Artificial Urinary Sphincter Research Articles

303 - Artificial urinary sphincter implantation preserving the bulbospongiosus muscle: an interesting option in patients with frail urethra

303 - Artificial urinary sphincter implantation preserving the bulbospongiosus muscle: an interesting option in patients with frail urethra

2 - Trends in the use of female artificial urinary sphincter in Europe: preliminary data from the VENUS study

2 - Trends in the use of female artificial urinary sphincter in Europe: preliminary data from the VENUS study

142 - Radiomics for Precision Assessment of Urethral Tissue Quality: Advancing Quantitative and Personalized Medicine in Artificial Urinary Sphincter interventions

142 - Radiomics for Precision Assessment of Urethral Tissue Quality: Advancing Quantitative and Personalized Medicine in Artificial Urinary Sphincter interventions

Prevalence and risk factors for overactive bladder symptoms in patients with artificial urinary sphincter

To demonstrate the prevalence and risk factors for overactive bladder symptoms associated with artificial urinary sphincter implantation, we investigated the patients who underwent primary artificial urinary sphincter implantation with severe urinary stress incontinence. Forty-eight patients who completely answered the questionnaires of the overactive bladder symptom score before surgery were included. Patient characteristics, urinary status at pre and 1, 3, 6, and 12 months post-device activation, and predictive factors for overactive bladder symptoms were examined. Sixty percent of the patients had preoperative overactive bladder symptoms. Until 12 months after device activation, 35–40% of all patients had overactive bladder symptoms. The rate of persistent and de novo postoperative overactive bladder symptoms was 44.8% and 26.3%, respectively. Daily pad use was not different between patients w/wo overactive bladder symptoms. The only risk factor for postoperative overactive bladder symptoms was a max cystometoric capacity < 200 mL measured by a preoperative urodynamic study. Attention must be given to both persistent and de novo overactive bladder symptoms associated with artificial urinary sphincter implantation for patients with stress incontinence. Counsel should equally be provided for preoperative overactive bladder symptoms, especially in cases with a cystometric capacity < 200 mL.

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.

Reply to Editorial Comment on “Timing Considerations for Artificial Urinary Sphincter Implantation Postpelvic Radiotherapy”

Reply to Editorial Comment on “Timing Considerations for Artificial Urinary Sphincter Implantation Postpelvic Radiotherapy”

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

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. 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 1year post surgery. Twelve patients consented for day-case procedure, and 13 patients had standard overnight care. Mean age was 69.5years (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 1year post procedure. 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.

Key Steps in Avoiding Problems During Placement of an Artificial Urinary Sphincter

Key Steps in Avoiding Problems During Placement of an Artificial Urinary Sphincter

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

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. 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. 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. 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.

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

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. 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. 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. 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.

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

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. 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. 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. 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.

Adjustable continence therapy (ProACT/ACTTM) with periurethral balloons for treatment of stress urinary incontinence: a narrative review.

First-line surgical management of stress urinary incontinence (SUI) currently involves implantation of an artificial urinary sphincter (AUS) in male patients and midurethral sling in female patients. Still, there is demand for a less invasive treatment option without the need to use a device during voiding. Since its first description in 2005, many clinics have implemented adjustable continence therapy balloons in male (ProACTTM) and female patients (ACTTM). Publications on the use of ProACT/ACTTM were reviewed from 2002 until September 2022, focusing on functional and safety outcomes, including predictors of treatment failure and complications. Most publications report the use of ProACTTM in patients after prostate surgery, with approximately 60% experiencing a cure rate and 82% achieving over 50% improvement. Consistent functional outcome assessment in female and neurogenic lower urinary tract dysfunction (NLUTD) patients lacks. Few predictors of treatment failure were described, resulting in an advise to not use the balloons after male pelvic radiation therapy. High revision rates were observed in all patient groups, with balloon defects as one of the most common causes for revision. Based on the current literature, ProACTTM is safe and effective in male patients after prostate surgery, but the role of ProACT/ACTTM in female and NLUTD patients is still unclear. There is need for research of higher level of evidence with uniform outcome assessments. Preferably, ProACTTM is prospectively compared with AUS in a randomized setting. In addition, development of better-quality balloons should reduce mechanical failure and revision surgeries, resulting in improved functional and patient satisfaction outcomes.

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.

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

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. 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. 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. 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.

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.

Lessons learned from the Sexual Medicine Society of North America fellowship bootcamp.

Sexual Medicine Society of North America (SMSNA) fellowships offer variable experience in sexual health domains: erectile dysfunction, Peyronie's disease, male infertility, male hypogonadism (low testosterone), reconstruction (including male incontinence), benign prostatic hyperplasia, gender affirmation surgery, sexual mental health, and female sexual dysfunction. To evaluate baseline and postbootcamp understanding and trust in these domains. In 2023, 28 of 31 urologists currently enrolled in SMSNA-endorsed fellowships participated in a 3.5-day training bootcamp in Minneapolis, Minnesota. Participants were asked to complete pre- and postbootcamp surveys. The bootcamp curriculum offered American Urological Association guidelines and case-based lectures, hands-on clinical training with cadavers (penile surgery) and models (collagenase training), and interaction with industry. Changes in knowledge, independence, and trust in performing the procedures, as well as billing issues and feedback for future bootcamps. Prebootcamp surveys revealed vastly varied residency experience. Reported time with an expert faculty member was greatest for benign prostatic hyperplasia and least for female sexual dysfunction, gender affirmation surgery, and low testosterone. The lowest prebootcamp confidence in performing surgery independently was for penile grafting procedures and elevating the neurovascular bundle. Postbootcamp results revealed several areas of significant improvement in confidence (P ≤ .03): intralesional injections for Peyronie's disease, manual modeling, penile plication, penile grafting procedures, and elevating the neurovascular bundle. There was a trend for improved confidence with the insertion of inflatable (P = .05) and semirigid (P = .08) penile prostheses. Nonsignificant improvement occurred in artificial urinary sphincter surgery (P = .12). Participants graded the bootcamp very highly and requested that next year's bootcamp have more content on female sexual dysfunction, male incontinence, and low testosterone, as well as more hands-on skills sessions and case-based lecture formats. Offering a bootcamp with hands-on instruction could significantly improve urologists' knowledge and confidence. As the main strength, this study was the first specialized bootcamp for urologists in the subject of men's health, taking into account hands-on and cadaver laboratories, as well as highlighting industrial and pharmaceutical products. The small sample size was the major limitation. Current SMSNA fellows present with varied levels of experience and confidence across sexual health domains. Notable confidence improvements were seen with topics that combined didactic lectures with hands-on trainings.

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

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. 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. 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. 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.

Artificial urinary sphincter: recent developments and the way forward.

The AMS 800 has dominated the treatment of postprostatectomy urinary incontinence (PPUI) due to intrinsic sphincter deficiency (ISD) for five decades. A narrative review from June 2022 to June 2024 was conducted using 'artificial urinary sphincter' (AUS) MeSH terms in Embase. We extracted information on innovative AUS, randomized controlled trials (RCTs) or prospective studies, and systematic reviews. We evaluated the latest guidelines and consensus and analyzed current trends to discuss options for advancing AUS practices. Of 465 papers identified, 320 were excluded (irrelevant, duplicates, non-AUS devices, non-English, veterinary), and 145 were reviewed, with 24 selected: seven on novel AUS in development, 7 with higher-level evidence (1 RCT, 1 prospective, 4 systematic reviews, 1 nonsystematic review), and 9 retrospective relevant studies [pressure regulating balloon (PRB), revision strategies, radiotherapy history, manual dexterity/cognition, transscrotal vs. transperineal approach]. The final paper summarized current guidelines from Asia & Pacific on AUS. In the past 2 years, six novel AUS have emerged, two female RCTs are ongoing, the SATURN study published its 1-year outcomes, and four systematic reviews on female AUS were conducted. These findings enhance evidence levels and position novel AUS to challenge the Gold Standard.

2210 The adjustable Transobturator male system (ATOMS) for urinary incontinence: 9 year sub analysis within the geriatric population

Abstract Introduction The ongoing rise in prostate cancer rates and consequent prostatectomy have led to an increase in rates of male stress urinary incontinence. ATOMS is an adjustable sling requiring no manual input and suitable for frailer patients. We investigated the long term efficacy of the ATOMsin managing SUI and performed a sub-analysis within the geriatric population (aged 75+). Method 69 men (mean: 70.2, range 50–81) underwent an ATOMS insertion between 2015–2019. Follow up data for up to 9 years were analysed (mean: 5.8, range 5–9 years). Out of the 69 men in the original cohort, 19 were aged 75+ (mean: 76.5, range: 75–81). 17 had SUI post radical prostatectomy, 1 post TURP and 1 post AP resection. Results Out of the 19 men, 14 (74%) were dry post ATOMsimplant insertion (ie using maximum one pad per day for reassurance). This rate is lower compared with the original cohort (79.7%). The average number of top ups to achieve dryness was 3 (same as the initial cohort). Out of the 14 men who remained incontinent in the initial cohort, 5 were 75+. Of these, 2 reported a significant improvement in their incontinence without meeting the ‘dry’ criteria. 1 had his ATOMsdevice removed due to infection. 1 was switched to an artificial urinary sphincter. 1 remains incontinent and is being managed with botox injections. There were no cases of mechanical failure. Conclusions ATOMS appears to be an efficacious and safe procedure in the geriatric population, with only marginal difference in dry rates compared to the non-geriatric cohort. The main benefit over an artificial sphincter is that it exerts a passive effect to prevent incontinence and requires no patient input for every void. This is especially prudent as geriatric patients may lose hand dexterity or cognitive ability over time.

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

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. 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. 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. 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.