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

Anatomy and Physiology

Urinary continence in phenotypic males is achieved through 2 smooth muscle sphincters, the bladder neck or internal sphincter and passive prostatic sphincter, and 3 striated muscle sphincters: the prostatic, membranous urethral, and periurethral striated sphincters.[13] The prostate helps maintain the shape of the bladder neck and the internal sphincter for urinary continence.

The periurethral striated sphincter allows for voluntary urinary control and is somatically innervated. While the pathophysiology of post-prostatectomy urinary incontinence is multifactorial, a commonly attributed etiology is sustained damage to the external urethral sphincter during the dissection and division of the distal prostatic urethra, resulting in an intrinsic sphincteric deficiency.[13][14][15]

Intraoperative factors during radical prostatectomy that increase the risk of developing postoperative urinary incontinence are extensive surgical dissection and damage to the neurovascular bundle. Male urinary continence is maintained by the actions of the detrusor muscle, proximal intrinsic sphincter, rhabdosphincter, and pubourethral ligaments. 

Radical prostatectomy removes the internal urethral sphincter, pubourethral ligaments, and part of the proximal urethral sphincter. The periurethral striated sphincter is mainly responsible for maintaining continence after prostatectomy. However, the action of the periurethral striated sphincter is also compromised by radical prostatectomy as the procedure damages the supplying neurovascular bundle.[16] The change in anatomic structure, interruption of innervation, and removal of supportive structures that contribute to preoperative urinary continence are all factors in post-prostatectomy urinary incontinence. The development of postoperative fibrosis is also a contributing factor.

Patient-related factors influencing post-prostatectomy urinary incontinence include age, diabetes mellitus, abnormal preoperative bladder function, and previously existing urinary incontinence.[11] Body mass index and patient lifestyle factors are currently being investigated as potential preoperative risk factors for developing post-prostatectomy urinary incontinence.[11]

Radiation therapy can negatively impact urinary continence, as the bladder and rectum often fall within the treatment field. Radiation damage results in chronic tissue inflammation, vascular insults, scar tissue formation, abnormal cell proliferation, and radiation cystitis. These changes can result in detrusor overactivity and urge urinary incontinence.[17] While prior radiation exposure can contribute to post-prostatectomy urinary incontinence, current prosthetic interventions are not intended to treat radiation-induced incontinence specifically.[18] Any use of these devices in patients with post-radiation urinary incontinence is considered off-label therapy; the implantation of these devices was not studied or approved for post-radiation incontinence.

Patients who undergo pelvic radiation therapy after prostatectomy have substantially lower continence rates with an AUS than similar patients who did not get radiotherapy.[19] Studies have demonstrated that radiotherapy was associated with significantly lower complete continence rates in all AUS patients, particularly primary AUS patients, and repeat implantation of an AUS was associated with poorer continence outcomes than primary AUS implantation.[18][19] Patients with a history of radiation therapy had similar rates of AUS device survival compared to nonirradiated patients if the final cuff size was at least 3.5 cm.[20]

Indications

The indication for an AUS is significant and bothersome urinary incontinence due to intrinsic sphincteric deficiency, often following prostate surgery, in patients who have failed to respond adequately to more conservative measures.[21][22] Careful patient selection is critical to the ultimate success of the AUS. Patients must be sufficiently motivated and capable of performing intermittent self-catheterization if required. Patients must also be willing, motivated, mentally competent, and physically able to find and operate the pump mechanism reliably. Advanced age is not a contraindication to AUS placement; patients more than 80 years of age have higher rates of infection and erosion but are still reasonable candidates for AUS implantation.[23]

The indication for a DBACT is stress incontinence arising from intrinsic sphincteric deficiency of at least 12 months duration following radical prostatectomy or transurethral resection of the prostate in patients who have failed to respond adequately to conservative therapy.[24]

Other causes of significant intrinsic sphincteric deficiency sufficient to justify surgical continence device implantation may include pelvic fractures, spinal cord injuries, posturethral reconstructions, neurogenic bladders with incompetent sphincter function, and failure of multiple previous continence procedures.

Contraindications

Absolute contraindications for AUS and DBACT therapy include patients who cannot tolerate anesthesia or possible surgical complications. A previously placed urethral sling is not a contraindication for either procedure.

The major contraindication to the AUS is an inability to operate the mechanical components due to cognitive dysfunction or poor manual dexterity.[1][25] Minor contraindications include patients with incontinence due to lower urinary tract obstruction, detrusor hyperreflexia, or bladder instability. The AUS is also contraindicated in patients with allergies to antibiotics, where the urinary tract cannot be made sterile, with active urinary tract infections, recurrent symptomatic or progressive urethral strictures, high post-void residual urine volumes, and a small bladder capacity.[22]

Significant vesicoureteral reflux should be surgically corrected before AUS placement to avoid reflux exacerbation. Recurrent nephrolithiasis and urothelial bladder tumors where regular cystoscopic instrumentation is expected are considered a relative contraindication as they increase the risk of cuff erosions in AUS patients.[22] Bladder neck contractures should be repaired and cystoscopically verified as permanently corrected at least 3 months post-correction before proceeding to AUS placement.[22]

Relative contraindications to DBACT include severe incontinence, a history of previous radiation therapy or planned radiation within 6 months of DBACT placement, and neurogenic stress urinary incontinence.[18][24] Other contraindications include an active urinary tract infection, incontinence due to detrusor instability or overactivity, reduced bladder compliance, post-void residual urine volumes >100 mL, significant urge incontinence, or uncorrected bleeding disorders.

Equipment

Artificial Urinary Sphincter 

The equipment for AUS placement typically includes:[26]

• 3-0 nonabsorbable polypropylene ties
• 10- and 30-mL disposable syringes
• 500- and 1000-mL graduated containers
• Absorbable suture for closure
• Antibiotic solution
• Artificial urinary sphincter kit with quick connect assembly tool and tubing passers
• Babcock clamps
• Catheters
• Contrast solution
• Dry skin dressings
• Electrocautery (monopolar or bipolar)
• Hegar dilators
• Mayo and Metzembaum scissors
• Penrose drain or vessel loop
• Retractors
• Right-angle clamps
• Rubber-shod hemostats for clamping tubing
• Sponge bowl and basin
• Sterile normal saline
• Umbilical tape

Dual-Balloon Adjustable Continence Therapy 

The equipment for DBACT placement typically includes:[27]

• 3-0 polyglycol absorbable suture
• 4-0 poliglecaprone skin suture
• 10-mL syringe
• 15- or 11-blade scalpel
• 50-mL Luer lock syringe
• Adjustable continence device kit 
• Adson forceps
• Allis clamp
• Antibiotic irrigation
• C-arm fluoroscopy system
• Dry skin dressings
• Metzenbaum scissors
• Rigid cystoscopy set
• Rubber-shod forceps
• Solution of contrast and sterile water
• Sterile bin or basin
• Sterile lubricating gel
• Sterile normal saline
• Sterile water
• Urology surgical instrument set

Personnel

Personnel for incontinence procedures typically include:

• Primary urologic surgeon
• Anesthesia provider
• Circulator or operating room nurse
• Surgical technologist or operating room nurse
• Radiology technician (if image capture is required)

Preparation

Before the surgical intervention, all patients should undergo a thorough investigation of their urinary incontinence. This investigation should include a comprehensive medical history, physical examination, completion of voiding diaries, and any other necessary testing, such as urodynamics or video-urodynamics.[1] A preoperative urine culture should be performed before DBACT and AUS placement. If the culture is positive, preoperative antibiotic treatment and complete eradication of the infection is imperative.

For AUS and DBACT placement, patients should undergo cystoscopy to evaluate the urethra and rule out strictures, bladder neck contractures, or any other anatomic abnormality. All patients should receive prophylactic antibiotics before the procedure.

Silicone readily attracts dust and lint; all device components should be submerged in basins with sterile saline until used. Extra care should be taken to rinse surgical gloves of any particulates or powder before use.

Artificial Urinary Sphincter

AUS placement through the perineum is the preferred approach and the method described here.[28][29][30][31] However, some studies suggest equivalent outcomes with the technically easier penoscrotal approach.[32][33][34][35] 

Implantation is typically performed at the bulbar urethra but can also be done at the bladder neck, albeit with some added difficulty. The bladder neck is theoretically the superior location for a compression cuff as there is thick, muscular, well-vascularized tissue in this area. However, following prostate surgery or radiation, the area surrounding the bladder neck becomes scarred, fibrous, and fixed to the surrounding structures, with a somewhat compromised blood supply leading to poorer healing.[9][10] Therefore, the bulbous urethra is usually chosen for cuff placement in men.[10]

Bladder neck implantation using a robotic-assisted laparoscopic approach to eliminate the morbidity associated with laparotomy has been reported for men and women. This approach is preferred in women where bladder neck placement of the AUS is required.[36][37][38][39][40][41][42]

The patient should be placed in the dorsal lithotomy position with appropriate padding of bony prominences and pressure points. The dorsal lithotomy position is preferred for AUS placement at the proximal bulbar urethra; this is the most common placement in cases of post-prostatectomy incontinence. Hair should be removed from the perineum to the infra-umbilical abdomen, and this area should be cleansed with chlorhexidine for 10 minutes with or without the addition of alcohol-based chlorhexidine.[43][44][45]

A 14F catheter should be placed for urine drainage and urethra identification. The scrotum should be elevated for ease of perineal access. The anus should be excluded from the field by draping. Sterile draping should allow for cystoscopy using a one-step cystoscopy draping set.

To prepare the device, place both tubing sets in a saline basin or basin of diluted contrast as per surgeon preference while holding the control pump. Using isotonic contrast fluid to facilitate identifying device leakage has been suggested and does not appear to affect device function, malfunction rate, the incidence of fluid leaks, or the incidence of reoperations.[46] Contrast should not be used in patients with a known allergy. The chosen fluid should be iso-osmolar to avoid fluid shifts. Fill the pump with fluid by holding it at a 45° angle and cycling through squeezing and releasing until all contained air has been replaced with fluid. While submerged, lightly clamp the tubing 4 to 5 cm from its end using a rubber-shod hemostat. Place the control pump in an empty sterile basin. 

To prepare the pressure-regulating balloon, prepare a 30-mL syringe with 25 mL of filling solution and attach a 15-gauge blunt needle. Manually deflate the balloon and then fill it with 20 mL of the filling solution via the balloon tubing. Ensure all bubbles have been removed, clamp with a rubber-shod hemostat, and place into the antibiotic basin.

Once the cuff size is known (see Technique below), the cuff is similarly prepared with 5 to 10 mL of filling solution in the syringe; the size of the cuff selected dictates the total volume. Remove all bubbles, lightly clamp the tubing with a rubber-shod clamp, and place it in a dry sterile bin.[26] Do not place the rubber-shod clamp at the tip of the tubing; allow enough length for future placement of the metal tunneling device. 

Dual-Balloon Adjustable Continence Therapy

The patient should be placed in the dorsal lithotomy position with appropriate padding of bony prominences and pressure points. Hair should be removed from the perineum. The perineum, penis, and surrounding area should be cleansed with chlorhexidine scrub. Although the instructions for use provided by the manufacturer state to use betadine, betadine is not the current standard of skin preparation for prosthetic urologic surgery, and this instruction should be ignored.[43][44][45] Contrast should not be used for balloon filling in patients with a known allergy.

Sterile draping should accommodate cystoscopy followed by device placement. The scrotum should be elevated to facilitate access to the perineum, and the anus should be excluded from the field with sterile towels.

Technique or Treatment

Artificial Urinary Sphincter Placement

Perform a vertical midline perineal incision with a scalpel into the skin overlying the bulbospongiosus muscle. Using a combination of blunt and sharp dissection and electrocautery, dissect the subcutaneous fat and tissues surrounding the urethra. Use handheld or self-retaining retractors to aid in dissection.

After exposing the spongiosum muscle overlying the bulbar urethra, identify the corporal bodies to assist urethral dissection. Utilize sharp dissection to divide the spongiosum muscle vertically, exposing the bulbar urethra. Continue to use retractors to expose the urethra. Once the urethra is thoroughly dissected, use a right-angle clamp to pass a Penrose drain or a vessel loop around the urethra. The vessel loop is used while mobilizing the urethra so that a space large enough for the cuff can be created as close to the crura as possible. For reference, the cuffs are approximately 1.8 cm when deflated.

The cuff sizer, when placed, should lay flat around the urethra, confirming adequate dissection. Wrap the cuff sizer around the urethra and measure the circumference. Sizes range from 3.5 to 11 cm in half-centimeter increments. The 4 cm cuff is used most often in men. A cuff measuring 6 to 8 cm is most commonly selected for women and is placed at the bladder neck.

Prepare the appropriate size cuff as described above. Grasp the tab of the cuff with a right-angle clamp. The implant should be placed with the mesh backing facing the outside and the inflatable side facing the urethra. Pass the cuff tubing through the hole in the mesh with a right-angle clamp, locking the system around the urethra and ensuring that the mesh locking mechanism is seated securely until the tab can be pulled over the tubing adapter.

Balloon reservoirs are available in 5 ranges of water pressure measured in centimeters of water (cm H₂O). Available ranges are 41 to 50, 51 to 60, 61 to 70, 71 to 80, and 81 to 90 cm H₂O. Selection of the reservoir pressure is based on the lowest pressure necessary for urethral closure; this is most commonly either 51 to 60 or 61 to 70 cm H₂O.

The pressure-regulating balloon is most commonly placed on the same side as the pump through a separate transverse inguinal incision above the pubic bone lateral to the midline. Dissect down to fascia with sharp dissection and electrocautery with the help of handheld retractors. Identify the external oblique or rectus fascia. Place 2 transverse 2-0 polydioxanone sutures, one placed superiorly on the fascia and the other inferiorly to delineate where the transverse incision will be and to use for future incision closure. Make a small transverse incision between the two sutures with a 15-blade scalpel.

Bluntly spread the muscle to create a finger-sized space large enough for the balloon in the preperitoneal or retropubic space. Seat the balloon in the pocket using your finger. Fill the balloon using the blunt-tipped syringe according to the cuff size to reach the desired cuff pressure based on manufacturing guidelines. Connect the tubing using the rubber-shod hemostats. Close the fascia with the previously placed polydioxanone sutures.

The scrotal pump can be inserted through a scrotal incision or tunneled to the scrotum from the abdomen. Make a pocket in the subdartos area using blunt dissection and ring forceps. This dissection can be facilitated by manually inverting the scrotum into the incision and creating the pocket over the finger. This pocket should be away from the testis and easily palpable as well as accessible for the patient.

Once an adequate pocket has been created, place the pump into the pocket with the deactivation button facing the skin and seat it into the scrotum. At this point, 2 tubing sets should come out of the transverse incision, one for the pump and one for the pressure-regulating balloon reservoir.

There should also be a set of tubing coming out of the perineal incision with a shod clamp on it that is connected to the cuff. Connect the metal tunneling device to the tubing going to the cuff and tunnel subcutaneously from the perineal incision to the transverse incision.

The connection tubing should now be placed close to the pubic bone but deep enough in the subcutaneous tissue to minimize patient discomfort. Once the tunneling is complete, re-shod the tubing that goes to the cuff and remove the perineal tubing shod. All shods should be placed proximal enough so there is room for fingers and the stainless steel quick-connect assembly tool.

The pump has two sets of tubing emerging from it; one clear and the other black. The black tubing connects to the balloon reservoir, and the clear tubing connects to the cuff. Once the connections have been estimated, trim any excess tubing to maximize patient comfort. To connect the tubing, place the collet holder into the tubing; the collet holder has several collets on it.

Slide a collet onto the tubing with the teeth of the collet facing toward the open tubing end. Repeat this action twice for each side that will be connected. Using a 22-gauge needle attached to a 10-mL syringe filled with filing solution, flush the connector and tubing to remove air and particulate matter. Push the end of the tubing to the middle wall of the connector and check for appropriate placement through the connector window.

Push the other end of the tubing into the middle wall. Recheck the connector window to ensure that both tubing ends are still touching the middle walls of the connector. Slide the collets towards the connector until the collet teeth touch the connector. Place the connection in the jaw of the quick connect assembly tool and squeeze the tool handles until the closure stop touches the opposite handle. The tool is used once for the straight connector and twice for the right-angle connector, once on each end.

After all tubing has been connected, cycle the device to ensure proper functioning and deactivate it. Be certain there is some fluid in the pump mechanism, or it can become much more difficult to activate later.

All incisions should be irrigated copiously with saline or antibiotic irrigation solution. Close the perineal and abdominal incisions in several layers with absorbable sutures, then close the skin and dress with a dry sterile dressing.[26][27] 

Dual-Balloon Adjustable Continence Therapy Device Placement

Perform a cystoscopy to ensure there are no anatomic abnormalities. If the decision is made to proceed with the procedure, retract the distal end of the cystoscope back to the bladder neck. Capture a fluoroscopic image to reference the location of the bladder neck during the procedure.

Remove the lens and bridge of the cystoscope and replace them with a blind obturator. Instill 50 mL of contrast through the cystoscope. Capture another image to identify how the contrast fills the bladder in relation to the bladder neck. This is important as the bladder neck can sometimes appear to be inside the bladder itself.

Once the anatomy has been identified, make a small transverse incision using a 15- or 11-blade scalpel at the level of the inferior pelvic ramus, typically 1 cm lateral to the midline raphe and 1.5 cm superior to the anus. Dissect the underlying tissue towards the inferior pubic ramus with a Kelly clamp. Palpate the ramus with the Kelly clamp under fluoroscopy to confirm the location is lateral to the urethra, which is delineated by the cystoscope.

The Kelly clamp should be parallel to the floor. It is imperative to confirm the dissection path before using the sharp trocar inside the U-shaped cannula. Under fluoroscopy, with the trocar introducer inside the U-shaped cannula and the open U facing the ceiling, place the trocar onto the bone at the junction of the angle of the inferior pubic ramus and the inferior portion of the pubic symphysis. The trocar should be parallel to the floor. Walk the trocar posteriorly off the bone and push the trocar through the urogenital diaphragm, all while hugging the anterior ramus inferiorly and staying parallel to the floor.

There should be a slight "popping" sensation when traversing the urogenital diaphragm; this may require twisting the trocar back and forth with gentle pressure. Care must be taken not to push the trocar too far into the bladder; space between the urogenital diaphragm and the bladder is minimal. After confirming complete penetration of the urogenital diaphragm and ideal trocar placement with fluoroscopic imaging, remove the sharp trocar and replace it with the blunt trocar.

Under live fluoroscopy, push on the bladder with the blunt trocar inside of the U-shaped cannula. A focal indentation of the bladder should be visualized. If there is movement of the entire bladder, left and right sides together, this is a sign that the urogenital diaphragm has not been perforated. Move the trocar side-to-side to see if the cystoscope moves. If the cystoscope does move, that denotes a location in the appropriate anterior-posterior plane. If no movement is appreciated or the trocar goes under the cystoscope, the location is too posterior, and a more anterior tract must be developed. Hugging the pelvic ramus anteriorly with the trocar helps prevent the posterior placement of the tract and balloon. 

Once in the proper anterior-posterior plane and through the urogenital diaphragm, position the trocar lateral to the urethra and distal to the bladder neck. Implantation of the balloon can proceed if the bladder has not been perforated. To assess for bladder perforation, remove the blunt trocar while keeping the U-shaped cannula in position. If contrast or clear fluid comes out of the U-cannula, this could indicate that a bladder perforation has occurred. If a bladder perforation is suspected, evaluate for bladder decompression and extravasation of contrast under fluoroscopy. If a perforation is confirmed, abort the procedure on that side and place a Foley catheter for temporary bladder decompression.

If the bladder is uninjured, take the prepared balloon on the guidewire and place one of the three wings of the lambda-shaped deflated balloon into the groove of the U-shaped cannula. Slide the balloon into the incision with intermittent fluoroscopy. Once the radiopaque marker is at the end of the cannula, stabilize the balloon in its position while retracting the U-shaped cannula approximately 1 to 1.5 cm. Begin filling the balloon with isotonic contrast, typically to a volume of 0.5 mL.

A round balloon should be visualized during fluoroscopy. There may also be a flattened edge along the boundary of the urethra. If the balloon shape resembles a snowman or hourglass, this may indicate that it is not entirely through the urogenital diaphragm. If this is the case, an attempt should be made to perforate the diaphragm with the trocar fully. Take care not to inflate the balloon while it is in the cannula.

Once the balloon has been inflated, remove the U-cannula. In patients without a history of pelvic irradiation, increase the balloon volume to 1.5 mL. In patients with a history of irradiation or scarring, limit the initial volume to 0.5 mL to reduce early erosion of the balloon into the urethra or bladder. 

Under fluoroscopic guidance, assess balloon placement by moving the cystoscope from right to left; the balloon should move with the cystoscope. If the balloon does not move, this could indicate an improper delivery of the balloon in the anterior-posterior plane.

Repeat these steps on the other side. Once this is complete, use fluoroscopy to visualize the balloons. They should be positioned lateral to the urethra but across from one another. Balloons can be offset in the superior-inferior plane and still be efficacious but may require more outpatient adjustments.

Remove the obturator from the cystoscope and replace it with a lens and bridge. Perform a cystourethroscopy to ensure no bladder, bladder neck, or urethral injury. If no injury is identified, retract the cystoscope to the bladder neck and pull on the balloon ports to visualize movement at the bladder neck in reference to the cystoscope. Sometimes, it is possible to visualize the balloons protruding into the urethra. Once the negative cystoscopy is complete, drain the bladder and remove the cystoscope.

Next, create a scrotal pocket using Metzenbaum scissors to create the subdartos scrotal pocket for the titanium ports. To accomplish this, estimate the placement by placing the ports over the scrotum and marking where the tip lands on the scrotal skin. This signifies the length of tunneling that needs to be performed. Have an assistant lift the scrotum to the ceiling for counter traction.

Using Adson forceps, Metzenbaum scissors, and blunt dissection, tunnel subcutaneously while staying superficial enough to facilitate office-based port access. Remove the internal wire and deliver the titanium port carefully into the created pocket to the previously marked level with an Allis clamp, Kelly clamp, or fingers.

Close the subcutaneous tissues with a 3-0 polyglycol interrupted stitch on each side. The skin should be closed using a 4-0 poliglecaprone suture with a single interrupted stitch. Cover the sites with dry, sterile dressings. Repeat on the other side. Use copious amounts of irrigation before and frequently throughout the closure. Some surgeons prefer to use a 0.05% chlorhexidine gluconate solution.[27] 

Postoperative Care

Artificial Urinary Sphincter (AUS): Traditionally, patients are admitted overnight with a urethral catheter in place, but same-day discharge has become more common.[8] AUA guidelines recommend no more than 24 hours of IV antibiotics postoperatively.[47] Oral antibiotics, such as trimethoprim-sulfamethoxazole, are optionally used for 1 or 2 weeks postoperatively; such antibiotic therapy has not been definitively shown to affect the incidence of postoperative infections or cuff erosions.[48][49] 

The device is left deactivated immediately after surgery and is not activated until 4 to 6 weeks postoperatively. During this period, incontinence must be managed with pads, intermittent self-catheterization, external condoms, a McGuire urinal, a Cunningham clamp, or some combination thereof.

Some suggest that the sphincter always be left deactivated overnight to allow a period where the urethra is not under compression by the cuff, possibly improving urethral blood flow and overall tissue health while reducing the risk of atrophy and erosions. Others believe this deactivation period is ineffective and serves only to make the patient incontinent overnight without proven benefit. There is no definitive data to support either method; further study is required.[50]

Patients should be carefully and repeatedly instructed that placement of a Foley catheter should only be attempted when the AUS is deactivated and the compression cuff is completely open. If a patient seeks care in an emergency department or healthcare facility, all personnel they encounter must be informed of this constraint. Any attempt to pass a Foley catheter without cuff deflation and deactivation could result in significant urethral injury or sphincter damage. Patients should be informed that most healthcare personnel will be unfamiliar with the AUS device and that they must know how to deactivate the device. The manufacturer provides a card for patients to carry with them at all times to identify them as having an artificial urinary sphincter that may require special attention. It is recommended that patients inform their medical power of attorney or healthcare proxy of the presence of the AUS should they be unable to relay that information themselves if incapacitated.

Dual Balloon Adjustable Continence Therapy: Overnight admission is not required. Placement of a Foley catheter is unnecessary unless the patient cannot void or other circumstances require it. Oral antibiotics can be used postoperatively per surgeon preference. The author uses trimethoprim-sulfamethoxazole for 1 week postoperatively. The patient should be seen in the clinic 2 weeks after the procedure for routine postoperative care. Adjustments to the device may begin 6 weeks postoperatively and monthly after that. 

Special Situations

If the urethra is injured during the procedure to place an AUS, the injury should be repaired and the case aborted. A Foley catheter should be placed after the repair. A pressure-regulating balloon placed before the urethral injury may remain in place if the tubing is capped with the stainless steel tubing plug and the tubing is buried. The stainless steel tubing plug is available in the deactivation package. 

If the urethra is injured during DBACT placement, the injury should be repaired and the case aborted. A Foley catheter should be placed after the repair. If the bladder is injured, place a Foley catheter for bladder decompression and abort the case. Patients with a history of pelvic radiation should have the initial balloon volumes limited to 0.5 mL, but the placement of DBACT in irradiated patients is considered off-label use. When performing this procedure in such patients, place the trocars slightly more lateral to mitigate the risk of future erosion.

Office-Based Adjustments of the Dual-Balloon Adjustable Continence Therapy Device

Office-based adjustment of balloon volumes requires the following materials: a 10-mL bottle of normal saline, a 23- and 18-gauge needles, a 3-mL syringe, alcohol wipes, and sterile gloves. This procedure should be treated similarly to obtaining port access.

Prepare the skin with alcohol wipes. In a sterile fashion, fill the syringe with 2 mL of normal saline using the 18-gauge needle and exchange this for the 23-gauge needle. The performing practitioner should stand on the side of the patient opposite their dominant hand. Hold the port with the non-dominant hand and deliver the needle through the scrotal skin with the dominant hand to access the port. Assistance may be required to retract the scrotal skin. Only 23-gauge needles should be used for device filling adjustments.

Depending on the severity of urinary leakage, 0.5 to 1.0 mL per balloon can be added at one time. If the patient experiences severe pain, do not add more volume. Volume adjustments should be based on patient tolerance. Patients with a history of radiation may experience more pain.

Complications

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.

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.

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]

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.

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. 

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%.

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

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.  

Clinical Significance

Both AUS and DBACT facilitate recovering urinary continence after prostate surgery in patients not responding to conservative measures. The AUS is regarded as an "active system" because it requires manipulation of the pump mechanism to operate the cuff. Adjustable continence therapy, like the DBACT, is considered a "passive system." 

The AUS has demonstrated significantly improved long-term outcomes in patients; 50% of patients report complete continence 5 years postoperatively, and another 40% require 1 pad or fewer per day 5 years postoperatively.[27][69] The expected life of the AUS device is approximately 10 years. Overall patient satisfaction rates in men are reportedly 85% or greater; satisfaction rates are similar in women.[70][71][72] According to the manufacturer, more than 94000 devices have been implanted.

DBACT placement is a minimally invasive procedure, with 30% to 67% of patients achieving complete continence and an additional 22% to 38% achieving at least a 50% improvement in leakage.[24][68] In one study of 26 patients, 96% indicated either significant improvement or complete continence, but in a larger study of 240 patients, only 67% were improved, and 33% were considered "failures."[68][73] Data collected 5 years after the procedure revealed the improvement was long-lasting and durable, with similar success rates.[73] The complication rate was 15% to 32%, with the most commonly reported problem consistently being balloon failure, usually successfully treated with balloon replacement.[68][73] 

The most recent meta-analysis of 1570 DBACT patients from 18 studies with a mean follow-up of 34.7 months demonstrated a mean dryness rate of 55%, an overall complication rate of 32%, and a 23% reoperation rate.[74] Proper patient selection, surgical experience with the DBACT device, and the lack of prior pelvic radiation appear to be important factors in reducing complications and improving dryness. The reported success rate decreased by more than one-third in previously irradiated patients; this is why DBACT is not recommended in this group.[75]

Although not approved in the United States, the global results in women using DBACT are similar, with about two-thirds indicating either dryness or improvement.[76][77][78][79] However, the most recent systematic review suggested that the overall success rate was relatively modest, with a significant complication and explantation rate.[77][80]

Device Selection

For patients with limited manual strength or dexterity, who desire a minimally invasive procedure, or who would otherwise find it difficult to operate an AUS for any reason, the DBACT would be the preferred selection. Patients who prefer an option with more long-term outcome data or desire a more "natural" functionality should probably receive the AUS device. Assuming a patient is a potential candidate for either device, shared decision-making incorporating surgeon experience and patient preference will provide the best outcome. However, due to the similar indications of AUS and DBACT, individual patient factors or preferences may be the determining factor in choosing one intervention over the other.

Many patients will expect perfect continence after surgery. Perfect continence is not impossible but may be unrealistic. Setting a more realistic expectation of improvement or "social continence," defined as needing no more than one incontinence pad daily, significantly improves postoperative satisfaction rates.

Future Developments

The AMS 800 is the only approved AUS device available in the United States and is considered the gold standard. However, the device has not been substantially updated since 1983 and would benefit from improvements. Complicated preoperative device preparation, difficult patient operation, awkward activation and deactivation, a relatively high rate of urethral atrophy, a relatively limited number of cuff sizes, and complex surgical insertion procedures are some targeted areas for improvement. Beneficial improvements would also include allowing adjustability without complete device replacement, decreasing the incidence of cuff erosions, decreasing fluid leakage from connections and the semipermeable tubing, and incorporating transmission of intraabdominal peak pressures to the cuff for compensatory closure pressure.[81][82]

Adding an implanted stress reservoir in selected patients with stress incontinence who already have an AUS is minimally invasive and effectively improves the functionality of AUS devices. Still, more studies are needed to verify the efficacy, long-term durability, and clinical viability of this additional procedure.[83]

Newer devices currently under development or available outside the United States have been designed to address some of these issues.[81] The Rigicon AUS device is designed to be easier to activate/deactivate, automatically adjust to changes in intraabdominal pressure, has a hydrophilic coating, and is available in more cuff sizes than the standard AMS product.[84] The Rigicon AUS device is being tested for possible approval in the United States; the device has been available in Europe since 2020.[81] 

The Victo AUS from Austria is a preconnected system that is adjustable through a self-sealing percutaneous port and contains an additional stress balloon designed for preperitoneal placement.[85][86] This modification permits peak intraabdominal pressures to be immediately transmitted to the urethral cuff for additional closure pressure.[86] The Victo AUS is currently available in many countries, including all of Europe, but not in the United States.[81]

The Zephyr is a one-piece preconnected AUS device designed in Switzerland that does not have an abdominal reservoir, instead using a pressure-regulating reservoir and pump placed in the scrotum.[87] Both the cuff and pressure regulator are adjustable.[82] The Zephyr AUS device is currently available in many countries, including all of Europe, but not in the United States.[81]

Enhancing Healthcare Team Outcomes

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.