Artificial Urinary Sphincter Device Research Articles

Risk Factors for Artificial Urinary Sphincter Explantation and Erosion in Male Nonneurological Patients.

This study was performed to assess the risk factors for artificial urinary sphincter (AUS) explantation in a large multicenter cohort. We retrospectively reviewed the medical records for all 1,233 implantations of the AMS-800 AUS device in male nonneurological patients from 2005 to 2020 across 13 French centers. Patients with neurological conditions were excluded from the study. To identify factors associated with explantation-free survival, survival analysis was performed. Explantation was defined as the complete removal of the device, whereas revision referred to the replacement of the device or its components. The study included 1,107 patients, of whom 281 underwent AUS explantation. The median survival without explantation was 83 months. The leading causes of explantation were infection and erosion. Univariate analysis revealed several significant risk factors for explantation: age above 75 years (34.6% in the explanted group vs. 25.8% in the nonexplanted group, P=0.007), history of radiotherapy (43.5% vs. 31.3%, P=0.001), and anticoagulant use (15% vs. 8.6%, P<0.001). In logistic regression analysis, the only significant risk factor was previous radiotherapy (odds ratio [OR], 2.05; P<0.05). Cox proportional hazards analysis revealed 2 factors associated with earlier explantation: transcorporal cuff implantation (hazard ratio [HR], 2.67; P=0.01) and the annual caseload of the center (HR, 1.08; P=0.02). When specifically examining explantation due to erosion, radiotherapy was the sole factor significantly associated with the risk of erosion (OR, 2.47; P<0.05) as well as earlier erosion (HR, 1.90; P=0.039). In this series, conducted in a real-world setting across multiple centers with different volumes and levels of expertise, the median survival without AUS explantation was 83 months. This study confirms that radiotherapy represents the primary independent risk factor for AUS erosion in male nonneurological patients.

Inguinal hernia repair in patients with artificial urinary sphincter after radical prostatectomy.

Stress urinary incontinence (UI) often develops after radical prostatectomy for prostate cancer, and in those patients with moderate-to-severe stress UI an artificial urinary sphincter (AUS) is implanted. Inguinal hernias (IHs) often occur after radical prostatectomy. As the prevalence of AUS implantation increases, it is possible to encounter patients with IHs undergoing AUS implantation (IHA). This study investigated our treatment and discussed an appropriate approach for IHAs. We retrospectively investigated patients who underwent IH repair with AUS implantation at our hospital from January 2018 to March 2023. We classified IHAs into Types A-D based on the positions of the IHs and AUS devices (the positions of the control pump, pressure-regulating balloon, and connecting tube). The hernia and control pump were ipsilateral in Types A and B, whereas the hernia and pressure-regulating balloon were ipsilateral in Types A and C. This study included 12 IHs of 11 patients. The median patient age was 77years. We conducted open repair in nine patients with all types and laparoscopic repair in two patients with Type B. The median operation times for unilateral and bilateral repairs were 96 and 182min, respectively. There were no complications with AUS or hernia surgeries. IHA has its own characteristics, and multidisciplinary knowledge thereof will help surgeons safely perform IH surgery.

PD35-01 ARTIFICIAL URINARY SPHINCTER DEVICES HARBOR MICROBIAL BIOFILMS THAT RECONSTITUTE DIFFERENTIALLY IN VITRO BY STRAIN AND MEDICAL DEVICE MATERIAL TYPE

You have accessJournal of UrologyCME1 Apr 2023PD35-01 ARTIFICIAL URINARY SPHINCTER DEVICES HARBOR MICROBIAL BIOFILMS THAT RECONSTITUTE DIFFERENTIALLY IN VITRO BY STRAIN AND MEDICAL DEVICE MATERIAL TYPE Glenn Werneburg, Daniel Hettel, Ava Adler, Kenneth Angermeier, Hadley Wood, Sandip Vasavada, Howard Goldman, Raymond Rackley, Bradley Gill, Daniel Shoskes, and Aaron Miller Glenn WerneburgGlenn Werneburg More articles by this author , Daniel HettelDaniel Hettel More articles by this author , Ava AdlerAva Adler More articles by this author , Kenneth AngermeierKenneth Angermeier More articles by this author , Hadley WoodHadley Wood More articles by this author , Sandip VasavadaSandip Vasavada More articles by this author , Howard GoldmanHoward Goldman More articles by this author , Raymond RackleyRaymond Rackley More articles by this author , Bradley GillBradley Gill More articles by this author , Daniel ShoskesDaniel Shoskes More articles by this author , and Aaron MillerAaron Miller More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003333.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The artificial urinary sphincter (AUS) is an effective surgical treatment for stress urinary incontinence, and about 9% of AUS devices require removal due to infection. We sought to determine microbial biofilm and metabolite composition on AUS devices, reconstitute biofilms from microbes isolated from indwelling AUSs in an environment mimicking human tissue, and compare their formation across strains and medical material types. We hypothesized AUSs would harbor unique bacterial and metabolite profiles, and that reconstitution of biofilms in vitro may lead to new strategies to prevent device-associated infection. METHODS: Devices from consented patients scheduled for AUS removal or revision were swabbed for biofilm. Samples and controls were subjected to next-generation sequencing, metabolomics, and culture-based approaches. Bacterial isolates were isolated from devices and grown in a continuous-flow stir-tank bioreactor designed to mimic human tissue with an indwelling medical device present, and biofilm-formation on medical device material types was assessed with plate-count assays and scanning electron microscopy. RESULTS: In the 17 analyzed devices, the most commonly detected phyla were Proteobacteria and Firmicutes. Diethanolamine (local anesthetic precursor), threonine-butyl-ester (precursor for peptide synthesis), 5-aminovaleric acid (bacterial metabolite of lysine; GABA agonist) were the most commonly detected metabolites. Microbes isolated from AUS devices consistently reconstituted biofilm in vitro, and biofilm deposition differed by both strain (Staphylococcus lugdunensis the greatest) and material type (polyurethane the greatest and titanium the least, ****p<0.0001). Micrococcus luteus, shown in the Figure 1, had intermediate biofilm overall, with silicone shown in the top micrograph and polyurethane on the bottom. CONCLUSIONS: AUS devices consistently harbored microbiota in the form of biofilms. Isolated strains reconstituted biofilm in vitro across a library of medical device materials. Biofilm formation differed by both strain and material type. Our methods and results open new avenues to screen for inhibitors of biofilm formation and novel medical device materials resistant to infection. Source of Funding: N/A © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e974 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Glenn Werneburg More articles by this author Daniel Hettel More articles by this author Ava Adler More articles by this author Kenneth Angermeier More articles by this author Hadley Wood More articles by this author Sandip Vasavada More articles by this author Howard Goldman More articles by this author Raymond Rackley More articles by this author Bradley Gill More articles by this author Daniel Shoskes More articles by this author Aaron Miller More articles by this author Expand All Advertisement PDF downloadLoading ...

MP78-20 EFFECT OF HYPOGONADISM ON OUTCOMES FOLLOWING ARTIFICIAL URETHRAL SPHINCTER IMPLANTATION

You have accessJournal of UrologyCME1 Apr 2023MP78-20 EFFECT OF HYPOGONADISM ON OUTCOMES FOLLOWING ARTIFICIAL URETHRAL SPHINCTER IMPLANTATION Zachary Pfeifer, Rano Matta, Joshua Horns, Nathan Driggs, Benjamin McCormick, James Hotaling, Kevin Hebert, and Jeremy Myers Zachary PfeiferZachary Pfeifer More articles by this author , Rano MattaRano Matta More articles by this author , Joshua HornsJoshua Horns More articles by this author , Nathan DriggsNathan Driggs More articles by this author , Benjamin McCormickBenjamin McCormick More articles by this author , James HotalingJames Hotaling More articles by this author , Kevin HebertKevin Hebert More articles by this author , and Jeremy MyersJeremy Myers More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003355.20AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The artificial urinary sphincter (AUS) has been the gold standard management in male stress urinary incontinence for the last 50 years. The most common complications requiring re-intervention include infection and erosion. Risk of late revision surgery or device removal range from 20-50%. Hypogonadism has been shown to impair wound healing and has been hypothesized to impact AUS device survival. Thus we sought to assess the incidence of AUS revision or removal in the setting of hypogonadism. METHODS: Using IBM MarketScan, a commercial claims database, patients undergoing AUS were identified using Current Procedural Terminology (CPT) and ICD-10 procedure codes between 2008 and 2017. ICD-9/10 codes were used to identify patients with pre-operative diagnoses of hypogonadism. National drug codes (NDCs) and J-Codes were used to identify patients undergoing androgen deprivation therapy (ADT) or testosterone replacement therapy (TRT). Incident rate ratios (IRR) were assessed using a multivariate model to determine association of hypogonadism with AUS revision and/or explantation. RESULTS: A total of 2740 men were identified that underwent primary AUS implantation of which 2228 had no prior history of hypogonadism or ADT therapy and were considered eugonadal. 512 (18.7%) men were hypogonadal or receiving TRT including active ADT 369 (13.5%) men, 92 (3.4%) hypogonadal without TRT, and 51 (1.9%) active TRT. On multivariate analysis, untreated hypogonadism (IRR 1.56; 95% CI [1.0-2.3]) was associated with an increased likelihood of re-operation when controlling for covariates. Active ADT (IRR 0.91; 95% CI [0.72-1.14]) and hypogonadism with active TRT (IRR 1.147; 95% CI [0.55-2.10] were not associated with increased risk of reoperation. CONCLUSIONS: In a cohort of 2740 patients undergoing primary AUS placement, untreated hypogonadism was associated with an increased likelihood of re-operation. TRT and ADT at the time of AUS surgery were not associated with increased rates of reoperation. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1139 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Zachary Pfeifer More articles by this author Rano Matta More articles by this author Joshua Horns More articles by this author Nathan Driggs More articles by this author Benjamin McCormick More articles by this author James Hotaling More articles by this author Kevin Hebert More articles by this author Jeremy Myers More articles by this author Expand All Advertisement PDF downloadLoading ...

MP71-11 ARTIFICIAL URINARY SPHINCTER CUFF IS MOST COMMON SITE OF MECHANICAL FAILURE

You have accessJournal of UrologyCME1 Apr 2023MP71-11 ARTIFICIAL URINARY SPHINCTER CUFF IS MOST COMMON SITE OF MECHANICAL FAILURE Maia E. Vandyke, Blake E. Johnson, Shaheer S. Ali, Brian T. Langford, Bryce P. Franzen, and Allen F. Morey Maia E. VandykeMaia E. Vandyke More articles by this author , Blake E. JohnsonBlake E. Johnson More articles by this author , Shaheer S. AliShaheer S. Ali More articles by this author , Brian T. LangfordBrian T. Langford More articles by this author , Bryce P. FranzenBryce P. Franzen More articles by this author , and Allen F. MoreyAllen F. Morey More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003339.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Although the artificial urinary sphincter (AUS) remains the gold standard for severe stress incontinence, roughly half of patients require surgical revision for mechanical or non-mechanical reasons. We sought to delineate sites of mechanical failure in our high-volume tertiary referral center experience. METHODS: A retrospective review of our AUS database from 2007–2021 was conducted to identify all men who had undergone AUS revision. Reason for revision was categorized as mechanical when attributed to failure at the pump, pressure regulating balloon (PRB), cuff, or tubing. Non-mechanical failures (e.g. infection, urethral erosion or atrophy) were excluded. Distribution and timing of component failure and patient characteristics were evaluated. RESULTS: During the study period, 765 patients underwent 1059 AUS surgeries. Incidence of mechanical failure for virgin AUS implants was 9% (51/568) during the study period. Among 377 (35.6%) revision cases, 74 (19.6%) cases with clearly documented site of mechanical failure were included in this analysis. Half of mechanical failures were due to cuff leak (37/74, 50.0%); PRB failure was the next most common (27/74, 36.5%) (Figure 1). Tubing leaks were identified in ten cases (13.5%); no documented cases of pump failure were identified. Using a one-way ANOVA, there was no significant difference in mean time to failure between cuff (57.5±43.9 months), PRB (33.7±29.1 months), or tubing (50.3±44.4 months) sites (p=.066). Other patient factors (age, BMI, ASA, and comorbidities) were similar between the three groups. Using a log-rank analysis, survival rates between cuff, PRB, and tubing failure groups were found to be statistically different, with poorest survival among cuff failures (χ2=133.1, p<.001) (Figure 2). CONCLUSIONS: The predominant site of AUS device failure is the cuff, followed by the PRB. No instances of pump failure were identified over a nearly 15-year period. Source of Funding: N/A © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1018 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Maia E. Vandyke More articles by this author Blake E. Johnson More articles by this author Shaheer S. Ali More articles by this author Brian T. Langford More articles by this author Bryce P. Franzen More articles by this author Allen F. Morey More articles by this author Expand All Advertisement PDF downloadLoading ...

Biofilms on Indwelling Artificial Urinary Sphincter Devices Harbor Complex Microbe-Metabolite Interaction Networks and Reconstitute Differentially In Vitro by Material Type.

The artificial urinary sphincter (AUS) is an effective treatment option for incontinence due to intrinsic sphincteric deficiency in the context of neurogenic lower urinary tract dysfunction, or stress urinary incontinence following radical prostatectomy. A subset of AUS devices develops infection and requires explant. We sought to characterize biofilm composition of the AUS device to inform prevention and treatment strategies. Indwelling AUS devices were swabbed for biofilm at surgical removal or revision. Samples and controls were subjected to next-generation sequencing and metabolomics. Biofilm formation of microbial strains isolated from AUS devices was reconstituted in a bioreactor mimicking subcutaneous tissue with a medical device present. Mean patient age was 73 (SD 10.2). All eighteen artificial urinary sphincter devices harbored microbial biofilms. Central genera in the overall microbe-metabolite interaction network were Staphylococcus (2620 metabolites), Escherichia/Shigella (2101), and Methylobacterium-Methylorubrum (674). An rpoB mutation associated with rifampin resistance was detected in 8 of 15 (53%) biofilms. Staphylococcus warneri formed greater biofilm on polyurethane than on any other material type (p &lt; 0.01). The results of this investigation, wherein we comprehensively characterized the composition of AUS device biofilms, provide the framework for future identification and rational development of inhibitors and preventive strategies against device-associated infection.

Characterizing the biofilm of artificial urinary sphincters (AUS).

There is a paucity of data regarding the bacterial colonization on artificial urinary sphincter (AUS) devices following revision surgery. We aim to evaluate the microbial compositions of explanted AUS devices identified on standard culture at our institution. Twenty-three AUS devices explanted were included in this study. During revision surgery, aerobic and anaerobic culture swabs are taken from the implant, capsule, fluid surrounding the device, and biofilm, if present. Culture specimens are sent to the hospital laboratory for routine culture evaluation immediately upon case completion. Differences in number of microorganism species detected across samples (richness) against demographic variables were determined through backwards selection of all variables using analysis of variance (ANOVA). We assessed the prevalence (how many times each species occurred) of microbial culture species. Statistical analyses were performed using the statistical package in R (version 4.2.1). Cultures reported positive results in 20 (87%) cases. Coagulase-negative staphylococci were the most commonly identified bacteria among explanted AUS devices (n=16, 80%). Among two of the four infected/eroded implants, more virulent organisms such as Escherichia coli and fungal species such as Candida albicans were identified. The mean number of species identified amongst culture positive devices was 2.15±0.49. The number of unique bacteria identified per sample was not significantly associated with demographic variables including race, ethnicity, age at revision, smoking history, duration of implantation, etiology for explantation, and concomitant medical comorbidities. The majority of AUS devices removed for non-infectious reasons harbor organisms on traditional culture at the time of explantation. The most commonly identified bacteria in this setting is coagulase-negative staphylococci, which may be a result of bacterial colonization introduced at the time of implant. Conversely, infected implants may harbor microorganisms with higher virulence including fungal elements. Bacterial colonization or biofilm formation on implants may not necessarily equate to clinically infected devices. Future studies with more sophisticated technology, such as next-generation sequencing or extended cultures, may evaluate microbial compositions of biofilm at a more granular level to understand its role in device infections.

Early activation of artificial urinary sphincter for stress incontinence is safe: A pilot study

Background: Artificial urinary sphincter (AUS) activation is usually deferred until 6 weeks following insertion. However, this timeframe for activation is based on traditional dogma. This study aims to assess the feasibility, efficacy and safety of earlier activation of AUS. Methods: A prospective database was established on consecutive patients undergoing AUS implantation (AMS-800 Boston Scientific) from March 2019 to March 2022 by a single fellowship-trained urologist. Early activation was defined as &lt;30 days from the date of implantation. Results: Twenty-one patients were included in the study with a median follow-up of 34 (range: 3–96) months. The most common indication for AUS insertion was post-prostatectomy stress urinary incontinence ( n = 19, 90%). All 21 patients had their AUS successfully activated and used before 30 days, with a median of 14 (range: 9–28) days. Median (range) pre-operative continence pad numbers were 3 (2–6) and 0 (0–1) at 4 weeks post-operatively. Median (range) pad weight per day was 600 g (190–1310 g) pre-operatively and 6 g (0–6 g) at 4 weeks post-operatively. There were no adverse events associated with early activation. Conclusion: To our knowledge, this is the first description of the early activation of the AMS-800 AUS device. Our preliminary experience indicates early activation is safe and acceptable for patients. Level of evidence: II

Abdominal vs Sub-Inguinal Placement of Pressure Regulating Balloon for Artificial Urinary Sphincter

ObjectivesTo compare peri- and postoperative outcomes following artificial urinary sphincter (AUS) insertion using an abdominal versus a sub-inguinal counterincision for pressure regulating balloon (PRB) placement. MethodsThis was a retrospective review of all AUS placements by a single surgeon from 2010-2020. Demographic, clinical, and surgical details were obtained from chart review. The cohorts were divided by PRB placement technique (sub-inguinal, abdominal, and attempted sub-inguinal converted intra-operatively to abdominal [“conversion group”]). ResultsThere were 182 AUS devices placed. The sub-inguinal approach was successfully completed in 132/144 (92%) and converted to abdominal PRB placement in 12/144 (8.3%). The risk of conversion was not increased by prior laparoscopically-assisted robotic prostatectomy (LRP) or radiotherapy (RT). Median operative time was 62, 75, and 77 minutes for sub-inguinal, abdominal, and conversion groups, respectively ( P = 0.30). Time to device activation was 25.0, 32.0, and 37.5 days for abdominal, sub-inguinal, and conversion groups, respectively (P<0.01). There were no bowel or bladder injuries and no PRB herniation in any group; however, there were five instances of pump migration superiorly, all in the sub-inguinal or conversion groups (P = 0.05). ConclusionsThe sub-inguinal approach to PRB placement during AUS is safe and can be successfully completed over 90% of the time. However, it is not faster than the abdominal approach to PRB placement and it is associated with an increased risk of pump migration, though the latter may be confounded by the sub-dartos pouch for pump placement that was used in all sub-inguinal cases.

MP52-09 SAFETY OF TRANSURETHRAL ENDOSCOPIC TREATMENT IN MEN WITH AN ARTIFICIAL URINARY SPHINCTER: A 15 YEAR ANALYSIS

You have accessJournal of UrologyCME1 May 2022MP52-09 SAFETY OF TRANSURETHRAL ENDOSCOPIC TREATMENT IN MEN WITH AN ARTIFICIAL URINARY SPHINCTER: A 15 YEAR ANALYSIS Corey Weinstein, and Jaspreet Sandhu Corey WeinsteinCorey Weinstein More articles by this author , and Jaspreet SandhuJaspreet Sandhu More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002627.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Incontinence after prostate treatment (IPT) is an uncommon but highly bothersome complaint for patients. Placement of an artificial urinary sphincter (AUS) is the gold standard treatment for IPT. Transurethral endoscopic treatment (TET) after AUS is typically avoided due to the presumed increased risk of AUS cuff erosion after passage of a cystoscope after AUS placement. We set out to determine the rate of erosion in patients undergoing TET after placement of an artificial urinary sphincter (AUS). METHODS: Patients with AUS devices implanted by two surgeons between January 1, 2006 and January 1, 2021 were examined. Patients undergoing a transurethral procedure were included; those that underwent TET for a work-up of a non-functioning AUS were excluded from analysis. Follow up was calculated by last assessment in the outpatient setting. RESULTS: 124 patients were identified that met inclusion criteria, 71 of which were in patients with a history of radiation therapy (RT). 179 AUS were implanted during the study period. Median follow up was 62.4 months. Mean number of TET was 2.5. Procedures included incision of bladder neck contracture, transurethral resection of bladder tumor, cystolitholapaxy, ureteroscopy, and surveillance cystoscopy. There were 10 device erosions (8%) during the follow up at an average of 26.5 months post AUS placement, 9 of which occurred in patients with a history of RT. CONCLUSIONS: TET is safe in patients post-AUS particularly in radiation naïve patients, and the rate of erosion in patients undergoing TET is similar to reported rates of erosion in all AUS patients within the literature. Further research with multi-institutional collaboration is necessary to better understand the risks of erosion in patients with an AUS device undergoing TET. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e889 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Corey Weinstein More articles by this author Jaspreet Sandhu More articles by this author Expand All Advertisement PDF DownloadLoading ...

MP22-06 THE IMPACT OF PROSTATE CANCER DISEASE PROGRESSION AND SALVAGE OR ADJUVANT TREATMENT ON ARTIFICIAL URINARY SPHINCTER DEVICE OUTCOMES

You have accessJournal of UrologyCME1 May 2022MP22-06 THE IMPACT OF PROSTATE CANCER DISEASE PROGRESSION AND SALVAGE OR ADJUVANT TREATMENT ON ARTIFICIAL URINARY SPHINCTER DEVICE OUTCOMES Shree Agrawal, Hanson Zhao, Joao Pedro Emrich Accioly, Hadley Wood, and Kenneth Angermeier Shree AgrawalShree Agrawal More articles by this author , Hanson ZhaoHanson Zhao More articles by this author , Joao Pedro Emrich AcciolyJoao Pedro Emrich Accioly More articles by this author , Hadley WoodHadley Wood More articles by this author , and Kenneth AngermeierKenneth Angermeier More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002561.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: While utilization of artificial urinary sphincter (AUS) for post prostate cancer intervention incontinence can improve quality of life, AUS placement in men with prostate cancer (CaP) progression to biochemical recurrence (BR) or distant metastatic disease (DM) with respect to AUS outcomes has yet to be characterized. METHODS: Retrospective review of patients who underwent AUS implantation from 1/2009-8/2021 was performed. Demographics, comorbidities, CaP treatment, pathology, progression, timing of AUS following primary intervention, surgical characteristics, incontinence outcomes and device revisions were assessed by chi-square and Pearson’s t-test analyses. Multivariable Cox proportional hazards and Kaplan Meier models were used to assess time to AUS device revision by CaP progression. RESULTS: We identified 526 patients who underwent AUS implantation, 255 had complete CaP and AUS characteristics as summarized in the table. Mean follow up from AUS and primary CaP treatment was 56 and 118 months, respectively. Among 134 patients treated with radiation, 40 developed AUS complications with 11 erosions and 11 with recurrent incontinence (p=0.21). In 78 patients treated with androgen deprivation therapy (ADT), AUS complications were noted in 22 with 7 erosions and 6 with recurrent incontinence, prompting revision (p=0.77). BR occurred in 101 patients (40%), with 16% requiring AUS revision (p=0.92). DM developed in 28 patients (11%), with 8 undergoing AUS after DM diagnosis. On univariate analysis, only transcorporal cuff use [HR 3.6 (95% CI 1.7-7.3), p=0.001] significantly correlated with AUS revision.There was no significant difference in continence rates following AUS for patients who underwent prostatectomy, radiation therapy, ADT, or who developed BR or DM. A majority (76%) reported 0-1 pads/day at last follow up. AUS durability for those with BR, by 2 years was 92%, 5 years 85%, and by 10 years 60% (p=0.55). In DM, this was 96% by 2 years, 90% by 5 years, and 71% by 10 years (p=0.26). CONCLUSIONS: There were no significant differences in AUS outcomes between patients without CaP disease progression and those with BR, local recurrence, or DM. Based on this data, AUS implantation in patients undergoing salvage or adjuvant therapy may still be an effective procedure. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e373 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Shree Agrawal More articles by this author Hanson Zhao More articles by this author Joao Pedro Emrich Accioly More articles by this author Hadley Wood More articles by this author Kenneth Angermeier More articles by this author Expand All Advertisement PDF DownloadLoading ...

MP52-08 ARTIFICIAL URINARY SPHINCTER CUFF DOWNSIZING IMPROVES CONTINENCE AND PATIENT SATISFACTION IN CASES OF SUB-CUFF ATROPHY

You have accessJournal of UrologyCME1 May 2022MP52-08 ARTIFICIAL URINARY SPHINCTER CUFF DOWNSIZING IMPROVES CONTINENCE AND PATIENT SATISFACTION IN CASES OF SUB-CUFF ATROPHY Kevin Krughoff, Brent D. Nosé, and Andrew C. Peterson Kevin KrughoffKevin Krughoff More articles by this author , Brent D. NoséBrent D. Nosé More articles by this author , and Andrew C. PetersonAndrew C. Peterson More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002627.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The management of suspected artificial urinary sphincter (AUS) sub-cuff atrophy remains controversial and clinical outcomes remain underreported. Our objective was to examine the impact of cuff downsizing on patient reported outcomes and pad use in cases of sub-cuff atrophy. METHODS: We reviewed our prospectively collected, institutional approved QI database from 2011 to 2021. IRB approval was obtained for the analysis. At our institution, the AUS is routinely filled with contrast solution and imaged radiographically upon initial activation for a baseline. This allows for better delineation between device failure or sub-cuff atrophy during standard multimodal workup of recurrent urinary incontinence with serial AP Pelvis radiography. Patients are seen on a routine basis following activation. Sub-cuff atrophy was diagnosed with serial AP pelvis films indicating atrophy, cystoscopy, assessment of symptom scores and pad use, and history and physical examination. Patients with post-prostatectomy incontinence who underwent cuff downsizing after the diagnosis of sub-cuff atrophy were included for analysis. Repeated measures T-tests were used to assess change in validated survey instruments, subjective outcomes measures and pad use. RESULTS: Over this time-period, 842 AUS devices were placed, 623 new and 219 revisions. Of these, 30 underwent cuff downsizing following a diagnosis of sub-cuff atrophy as determined by the appearance of more fluid in the cuff versus baseline on AP pelvis film, cystoscopy with incomplete coaptation, patient interview and questionnaires, and evaluation of number pads used per day. The initial AUS was in place for a median of 668 days (292, 1601) prior to the diagnosis of sub-cuff atrophy. Median follow up duration after cuff downsizing was 3561 days (2247, 4704). At time of most recent assessment, 23 (73.3%) of downsized cuffs remained in place, 2 (6.6%) were revised for mechanical failure, 2 (6.6%) for further atrophy and 3 (10.0%) for erosion. Following downsize, 96.7% reported subjective improvement and 92.0% experienced a decrease in pad count, with a median decrease of 2 and mean decrease of 2.21 (± 1.45) pads per day (p<0.01). Of those who completed the AUA Symptom Score before and after downsize, 82% experienced an improvement on the bother index score (mean decrease 1.63 ± 1.74, median 1, p=0.01). CONCLUSIONS: Cuff downsizing improves continence control and patient satisfaction in cases of multimodal diagnosed sub-cuff atrophy. Source of Funding: Boston Scientific Fellowship Grant © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e889 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kevin Krughoff More articles by this author Brent D. Nosé More articles by this author Andrew C. Peterson More articles by this author Expand All Advertisement PDF DownloadLoading ...

Urethral Stricture Formation Following Cuff Erosion of AMS Artificial Urinary Sphincter Devices: Implication for a Less Invasive Explantation Approach.

ObjectivesThe objective of this study is to describe a standardized less invasive approach in patients with artificial urinary sphincter (AUS) explantation due to cuff erosion and analyze success and urethral stricture rates out of a prospective database. Evidence regarding complication management is sparse with heterogenous results revealing high risk of urethral stricture formation despite simultaneous urethroplasty in case of AUS explantation.Patients and MethodsData of all patients undergoing AUS implantation due to stress urinary incontinence (SUI) in our tertiary center were prospectively collected from 2009 to 2015. In case of cuff erosion, AUS explantation was carried out in an institutional standardized strategy without urethroplasty, urethral preparation or mobilization nor urethrorrhaphy. Transurethral and suprapubic catheters were inserted for 3 weeks followed by radiography of the urethra. Further follow-up (FU) consisted of pad test, uroflowmetry, postvoiding residual urine (PVR), and radiography. Primary endpoint was urethral stricture rate.ResultsOut of 235 patients after AUS implantation, 24 (10.2%) experienced cuff erosion with consecutive explantation and were available for analysis. Within a median FU of 18.7 months after AUS explantation, 2 patients (8.3%) developed a urethral stricture. The remaining 22 patients showed a median Qmax of 17 ml/s without suspicion of urethral stricture. Median time to reimplantation was 4 months (IQR 3-4).ConclusionWe observed a considerably low stricture formation and could not prove an indication for primary urethroplasty nor delay in salvage SUI treatment possibilities. Therefore, the presented standardized less invasive explantation strategy with consequent urinary diversion seems to be safe and effective and might be recommended in case of AUS cuff erosion.

A comparison of artificial urinary sphincter outcomes after primary implantation and first revision surgery

ObjectiveThe artificial urinary sphincter (AUS) is the gold standard for severe male stress urinary incontinence, though evaluations of specific predictors for device outcomes are sparse. We sought to compare outcomes between primary and revision AUS surgery for non-infectious failures. MethodsWe identified 2045 consecutive AUS surgeries at Mayo Clinic (Rochester, MN, USA) from 1983 to 2013. Of these, 1079 were primary AUS implantations and 281 were initial revision surgeries, which comprised our study group. Device survival rates, including overall and specific rates for device infection/erosion, urethral atrophy and mechanical failure, were compared between primary AUS placements versus revision surgeries. Patient follow-up was obtained through office examination, written correspondence, or telephone correspondence. ResultsDuring the study period, 1079 (79.3%) patients had a primary AUS placement and 281 (20.7%) patients underwent a first revision surgery for mechanical failure or urethral atrophy. Patients undergoing revision surgery were found to have adverse 1- and 5-year AUS device survival on Kaplan–Meier analysis, 90% vs. 85% and 74% vs. 61%, respectively (p<0.001). Specifically, revision surgery was associated with a significantly increased cumulative incidence of explantation for device infection/urethral erosion (4.2% vs. 7.5% at 1 year; p=0.02), with similar rates of repeat surgery for mechanical failure (p=0.43) and urethral atrophy (p=0.77). ConclusionsOur findings suggest a significantly higher rate of overall device failure following revision AUS surgery, which is likely secondary to an increased rate of infection/urethral erosion events.

Continence and Complication Rates of Artificial Urinary Sphincter Devices (AMS 800) for Parkinson and Stroke Patients with Incontinence after Prostate Surgery: Retrospective Analysis of a Prospective Database

Objectives: The artificial urinary sphincter (AUS) is the gold standard treatment for severe stress urinary incontinence (SUI). According to the literature, patients suffering from Parkinson’s disease (PD) or stroke (ST) show adverse continence outcomes after prostate surgery and, therefore, constitute a challenging cohort for continence surgery. However, little is known with respect to the results of AUS surgery in these patients. A retrospective analysis of our institutional, prospectively maintained AUS database aims to address this aspect with a focus on surgical and functional outcomes. Methods and Patients: All data of patients with an AUS implantation were prospectively collected in our database since 2009. The AUS was implanted according to a standardized protocol and activated at 6 weeks postoperatively at our institution. Further follow-up (FU) consisted of pad-test, uroflowmetry, residual urine, and radiography as well as a standardized questionnaire including the Incontinence Quality of Life questionnaire (I-Quol) and International Consultation on Incontinence questionnaire (ICIQ-SF) and is scheduled at 6 and 24 months and every 2 years thereafter. Patients received a preoperative urodynamic evaluation (UD). Patients with normal voiding and storage function were considered for AUS implantation. All patients performed a preoperative test for manual dexterity. Patients with a history of ST or PD were grouped and compared to nonneurological patients. Primary/secondary endpoints of the study were complications/continence. Results: 234 patients were available for analysis. The median FU was 24 months (interquartile range 7–36). Twenty-four patients (10%) had a neurological history (PD and ST). Neurological patients showed significantly worse outcomes regarding continence (objective/subjective/social continence; p = 0.04/p = 0.02/p = 0.1). Significant differences concerning explantation rates were not observed (p = 1). Kaplan-Meier analysis showed no significant difference regarding explantation-free survival (log-rank p = 0.53). Conclusion: AUS implantation shows significantly worse continence rates for neurological patients, despite the fact that all patients showed normal UD results and sufficient manual dexterity. Although neurological patients showed worse outcomes for continence, AUS implantation seems to be a safe and viable treatment for patients with a history of neurological disease.

Robot-assisted artificial urinary sphincter implantation.

The aim of the present manuscript was to provide an overview on the current state of robotic artificial urinary sphincter (AUS) implantation in male and female patients. Over the past few years, several series have been reported, with promising outcomes for the most part. This has contributed to expand the use of bladder neck AUS, especially in female patients, which was, until then, hampered by its perioperative morbidity. Robotic AUS has been developed to overcome the technical challenge of bladder neck implantation in female patients and in specific male subgroups, especially self-catheterizing neurological patients. All the series of robotic AUS implantation published in the past few years reported much lower rates of cuff erosion and AUS explantation than the historical open cohorts suggesting that the robotic approach might become the standard for female AUS implantation. This less morbid approach along with technological improvement of the AUS device may contribute to make it a more popular option in the treatment of female stress urinary incontinence due to intrinsic sphincter deficiency. There are much less data available on robotic bladder neck AUS implantation in male patients.

Long-term outcomes of artificial urinary sphincter in female patients with spina bifida.

To report the long-term functional outcomes of artificial urinary sphincter (AUS) implantation in female patients with spinal dysraphism and stress urinary incontinence (SUI) related to intrinsic sphincter deficiency (ISD). The charts of all spina bifida female patients with SUI due to ISD who underwent AUS (AMS 800) implantation between 2005 and 2019 at three academic departments of urology were retrospectively reviewed. Reoperation was defined as either revision or explantation of the AUS device. Reoperation-free survival of the AUS device was estimated using the Kaplan-Meier method. Continence status as per patients' subjective assessment was categorized as follows: complete continence (no pads), improved continence, unchanged SUI or worsened SUI. Twenty-three patients were included, 69.6% were self-catheterizing. The median follow-up was 14 years. Median time to first reoperation was 10 years. Survival rates without reoperation were 85.9%, 41.8%, 34.6%, and 20.9% at 5, 10, 15, 20 years, respectively. Survival rates without AUS explantation were 90.7%, 66.3%, 55.2%, and 41.4% at 5, 10, 15, 20 years, respectively. None of the patients who underwent device explantation had a new AUS implanted. The only predictive factor of reoperation-free survival was the type of spinal dysraphism (hazards ratio = 3.60 for closed vs. open dysraphism; p = .04). At last follow-up, 17 of the 23 patients were fully continent (73.9%). AUS in female patients with spina bifida may be associated with satisfactory long-term functional outcomes and a high reoperation rate. The median time to first reoperation was similar to what is reported in the male AUS literature (10 years).

MP40-09 POST-ARTIFICIAL URINARY SPHINCTER PROSTATE RADIATION IS A PREDICTOR OF URETHRAL ATROPHY WITH RECURRENT INCONTINENCE

INTRODUCTION AND OBJECTIVE:Prior data suggests radiation is associated with shorter artificial urinary sphincter (AUS) device survival. However, there is a paucity of data on outcomes of patients u...

MP40-14 THE IMPACT OF PRIOR EXTERNAL BEAM RADIATION THERAPY ON DEVICE OUTCOMES FOLLOWING ARTIFICIAL URINARY SPHINCTER REVISION SURGERY

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Male Incontinence: Therapy I (MP40)1 Apr 2020MP40-14 THE IMPACT OF PRIOR EXTERNAL BEAM RADIATION THERAPY ON DEVICE OUTCOMES FOLLOWING ARTIFICIAL URINARY SPHINCTER REVISION SURGERY Madeleine G. Manka*, Brian J. Linder, Laureano J. Rangel, and Daniel S. Elliott Madeleine G. Manka*Madeleine G. Manka* More articles by this author , Brian J. LinderBrian J. Linder More articles by this author , Laureano J. RangelLaureano J. Rangel More articles by this author , and Daniel S. ElliottDaniel S. Elliott More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000889.014AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Previous reports on the effect of radiation therapy on primary artificial urinary sphincter (AUS) device survival have met with conflicting results, and data evaluating this after revision surgery is sparse. Thus, we evaluated artificial urinary sphincter device outcomes after revision surgery, and compared them among individuals who did versus did not undergo prior radiation therapy. METHODS: A database of patients who underwent AUS revision surgery at our institution was used to perform a retrospective review. Device survival endpoints, including overall survival, infection/erosion, urethral atrophy, and device malfunction were evaluated. Overall device survival (i.e. any repeat surgery) was compared between groups, stratified by external beam radiation status, via Kaplan-Meier method. Proportional hazard regression and competing risk analysis were used to evaluate association between prior radiation therapy and device outcomes. RESULTS: From 1983 to 2016, a total of 527 patients underwent AUS revision surgery. Of these, 173 (33%) patients had undergone prior radiation therapy. Patients with prior radiation therapy were more likely to have diabetes mellitus (22% vs 14%; p = 0.05), hypertension (70% vs 56%; p < 0.01), previous vesicourethral anastomotic stenosis (41% vs 19%; p < 0.0001), as well as prior androgen deprivation therapy (26% vs 6%; p < 0.0001). Overall, there was not enough evidence to support the existence of a significant difference in device survival among patients with or without a history of radiotherapy, with 1 and 5 year-overall survival of 84% vs 85% and 50% vs 64%, respectively (p = 0.08). On competing risk analysis, a history of pelvic radiation therapy was not enough evidence to support a significant association with the risk of device infection/erosion, mechanical failure, or urethral atrophy. CONCLUSIONS: There was not enough evidence of a difference in the rate of device erosion or infection, cuff atrophy, malfunction, or overall device survival following AUS revision surgery between patients with and without a history of pelvic radiation. These findings may be helpful when counseling patients regarding outcomes after AUS revision. Source of Funding: None © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e591-e591 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Madeleine G. Manka* More articles by this author Brian J. Linder More articles by this author Laureano J. Rangel More articles by this author Daniel S. Elliott More articles by this author Expand All Advertisement PDF downloadLoading ...

The impact of prior external beam radiation therapy on device outcomes following artificial urinary sphincter revision surgery.

Previous reports on the effect of radiation therapy on primary artificial urinary sphincter (AUS) device survival have met with conflicting results, and data evaluating this after revision surgery is sparse. Thus, we evaluated AUS device outcomes after revision surgery, and compared them among individuals who did versus did not undergo prior radiation therapy. A database of patients who underwent AUS revision surgery at our institution was used to perform a retrospective review. Device survival endpoints, including overall survival, infection/erosion, urethral atrophy, and device malfunction were evaluated. Overall device survival (i.e., any repeat surgery) was compared between groups, stratified by external beam radiation status, via Kaplan-Meier method. Proportional hazard regression and competing risk analysis were used to evaluate association between prior radiation therapy and device outcomes. From 1983 to 2016, a total of 527 patients underwent AUS revision surgery. Of these, 173 (33%) patients had undergone prior radiation therapy. Patients with prior radiation therapy were more likely to have diabetes mellitus (22% vs. 14%; P=0.05), hypertension (71% vs. 56%; P<0.01), previous vesicourethral anastomotic stenosis (41% vs. 19%; P<0.0001), as well as prior androgen deprivation therapy (26% vs. 6%; P<0.0001). Overall, there was not enough evidence to support the existence of a significant difference in device survival among patients with or without a history of radiotherapy, with 1- and 5-year-overall survival of 84% vs. 85% and 51% vs. 64%, respectively (P=0.07). On competing risk analysis, a history of pelvic radiation therapy was not enough evidence to support a significant association with the risk of device infection/erosion, mechanical failure, or urethral atrophy. There was not enough evidence of a difference in the rate of device erosion or infection, cuff atrophy, malfunction, or overall device survival following AUS revision surgery between patients with and without a history of pelvic radiation. These findings may be helpful when counseling patients regarding outcomes after AUS revision.