Primary Artificial Urinary Sphincter Research Articles

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.

Immediate and Long-term Outcomes of Lateral Retroperitoneal Pressure Regulating Balloon Placement During Artificial Urinary Sphincter Implantation

ObjectiveTo describe immediate and long-term outcomes of pressure regulating balloon (PRB) placement, exchange, and extraction from the lateral retroperitoneum (LR) in male patients receiving an artificial urinary sphincter (AUS). MethodsA retrospective chart review was performed on all patients that underwent primary AUS placement between 2006 to 2021. All patients had the PRB placed in the LR during the study period. Intraoperative complications during PRB placement, exchange, or removal, and indications for PRB revision, such as infection, erosion, or mechanical failures were analyzed. Results541 patients were included in the study. All patients underwent primary implantation with no intraoperative complications including no incidents of bowel or vascular injury during PRB placement. In addition, there were no instances of intraoperative injury during PRB removal (with or without PRB replacement). After mean follow-up of 54.8 months (range: 1 – 181 months), 9 patients (1.7%) developed a reservoir-specific complication with infection (5 patients, 0.9%) being the most common issue found. The second most common type or reservoir issue was a palpable or herniated reservoir. There were 2 patients (0.4%) who herniated their reservoirs and one patient with a non-bothersome, but palpable reservoir. Lastly, there were 2 incidents (0.4%) of mechanical failure caused by a leak in the PRB. ConclusionDue to the ease and safety of placing and removing PRBs from this location and exceedingly low rates of PRB-related complications in long term follow-up, the LR should be considered as an ideal location for PRB placement in male patients receiving an AUS.

Male Hypogonadism Does Not Affect Surgical Outcomes After Primary Artificial Urinary Sphincter Placement

Purpose: Studies suggest a link between hypogonadism and complications after artificial urinary sphincter (AUS) placement. We investigated this association and evaluated whether testosterone replacement therapy (TRT) before AUS placement attenuates this risk in hypogonadal patients. Materials and Methods: A retrospective cohort study was conducted using the TriNetX network between 2008 and 2022. We defined 2 groups undergoing primary AUS: (1) eugonadal and (2) hypogonadal patients. We further assessed the hypogonadal cohort by comparing TRT recipients with TRT-naïve patients before AUS. Propensity score matching was used to account for differences in covariates between eugonadal and hypogonadal cohorts. Outcomes included 5-year all-cause revision, erosion, mechanical failure, or device infection. Results: A total of 4308 eugonadal and 514 hypogonadal patients (95 with TRT, 409 TRT-naïve) were included. After matching, the eugonadal and hypogonadal cohorts each contained 504 patients. The median follow-up times for the eugonadal and hypogonadal cohorts were 6 and 5 years, respectively. We found no difference in 5-year all-cause revision (25% vs 28%, P = .35), erosion (1.2% vs 2.2%, P = .22), device infection (3.6% vs 4.0%, P = .74), or mechanical failure (16% vs 17%, P = .67) between eugonadal and hypogonadal patients. In the hypogonadal subanalysis, we found no difference in 5-year device outcomes between TRT recipients and TRT-naïve patients. Post-AUS, only 22 (5%) patients in the TRT-naïve arm received new TRT, suggesting minimal crossover. Conclusions: In matched cohorts of eugonadal and hypogonadal patients undergoing primary AUS placement, we observed no difference in 5-year device outcomes. TRT does not appear to affect surgical outcomes in hypogonadal patients undergoing AUS placement. These hypothesis-generating findings warrant further evaluation.

(499) Exploring Risk Factors for Re-Operation Following Male Artificial Urinary Sphincter and Urethral Sling Implantation in a Multiethnic, Diverse Academic Center

Abstract Introduction New onset stress urinary incontinence (SUI) is the second most common complication following a prostatectomy, significantly affecting an estimated 10-20% of patients. Severe cases of SUI are often managed surgically by artificial urinary sphincter (AUS) or urethral sling implantation, depending on patient preference and incontinence severity. However, despite a large portion of these patients requiring surgical revision, there is a lack of information regarding the risk factors associated with reoperation, particularly in diverse populations. Thus, in this study, we analyzed the impact of demographic and intraoperative characteristics on reoperation risk following sling and AUS device implantation. Objective To identify risk factors for reoperation following primary AUS and urethral sling implantation. Secondarily, we aim to see if there was a difference in reoperation rates between the two procedures. Methods We performed a retrospective review of primary AUS and urethral slings implanted at a single academic center from July 2015 to May 2022. Demographic data, SUI severity (measured in pads per day), intraoperative characteristics, and 30-day safety outcomes were collected. Baseline characteristics were analyzed using a two-sample t-test, chi-square, or Mann-Whitney U test depending on distribution normality. Reoperation risk factors were analyzed utilizing Cox proportional hazard models for univariate and multivariate analysis, and a Kaplan Meier curve was used to depict re-operation time between sling and AUS. Results A total of 116 patients were included, 72 (62.1%) of which underwent urethral sling placement and 44 (37.9%) AUS implantation. The reoperation rate was 19.4% for urethral slings and 34.1% for AUS (p=0.077). Baseline characteristics between slings and sphincters differed in mean age (64.0 [7.1] vs 67.2 [7.5], p=0.024), median preoperative pads per day (2 [1-3] vs 3 [2-5], p&amp;lt;0.001), and history of XRT (11.1% vs 29.5%, p=0.012). After controlling for factors significant on univariate analysis (age, cardiovascular disease, and hyperlipidemia), multivariate analysis revealed that higher pads per day (OR=1.71, p=0.027) significantly increased the likelihood of sling reoperation, while age (OR=1.17, p=0.005) significantly increased the likelihood of AUS reoperation. Cardiovascular disease (CVD) (OR=0.10, p=0.003) and former smoking status (OR=0.17, p=0.018) were protective of AUS reoperation. There was no difference between sling and AUS reoperation on a log rank test (p=0.21). Conclusions A greater number of preoperative pads per day is associated with increased rates of reoperation following sling implantation, while age, CVD, and former smoking status are associated with AUS reoperation. Further research is warranted to identify patient-specific risk factors, particularly to clarify the effects of CVD and former smoking status on reoperation. Disclosure No

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 ...

MP52-05 PRE-EXISTING DETRUSOR OVERACTIVITY LEADS TO EARLIER ARTIFICIAL URINARY SPHINCTER FAILURE AND NEED FOR REVISION

You have accessJournal of UrologyCME1 May 2022MP52-05 PRE-EXISTING DETRUSOR OVERACTIVITY LEADS TO EARLIER ARTIFICIAL URINARY SPHINCTER FAILURE AND NEED FOR REVISION Kevin Krughoff, and Andrew C. Peterson Kevin KrughoffKevin Krughoff 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.0000000000002627.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The artificial urinary sphincter (AUS) is the gold standard treatment for post-prostatectomy stress urinary incontinence. While clinical risk factors such as radiation exposure have been evaluated for erosion, bladder mechanics may play an unknown role in device longevity. We hypothesized that poor bladder mechanics such as detrusor overactivity (DO) are associated with the need for earlier surgical device revision. METHODS: A prospectively maintained, IRB approved institutional database was queried for CPT codes 53445-53449 spanning years 1997-2021. 2,243 encounters comprising 524 unique patient records were individually reviewed. Records with primary AUS removal or replacement, history of radical prostatectomy, baseline urodynamic study (UDS), voiding diary and pad weights were included for analysis. Results from cystoscopy and pelvic x-ray of the contrast-filled devices were reviewed to assess failure etiology. Multiple imputation of chained equations was performed for missing data elements. Variables with significant correlation on univariate analysis or strong theoretical association with AUS longevity were entered for Cox proportional hazards modeling. Partial correlation coefficients between variables were assessed for collinearity. RESULTS: Ninety-two records met criteria for analysis. The median time to intervention was 2070 days (823, 3442). Intervention was prompted by mechanical failure (41.8%), sub-cuff atrophy (38.8%), erosion (9.0%), infection (8.8%) or patient preference (1.5%). AUS longevity was associated with age (p=0.01), volume at strong sensation (p<0.01), capacity (p<0.01) and DO (p<0.01). On multivariate analysis, DO was significantly associated with time to intervention (HR = 2.03; 95% CI 1.24 – 3.36; p<0.01) when controlling for radiation history, BMI, diabetes and smoking status. No other clinical variables were associated with AUS longevity. CONCLUSIONS: In men with uncomplicated post-prostatectomy incontinence, the intervention rate for AUS removal or replacement is twice as high in men with pre-existing DO. Clinical characteristics typically related to tissue quality and healing potential were not significantly related to device longevity when accounting for bladder dynamics. Source of Funding: Boston Scientific Fellowship Grant © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e887 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kevin Krughoff More articles by this author Andrew C. Peterson More articles by this author Expand All Advertisement PDF DownloadLoading ...

Peri-operative outcomes between primary and replacement artificial urinary sphincter surgery: An ACS-NSQIP analysis.

To evaluate differences in perioperative clinical outcomes in men undergoing artificial urinary sphincter (AUS) implantation in primary versus replacement settings. Secondarily, we aimed to identify patient-related factors contributing to complications associated with AUS placement. A review of the American College of Surgeons-National Surgical Quality Improvement Program was performed between 2010 and 2018 identifying males undergoing AUS implantation. Subjects were further subdivided into primary implantation or removal/replacement of AUS simultaneously via current procedural terminology codes 53445 and 53447, respectively. 30-Day postoperative outcomes were compared between cohorts using t-test and Fisher's exact test. The relationship between patient factors and complications was evaluated using logistic regression. A total of 1,892 patients were identified: 1,445 primary AUS placement and 447 AUS replacement procedures. Patients undergoing AUS replacement were statistically older than those undergoing primary implantation (71.4 vs 69.7 years, P < .001). AUS replacement procedures were associated with an increased rate of superficial surgical site infection (SSI) compared to primary procedures (1.3% vs 0.4%, P ¼ .042). There were no differences identified between cohorts for deep SSI, cardiopulmonary complications, reoperation, operative time, or length of stay. Logistic regression demonstrated that higher body mass index was found to be independent risk factors for any complications, and diabetes mellitus was associated with increased risk of AUS-related readmission. Within the perioperative period, patients undergoing replacement AUS have an increased risk of superficial SSI compared to primary AUS implantation. These findings can assist with appropriate perioperative counseling of patients undergoing primary and replacement AUS implantations.

Prior Placement of Male Urethral Slings Can Increase the Need for Revision of Artificial Urinary Sphincters.

Background: Recurrent stress urinary incontinence (SUI) following male sling can be managed surgically with artificial urinary sphincter (AUS) insertion. Prior small, single-center retrospective studies have not demonstrated an association between having failed a sling procedure and worse AUS outcomes. The aim of this study was to compare outcomes of primary AUS placement in men who had or had not undergone a previous sling procedure. Methods: A retrospective review of all AUS devices implanted at a single academic center during 2000–2018 was performed. After excluding secondary AUS placements, revision and explant procedures, 135 patients were included in this study, of which 19 (14.1%) patients had undergone prior sling procedures. Results: There was no significant difference in demographic characteristics between patients undergoing AUS placement with or without a prior sling procedure. Average follow up time was 28.0 months. Prior sling was associated with shorter overall device survival, with an increased likelihood of requiring revision or replacement of the device (OR 4.2 (1.3–13.2), p = 0.015) as well as reoperation for any reason (OR 3.5 (1.2–9.9), p = 0.019). While not statistically significant, patients with a prior sling were more likely to note persistent incontinence at most recent follow up (68.8% vs. 42.7%, p = 0.10). Conclusions: Having undergone a prior sling procedure is associated with shorter device survival and need for revision or replacement surgery. When considering patients for sling procedures, patients should be counseled regarding the potential for worse AUS outcomes should they require additional anti-incontinence procedures following a failed sling.

PD22-12 COMPARISON OF OUTCOMES AFTER PRIMARY ARTIFICIAL URINARY SPHINCTER PLACEMENT IN POST-RADIATION PATIENTS WITH AND WITHOUT HYPERBARIC OXYGEN THERAPY

You have accessJournal of UrologyTrauma/Reconstruction/Diversion: Urethral Reconstruction (including Stricture, Diverticulum) II (PD22)1 Sep 2021PD22-12 COMPARISON OF OUTCOMES AFTER PRIMARY ARTIFICIAL URINARY SPHINCTER PLACEMENT IN POST-RADIATION PATIENTS WITH AND WITHOUT HYPERBARIC OXYGEN THERAPY Samantha Nealon, Joseph Balbona, and Lucas Wiegand Samantha NealonSamantha Nealon More articles by this author , Joseph BalbonaJoseph Balbona More articles by this author , and Lucas WiegandLucas Wiegand More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002011.12AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Prior radiation therapy is a well-documented risk factor for postoperative complications after artificial urinary sphincter (AUS) placement. Hyperbaric oxygen therapy (HBOT) has been shown to improve tissue quality in patients with prior radiation. However, no previous study has investigated the role of HBOT in reducing complications following AUS surgery in patients with pelvic radiation. METHODS: Patients identified had a radiation history and underwent primary AUS insertion by a single surgeon August 2015 - March 2019. Demographics, comorbidities, continence, and postoperative complications were analyzed. Surgical outcomes in patients who had received HBOT prior to AUS insertion were compared to those who had not. RESULTS: 31 patients underwent AUS placement. 10 patients (median age 73.4) underwent HBOT while 21 patients (median age 69.3) did not receive HBOT. More patients in the non-HBOT group received EBRT (94.7%), compared to the HBOT group in which 55.6% received EBRT while the remaining received either EBRT plus brachytherapy or brachytherapy alone (p=0.03). Average time since radiation therapy was 9.3 years in the HBOT group and 7.6 years in the non-HBOT group. Average follow up was not significantly different between groups (p=0.5). Pads per day preoperatively were 6.6 and 7.2 in the HBOT and non-HBOT groups. Postoperative pads per day were 1.0 and 2.2 in the HBOT and non-HBOT groups. Preoperative and postoperative pads per day were not statistically different between the two groups. No statistically significant difference was seen in postoperative complications between the HBOT and non-HBOT groups (50% vs. 57.1%, p<0.70). Patients treated with HBOT had an overall lower rate of erosions and revisions than patients without HBOT, however neither difference reached significance (p=0.52 and p=0.31, respectively). CONCLUSIONS: HBOT has been shown to improve post-radiation tissue damage. In our current series, rates of AUS erosion were lower in patients treated with HBOT prior to AUS placement, but this did not reach statistical significance. While our study was not powered to be statistically significant, these results indicate that an additional higher-powered study is needed to determine whether HBOT can prevent complications related to AUS placement. Source of Funding: N/A © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e384-e385 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Samantha Nealon More articles by this author Joseph Balbona More articles by this author Lucas Wiegand More articles by this author Expand All Advertisement Loading ...

PD22-01 PREOPERATIVE CASTRATE LEVEL OF TESTOSTERONE DOES NOT IMPACT OUTCOMES AFTER AUS PLACEMENT

You have accessJournal of UrologyTrauma/Reconstruction/Diversion: Urethral Reconstruction (including Stricture, Diverticulum) II (PD22)1 Sep 2021PD22-01 PREOPERATIVE CASTRATE LEVEL OF TESTOSTERONE DOES NOT IMPACT OUTCOMES AFTER AUS PLACEMENT Paula Domino, Nicole Benfante, Amy Tin, and Jaspreet Sandhu Paula DominoPaula Domino More articles by this author , Nicole BenfanteNicole Benfante More articles by this author , Amy TinAmy Tin More articles by this author , and Jaspreet SandhuJaspreet Sandhu More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002011.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The impact of androgen deprivation therapy (ADT) on artificial urinary sphincter (AUS) outcomes is unclear, though relevant due to the increasing number of high risk patients undergoing prostatectomy. We determined the rate of the early complications - infection, urethral erosion, or re-implantation within 90 days of AUS placement - based on whether patients had ADT prior to AUS placement. We further determined whether re-implantation at any time is driven by ADT. METHODS: Patients who underwent a primary AUS between January 1996 and July 2020 with or without prior ADT and had adequate followup were identified. Early complications and the need and time to AUS reimplantation were recorded. We reported unadjusted rates of early complications based on prior ADT. We then assessed the association between time to AUS replacement and ADT use using a multivariable Cox regression with time to AUS replacement as the outcome and whether patients had ADT prior to AUS as the primary predictor, with age at initial AUS placement and history of radiation treatment prior to initial AUS placement as covariates. RESULTS: We identified 353 prostate cancer patients who underwent a primary AUS with adequate follow-up. Over a quarter (26%, n=91) had ADT before their AUS placement, of which 29 (32%) had metastatic prostate cancer. Six patients had early complications, with rates low in both groups, and we can exclude a large increase in rates associated with ADT: 2 cases (2.3%) in men with prior ADT versus 4 cases (1.6%) in men without ADT, difference = 0.8%, 95% C.I. 2.8%, 4.3%, p-value = 0.6. One-hundred and six patients had an AUS replacement during follow-up. The Kaplan Meier figure shows the estimated risk of replacement AUS based on whether patients underwent ADT prior to their initial AUS placement. We did not find evidence of a difference in time to replacement between groups on multivariable analysis (p=0.4). CONCLUSIONS: ADT or metastatic prostate cancer does not result in higher complications or re-operative rates and therefore should not be a deterrent to offering an AUS to these patients. Source of Funding: none © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e380-e380 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Paula Domino More articles by this author Nicole Benfante More articles by this author Amy Tin More articles by this author Jaspreet Sandhu More articles by this author Expand All Advertisement Loading ...

Early Revision after Artificial Urinary Sphincter Implantation Does Not Impair the Long-Term Treatment Success

Introduction: After implantation of an artificial urinary sphincter (AUS) due to stress urinary incontinence, in some cases revision procedures may be necessary. This is mostly due to device infection or cuff erosion in the long term. The aim of this study was to evaluate the impact of early revision procedures (prior to or immediately after AUS activation) on the long-term outcome. Methods: We retrospectively evaluated patients who underwent primary AUS implantation between 2006 and 2019. Patients with previous radiotherapy, urethroplasty, urethral stent placement, or repeat AUS implantation were excluded. Early revision was defined as prior to or immediately after AUS activation and comprised pump repositioning or cuff size adaptation due to difficulties in using the pump, persistent urinary incontinence, or urinary retention. Patients were compared with regard to complication rates, functional outcome, and patient satisfaction. Univariable and multivariable logistic regression analyses were performed to analyze risk factors for early AUS revision. Kaplan-Meier analysis evaluated explantation-free survival. Results: A total of 250 patients were included. Twenty patients (8%) required early revision (pump repositioning in 15 cases [75%], cuff downsizing in 3 cases [15%], and cuff upsizing in 2 cases [10%]). Mean follow-up was 78.6 months. 96.4% of all patients were objectively continent at the time of last follow-up without differences between both groups, and patient satisfaction was high in both groups. No differences with regard to mechanical implant failure, tissue atrophy, and AUS explantation due to cuff erosion or implant infection were observed. Explantation-free survival was comparable in both groups. On univariable logistic regression analysis, coronary artery disease and transcorporal cuff placement were associated with early AUS revision. Conclusion: Early revision after AUS implantation can be performed without negative impact on the long-term outcome.

P0106 - New technique of robot-assisted laparoscopic artificial urinary sphincter implantation in female by a posterior approach with intraoperative cystoscopic monitoring

To report the early experience of a modified technique of robot-assisted artificial urinary sphincter (AUS) implantation in female, with a posterior approach to the bladder neck and intraoperative real-time cystoscopic monitoring. Retrospective monocentric study included all consecutive female who underwent a primary robot-assisted AUS implantation between 2017 and 2019. Real-time intraoperative cystoscopic monitoring was carried out to check the correct level of the dissection and to avoid any injury during bladder neck dissection. Perioperative and intraoperative data, functional outcomes and complications were assessed. Continence was defined as 0 to 1 pad per day. Twenty-four patients were included, the median age was 66 years, 23/24 (96%) had previous SUI or prolapse surgery. Two conversions to open surgery and 2 modifications of the surgical technique with anterior dissection of the bladder neck were required due to major vesicovaginal adhesions. Overall, 20 patients underwent the robotic posterior approach. Eleven intraoperative complications in 10 patients (50%) occurred, including 7 bladder injuries 4 vaginal injuries, without the need to stop the procedure. The median hospital stay was 3 days (2–7). One AUS was removed at 1 year due to vaginal erosion. At last follow-up (median 26 months (22–36)), 95% of the devices were in place and activated and the continence rate was 84%. Early functional results of robot-assisted AUS implantation with a posterior approach to the bladder neck and intraoperative cystoscopic monitoring are promising despite the high rate of intraoperative complications due to previous surgeries. Further evaluation of this technique is required.

New technique of robot-assisted laparoscopic artificial urinary sphincter implantation in female by a posterior approach with intraoperative cystoscopic monitoring

To report the early experience of a modified technique of robot-assisted artificial urinary sphincter (AUS) implantation in female, with a posterior approach to the bladder neck and intraoperative real-time cystoscopic monitoring. Retrospective monocentric study included all consecutive female who underwent a primary robot-assisted AUS implantation between 2017 and 2019. Real-time intraoperative cystoscopic monitoring was carried out to check the correct level of the dissection and to avoid any injury during bladder neck dissection. Perioperative and intraoperative data, functional outcomes and complications were assessed. Continence was defined as 0 to 1 pad per day. Twenty-four patients were included, the median age was 66years, 23/24 (96%) had previous SUI or prolapse surgery. Two conversions to open surgery and 2 modifications of the surgical technique with anterior dissection of the bladder neck were required due to major vesicovaginal adhesions. Overall, 20 patients underwent the robotic posterior approach. Eleven intraoperative complications in 10 patients (50%) occurred, including 7 bladder injuries 4 vaginal injuries, without the need to stop the procedure. The median hospital stay was 3days (2-7). One AUS was removed at 1year due to vaginal erosion. At last follow-up (median 26months (22-36)), 95% of the devices were in place and activated and the continence rate was 84%. Early functional results of robot-assisted AUS implantation with a posterior approach to the bladder neck and intraoperative cystoscopic monitoring are promising despite the high rate of intraoperative complications due to previous surgeries. Further evaluation of this technique is required.

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.

Overactive bladder and urgency urinary incontinence in men undergoing artificial urinary sphincter placement.

To assess persistent and de novo rates of overactive bladder (OAB) and urgency urinary incontinence (UUI) in patients with incontinence after prostate treatment (IPT) focusing on differences between surgical intervention vs radiation. We performed a retrospective review of 79 patients who underwent primary artificial urinary sphincter (AUS) placement and activation from a single surgeon between February 2012 and November 2017. Four patients with neurogenic bladder were excluded and two with insufficient follow-up. The primary outcome measures were persistent OAB, persistent UUI, and pad usage before and after AUS placement. After activation of the AUS, 67% of non-radiated patients had resolution of urgency incontinence vs only 31% of the radiated patients (P = .096). After activation of the AUS, resolution of OAB symptoms was more common in the non-radiated group. We found 53% of the non-radiated group vs only 22% of the radiated group had resolution of their urinary urgency (P = .045). Previous history of radiation was a risk factor for OAB after implantation of AUS (odds ratio [OR], 3.63; P = .010). Postoperative oral medical pharmacotherapy for OAB was higher in those with previous radiation vs those without prior radiation (66.7% vs 25.7%, P = .001). A history of OAB or UUI did not affect social continence after AUS placement. Radiation is a risk for continued OAB after AUS activation. Appropriate counseling is necessary pre- and postoperatively to manage patient expectations and provide additional medical therapies. Mixed urinary incontinence or OAB symptoms should not exclude patients from undergoing AUS placement.

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.

Long-term device survival and quality of life outcomes following artificial urinary sphincter placement.

Artificial urinary sphincter (AUS) placement is the standard for treatment of severe male stress urinary incontinence (SUI). While there is evidence to suggest satisfactory device survival, there is a paucity of data addressing long-term quality of life outcomes. We identified patients who underwent primary AUS placement from 1983 to 2016. We assessed rates of secondary surgery (overall, device infection/erosion, urethral atrophy, malfunction) and factors associated with these endpoints. Quality of life was evaluated by pad usage and Patient Global Impression of Improvement (PGI-I) at various time points from primary surgery. Follow-up was obtained in clinic or by phoned/mailed correspondence. During the study time frame, 1,154 patients were eligible and included in the analysis. Patients had a median age of 70 years (IQR, 65-75 years) and median follow up of 5.4 years (IQR, 1.6-10.5 years). Overall device survival was 72% at 5 years, 56% at 10 years, 41% at 15 years, and 33% at 20 years. On univariate analysis, variables associated with need for secondary surgery were prior cryotherapy (HR 2.7; 95% CI, 1.6-4.6; P<0.01) or radiation therapy (HR 1.4; 95% CI, 1.1-1.7; P=0.01). On multivariable analysis, only cryotherapy remained significantly associated with this endpoint (HR 2.4; 95% CI, 1.3-4.2; P<0.01). While 36% and 23% of patients 5-10 years out from surgery and >10 years out from surgery, respectively, reported using a security pad or less per day, 78% and 81% of those patients, respectively, reported their PGI-I as at least "much better". AUS placement has excellent long-term outcomes, and is associated with sustained improvement in patient quality of life.

021 Do Prior Anti-incontinence Procedures Influence the Success of Artificial Urinary Sphincter Placement?

Male urethral slings offer a less invasive surgical approach to manage stress urinary incontinence (SUI) compared to the gold standard artificial urinary sphincter (AUS) insertion. Recurrent or incompletely treated SUI following male sling can be managed surgically with repeat sling operation or with AUS insertion. Prior small, single-center retrospective studies demonstrated no association between having failed a sling procedure and worse AUS outcomes. The aim of this study was to compare outcomes of primary AUS placement in men who had or had not undergone a previous sling procedure. A retrospective review of all artificial urinary sphincters implanted at a single academic center during 2000-2018 was performed with attention to patient demographics, urologic history, surgical specifics, postoperative continence, complications, and patient follow up. A total of 225 AUS implantations were performed. After excluding secondary AUS placements, revision and explant procedures, 135 patients were included in this study, of which 20 (14.8%) patients had undergone prior sling procedures. Prior slings included Stamey, AdVance, InVance, and Virtue devices.

Artificial urinary sphincter revision with Quick Connects® versus suture-tie connectors: does technique make a difference?

To evaluate characteristics of artificial urinary sphincter (AUS) mechanical failures and compare outcomes based on the use of either suture-tied connections or Quick-Connects® (QC) for single-component revisions. A total of 46 patients underwent single-component AUS revisions following primary AUS placement from January 1983 to January 2011 at our institute. Prior to 1996 all revision cases were performed with suture-tie connections and after that time we used QC for revisions. Device success was evaluated for a potential association with revision surgery including the type of connector used. Forty-six patients underwent single-component revision surgery for primary device malfunction. In these cases, the tubing connections were performed using suture-tie connectors in 34 (74%), and QC in 12 (26%) cases. The median age was 68.8 years for suture-tie vs 70.6 years for QC (p=0.52). The median follow-up period after revision surgery was 24 months (IQR 7.2, 55.2). There was no statistically significant difference in 5-year device survival rates between suture-tie and QC (36% vs. 61%; p=0.85) techniques. There were no cases of device infection or repeat mechanical failure at the connector among cases of revision performed using QC, as compared to five device infections and four repeat mechanical failures among the suture-tie cohort. The use of QC for single-component AUS revision for mechanical failures appears to be safe, efficient and reliable. There is not enough evidence supporting the presence of an association between connector type with the risk of overall device failure.

Impact of previous urethroplasty on the outcome after artificial urinary sphincter implantation: a prospective evaluation.

To evaluate the impact of previous urethroplasty on complication rates and postoperative continence after primary artificial urinary sphincter (AUS) implantation in male patients with severe stress urinary incontinence. A prospective evaluation of patients undergoing primary AUS implantation was conducted. Patients with previous radiotherapy, AUS implantation or urethral stent placement were excluded. Main endpoints were postoperative continence and complication rates including necessity of AUS explantation. Kaplan-Meier analysis evaluated explantation-free survival. Logistic regression analyses were performed to identify potential predictors for AUS explantation. 105 patients were included with a mean follow-up of 76.6months (SD 15.9). 30 of these patients had a history of urethroplasty. Postoperatively, 96.2% of all patients were objectively continent (≤ 1 pad/day). No differences in postoperative continence and early complication rates were observed. Concerning long-term complications, infection, mechanical implant failure, and tissue atrophy were also comparable. Overall sphincter erosion rate was 12.3%, but significantly higher in urethroplasty patients (23.3% vs. 8.0%, p = 0.038) and sphincter explantation rate was threefold higher (p = 0.016) in the urethroplasty group. Furthermore, explantation-free survival was reduced compared to the non-urethroplasty group (p = 0.044). On logistic regression analysis, the previous urethroplasty was the only significant predictor for AUS explantation (p = 0.016). AUS implantation in patients with former urethroplasty can provide satisfying results. Compared to patients without the previous urethroplasty, the higher risk of cuff erosion and AUS explantation has to be addressed during preoperative consultation. Patients with the previous urethroplasty with grafting, long strictures and previous visual internal urethrotomy might be at highest risk.