to repair the urethra and abort the AUS procedure to allow for urethral healing. Intraoperative urethral injuries are most likely to occur at the 12 o'clock position, where the urethra is fixed to the corpus cavernosum. Injuries can occur from direct contact, crushing injury, instrumental perforation, or thermal damage from cautery. If such an injury is not recognized, early cuff erosion and urethral tissue necrosis are likely. If intraoperative urethral injury occurs, another attempt at AUS implantation can be made at a later date; the recommended waiting period is 3 months. Previous pelvic surgery or radiation, scarring, and adhesions will all increase the risk of bladder perforation. This risk is minimized by continuous intraoperative drainage with a Foley catheter. An initial transcorporal implantation has been suggested for use in these higher-risk patients to minimize complications.[51] Concomitant radical prostatectomy and radiation therapy significantly increase the risks of erosions, infections, persistent urinary incontinence, and urethral atrophy.[52] Inadvertent peritoneal entry and bowel injuries have been reported. A bowel perforation would require an immediate repair and abandoning the artificial sphincter implantation procedure. A critical point in female AUS placement is creating the proper plane between the bladder neck and vagina, as an injury may otherwise occur to immediately adjacent structures. Cystoscopy and a Cutter clamp have been used to assist in the dissection, and some surgeons will even open the bladder for better visualization of the ureteral orifices and bladder neck. An inadvertent vaginal perforation can be immediately closed, but a rectal injury requires abandonment of the procedure.

complicationsstatpearls· Complications· item NBK597382

A critical point in female AUS placement is creating the proper plane between the bladder neck and vagina, as an injury may otherwise occur to immediately adjacent structures. Cystoscopy and a Cutter clamp have been used to assist in the dissection, and some surgeons will even open the bladder for better visualization of the ureteral orifices and bladder neck. An inadvertent vaginal perforation can be immediately closed, but a rectal injury requires abandonment of the procedure. The most common postoperative complications of AUS placement are loss of fluid from the device, urethral tissue atrophy, erosion, infection, the need for additional surgery, no change in the quality of life, and continued lower urinary tract symptoms, such as stress or urge urinary incontinence, frequency, and nocturia.[14][53] Gross hematuria, dysuria, and difficulty urinating are all potential symptoms of infection, device erosion, or malfunction. Urinary retention in the first 24 hours after AUS placement can be managed with a Foley catheter. If the retention lasts more than 48 hours, a suprapubic catheter can be placed to facilitate bladder drainage. If the retention persists, the urethral cuff may be too small and require revision. Postoperative infection rates vary between 2% and 3% and are increased in patients with a history of pelvic radiation. The most common pathogens are Staphylococcus aureus and Streptococcus epidermidis. The AUA recommends prophylactic antibiotic therapy with vancomycin to mitigate this risk. If patients develop signs of infection, immediate removal of the device is required. Signs of infection include pain at the pump site, erythema, edema, and purulent discharge. Urethral tissue atrophy is the most common cause of recurrent incontinence due to the loss of cuff compression functionality requiring surgical revision. This atrophy is generally from chronic tissue compression and ischemia, resulting in urethral thinning with a loss of mucosal coaptation and subsequent leakage. These processes occur over a long period, and patients report that the sphincter works properly but no longer provides continence. Tissue atrophy should be suspected in this clinical scenario.

complicationsstatpearls· Complications· item NBK597382

Urethral tissue atrophy is the most common cause of recurrent incontinence due to the loss of cuff compression functionality requiring surgical revision. This atrophy is generally from chronic tissue compression and ischemia, resulting in urethral thinning with a loss of mucosal coaptation and subsequent leakage. These processes occur over a long period, and patients report that the sphincter works properly but no longer provides continence. Tissue atrophy should be suspected in this clinical scenario. Using a narrowed outer band to the cuff has helped reduce the occurrence of urethral tissue atrophy to less than 10%. Deactivation of the AUS device overnight has also been suggested to minimize compressive ischemia of the urethra, but there is no current evidence of any definitive benefit. The obligatory nighttime incontinence with cuff deactivation is bothersome to patients, and the adoption of this technique remains controversial.[50] Treatment of urethral atrophy includes the use of tandem dual cuff implants, transcorporal cuff placement, transposition or movement of the cuff to an alternate urethral site, urethral bulking with fibrin-coated collagen fleece, changing to a higher pressure reservoir, and cuff downsizing.[54][55][56][57][58][59][60] Using a higher pressure will help temporarily, but this is likely to lead to further tissue atrophy and a recurrence of incontinence. Switching to a smaller cuff size can also be helpful, but as most men already use a small size, this may not be possible.[61] Moving the cuff to a healthier urethral location or using dual tandem cuffs are usually the best corrective choices.[58][59][60] However, the initial placement of dual tandem cuffs is not recommended as it extends operative time and increases the complication rate fourfold.[62][63]

complicationsstatpearls· Complications· item NBK597382

Treatment of urethral atrophy includes the use of tandem dual cuff implants, transcorporal cuff placement, transposition or movement of the cuff to an alternate urethral site, urethral bulking with fibrin-coated collagen fleece, changing to a higher pressure reservoir, and cuff downsizing.[54][55][56][57][58][59][60] Using a higher pressure will help temporarily, but this is likely to lead to further tissue atrophy and a recurrence of incontinence. Switching to a smaller cuff size can also be helpful, but as most men already use a small size, this may not be possible.[61] Moving the cuff to a healthier urethral location or using dual tandem cuffs are usually the best corrective choices.[58][59][60] However, the initial placement of dual tandem cuffs is not recommended as it extends operative time and increases the complication rate fourfold.[62][63] If device erosion occurs, infection of the device is assumed. A Foley catheter should be placed, and the device should be removed. A rest and recovery period of at least 3 months is recommended before device replacement. The urethra should be carefully evaluated before a second AUS placement. While there is a significant risk of urethral stricture development following device erosion, this is usually associated with a prior history of radiation therapy; cuff erosion is approximately 50% more common in men with a history of pelvic radiation.[64] Signs of cuff erosion include obstructive urinary symptoms, worsening incontinence, and scrotal inflammation characterized by redness, swelling, and tenderness.[65] There is evidence that patients with low testosterone levels have a threefold risk of AUS erosions.[66][67] Overall, the long-term AUS reoperation rate approaches 20%. Troubleshooting the Artificial Urinary Sphincter If the patient finds that the device is not working after placement, a physical examination is required; imaging may be necessary. It is recommended to work through the following steps when troubleshooting an AUS. If the patient never achieves continence after AUS activation, the most common causes are either the implanted cuff is too large or the reservoir has insufficient pressure.

complicationsstatpearls· Complications· item NBK597382

If the patient finds that the device is not working after placement, a physical examination is required; imaging may be necessary. It is recommended to work through the following steps when troubleshooting an AUS. If the patient never achieves continence after AUS activation, the most common causes are either the implanted cuff is too large or the reservoir has insufficient pressure. The first recommended step is an assessment of the scrotal pump. If palpation of the scrotal pump reveals a dimple in the pump, the pump is deactivated in the open position. Resolve this by giving the pump a deliberate compression to open the valve mechanism within the pump itself. If the maneuver is successful, the pump will activate, and the sphincter will fill. The pump should inflate, and the palpable dimple should disappear. If the patient reports they cannot pump the device and there is no dimple, the pump may be inactivated in the closed position. The solution to this scenario requires the same maneuver: deliberately squeeze the pump, and the pump should automatically cycle. If the patient cannot pump the device and physical examination reveals the pump is entirely flat, this could be due to one of two scenarios: either the pump is completely deactivated in the closed position with all of the fluid in the pressure-regulating balloon or there is no fluid in the system due to a leak. If the patient has difficulty pumping the device, it may have become deactivated. If the number of pump compressions required to allow voiding increases, urethral tissue atrophy or a fluid leak is likely. There are two options to resolve this situation. The first option is to press down on the deactivation button for a few minutes to allow some fluid to leak from the pressure-regulating balloon into the pump and allow for a switch of the valve into the open position. The second option is to use a very narrow instrument, such as the tip of a hemostat or the back of a cotton-tipped applicator, to manually push the piston open on the exact opposite side of the deactivation button. To accomplish this, bring the pump up against the scrotal skin. Patients may require a local anesthetic due to the sensitivity of this area.

complicationsstatpearls· Complications· item NBK597382

There are two options to resolve this situation. The first option is to press down on the deactivation button for a few minutes to allow some fluid to leak from the pressure-regulating balloon into the pump and allow for a switch of the valve into the open position. The second option is to use a very narrow instrument, such as the tip of a hemostat or the back of a cotton-tipped applicator, to manually push the piston open on the exact opposite side of the deactivation button. To accomplish this, bring the pump up against the scrotal skin. Patients may require a local anesthetic due to the sensitivity of this area. If the device remains nonoperational after troubleshooting, a cystoscopy is recommended to assess the cuff. If properly implanted, a closed cuff will have a starfish-shaped appearance. If the cuff appears closed, more fluid needs to go into the pump, or the piston needs to be opened. If the cuff is open, there is most likely a leak in the system. In the case of a leak in the system, the entire system needs to be replaced. If the patient reports difficulty urinating despite being able to open the cuff, has recurrent urinary tract infections, or physical examination reveals a new thickening over the pump, cystoscopic evaluation is required to evaluate for possible urethral erosion. This cystoscopy should be performed with the cuff in the open and deactivated position. If the cuff is eroded, a Foley catheter should be placed until the mucosa has healed. The AUS is made of a silicone elastomer that is somewhat permeable and tends to deteriorate slowly over time. It is expected that the cuff will gradually lose closing pressure as fluid escapes. To minimize osmotic fluid shifts into or out of the AUS device, only iso-osmolar filling solutions should be used. The reservoir typically holds 20 to 22 mL of filling solution. If the volume falls below 14 mL, the pressure drops dramatically. In this scenario, the patient would require more pump squeezes to open the cuff. Balloon leaks have been reported to occur in up to 13% of patients. However, the cuff may also thin and lose fluid from usage. This is most often noted on the lower cuff surface. Starting in 1983, additional reinforcement of fluorosilicone gel was added to the lower cuff surface, dramatically decreasing the cuff leak rate to a reported 1.3%.

complicationsstatpearls· Complications· item NBK597382

The AUS is made of a silicone elastomer that is somewhat permeable and tends to deteriorate slowly over time. It is expected that the cuff will gradually lose closing pressure as fluid escapes. To minimize osmotic fluid shifts into or out of the AUS device, only iso-osmolar filling solutions should be used. The reservoir typically holds 20 to 22 mL of filling solution. If the volume falls below 14 mL, the pressure drops dramatically. In this scenario, the patient would require more pump squeezes to open the cuff. Balloon leaks have been reported to occur in up to 13% of patients. However, the cuff may also thin and lose fluid from usage. This is most often noted on the lower cuff surface. Starting in 1983, additional reinforcement of fluorosilicone gel was added to the lower cuff surface, dramatically decreasing the cuff leak rate to a reported 1.3%. A tube length that is too short can pull apart connections or cause pump migrations. However, a tube that is too long may develop kinks that can impair regular device operation. Using kinkproof tubing has dramatically reduced this complication, especially after 3 months postimplantation of the device. The pump mechanism is small, which can make its operation more difficult. The pump mechanism may also rotate, twist, or migrate into the groin, further complicating its usage. The locking mechanism does not have tactile feedback, and it can be challenging to determine if the mechanism is open or locked. Some fluid must be in the pump to activate or unlock the device. Compression on both sides of the locking button will allow some fluid to return to the pump and bypass the delayed-refill resistor mechanism. Radiographic studies can be a useful diagnostic tool if contrast was initially used as a filling fluid. When inactive or open, contrast should be visible in the pump and the reservoir but not in the cuff. When active or closed, a ring of contrast should be visible at the cuff site. If no contrast is visible, there is a leak. A urethral pressure profile can be done with the cuff in active and inactive positions. A minimal change in the readings indicates a sphincteric malfunction. Retrograde perfusion sphincterometry with cystoscopy and electrical conductance testing can also help determine if the device is leaking. Dual-Balloon Adjustable Continence Therapy Device

complicationsstatpearls· Complications· item NBK597382

A urethral pressure profile can be done with the cuff in active and inactive positions. A minimal change in the readings indicates a sphincteric malfunction. Retrograde perfusion sphincterometry with cystoscopy and electrical conductance testing can also help determine if the device is leaking. Dual-Balloon Adjustable Continence Therapy Device Bladder or urethral perforation is the most common intraoperative complication of DBACT placement, although other urethral injuries may occur. Acute urinary retention may be encountered and is managed by removing fluid volume from implanted balloons, with or without urethral catheterization. Device migration or erosion can also occur. Migration of the device can be due to poor initial positioning or excessive initial inflation.[24][68] Device removal usually resolves all long-term complications. Patients may undergo device reimplantation or receive more invasive treatment at a later date.[24] Troubleshooting the Dual-Balloon Adjustable Continence Therapy Device If the patient is suddenly unable to urinate, after either being able to urinate or having continued incontinence with the DBACT in place, a cystoscopy is required to assess for the erosion of one or both balloons into the urethra. If erosion is present, the eroded balloon(s) should be deflated and removed. This can be done in the office by administering appropriate analgesia over the port, deflating the balloon, and pulling the device out. A Foley catheter should be placed for several weeks to allow mucosal healing. In situations of continued incontinence, a 5 mL adjustment in balloon volume should be made. If the incontinence does not improve, imaging is required. Pelvic radiography or computed tomography should be performed to assess balloon position and volume, as there may be leakage. The balloons should appear identical in position and inflation. If this is not the case, a balloon may be leaking, moved out of position, or the original placement may not have been optimal. If the balloon position is adequate, more fluid volume can be added. If there is urethral displacement towards only one side, volume needs to be added to only one balloon. However, if the balloons are completely misaligned, the balloons can be removed in the office and replaced later in the operating room.

enhancing_healthcare_team_outcomesstatpearls· Enhancing Healthcare Team Outcomes· item NBK597382

Artificial urinary sphincters and dual-balloon adjustable continence therapy are surgical treatment options employing prosthetic implants for significant stress urinary incontinence due to intrinsic sphincter deficiency, not amenable or responsive to alternative treatments. Patients must be appropriately counseled on the indications, risks, and potential reasonable surgery outcomes. Patients should be informed that prophylactic antibiotics will be needed for future dental and other surgical procedures due to the implanted device. Communication between healthcare team members helps with the multifaceted approach to care from the preoperative to the postoperative setting and improves patient outcomes.[88] Many patients undergoing surgical treatment for urinary incontinence utilize medications for symptom mitigation at some point during their treatment, have nurse visits in the clinic, and require preoperative counseling from anesthesiology providers. Collaboration on shared goals with nurses, pharmacists, surgeons, and other team members contributes to optimal patient outcomes. When a patient seeks care in an emergency department or healthcare facility for any reason, all personnel they encounter must be informed of the presence of the prosthetic implant. This is particularly true for the AUS. Any attempt to pass a Foley catheter without cuff deflation and deactivation could result in significant urethral injury or sphincter damage.