Robotic female artificial urinary sphincter implantation vs. male artificial urinary sphincter implantation for non-neurogenic stress urinary incontinence.

PURPOSE: Previous studies suggested better functional outcomes and longer device survival for female artificial urinary sphincter (AUS) implantation compared to male AUS implantation. We hypothesized that the adoption of robotic approaches for female implantation might have influenced these comparisons. This study aimed to compare the outcomes of robotic female AUS and male AUS implantation for non-neurogenic stress urinary incontinence (SUI). METHODS: We retrospectively reviewed charts of male patients who had AUS implantation and female patients who underwent robotic AUS implantation for non-neurogenic SUI between 2010 and 2022 at a single center. Prior AUS implantations were exclusion criteria. The primary endpoint was continence status at 3 months, categorized as complete resolution of SUI (0 pad), improved SUI (1pad), or unchanged SUI (>1pad). RESULTS: After excluding 79 patients, 171 were included: 70 women and 101 men. Operative time was shorter in males (126.9 vs. 165.5 min; p < 0.0001). Postoperative complication rates were similar (17.3% vs. 22.9%; p = 0.38). Continence status at 3 months and last follow-up favored females. The ICIQ-SF decrease at 3 months was greater in females (-7.2 vs. -4.6; p < 0.001). The 5-year estimated explantation-free survival was similar (78.6% vs. 73.7%; p = 0.94) as was the revision-free survival (67.4% vs. 61.7%; p = 0.89). Multivariate analysis showed that female gender was associated with better continence at last follow-up (OR = 4.3; p = 0.03). CONCLUSION: Robotic female AUS implantation is associated with better functional outcomes than male AUS implantation, with similar morbidity and survival rates.

Management of Infections Associated with Penile Prostheses and Artificial Urinary Sphincters.

Prosthetic urology can substantially enhance the quality of life for patients. However, it is not without challenges. Infections of penile prostheses and artificial urinary sphincters are often difficult to diagnose, manage, and treat. Over time, device improvements, refined surgical methods, better understanding of microbiology, and biofilms in combination with higher sterility standards and protocols, have significantly reduced the rates of infection. Here, the authors offer a comprehensive overview of prosthetic urologic infections and their management in the current era.

Day-case artificial urinary sphincter for post-prostatectomy incontinence: A comparative pilot study.

Objectives: Implantation of an artificial urinary sphincter (AUS) to treat post-prostatectomy incontinence (PPI) has been traditionally offered with an overnight hospital stay. The aim of this prospective, comparative pilot study was to assess the feasibility and outcomes of the AUS procedure in a day-case setting. Patients and methods: We included consecutive patients having primary or redo AUS surgery over an 18-month period. We excluded patients with previous urethral erosion of AUS, urethroplasty or high anaesthetic risk. All patients were offered day-case surgery. Patients who declined or could not have day-case surgery for logistical reasons had standard care with overnight stay and formed the control group for the study. Primary outcome was the proportion of successful same day-discharges in the day-case group. We also compared baseline characteristics, complications and continence at 1 year post surgery. Results: Twelve patients consented for day-case procedure, and 13 patients had standard overnight care. Mean age was 69.5 years (range 58-79). Twenty-one patients (84%) had primary AUS, whereas 4 (16%) had a redo procedure. There were no significant differences between the groups in baseline demographics. Median number of pads/24 h was 5 in the day-case group and 4 in the overnight group. Eight of 12 patients (66.7%) in the day-case group were successfully discharged on the same day. Failed discharges were due to anaesthetic recovery (n = 2), high post-void residuals that resolved spontaneously (n = 1) and intraoperative superficial urethral injury (n = 1). All patients in the day-case group and all but one in the standard of care group were socially continent (0-1 pads) at 1 year post procedure. Conclusion: Day-case catheter-free discharge of AUS patients is feasible and safe in selected patients with comparable continence outcomes and complication rates to those with standard overnight stays.

Treatment strategies for revision surgery of artificial urinary sphincter: A review.

Artificial urinary sphincters (AUS) are an effective treatment for male stress urinary incontinence (SUI). However, infection, erosion, mechanical failure, atrophy, and balloon deterioration cause device malfunction in approximately half of patients by 10 years after implantation. Many patients desire to regain urinary continence and require revision surgery (RS), including device removal and simultaneous or delayed implantation. Patients for whom RS is considered should be examined physically and by interview for signs of infection. Urethral erosion should be assessed using cystoscopy. If there is infection or erosion, all devices should be removed first, and a new device should be implanted several months later. During the RS, after strong adhesion around the urethra, transcorporal cuff implantation is a safe choice. Device removal and simultaneous implantation can be performed in the absence of infection or erosion. If a long time has passed since device implantation, the entire device should be replaced due to device aging and deterioration; however, if the time is short, only the defective component need be replaced. Intraoperative assessment of urethral health is necessary for device removal and implantation. If the urethra is healthy, a new cuff can be placed in the same position as the old cuff was removed from; however, if the urethra is unhealthy, the cuff can be implanted in a more proximal/distal position, or a transcorporal cuff implant may be chosen. This article reviews the literature on diagnostic and treatment strategies for recurrent SUI in male patients with AUS and proposes a flowchart for AUS revision.

The electronic artificial urinary sphincter: ongoing innovation of a classic device-a narrative review.

Background and Objective: While the modern artificial urinary sphincter (AUS) has benefited from incremental innovation, which has improved both device efficacy and complication rates, the foundational technology in use in Boston Scientific's AMS800 can be traced back to the fundamental hydraulic tenets of the AS721. Research and development in adaptive technology and electronic integration stand to further improve AUS outcomes. Methods: The Medline online retrieval system was queried using the MeSH terms "artificial urinary sphincter", "electronic", "complications", "history", and "development" in various combinations. Publications were reviewed if applicable, and their reference lists were used to collect additional articles as needed. Final article inclusion was based on senior author discretion. Key Content and Findings: The AMS800 AUS is the gold standard for male stress incontinence implants. A 2015 consensus conference set out the goals for sphincter device development in the coming decades. A future ideal sphincter would adjust cuff pressure dynamically as well as function with minimal manipulation, or even via electronic control. Multiple new devices are in various states of development. During the next decade, artificial urinary sphincter technology is likely to include multiple Food and Drug Administration (FDA)-approved devices with varying features aimed at satisfying the 2015 consensus conference goal for an "ideal" AUS. Conclusions: The future of stress incontinence therapy lies in both continued innovation for the AUS, as well as advances in regenerative medicine. Electronic and adaptive developments in AUS technology will increase device safety, efficacy, and longevity while improving the user and caregiver experience. For some, regenerative medicine may even make AUS technology obsolete.

Surgical strategies in artificial urinary sphincter revision surgery: troubleshooting the complications.

Post-prostatectomy urinary incontinence (PPUI) is an important issue in the urological practice and imposes a negative effect on quality of life (QoL). Despite recent technological advances, PPUI remains a common complication and the artificial urinary sphincter (AUS) is regarded as the most effective long-term surgical treatment for moderate-to-severe stress urinary incontinence. Success rates for AUS as defined by a continence status of zero to one pad per day range from 59% to 90%. One potential downside of the AUS is the need for periodic revisions in a number of patients. Revision and explantation rates due to mechanical failure, urethral atrophy, infection and erosion vary considerably among studies with reports of 8-45% and 7-17%, respectively. These complications can be classified into different categories, including recurrent or refractory incontinence, erosion and/or infection, and other complications. This review article aims to describe the main AUS-related complications and their management strategies. Diagnostic work-up strategies are explored to facilitate timely identification and management of these complications. Additionally, emerging technologies and future directions in AUS development are discussed, highlighting potential advancements to mitigate complications and enhance device performance. This review consolidates current knowledge and provides insights for clinicians to manage the complexities associated with AUS therapy effectively.

The fragile urethra: what to do next?-a narrative review.

Background and Objective: Although the artificial urinary sphincter (AUS) has demonstrated successful outcomes in treating male stress urinary incontinence (SUI) for the past five decades, this procedure also carries inherent risks, including recurrent SUI, device malfunction, local tissue compromise, and infection/erosion, all of which may require revision surgery with or without device replacement. Patients that are at the highest risk for such untoward events often possess unhealthy urethral tissue (termed a "fragile urethra") that is compromised and unable to provide optimal cuff coaptation and continence. Accordingly, there are several techniques to address recalcitrant SUI in the setting of a fragile urethra to afford an improved chance of return to continence. Here, we review characteristics of patients that are at higher risk for an untoward outcome following AUS implantation and further define strategies to promote optimal success with device implantation. The aim of this paper is to review the available literature and describe surgical options for male SUI in patients with known or anticipated urethral tissue compromise. Methods: A thorough literature review was completed by querying PubMed for relevant articles. Search terms included artificial urinary sphincter, failure, recalcitrant, urethral atrophy, fragile urethra, revision, radiation, cystectomy, incontinence, and/or urethroplasty published between 1975 and 2022. Key Content and Findings: Options for management of the fragile urethra include cuff relocation, cuff downsizing, tandem cuff placement, transcorporal cuff placement, pressure regulating balloon exchange with increased or decreased pressure, bulbospongiosus preservation, sub-cuff ventral capsulotomy, urethral wrapping with graft, and in select cases, urinary diversion, or complete device removal with a return to SUI. Proper patient selection is paramount to optimize outcomes. Advantages and disadvantages of each strategy are reviewed. Conclusions: Numerous techniques are viable options for patients with recalcitrant SUI in the setting of a fragile urethra, but high-quality evidence with reproducible outcomes for many of these strategies remain limited. Proper patient selection as well as adequate counseling by experienced implant surgeons may help optimize outcomes. Further multi-institutional investigations with longer term outcomes are needed to improve patient selection and counseling with shared decision-making prior to any intervention.

Narrative review: evolution in device technology and advances in surgical techniques on AMS 800 device in the last 50 years.

Background and Objective: The current AMS 800 artificial urinary sphincter (AUS) device is designed to simulate the function of the biological urinary sphincter to prevent urinary flow through mucosal coaptation, compression, and pressure transmission. The challenges in designing the AMS 800 device involve not only the mechanical operation of the artificial sphincter device but also producing a device that is effective, safe, and durable for patients in the long term. The following article provides a narrative review regarding the evolution and development of the AMS 800 devices over the years and evaluates the advances in surgical techniques relating to AMS 800 implantation. Methods: Available literature pertaining to the AMS 800 device was reviewed from the MEDLINE and EMBASE databases between 1 January 2000 to 31 December 2022. Emphasis is placed on key scientific publications including previous reviews and clinical guidelines relevant to AMS 800 device(s) and surgical techniques. Key Content and Findings: From the engineering point of view, the current AMS 800 device is ingenious and has stood the test of time. The basic design of this modern AUS consists of 3 separate components namely a pressure regulating balloon (PRB), an inflatable cuff, and a control pump. Continued innovations in device design and technology, coupled with refinements in surgical techniques over the past 5 decades have ensured that the AMS 800 device is and remains the standard of care in male stress urinary incontinence. While the long-term AMS 800 efficacy, safety, and durability are well documented, it is not without its limitations and complications. Mechanical and non-mechanical complications can occur especially in high-risk populations (such as in radiated patients) despite strict adherence to surgical principles and manufacturer's guidelines. Conclusions: Continued innovations in device design, technology, and surgical techniques have ensured that the AMS 800 device is an effective and safe treatment for male stress urinary incontinence (SUI). Future directions in the treatment of male SUI likely reside in cellular regenerative therapy and nanotechnology to restore, replace, or simulate the damaged native urinary sphincter.

A new adjustable artificial urinary sphincter for male stress urinary incontinence (VictoTM): preliminary clinical results.

Background: Artificial urinary sphinkter (AUS) are still the gold standard for treatment of male stress urinary incontinence with good clinical outcomes and high patient's reported satisfaction rate. However, more than half of the patients with an AUS will require additional procedures, most likely revisions. To introduce a novel adjustable AUS for treatment of male stress urinary incontinence and perform a preliminary clinical investigation to determine the safety and efficacy of the device. Methods: Men with urodynamically proven SUI following radical prostatectomy (RP), transurethral resection of prostate (TURP) and pelvic injuries were implanted with the Victo-AUS. Patients with three or more previous incontinence surgeries were excluded from the series. Patients were monitored over a mean follow up of 29 months (range, 13.7-47.9 months). The device was tested for efficacy by using objective measurements of urinary leakage and continence. We used validated questionnaires at baseline and clinical follow-ups. The key outcomes were overall improvement, patients reported satisfaction and complication rate. Results: A total of 88 patients between December 2016 and December 2019 have been enrolled in this trial. Improvement was defined as a reduction in pad usage per day (p/d) over 50% compared to baseline. In total, 70 (88%) patients were reported to be improved. Treatment success according to the definition of 0-1 p/d was accomplished in 56 (70%) patients. Urethral erosion, infection or mechanical failure occurred in 4 (5%), 4 (5%) and 1 (1.3%) patient respectively. Explantation of the device was mandatory in 6 patients due to erosion, infection or mechanical failure. Conclusions: In this series, a continence rate of 70% was achieved with an acceptable complication-rate. These results together with a high satisfaction rate demonstrate effectiveness and safety of the Victo system in mid-term follow-up for the treatment of male SUI.

A narrative review on synchronous concurrent versus delayed sequential surgery in the artificial urinary sphincter and penile prosthesis implantation.

Background and Objective: In a patient who complains of both stress urinary incontinence (SUI) and erectile dysfunction (ED), prosthetic surgery with a urinary continence device and penile prosthesis implant can offer a definitive solution to address both problems. The AMS 800 artificial urinary sphincter (AUS) device is considered the standard of care to restore SUI while the inflatable penile prosthesis (IPP) device is thought to be superior to a malleable prosthesis to provide a more natural penile erection with higher patient satisfaction rates. The following article explores the current understanding of AMS 800 AUS surgery and IPP device in treating males with concurrent SUI and ED as well as evaluates the advantages and disadvantages of concurrent synchronous dual vs. delayed or staged device implantation. Methods: The available literature on AUS and IPP implantation was reviewed on PubMed and Embase databases between 1 January 2000 and 1 December 2022. This narrative review evaluates relevant key features pertaining to prosthetic surgery with an emphasis on arguments for concurrent synchronous dual vs. delayed sequential surgery for AUS and IPP devices. Additionally, this paper provides a brief surgical description of the techniques and potential complications relating to both prosthetic procedures. Key Content and Findings: While a great deal is known about the excellent outcomes of both AUS and IPP implantation, there is limited literature published on the outcomes of dual AUS and IPP surgery. The decision to proceed with concurrent synchronous dual vs. delayed sequential two-stage implants is likely determined by the patient's preference, the surgeon's expertise, and the availability of prostheses. In either situation, patients should be counselled regarding the advantages and disadvantages of undergoing synchronous concurrent vs. delayed sequential implants and associated surgical challenges are likely dependent on the patient's anatomy and the surgeon's preference. Conclusions: For carefully selected patients with SUI and ED, dual implantation of AUS and IPP provides a definitive treatment to address both conditions at the same time. Patients should be counselled regarding the advantages and disadvantages of synchronous concurrent vs. sequentially delayed implants while technical considerations regarding the sequence of prosthetic device surgery are likely dependent on the patient's factors and the surgeon's preference and surgical expertise.

Narrative patent review of penile clamp, artificial urinary sphincter, and sling innovation in the management of male stress urinary incontinence.

Background and Objective: Stress urinary incontinence (SUI) is the involuntary loss of urine affecting 1-3% of the male population. To manage leakage, patients may try a plethora of penile clamps. and may even consider artificial urinary sphincters (AUS) or sling implantation. We aimed to synthesize the evolution of the modern clamp, AUS, and sling through a comprehensive patent search. Methods: Patents were found through the databases of United States Patent and Trademark Office (USPTO), GooglePatents, and the World Intellectual Property Office Patentscope, covering patents published through January 6, 2024. Key Content and Findings: We found 30 different patents (10 clamps, 13 AUS, and 7 slings), including the patents pertaining to the functionalities and design of five commercially available penile clamps, the American Medical System 800 (AMS 800), the InVance, AdVance, AdVance XP, and Virtue Slings. The clamps, spanning back to 1938 with Bard Cunningham's clamp, have undergone significant refinements. For example, inventors such as Edson S. Outwin and Juan F. V. Wiesner, have modified the location of the primary pressure point. Accessibility has also improved with inventors, such as Gerald French and John W. Timmons, fastening the clamps with Velcro®, as opposed to the screw and ratchet catch closing mechanism, as in Cunningham's clamp. Similarly, the AUS has greatly evolved since Foley's 1947 "Artificial Sphincter and Method", which was the primary AUS precedent to Mark Polyak's AUS invention, which covered the essential elements and functionalities, such as the incorporation of a balloon reservoir, for the AMS 800. In addressing AUS limitations, inventors such as David W. Anderson and Louisa Thomas have created non-hydraulic AUSs. Likewise, the male sling has seen an evolution in the method of securement, from the use of fixed bone anchors in the InVance sling to the transobturator route used in the AdVance XP, avoiding bone complications. Additionally, innovation in sling adjustment of urethral compression allows for adjustable urethral elevation and distal compression respectively. Recent patents have claimed technological integration for clamps, AUS, and slings, especially concerning automation. Conclusions: Overall, patents have built upon the limitations of previous devices. However, there is still a need to innovate for increased clamp comfort and reduced reoperation rates for the AUS and sling.

The male slings: an effective and safe alternative surgical treatment to the artificial urinary sphincter for male stress urinary incontinence?-a narrative review.

Background and Objective: The ideal candidate for a male sling (MS) should have a mild to moderate degree of stress urinary incontinence (SUI). This narrative review article evaluates the current MS devices in the commercial market and examines the role of MS as an effective and safe alternative treatment option for male SUI. Methods: The available literature on MS was reviewed and relevant clinical studies pertaining to each MS were summarised with emphasis on device design and technology as well as specific surgical findings relating to clinical outcomes. Key Content and Findings: Over the past two decades, there have been considerable scientific advances in MS design and technology, and MS is an attractive alternative for patients who might not require or want an artificial urinary sphincter. The modern MS can be classified as adjustable or non-adjustable types and is placed either through a retropubic or transobturator (TO) approach. Strict patient selection and counselling, selection of MS with proven clinical records, and safe surgical practice are paramount to ensure a high continence rate, good patient satisfaction, and low postoperative complications. Published data on various MS materials and devices showed reasonable clinical efficacy and safety outcomes, although many of these synthetic MS devices may not be available worldwide due to a lack of regulatory approval in many countries. While the ideal MS is probably yet to be developed, continued scientific advances in slings design, mesh technology, and more refined surgical techniques will improve the continence rate and deliver better safety records. Conclusions: As clinical data matures with longer-term outcomes coupled with advances in scientific designs and technology, the ability to have and select the optimal MS for a particular patient will come to fruition.

Artificial urinary sphincter and female stress urinary incontinence over the past 50 years: a narrative review.

Background and Objective: The aim of the present report was to provide an overview of the use of the artificial urinary sphincter (AUS) in adult females with stress urinary incontinence (SUI) over the past 50 years. Methods: A literature search was conducted in December 2022 and January 2023 using the MEDLINE and Embase databases, screening for randomized controlled trials (RCTs), prospective and retrospective series and reviews on AUS. Only articles published in English or French were included. The search strategy involved a free text protocol and the narrative review reporting checklist was completed. Key Content and Findings: The AUS is a device used over the past 50 years for SUI caused by intrinsic sphincter deficiency (ISD). It has the theoretical ability to simulate the function of a biological urinary sphincter. Although the role of the AUS for females with ISD remains heterogeneous from one part of the world to the other, the existing literature demonstrates that AUS yields satisfactory functional outcomes in female SUI patients, comparable or better to what has been reported in male AUS series. Hence, the main barrier to its adoption has so far been the technical challenge of its implantation at the bladder neck. Regarding the results of AUS implantation in females, we included in this review 3 reviews, retrospective studies and 1 prospective study. In recent years, robotic techniques of female AUS implantation have spread significantly with promising outcomes including numerous reports suggesting that it may decrease its morbidity. In the near future, the development of electromechanical devices may further expand the role of AUS in the management of female SUI. Conclusions: While the use of AUS in female patients provides excellent functional outcomes, it has been limited to scarce centers. However, due to the rise of minimally invasive approaches, it has started spreading again over the past few years. The future of AUS is likely to be bright, fed by technological advances of the device and robotic surgical system, high level of evidence studies and joint efforts of the urological community to facilitate its diffusion across the world.

Artificial urinary sphincter for neurogenic urinary incontinence: a narrative review.

Background and Objective: The artificial urinary sphincter (AUS) is most known for its use in the treatment of moderate to severe post-prostatectomy stress urinary incontinence. However, another lesser-known indication includes stress incontinence related to intrinsic sphincter deficiency (ISD) in the neurogenic bladder population. The purpose of this review is to discuss specific technical considerations related to device implantation in this population, efficacy, durability, and complications. Methods: We performed a non-systematic literature review using the PubMed Database to identify articles specifically related to treatment of neurogenic urinary incontinence using an artificial urinary sphincter. Key Content and Findings: More proximal placement of the cuff at the bladder neck is preferred in the neurogenic population due to higher rates of erosion and complications related to frequent clean intermittent catheterization or cystoscopic procedures when placed along the bulbar urethra. Robotic-assisted laparoscopic cuff placement has emerged as a safe and effective alternative to open surgery in select patients. Although continence rates are highly variable due the subjectivity of the term, functional continence (≤1 pad, ± nighttime incontinence) is reported to be between 75-90%. The need for secondary surgery for explanation with or without revision/replacement is higher in neurogenic patients compared to non-neurogenic patients. Conclusions: Neurogenic urinary incontinence is a complex condition due to the interplay of urethral resistance and bladder function/compliance. While there are a variety of strategies to treat neurogenic incontinence, high quality data from direct comparisons are lacking. Although AUS comes with a high revision rate, functional outcomes for continence with bladder neck placement are promising in this population.

Rigicon ContiClassic and ContiReflex artificial urinary sphincter devices.

The modern AMS 800 artificial urinary sphincter (AUS) is often considered the standard of care for the treatment of moderate to severe stress urinary incontinence in male patients. Nonetheless, the AMS 800 device has several inherent limitations, and these factors can potentially impact its clinical utility and impede excellent clinical outcomes. The new Rigicon AUS devices such as ContiClassic and ContiReflex urinary sphincters are designed to overcome some of the existing issues pertaining to the AMS 800 device. The ContiClassic device is similar in terms of device design to the AMS 800 apart from the inclusion of a hydrophilic coating, has a greater range of cuff sizes with 0.25-cm diameter increments, and an Easy Clink Connectors which negates the need for an assembly tool. In contrast, The ContiReflex device differs from the ContiClassic model in that it features an extra stress relief balloon (SRB) to provide a safeguard on the urethral occlusive mechanism against any sudden increase in intra-abdominal pressure, and a larger pump system that is responsible to cycle fluid between the higher pressure two-balloon system and the sphincteric cuff. The following brief report evaluates the current device design and technology of the Rigicon ContiClassic and ContiReflex AUS devices.

Male sling versus artificial urinary sphincter for the treatment of incontinence after prostate surgery: a systematic review with meta-analysis.

Background: Urinary incontinence following prostate treatment (IPT) represents a significant complication that detrimentally impacts the quality of life for patients who have undergone prostate surgery. Presently, there is a scarcity of evidence regarding the preferred surgical techniques for IPT. We conducted a meta-analysis to compare the outcomes of the male sling and artificial urinary sphincter (AUS) in the treatment of IPT. Methods: Data were extracted through electronic literature searches on PubMed, Web of Science, and Embase databases until September 2023. Eligible studies included patients who underwent AUS or male sling procedures for IPT and had a follow-up duration exceeding 12 months. The primary end point was the success rate, with the secondary outcome focusing on complication rates. A fixed-effects or random-effects models were used to calculate the pooled estimate and its 95% confidence interval (CI). The publication bias was assessed using funnel plots and Egger's regression test. Results: The meta-analysis included nine studies, involving a total of 1,350 participants. No statistically significant difference in success rates was found between AUS and male sling [odds ratio (OR): 0.96, 95% CI: 0.91-1.01]. In terms of the complication rate, there was no significant disparity between the two procedures (OR: 0.87, 95% CI: 0.86-1.12). Conclusions: The findings from this study indicated that male sling surgery yielded success and complication rates comparable to those of AUS. This suggests that male sling could serve as a viable alternative surgical option in the treatment of IPT.

Artificial urinary sphincter and stricture disease: surgical principles in management.

Iatrogenic stress urinary incontinence (SUI) is the most common complication of surgical treatment of prostate cancer, regardless of operative approach, and has a major impact on patients' quality of life. Although SUI can occur after surgical treatment of benign prostatic hyperplasia, specifically transurethral prostate resection, laser enucleation of the prostate, and simple open prostatectomy, these therapeutic modalities play a much less significant role in the etiology of SUI. Artificial urethral sphincter (AUS) implantation is considered the standard treatment modality providing high success rates, including durable efficacy, and optimal patient satisfaction for moderate to severe urinary incontinence resulting mainly from radical prostatectomy. However, although complication rates are generally acceptably low, revision and/or explantation may be required due to mechanical failure and non-mechanical problems, specifically urethral atrophy/cuff deficient occlusion, infection, and cuff erosion. Several risk factors for AUS failure associated with a fragile, compromised urethra have been identified and these play a critical role in device cuff erosion and subsequent removal of the device. Among others, apparently the most impacting factors are irradiation, urethral stent placement, a previous AUS placement, and importantly presence of urethral stricture or prior urethroplasty. Generally, any clinical situation leading to a diseased urethra or lack of urethral integrity is associated with impaired local blood perfusion, and consequently lower success rates. The present review aims to evaluate the impact of the presence of prior urethral strictures and urethroplasty on the outcomes of AUS implantation on one hand, and vice-versa, the influence of AUS placement on later urethral stricture surgery, particularly following cuff erosion.

Outcomes of the Victo™ adjustable artificial urinary sphincter in the treatment of male incontinence.

OBJECTIVES: To report the clinical outcomes of the Victo™ (Promedon, Cordoba, Argentina) adjustable artificial urinary sphincter (AUS) implantation in a cohort of patients with severe urinary incontinence (UI) after prostate surgery. PATIENTS AND METHODS: This study enrolled patients with UI following prostate surgery who underwent a Victo implantation between May 2018 and December 2023. Patients were prospectively evaluated at baseline, and at 3 and 12 months after device activation, and thereafter annually. The 24-h pad-weight test (24hPWT) was used to assess severity of UI, while the Patient Global Impression of Improvement (PGI-I) and patient satisfaction according to a Likert scale were used to measure patient-reported outcomes. RESULTS: A total of 96 patients with a median (interquartile range [IQR]) age of 68 (65-72) years were included in the final analysis. The median (IQR) follow-up was 3 (1-4) years. In all, 10 patients completed the 5-year follow-up. After the treatment, we observed a significant reduction in 24hPWT by the median of 83% (P < 0.001) at 3 months and by a median of 79% (P < 0.001) at 3 years. According to the PGI-I, a total of 87%, 92%, 87%, 81%, 83%, and 50% (five of 10) of patients rated their condition/incontinence as 'very much improved', 'much improved' or 'little improved' at 3 months, 1-, 2-, 3-, 4-, and 5-year follow-up visits, respectively. The proportion of patients, who were 'very satisfied' or 'satisfied' with the treatment outcome was 79%, 80%, 75%, 69%, 80%, and 60% (six of 10) at 3 months, 1-, 2-, 3-, 4-, and 5-years, respectively. There were a total of 13 (14%) device failures during the follow-up period. CONCLUSION: In conclusion, our data suggest that Victo AUS significantly reduces the severity of UI after prostate surgery and provides a reasonably high patient-reported satisfaction with treatment outcomes at mid-term follow-up.

Comparing the lifespan of virgin artificial urinary sphincters in radiated patients: transcorporal vs. standard placement.

PURPOSE: To compare the lifespan of first transcorporal cuff (TC) placement of an artificial urinary sphincter (AUS) versus standard placement (SP) in patients with prior radiotherapy (RT) for prostate cancer (PCa). METHODS: We reviewed first (virgin) AUS placements from two high-volume care centers between 1/2011 and 1/2021, including PCa patients with RT history. AUS lifespan was assessed via the hazard ratio of device explantation and/or revision within a ten-year timeframe for the TC vs. SP approaches. Chi-square, Fisher's exact, and t-tests compared clinicodemographic variables. Kaplan-Meier curve compared TC and SP lifespan. RESULTS: 85/314 men with AUS met inclusion criteria, with 38.8% (33/85) in the TC group and 61.2% (52/85) in the SP group. Median ages were 69.8 (IQR = 65.2-73.6) and 67.1 (61.6-72.9), respectively, p = 0.17. Over a median follow up of 51.9 (15.8-86.1) and 80.4 (28.1-128.3) months for the TC and SP, overall, 12 (36.4%) TC devices were removed (four [12.1%] due to mechanical failures; eight [24.2%] erosions, and two [6.1%] infections) vs. 29 (55.8%) in the SP group (14 [26.9%] mechanical failures; 11 [21.1%] erosions, and five [9.6%] infections). No statistically significant differences were observed between the two approaches, with HR = 0.717, 95% CI 0.37-1.44, p = 0.35. The calculated device survival probabilities for the TC vs. SP at one, five, and 10 years were 78.8% vs. 76.9%, 69.3% vs. 58.7%, and 62.1% vs. 46.7%, respectively. CONCLUSIONS: TC cuff insertion for the first AUS implantation in pre-radiated patients showed to be comparable to SP when it comes to device survival, with comparable complication rates. Current guidance for approach selection is primarily based on patient selection and surgeon preference.