Artificial Urinary Sphincter Revision Research Articles

Artificial urinary sphincter implantation in non-neurogenic men: a place for out-patient surgery.

To assess feasibility, safety and risk factors for failure associated with out-patient surgery for artificial urinary sphincter (AUS) implantation/revision in non-neurogenic men. In the present retrospective monocentric study conducted between May 2016 and March 2020, 81 patients undergoing AUS implantation or revision during an out-patient surgery were included. The primary outcome was the success rate of out-patient surgery. Success was assessed using two distinct definitions, a narrow definition, where success was defined as a one-day hospitalization and the absence of any unscheduled consultation or re-hospitalization within the 3days following surgery, a broad definition, where success was defined as a one-day hospitalization and the absence of any unscheduled re-hospitalization within the 3days following surgery. In parallel, risk factors for failure of out-patient surgery, as well as efficacy and safety were assessed. Eighty-one patients were enrolled, with a mean age of 71.2years ± 5.9. Out-patient surgery was successfully completed in 58 men (71.6% [95% CI 60.5-81.1]) and in 76 men (93.8% [95% CI 86.2-97.9]) according to the narrow and the broad definition, respectively. After multivariate analysis, anticoagulant therapy (OR 25.97 [95% CI 4.44-152.04]) and low socio-professional status (OR 22.1 [95% CI 3.701-131.95]) were statistically associated with failure of out-patient surgery. The continence rate after a 90-day follow-up was 79%. AUS implantation/revision in non-neurogenic men could be safely proposed in out-patient surgery. Special attention may however be paid to patients undergoing anticoagulant therapy or belonging to a low socio-professional category. DEC20-173 (French National Commission for Data Protection and Liberties).

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.

111 First-time Transcorporal vs Standard Artificial Urinary Sphincter Placement in Patients with Prior Tadiation for Prostate Cancer: A Comparison of Outcomes

The artificial urethral sphincter (AUS) is the gold standard treatment for male stress urinary incontinence which commonly Results from prostatectomy or pelvic radiation for prostate cancer. Radiation therapy is a well-established risk factor for complications following artificial urinary sphincter placement including increased risk of sphincter erosion and need for revision surgery. Patients with a history of radiation are 1.56 times more likely to undergo artificial urinary sphincter revision surgery with rates of infection or erosion as high as 50% at 2 years. The transcorporal technique for artificial urinary sphincter placement has primarily been used for revision surgery to mitigate the risks of recurrent urethral erosion by interposing the tunica albuginea between the cuff and thin dorsal urethra.

The Role of Educational Level and Cognitive Status in Men Undergoing Artificial Urinary Sphincter Implantation

OBJECTIVETo examine the relationship between education level, cognitive function of patients and the success/ revision rates of artificial urinary sphincter (AUS) implantation in men with postprostatectomy incontinence. METHODSBetween January 2010 and March 2018, 163 patients (mean age, 68 ± 6.8 years) with moderate-to-severe stress urinary incontinence who underwent AUS implantation were retrospectively examined. Demographic data, body mass index, comorbidities, surgical technique, previous strictures, and radiation therapy were recorded. Incontinence was measured by daily pad use and evaluated by International Consultation on Incontinence Questionnaire-short form. Patients’ overall improvement was assessed using the Patient Global Impression of Improvement questionnaire. Education level was determined using the International Standard Classification of Education. Cognitive status was assessed using the Mini-Mental State Examination. Treatment success was defined as the need for ≤1 pad/day at last follow-up. RESULTSAUS was successful in 77.3% of patients. The International Consultation on Incontinence Questionnaire-short form score improved significantly from 19.9 ± 2.9 to 4.4 ± 5.4 (P = .001). The median outcome reported subjectively on the Patient Global Impression of Improvement scale was 2.1 ± 1.5 (1-7) and self-reported as “much better.” Patients’ education level had statistically no significant relationship with AUS success and revision rates. Similarly, there was no significant relationship between cognitive status, educational level and the need for revision of AUS (P >.05). However, patients with moderate cognitive impairment and a body mass index >30 showed significantly lower AUS success rates (P <.05). CONCLUSIONAUS implantation is safe and effective treatment option especially for nonobese and cognitively intact patients of all educational levels.

Improved artificial urinary sphincter outcomes using a transcorporal cuff placement in patients with a "fragile urethra".

The artificial urinary sphincter (AUS) is the most effective treatment option for incontinence after prostate cancer treatment. However, patients with a "fragile urethra" (defined as prior radiotherapy, previous failed AUS, or previous urethroplasty) are at increased risk of AUS failure. The aim of this study was to evaluate outcomes using standard and transcorporal cuff placement in this group of patients. A retrospective review was performed on patients with a fragile urethra who underwent AUS insertion between 2004 and 2017. The primary outcome was the need for AUS revision. Secondary outcome measures included change in pad use, patient satisfaction, continence (≤1 pad/day), improvement (≥50% change in pad use), and cuff erosion rates. Seventy-six patients met the criteria for inclusion, with a mean age of 71.6 years and a mean followup of 37.9 months. A total of 42.1% had prior radiotherapy, 56.6% had a history of failed AUS, and 19.7% had previous urethroplasty. Transcorporal cuff placement was performed in 31.6% (n=24). These patients had lower revision (20.8% vs. 36.5%; p=0.05) and erosion rates (8.3% vs. 17.3%; p=0.09). There was no significant difference in functional outcomes such as continence (66.7% vs. 73.1%; p=0.57), improvement (100% vs. 90.4%;p=0.17), or satisfaction (82.6% vs. 69.4%; p=0.26), nor for 90-day complications (4.2% vs. 9.6%; p=0.41). AUS insertion is an effective treatment option for post-prostatectomy incontinence in the setting of a fragile urethra. Transcorporal cuff placement in this subset of patients may be recommended, as it is associated with lower revision and erosion rates compared to standard cuff placement.

A new paradigm for surgical revision of the artificial urinary sphincter for recurrent stress urinary incontinence: Wilson's Workshop 11.

Although the artificial urinary sphincter (AUS) is widely regarded as the "gold standard" for surgical correction of male stress urinary incontinence, long-term durability for symptom control is variable. A significant number of men will experience a decline in device-related improvement over time. With erosion of initial success, men sufficiently bothered by recurrent incontinence not caused by device malfunction may seek surgical revision. Secondary surgery requires careful consideration on the part of the prosthetic urologist and a keen awareness of sound surgical techniques. The armamentarium for revision has traditionally consisted of strategies involving cuff downsizing and/or relocation, modification of the pressure regulating balloon, urethral wrapping, addition of a tandem cuff, or use of transcorporal cuff placement. These options will be presented in view of their evidence and theoretical advantages and disadvantages. In addition, we will discuss a newer approach of growing popularity that serves to challenge existing dogma and shift the paradigm of AUS revision surgery.

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 ...

Urethral atrophy is now a rare cause for artificial urinary sphincter revision surgery in the contemporary 3.5 cm cuff era.

Urethral atrophy has long been suggested as the leading cause of artificial urinary sphincter (AUS) revision. Since the introduction of the 3.5 cm AUS cuff in 2010, precise cuff sizing primarily has been suggested to reduce revisions due to urethral atrophy. We evaluated a large contemporary series of reoperative AUS cases to determine reasons for revision surgery. We retrospectively reviewed our tertiary referral center database of male AUS procedures performed by a single surgeon from 2007-2019. AUS revision or replacement procedures were included for analysis. Cuff sizes and reasons for reoperation were recorded based on intraoperative findings and evaluated for temporal trends. Patients with cuff erosion or lacking follow-up were excluded. Among 714 AUS cases, 177 revisions or replacements were identified. Of these, 137 met inclusion criteria [mean age 71.7 years, median follow-up 52.7 months (IQR 22.3-94.6 months)]. Urethral atrophy was cited as the cause of AUS failure in 8.0% (11/137) of cases overall, virtually never among those with a 3.5 cm cuff placement (1/51, 2.0%). In those with ≥4.0 cm cuffs, urethral atrophy was the reason for revision in 10/86 (11.6%). Pressure regulating balloon (PRB) failure was the most frequently cited cause of failure (47/137, 34.3%). Cuff-related failure (23/137, 16.8%) and mechanical failure of unspecified device component (16/137, 11.8%) were the next most frequent causes of failure. Urethral atrophy has become a rare cause of AUS revision surgery since the availability of smaller cuffs. PRB-related failure is now the leading cause of AUS reoperation.

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.

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.

Re: Analysis of Cost of Component Replacement versus Entire Device Replacement during Artificial Urinary Sphincter Revision Surgery.

Re: Analysis of Cost of Component Replacement versus Entire Device Replacement during Artificial Urinary Sphincter Revision Surgery.

Predictors of Device-related Complications After Exchange of the Pressure-regulating Balloon in Men With an Artificial Urinary Sphincter

OBJECTIVETo identify patient and component specific factors that predispose patients to device-related complications when undergoing pressure-regulating balloon (PRB) exchange in men with an artificial urinary sphincter (AUS). METHODFrom 2009 to 2018, 55 patients underwent AUS revision with placement of a higher pressure 71-80 cm H2O PRB to treat recurrent stress incontinence. Patient demographics, perioperative data, and postoperative outcomes were examined and multivariable logistic regression analyses performed to identify predictors of erosion and mechanical failure. RESULTAfter a median follow-up of 26.4 months (range: 6-103.7 months), 21 of 55 (38.1%) patients developed a device-related complication that required operative repair or removal of the AUS. Four (7.3%) patients developed erosion after the PRB pressure increase and 5 patients showed evidence of impending erosion on follow-up and underwent successful revision surgery. Twelve patients developed mechanical failure (cuff leak, n = 7; pump malfunction, n =4; unidentified fluid loss, n = 1). Multivariable logistic regression analysis found that increasing body mass index was a predictor of mechanical failure. Hypertension and lower body mass index were found to increase the risk of cuff erosion whereas radiotherapy was not. CONCLUSIONIn the carefully selected patient, PRB exchange can be performed to treat recurrent incontinence in patients with an AUS, including those treated with pelvic radiotherapy. Our data suggest that this technique is susceptible to a high rate of revision surgery. As such, when revising a functional AUS system, meticulous preoperative screening, comprehensive informed consent, and follow-up protocols are essential in minimizing adverse events.

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.

Bacterial Cultures at the Time of Artificial Urinary Sphincter Revision Surgery in Clinically Uninfected Devices: A Contemporary Series.

We evaluated the rate of bacterial colonization in artificial urinary sphincters during revision surgery for noninfectious etiologies. We evaluated bacterial culture swab data on all explanted artificial urinary sphincter components (cuff, pump and reservoir) in patients who underwent revision surgery between February 2016 and July 2018. Those treated with revision for infection or erosion were excluded from study. Patient demographic variables were assessed to identify factors associated with colonization. Cultures were obtained from 200 components, including 86 cuffs, 56 pumps and 58 reservoirs among the total of 80 patients. The etiology of revision included urethral atrophy in 31 cases (39%) and mechanical failure in 49 (52%). Median time after prior artificial urinary sphincter placement was 4.3 years (IQR 2-9). Median operative time was 37.5 minutes (IQR 32-46). All components were explanted and replaced in 55 patients (69%) and a single component was replaced in 23 (28%). Positive culture swabs were identified in 37 of the 200 components (19%), including 25 of 86 cuffs (29%), 7 of 56 pumps (13%) and 5 of 58 reservoirs (9%). Of the 80 patients 31 (39%) had at least 1 positive component culture and were more likely to have a history of radiation (65% vs 33%, p = 0.006). Identified organisms included Staphylococcus species in 57% of cases, Propionibacterium in 10% and Aerococcus in 5%. Positive artificial urinary sphincter component bacterial swab cultures were found in 39% of patients undergoing artificial urinary sphincter revision in the absence of clinical infection. Those with positive cultures were more likely to have a history of pelvic radiation. These results suggest that bacterial colonization of organisms with low virulence may not lead to device infection.

Sphincter urinaire artificiel robot chez la femme : début d’expérience

To analyze the medium-term results and complications of the artificial urinary sphincter (AUS) AMS 800 implanted using laparoscopic robot surgery in women with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD). We conducted a prospective cohort study, which included all procedures done in the CHU of Nîmes from July 2015 to January 2017. Patients with SUI by ISD needing an AUS or patients with a malfunctioning AUS needing to be changed were included. We collected data on intraoperative complications, length of hospitalization, postoperative complications, continence rate at twelve months and satisfaction of patients. Nineteen patients were included, 10 for primo-implantation and 9 for AUS revision. There were 4 postoperative bladder injuries, of which 2 led to laparoconversions. The mean length of hospitalization was 4.1days. Three patients had postoperative complications, which needed an intervention without AUS removal. One patient with persisting SUI due to bladder weakness preferred AUS ablation rather than having a cuff change. There was a median follow-up of 22months (12 to 33months). Sixteen patients out of 19 were completely continent and were satisfied of their intervention and the improvement of their quality of life. The laparoscopic robot surgery for AUS implantation is safe and reproducible with good medium-term results. 4.

EDITORIAL COMMENT

The paper above adds to the growing body of evidence that the pressure regulating balloon (PRB) of the artificial urinary sphincter (AUS) system plays a critical role in controlling and effecting continence rates. Many urologists who perform AUS insertion feel that the pressure generated from the PRB can be inconsistent and there is a real need for future investigations to evaluate PRBs with a manometer to better analyze pressures. Perhaps these authors will prospectively assess this in future patients to better pinpoint revision approach. Also, there are many instances when performing an AUS revision that there is fluid loss in the PRB without any discernible evidence of leak from any of the components. This presents a conundrum to clinicians and frequently necessities compete revision with an entire new AUS system. Regardless, the results of this small series suggest that improved continence rates can be obtained by switching the 61-70 cm H2O pressure PRB to a 71-80 cm H2O pressure in select situations. The obvious advantage to this revision technique is it greatly simplifies the procedure by avoiding urethral dissection and allows patients to immediately reactivate the device, because there will be no scrotal swelling associated with the new placement of a pump. It would have been helpful if the authors had been able to identify those patients who had prior AUS with reasons for previous explant, but the retrospective nature of this series did not allow this. In addition, there is a clear distinction between patients with persistent vs recurrent incontinence which was not evaluated in this series. Persistent incontinence indicates a possible cuff sizing issue, while recurrent incontinence is more consistent with a device malfunction, eg, like a PRB losing pressure. In general, all surgeons in this arena could benefit from a better systematic way to trouble-shoot the AUS and especially assess for urethral atrophy. Cystoscopic inspection can be fraught with uncertainty in some cases and the premise of this manuscript is upregulating the PRB is effective when urethral atrophy has not occurred. Finally, some continued sobering reminders that irradiated patients have a higher risk of erosion and in fact constituted the 3 erosions seen in this cohort.

Causes of Artificial Urinary Sphincter Failure and Strategies for Surgical Revision: Implications of Device Component Survival

BackgroundUp to 50% of patients receiving an artificial urinary sphincter (AUS) require surgical revision after initial placement. However, the literature is heterogeneous regarding the leading causes of AUS failure and appropriate surgical management. ObjectiveTo inform a revision approach by tabulating the causes of AUS failure, assessing AUS component survival, and examining the single-component revision efficacy. Design, setting, and participantsWe retrospectively reviewed 168 patients receiving AUS placements carried out by a single surgeon from 2008 to 2016 at a high-volume academic institution. The median follow-up from initial placement was 2.7 yr, with 37.5% experiencing recurrent incontinence. The cuff size ranged from 4.0 to 5.5cm, with median size of 4.5cm. InterventionPatients without infection or erosion underwent systematic device interrogation and revision, starting with the pressure-regulating balloon (PRB) and then, if necessary, the urethral cuff. Device revision involved either PRB-only correction or cuff and PRB revision. Outcome measurements and statistical analysisWe used bootstrapped intervals to estimate the mean time to failure for individual AUS components. Kaplan-Meier estimates were used to compare survival for individual components and for revised devices by revision technique. Results and limitationsPRB malfunction most commonly caused device failure, while cuff or pump malfunction was rare. Among patients undergoing surgical revision, those with PRB-only correction had similar outcomes to those with more extensive device correction (cuff and PRB exchange; p=0.46). This study, while systematic and detailed, is limited by sample size, follow-up length, and its retrospective nature. ConclusionsPRB malfunction most commonly caused AUS failure in our cohort. PRB-only correction may satisfactorily restore AUS function in select patients. Consequently, initial interrogation of the PRB may avoid a second incision and urethral exposure for many patients requiring AUS revision. Patient summaryArtificial urinary sphincters remain prone to failure over time. In many instances, correcting only the pressure-regulating balloon may effectively restore device function, allowing for a less invasive revision.

197 Artificial Urinary Sphincter Revision for Recurrent Incontinence: Single Component Replacement is Both Feasible and Efficacious

Artificial Urinary Sphincter (AUS) placement is the gold-standard for moderate to severe post-prostatectomy stress urinary incontinence. Up to 50% of patients will require AUS revision due to recurrent incontinence secondary to mechanical failure or urethral atrophy. However, it is controversial if single component revision is feasible and effective or if the entire device should be replaced. We retrospectively identified 168 patients from 2008-2016 receiving an AUS from a single surgeon. Patients were presumed to have a functional AUS until they presented for recurrent incontinence or at last review of the database. During AUS revision, the pressure regulating balloon (PRB) was interrogated and if defective replaced. If the PRB was functional, it was left in-situ and the additional components interrogated with only the defective part replaced. Revisions were performed as outpatient procedures and devices left active unless the pump was replaced. At a median follow-up of 2.7 years, 63 patients (37.5%) required revision. The most common cause of AUS failure was PRB malfunction (36.5%) followed by urethral atrophy (22.2%). History of adjuvant radiation and prior sling placement were predictive of failure. On Kaplan-Meier analysis, PRB (84.3%) had significantly shorter survival at 5 years compared to urethral cuff (95.9%) and control pump (96.6%). Patients who underwent single component PRB replacement had similar device survival compared to a total AUS replacement (2.5 year survival: 71.1% vs. 87.5%, p =0.20).

Artificial urinary sphincter implantation: an important component of complex surgery for urinary tract reconstruction in patients with refractory urinary incontinence

BackgroundWe review our outcomes and experience of artificial urinary sphincter implantation for patients with refractory urinary incontinence from different causes.MethodsBetween April 2002 and May 2017, a total of 32 patients (median age, 40.8 years) with urinary incontinence had undergone artificial urinary sphincter placement during urinary tract reconstruction. Eighteen patients (56.3%) were urethral injuries associated urinary incontinence, 9 (28.1%) had neurogenic urinary incontinence and 5 (15.6%) were post-prostatectomy incontinence. Necessary surgeries were conducted before artificial urinary sphincter placement as staged procedures, including urethral strictures incision, sphincterotomy, and augmentation cystoplasty.ResultsThe mean follow-up time was 39 months. At the latest visit, 25 patients (78.1%) maintained the original artificial urinary sphincter. Four patients (12.5%) had artificial urinary sphincter revisions. Explantations were performed in three patients. Twenty-four patients were socially continent, leading to the overall success rate as 75%. The complication rate was 28.1%; including infections (n = 4), erosions (n = 4), and mechanical failure (n = 1). The impact of urinary incontinence on the quality of life measured by the visual analogue scale dropped from 7.0 ± 1.2 to 2.2 ± 1.5 (P <0.001).ConclusionsThe primary sources for artificial urinary sphincter implantation in our center are unique, and the procedure is an effective treatment as a part of urinary tract reconstruction in complicated urinary incontinence cases with complex etiology.

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OBJECTIVES/SPECIFIC AIMS: Stress urinary incontinence (SUI) significantly affects quality of life and occurs in 60% of men after radical prostatectomy, with 5% requiring surgical treatment. The artificial urinary sphincter (AUS) offers these patients excellent control of their post-prostatectomy SUI. The device contains 3 parts: the pump, urethral cuff, and pressure regulating balloon. Despite the effectiveness of AUS, up to 50% of patients require surgical revision after initial placement due to recurring SUI. Thus far, literature is heterogeneous regarding the causes of mechanical AUS failure and appropriate surgical management. Our study aims to characterize the most common reasons of AUS failure requiring surgical revision and the survival of each AUS component. METHODS/STUDY POPULATION: We report a series of 48 patients who received AUS placement and/or revision by 1 surgeon from 2010 to 2013. Upon presenting for revision, intraoperatively, the surgeon systematically evaluated the device for failure of the balloon, cuff and pump as well as urethral erosion and atrophy. In patients not requiring revision all device components were presumed functional. We conducted retrospective chart review to collect baseline characteristics, intraoperative findings, and postoperative outcomes. Using Kaplan-Meier estimates, we calculated incidence rates of component failure for the cuff, pump, and balloon. To identify risk factors for AUS failure, Cox regression was performed for univariate and multivariable testing. Multivariable modeling included those variables considered biologically plausible and significant in univariate testing. RESULTS/ANTICIPATED RESULTS: In total, 48 patients were studied with median follow up of 4.25 years. All patients received an AMS 800 device with a 61–70 mL balloon filled with 27 cc of isotonic contrast. Cuff sizes ranged from 3.5 to 5.5 cm, with 4.5 cm selected in 33/48 cases (68.8%); 19 of the patients required AUS correction (41.7%). Balloon leak constituted 57.9% (11/19) of failures, followed by cuff failure/urethral atrophy (21.1%), urethral erosion (10.5%), and individual cases of infection and pump failure. Median time to mechanical failure due to balloon leak was 3.67 years (IQR 2.17, 5.33); median time to failure for nonballoon causes was 0.54 years (IQR 0.25, 1.83). Survival of the balloon, cuff, and pump was 100%, 95.7%, and 97.9% at 1 year and 76.9%, 91.0%, and 97.9% at 5 years, respectively. DISCUSSION/SIGNIFICANCE OF IMPACT: Our study identifies fluid leakage from the balloon as the most common cause of AUS failure, particularly in patients presenting between 1 and 5 years after initial placement. For such patients, interrogating the balloon first can decrease infection risk and surgical morbidity as it can avoid manipulation of the urethral cuff. Furthermore, simply replacing lost fluid saves cost and allows for immediate reactivation of the AUS device.