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Artificial urinary sphincter

An artificial urinary sphincter () is an implantable hydraulic designed to treat severe stress urinary incontinence caused by intrinsic deficiency, primarily in men following . It comprises three key components: an inflatable silicone that encircles the bulbar to provide controlled and prevent urine leakage, a manually operated typically placed in the for , and a pressure-regulating implanted in the lower to maintain appropriate levels. Upon , the transfers from the to the , temporarily deflating the to allow voluntary voiding; the then passively refills within 3 to 5 minutes to restore continence. This mechanism mimics natural function, offering a reliable solution for unresponsive to conservative treatments like exercises or absorbent pads. While the AMS 800 remains the gold standard, emerging electronic artificial urinary sphincters, such as the UroActive device, are showing promise in clinical trials as of 2025.

Introduction

Definition and Purpose

The artificial urinary sphincter (AUS) is an implantable hydraulic designed to mimic the function of the natural urethral by providing controlled compression to the , thereby regulating flow and preventing involuntary leakage. It typically consists of an occlusive cuff placed around the , a pressure-regulating , and a control pump, all connected by tubing, allowing for deactivation to facilitate . This device is surgically implanted and operates on a hydraulic principle to restore voluntary control over the urinary process in patients with sphincteric deficiency. The primary purpose of the is to treat moderate to severe stress urinary incontinence (SUI), particularly in men following procedures such as radical for , where damage to the natural sphincter leads to persistent leakage during physical activities or increased abdominal pressure. It is indicated for patients who have not achieved adequate continence through conservative measures like exercises, medications, or absorbent products, offering a reliable means to achieve social continence (defined as using zero to one pad per day). By enabling adjustable urethral compression, the AUS restores patient confidence and , with the maintaining to prevent until the patient activates the to temporarily relax it. Since its introduction in the early 1970s, the AUS has been established as the gold standard surgical treatment for post-prostatectomy in men, with the first multi-component inflatable device developed by F. Brantley Scott in the early 1970s. Over decades of clinical use, it has demonstrated durable efficacy, with long-term studies reporting high patient satisfaction rates despite potential need for revisions, solidifying its role as the preferred intervention for severe cases unresponsive to other therapies.

Mechanism of Action

The artificial urinary sphincter (AUS) operates through a hydraulic system comprising three primary components: an inflatable cuff encircling the , a pressure-regulating balloon implanted in the , and a manual control pump positioned in the (for male patients) or (for female patients). These elements are interconnected by tubing filled with saline, enabling fluid transfer to regulate urethral and restore continence in patients with sphincter deficiency. The system mimics the natural role by providing controlled compression, but relies on mechanical rather than biological . In its normal resting state, the cuff remains inflated with fluid from the pressure-regulating balloon, exerting gentle compression on the urethra to prevent involuntary urine leakage and maintain continence during daily activities. To initiate voiding, the patient manually compresses the pump bulb multiple times (typically 5-7 squeezes), which transfers fluid from the cuff to the balloon reservoir via one-way valves, thereby deflating the cuff and opening the urethra to allow unobstructed urination. Once voiding is complete, a built-in hydraulic resistor in the pump automatically facilitates the gradual return of fluid from the balloon to the cuff over 2-5 minutes, reinflating the cuff to reestablish closure without patient intervention. The pressure dynamics are critical to the device's efficacy and safety, with the typically set to deliver a constant pressure of 60-70 cm H₂O during implantation, which is sufficient to occlude the while minimizing tissue ischemia. This pressure is predetermined intraoperatively based on and incontinence severity, allowing customization of volumes (e.g., 61-70 cm H₂O for moderate cases) to prevent over-compression that could lead to urethral or . Unlike the dynamic, neurologically mediated adjustments of the native sphincter, the functions as a passive, on-demand system that requires activation for voiding, integrating with physiological filling but demanding manual control to simulate voluntary continence.

History and Development

Early Innovations

The concept of an artificial urinary sphincter originated in the mid-20th century with efforts to address severe through mechanical compression of the . In 1947, Frederic E.B. Foley described the first externally worn , consisting of an inflatable cuff placed around a surgically isolated segment of the corpora spongiosum, connected to a detachable for manual inflation and deflation to control continence. This prototype, patented the previous year, represented a significant but was limited by its external nature, lack of precise pressure regulation, and impracticality for long-term use. During the 1950s and 1960s, developments shifted toward implantable prototypes using compressive materials to mimic sphincter function, though these remained passive and non-adjustable. In 1961, John L. Berry introduced an prosthesis implanted between the bulbous and the bulbocavernosus muscle to provide fixed , achieving initial success in select post-prostatectomy cases but plagued by complications such as , , and formation, leading to its abandonment. By the late 1960s, efforts incorporated for improved flexibility; for instance, Joseph J. Kaufman developed early silicone gel-based devices in the early 1970s, involving manual via perineal pressure, which offered better tissue tolerance than but still suffered from and inadequate durability. These prototypes highlighted the need for dynamic, patient-controlled mechanisms to overcome the limitations of static . A pivotal advancement occurred in 1972 when F. Brantley Scott, William E. Bradley, and Gerald W. Timm at in performed the first successful implantation of a fully implantable hydraulic artificial urinary sphincter in a human patient, marking the transition to modern designs. This device, refined and commercially introduced as the AMS 721 model in 1973 by American Medical Systems, featured a silicone cuff around the or neck, connected to a pressure-regulating and a manually activated pump bulb, allowing patients to deactivate the cuff for voiding. Subsequent iterations, such as the AMS 791 in 1977, streamlined the components for bulbar urethral placement, improving ease of implantation while maintaining hydraulic adjustability. These early AMS models laid the for widespread adoption, with initial series reporting continence restoration in over 70% of cases. Key challenges in these initial designs included material and control, which were addressed through material innovations and procedural refinements. Early and rigid prototypes caused erosion due to poor compliance with urethral , prompting the shift to elastomers reinforced with Dacron for better integration and reduced inflammatory response. rates, often exceeding 10% in prototypes, were mitigated by antibiotic protocols and a delayed technique—keeping the device deactivated for 4-6 weeks post-implantation to allow healing—significantly lowering complication risks and enabling safer clinical use.

Modern Advancements

In the , significant refinements to artificial urinary sphincter () design addressed early limitations in tissue interaction and risk. The AMS 800, introduced by American Medical Systems, featured narrower cuffs to enhance pressure transmission to the underlying , reducing and reoperation rates compared to prior models. During the 2000s and 2010s, advancements focused on accommodating challenging anatomies, particularly in patients with radiation-damaged . Narrow-backed cuffs, building on 1980s designs and introduced in , were optimized for smaller urethral circumferences in irradiated patients, demonstrating lower erosion risks when sized appropriately, such as the 3.5 cm variant. The InhibiZone antibiotic coating, introduced in 2007, minimized bacterial adhesion and incidence by releasing and rifampin over time. Surgical approaches evolved with the adoption of transobturator and transcorporal techniques, which facilitated cuff placement around the while avoiding compromised bulbar , improving outcomes in post-radiation cases. In the 2020s, novel models have introduced simplified and adjustable designs to enhance and ease of implantation. The ZSI 375, a single-component device without a separate pressure-regulating , integrates the , , and into one unit filled with saline, allowing for streamlined and reduced component failure. Similarly, the VICTO AUS features an adjustable mechanism with a self-sealing for post-implantation customization; preliminary 2025 data indicate a 73% social continence rate at six months follow-up. Ongoing innovations emphasize infection prevention, user control, and gender-specific modifications. Biofilm-resistant materials, including advanced coatings like on components, have shown promise in preclinical tests by inhibiting microbial encrustation and adhesion on AUS surfaces. Remote trials, such as those for the UroActive electronic AUS, enable wireless control via apps, with first-in-human studies reporting successful and continence restoration at one year without increased complications. For patients, adaptations include bladder neck cuff placement and labial pump positioning in devices like the AMS 800, yielding continence rates up to 80% in severe stress while preserving voiding function.

Indications and Patient Selection

Primary Conditions Treated

The artificial urinary sphincter (AUS) is primarily indicated for the of moderate-to-severe in men following radical prostatectomy, which accounts for approximately 90% of all AUS implantations. This condition arises due to intrinsic sphincter deficiency resulting from surgical disruption of the urethral sphincter mechanism during prostate removal for cancer. Guidelines from the American Urological Association (AUA) recommend discussing AUS as an option for patients experiencing mild to severe (typically 1-5+ pads per day) after , particularly if symptoms persist despite conservative therapies such as exercises or absorbent products. AUS is also indicated for other etiologies of severe SUI in men, including post-radiation incontinence, where it is preferred over alternatives like male slings due to higher efficacy in irradiated tissue. Additional applications encompass neurogenic bladder-related incontinence from conditions such as or , pelvic trauma leading to sphincter damage, and cases of persistent SUI following failed prior interventions like bulking agents or slings. The European Association of Urology (EAU) guidelines similarly endorse AUS for moderate-to-severe post-prostatectomy SUI after fails, emphasizing its role in improving when leakage significantly impacts daily activities. In women, AUS use remains emerging but is indicated for severe SUI due to intrinsic sphincter deficiency, often following , urethral hypermobility, or prior failed anti-incontinence surgeries. This application is typically reserved as a last-resort option after conservative and minimally invasive treatments prove inadequate, with ongoing studies supporting its feasibility despite higher complexity in female anatomy.

Contraindications and Risk Factors

Implantation of an artificial urinary sphincter (AUS) is contraindicated in certain clinical scenarios to minimize risks of severe complications. Absolute contraindications include active or , as these increase the likelihood of postoperative infection and device failure. Untreated dysfunction, such as significant fibrosis or irresolvable detrusor , is also an absolute contraindication, as it can lead to inadequate device function and potential . Additionally, patients with limited manual dexterity or cognitive impairments that prevent reliable operation of the pump mechanism are unsuitable candidates, as they may be unable to deactivate the device for voiding. Patients unable to tolerate or those deemed poor surgical candidates due to overall health status represent further absolute exclusions. Relative contraindications involve conditions that elevate complication risks but may not preclude implantation in carefully selected cases. Prior urethral erosion from a previous AUS or other interventions heightens the chance of recurrent erosion, making reimplantation riskier. Severe to the pelvic tissues is a relative contraindication, as it compromises urethral integrity and increases erosion potential. or ongoing anticoagulation therapy constitutes a relative contraindication due to heightened risks during , though perioperative management may mitigate this in some patients. Risk stratification is essential for assessing suitability, particularly regarding and explantation. Patients with a history of pelvic face substantially higher rates, up to 21% compared to 4% in non-radiated individuals, necessitating cautious cuff sizing and placement strategies. greater than 75 years serves as a modifier, correlating with increased explantation rates (34.6% in older patients versus 25.8% overall), likely due to comorbidities and reduced tissue resilience. independently elevates complication risks, including and device issues, influencing overall candidacy. Patient selection incorporates diagnostic tools to evaluate incontinence severity and function. Urodynamic testing is routinely employed to confirm intrinsic sphincter deficiency, exclude detrusor overactivity, and assess overall lower urinary tract dynamics prior to AUS consideration. The 24-hour pad weight test quantifies urine leakage (e.g., ≥100 grams indicating moderate-to-severe incontinence), aiding in determining treatment appropriateness and expected outcomes.

Device Design and Types

Core Components

The artificial urinary sphincter (AUS) is a multicomponent implantable device designed to restore continence by mechanically occluding the . Its core elements include the urethral cuff, pressure-regulating balloon, control pump, and interconnecting tubing, which together form a closed hydraulic system. These parts are typically constructed from biocompatible to minimize reaction and ensure long-term functionality. The urethral cuff is the primary occlusive component, consisting of an inflatable ring that encircles the bulbar to compress it against the corpora spongiosa, thereby preventing leakage. Available in sizes ranging from 31 to 61 mm, the cuff is selected based on urethral diameter to achieve complete but reversible coaptation without excessive that could compromise blood flow. When inflated, it maintains urethral closure pressures sufficient for continence during daily activities. The -regulating serves as the fluid , typically placed in the to provide a stable hydraulic of 51 to 70 cm H₂O, which is transmitted to the for sustained . Filled with approximately 20 mL of radiopaque solution, the ensures consistent function and allows for customization to match patient needs, balancing continence with voiding ease. The control pump is a manual activation bulb, positioned in the for male patients or the for females, enabling user-initiated voiding. Squeezing the pump transfers fluid from the to the , deflating the to open the ; the system then automatically refills the from the within 3 to 5 minutes, restoring closure. This design promotes patient autonomy while preventing prolonged incontinence episodes. Silicone tubing connects the , , and , forming a sealed circuit for fluid transfer. Engineered to be kink-resistant, the tubing reduces the risk of obstruction during implantation or movement, and many modern devices incorporate antibiotic impregnation, such as rifampin and coatings, to lower rates.

Commercially Available Models

The AMS 800, manufactured by American Medical Systems (now part of ), is a three-component artificial urinary sphincter consisting of an inflatable , a , and a pressure-regulating (PRB), all connected by kink-resistant tubing and filled with radiopaque saline. It has been the gold standard for treating moderate to severe male stress since its commercial introduction in 1983, with over 250,000 units implanted worldwide. The device features circumferences ranging from 31 to 61 mm to accommodate varying urethral sizes, and PRB pressures from 51-60 to 71-80 cm H₂O to provide customizable urethral . The ZSI 375, developed by Zephyr Surgical Implants, represents a single-component alternative that integrates the cuff and pump into one unit, eliminating the need for a separate and simplifying the design for potentially easier implantation. This silicone-based device includes an adjustable cuff that wraps circumferentially around the bulbar , with a manual pump mechanism allowing deactivation for up to 30 minutes to facilitate voiding. It is indicated for moderate to severe in males, particularly post-prostatectomy, and has been implanted in clinical settings across and beyond since its approval. VICTO, produced by Promedon, is an emerging adjustable three-component model pre-connected for streamlined surgical handling, featuring an , an ergonomic pump, and a PRB with a self-sealing port for postoperative pressure adjustments in an outpatient setting. Available in cuff sizes from 3.7 to 5.5 cm, it allows fine-tuning of occlusion pressure to as low as needed for continence while aiming for a reduced complication profile through its conditional mechanism. Introduced in recent years and gaining traction by 2025, VICTO targets male with a focus on adaptability and durability, backed by a five-year warranty. Earlier AMS models, such as the 791, which featured a simplified single-unit control assembly, have been phased out in favor of the more refined design. For female patients, adaptations of the are used, often placed periurethrally or at the bladder neck to address intrinsic sphincter deficiency, though implantation remains less common than in males due to anatomical considerations.

Surgical Procedure

Preoperative Preparation

Preoperative preparation for artificial urinary sphincter (AUS) implantation involves a systematic diagnostic to confirm stress urinary incontinence () and exclude factors such as urethral obstruction. Urodynamic studies are recommended for high-risk patients, including those with neurological conditions or prior pelvic radiation, to assess detrusor function, , and outlet obstruction, helping to predict surgical success and identify coexisting issues like detrusor overactivity. is considered mandatory to evaluate the and for abnormalities such as strictures, , or contractures that could compromise device placement or function. Additionally, preoperative urine cultures are essential to identify and treat any asymptomatic , as positive cultures increase risk and should be sterilized prior to to minimize device-related complications. Patient counseling is a critical component, focusing on and setting realistic expectations to enhance satisfaction and reduce decisional regret. Discussions should cover key risks, including device infection (rates of 1-5%) and urethral cuff (5-10%), both of which often necessitate device explantation and subsequent revision . Patients are advised on necessary adjustments, such as avoiding heavy lifting during the initial period, and the standard activation delay of 4-6 weeks postoperatively to allow tissue healing and reduce early risk. Validated quality-of-life tools, like the Incontinence Quality of Life questionnaire or Index, are used to quantify incontinence bother and guide shared decision-making. Medical optimization aims to mitigate modifiable risk factors that elevate complications. is strongly encouraged, as use impairs and is associated with higher rates in prosthetic surgeries, though direct evidence for AUS is limited. Anticoagulation management involves balancing thrombotic and bleeding risks, with guidelines recommending discontinuation or bridging for high-risk agents to prevent formation without excessive . Control of comorbidities, such as achieving HbA1c ≤7% in diabetic patients, reduces susceptibility, while frailty assessment via tools like the NSQIP-FI (scores ≥0.27 indicate elevated complication odds, OR 3.5) informs planning. Although mechanical bowel preparation is sometimes employed to lower risk in abdominal approaches, its routine use remains variable and is not universally mandated. Anesthesia planning typically involves general or spinal techniques, selected based on comorbidities and surgical approach, with spinal preferred in some cases to reduce cardiopulmonary . antibiotic prophylaxis is standard, with as the first-line agent (2 g ) administered within 60 minutes of incision to prevent surgical site infections, per AUA recommendations tailored to local resistance patterns.

Implantation Techniques

The implantation of an artificial urinary sphincter (AUS) primarily utilizes the standard perineal approach, which allows precise placement of the cuff around the bulbar while minimizing to surrounding tissues. The is positioned in the dorsal lithotomy configuration under general or spinal , with a inserted for urethral guidance. A vertical midline perineal incision, approximately 5-6 cm long, is made over the to expose and mobilize the bulbar by sharply dividing the muscle fibers longitudinally. A separate low transverse suprapubic or subinguinal incision is created for retropubic placement of the pressure-regulating balloon, typically filled with 20-25 mL of saline or isotonic contrast solution, while the control pump is positioned in a dartos pouch within the via a small scrotal or inguinal incision. Key surgical steps include measuring the urethral using a dedicated sizer to select a that provides a snug fit, typically 4-4.5 cm in diameter, ensuring 1-2 mm of overlap without excessive tension. The is then passed around the mobilized using right-angle or a pre-placed , secured with sutures, and connected to the pump and balloon via kink-resistant tubing. The system is cycled several times intraoperatively to verify patency and function, after which the device is deactivated by deflating the to promote tissue healing; activation occurs 4-6 weeks postoperatively. Alternative minimally invasive techniques, such as the penoscrotal approach, employ a single transverse incision at the penoscrotal junction to access the bulbar , balloon reservoir, and , thereby reducing the number of incisions and potential sites. This method facilitates urethral through the tunica dartos, placement proximal to the bulbar , and direct tunneling for component connections, often shortening operative time to 35-90 minutes compared to the traditional multi-incision perineal method. Emerging techniques as of 2025 include robotic-assisted implantation, particularly for female patients, with 5-year outcomes showing sustained , and protocols enabling same-day catheter-free discharge in select cases. Operative considerations for AUS implantation generally include a total procedure duration of 60-120 minutes, estimated blood loss under 200 mL, and a postoperative stay of 1-2 days, with the removed prior to following confirmation of voiding ability. Prophylactic antibiotics and meticulous are standard to mitigate early risks, building on thorough preoperative evaluation including and urine cultures.

Clinical Outcomes

Efficacy and Success Rates

The artificial urinary sphincter () demonstrates high efficacy in restoring continence for men with moderate to severe following , with recent meta-analyses reporting social continence rates (defined as dry or using 0-1 pad per day) of 80-90% at 1 year post-implantation. At 5 years, these rates typically range from 60-80%, reflecting sustained but gradually declining performance due to factors such as device wear and tissue changes. These outcomes are assessed using standardized metrics, including reduction in daily pad usage (often from ≥2 pads preoperatively to ≤1 postoperatively), the 24-hour pad weight test (measuring leakage volume under controlled conditions), and scores from the International Consultation on Incontinence Questionnaire (ICIQ), which quantifies symptom severity and impact. Success rates vary significantly based on patient factors, particularly prior radiation therapy. In non-radiated patients, continence achievement approaches 90%, whereas radiated patients experience approximately 70% success, corresponding to a 65% reduced odds of achieving no incontinence (OR 0.35, 95% CI 0.21-0.59) in a 2022 systematic review and meta-analysis of over 700 cases. This disparity arises from radiation-induced urethral fibrosis and reduced tissue compliance, which impair device function despite equivalent surgical techniques. In women with intrinsic sphincter deficiency, AUS implantation achieves continence rates of approximately 72% based on a 2024 systematic review and meta-analysis of 300 patients. Regarding durability, AUS devices exhibit 40-56% survival at 10 years in large cohort studies of men, with mechanical failure rates remaining low at 5-10% over the same period, primarily due to cuff or pump malfunctions rather than erosion or infection. Radiation therapy is associated with shorter time to device of any cause.

Patient Satisfaction and Quality of Life

Patient satisfaction with artificial urinary sphincter (AUS) implantation is generally high, with overall rates ranging from 85% to 95% reported in recent studies. In a 2025 study, 90.7% of patients indicated they would definitely or probably recommend the procedure to others, reflecting strong endorsement despite potential challenges. Approximately 90% of patients express willingness to undergo AUS implantation again, underscoring its perceived value in managing stress urinary incontinence. Quality of life improvements following AUS placement are substantial and multifaceted, including reduced and enhanced emotional well-being. Men with post-prostatectomy incontinence often experience , social withdrawal, and embarrassment prior to treatment, but AUS implantation alleviates these issues by restoring continence and confidence in daily activities. is largely preserved, with studies showing no significant decline in erectile function or sexual satisfaction scores six months post-implantation. Validated instruments demonstrate meaningful gains, such as drops in International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) scores of 10 to 15 points, indicating reduced incontinence severity and bother. Factors influencing satisfaction include manual dexterity required for pump activation, with patients exhibiting better fine motor skills reporting easier device handling and higher confidence in use. Female patients face greater challenges in pump manipulation, often due to anatomical differences or dexterity limitations, leading to higher rates of incomplete activation and adjustment difficulties compared to males. Long-term surveys reveal sustained but gradually declining satisfaction, with approximately 75% of patients reporting contentment at five years post-implantation, though rates may decrease due to the need for revisions. Despite this, AUS outcomes remain superior to alternative treatments for severe incontinence in terms of overall benefits.

Complications

Intraoperative and Early Postoperative Issues

Intraoperative complications during artificial urinary sphincter (AUS) implantation primarily include , , and component malposition. , often manifesting as scrotal , occurs in a notable proportion of cases, with rates up to 30% in patients on anticoagulation therapy compared to 6% in those without, typically requiring surgical evacuation only in severe instances. , the most common intraoperative issue, arises from catheter placement or and affects approximately 1-5% of procedures, sometimes necessitating abandonment of the if significant. Component malposition, such as pump migration, is reported in about 11% of revision cases but can occur initially, leading to discomfort or functional issues that demand immediate repositioning via confirmation like . Early postoperative complications within 0-30 days encompass , , and , contributing to an overall 30-day complication rate of 15-20%. Infection rates range from 1-5%, including urinary tract infections in 7.6% of patients, often requiring culture-specific antibiotics and, in severe cases, device explantation to prevent . Urinary retention affects 8-32% of patients, particularly with transcorporal cuff placement, and typically resolves with temporary catheterization. Wound dehiscence is less frequently quantified but is associated with underlying or infection, potentially prolonging recovery. Management of these issues emphasizes preventive and supportive measures to minimize morbidity. Prophylactic antibiotics are administered perioperatively in line with AUA statements to reduce risk, with no proven benefit from extended postoperative oral antibiotics. A urethral (10-14 Fr) is routinely placed for 24-48 hours post-implantation to manage initial retention and prevent , transitioning to suprapubic diversion if prolonged. Early ambulation is encouraged to promote circulation and reduce formation, alongside vigilant monitoring for signs of or bleeding during the initial hospital stay. One of the primary long-term complications associated with artificial urinary sphincter () implantation is urethral , where the device abrades the urethral mucosa, leading to tissue breakdown. This occurs in approximately 3.8% to 10% of cases overall, with rates increasing to 21% in patients who have undergone prior compared to 4% in non-radiated individuals. Erosion typically presents with symptoms such as gross , , worsening incontinence, or perineal pain, often manifesting within the first 2 years post-implantation but persisting or emerging up to 10 years later. Risk factors include prior , smaller sizes, low testosterone levels, and multiple prior urethral interventions, which compromise urethral integrity and elevate the likelihood of this complication. Urethral atrophy and device malfunction represent additional chronic issues that can compromise AUS functionality over time. Urethral , characterized by tissue thinning beneath the cuff leading to recurrent incontinence, affects 4% to 26% of patients in historical series, though rates have decreased to 9.6-11.4% with contemporary designs such as the narrow-backed 3.5 cm cuff; often necessitating cuff downsizing or tandem cuff placement in 10% to 20% of revision cases. Mechanical failures, such as pump leaks or fluid loss from the reservoir, account for up to 83% of device revisions and occur at a rate of approximately 6.2% (ranging from 2% to 13.8%), with median onset around 11 to 68 months post-implantation. These malfunctions are more prevalent in replacement procedures than initial implants, highlighting the cumulative wear on device components. Late-onset infections, though less common than early postoperative ones, pose a significant for device salvage, occurring in 1% to 7% of cases beyond the initial period and often requiring complete explantation due to biofilm formation. These infections may recur in 2% to 4% of patients with predisposing factors like or prior explantations, presenting with scrotal or systemic symptoms that necessitate urgent intervention to prevent further complications. Overall revision rates for reflect the cumulative impact of these long-term problems, with 20% to 30% of devices requiring surgical intervention by 5 years and up to 45% by 10 years, based on prospective studies tracking durability. Factors such as history and the need for cuff downsizing contribute to these rates, with surgery-free survival dropping to 56% at 10 years in some populations. While revisions can restore function, repeated procedures increase the risk of subsequent failures, underscoring the importance of patient selection and ongoing monitoring.

Follow-up and Management

Immediate Post-Discharge Care

Following hospital discharge after artificial urinary sphincter (AUS) implantation, patients receive specific instructions to promote healing and prevent complications during the initial recovery period. A urinary is typically in place for 24 to 48 hours postoperatively, with removal occurring in the hospital or at an early clinic visit if prolonged drainage is needed. Patients are advised to complete any prescribed course, often lasting 7 to 14 days, to reduce risk. Wound care emphasizes maintaining cleanliness and dryness at the incision sites, which are usually located in the lower , (for male patients), or (for female patients). Showering is permitted approximately 48 hours after surgery, but patients should avoid scrubbing the surgical sites and pat them dry gently without rubbing; submersion in baths, hot tubs, or swimming pools is prohibited for at least 2 weeks to minimize risk. Bandages should be changed if they become wet or soiled, and ice packs may be applied intermittently to the or perineal area for 48 hours to reduce swelling and bruising. Patients are instructed to monitor for signs of , including fever above 101°F (38.3°C), increasing redness, swelling, of , severe , or difficulty urinating, and to contact their urologist immediately if these occur. Activity restrictions are designed to protect the device and surgical sites during the early healing phase. Light activities and a normal diet can resume immediately, but heavy lifting exceeding 10 pounds, strenuous exercise, or straddle-position activities (such as biking or horseback riding) should be avoided for 4 to 6 weeks. A scrotal support garment is recommended for patients during the first week to minimize swelling, and a doughnut-shaped may aid comfort when sitting. is permitted once narcotic pain medications are discontinued, typically within a few days, and a gradual return to work is encouraged based on the patient's occupation, often within 1 to 2 weeks for sedentary roles. Sexual activity is generally deferred for at least 6 weeks or until device activation and clearance by the urologist. The device remains deactivated immediately after implantation to allow tissue healing around the , with performed by the urologist during a follow-up visit, typically 4 to 8 weeks postoperatively. At this appointment, patients receive education on proper voiding technique, including how to manually squeeze and release the pump in the or to open the for , ensuring continence between voids. Until , some urinary leakage is expected and managed with absorbent pads. Follow-up care begins with a visit approximately 2 weeks after discharge to assess , remove any remaining drains or catheters if applicable, and monitor for early issues. A subsequent visit at 4 to 6 weeks focuses on device activation and initial instruction. Patients are encouraged to schedule these appointments promptly and report any concerns, such as persistent pain or changes in urinary output, to facilitate a smooth transition to long-term management.

Ongoing Monitoring and Revision

Patients with an artificial urinary sphincter () require lifelong surveillance to ensure device functionality and address potential deterioration. Annual urological evaluations are recommended to assess overall device performance, including of the to verify fluid transfer and deflation efficiency. If recurrent incontinence develops, further diagnostic testing such as urodynamic studies is indicated to evaluate for underlying issues like detrusor overactivity or elevated storage pressures, with the deflated during the procedure to avoid complications. Revisions are common over the device's lifespan, with indications including urethral requiring replacement or relocation, necessitating downsizing or tandem placement, and failure or fluid loss prompting full device adjustment or replacement. Explantation occurs in approximately 10% of cases lifetime due to severe or , though overall revision rates reach 24% at 5 years and 50% at 10 years. Reimplantation after explantation is feasible in approximately 50% of explanted cases, often after a period of urethral rest to promote healing, with success rates comparable to primary procedures in non- scenarios. To optimize long-term outcomes, patients receive guidance on modifications, such as maintaining adequate to support urinary flow and incorporating high-fiber intake or laxatives to prevent , which could strain the device. Early reporting of malfunction, persistent leakage, or is emphasized to facilitate timely and reduce the risk of . At end-of-life, deactivation of the is advised prior to to prevent complications during postmortem handling or unrelated procedures; this involves deflating the to minimize pressure on the .

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