Primary Artificial Urinary Sphincter Placement Research Articles

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.

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 ...

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 ...

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.

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.

Evaluating the impact of radiation therapy on patient quality of life following primary artificial urinary sphincter placement.

The impact of prior radiation therapy on patient satisfaction following primary artificial urinary sphincter (AUS) placement is not well described, therefore our aim was to evaluate the effect of radiation on patient satisfaction among men undergoing primary AUS with and without a history of prior radiation. From 1983-2011, 1,082 men underwent primary AUS placement at our institution. Of these, 467 were alive, with an intact primary AUS and invited to participate in a mailed survey assessing AUS status, patient satisfaction, and urinary control. Clinical subjective outcomes were assessed via reported change in urinary control from pre-operative to post-AUS placement. In total, 229/467 (49%) of men with an intact primary AUS completed the survey, with a median follow-up of 8.4 years [interquartile range (IQR) 5.8-11.4]. Of these, 64 men (28%) had a prior history of radiation therapy. Both men with and without history of radiation, reported a high likelihood of electing to have AUS surgery again, 87% vs. 91% respectively (P=0.87), and of recommending AUS surgery to a family member, 86% vs. 93% respectively (P=0.18). There were no significant differences between those with and without prior radiation with regard to rates of reported: substantial improvement in urinary control following surgery (72% vs. 78%, P=0.30), minimal bothersome leakage (57.1% vs. 66%, P=0.31), and pad use ≤1 pad/day (49% vs. 59%, P=0.06). In a large cohort of primary AUS implants with and without prior radiation therapy we noted a high-level of satisfaction and though many patients still utilized 1 or more pads/day with long-term follow-up. Importantly, there was no significant difference in quality of life (QoL) outcomes compared between those with and without prior radiation therapy.

Risk factors for subsequent urethral atrophy in patients undergoing artificial urinary sphincter placement.

Artificial urinary sphincter (AUS) device failure or revision can be due to multiple etiologies including erosion, infection, mechanical malfunction, and urethral atrophy. However, few studies have evaluated factors that predispose patients to urethral atrophy. Here, we sought to identify preoperative and perioperative risk factors associated with urethral atrophy in men undergoing primary artificial urinary sphincter (AUS) placement for stress urinary incontinence. From 1987 to 2013, 1829 AUS procedures were performed at our institution. A total of 1068 patients underwent primary AUS placement and were the focus of our study. Multiple clinical and surgical variables were evaluated for a potential association with revision for atrophy. Those found to be associated with atrophy and relevant competing risks were further evaluated on multivariable analysis. With a median follow-up of 4.2 years (IQR 1.3-8.1), 89 men (8.3%) had urethral atrophy requiring reoperation. Median time to revision was 4.5 years (IQR 1.9-7.6). On univariable analysis, only smaller cuff size (4.0-cm versus 4.5-cm; HR 3.1, p=0.04) was associated with an increased rate of urethral atrophy. Notably, patient age at the time of surgery (p=0.62), body mass index (0.22), and smoking status (p=1.00) were not associated with a risk of atrophy. On multivariable analysis smaller urethral cuff size remained significant (HR 2.8, 95% CI 1.1-7.1; p=0.01). Revision surgery for urethral atrophy was performed in approximately 8% of men undergoing primary AUS placement. Utilization of a smaller AUS cuff size appears to be an independent factor associated with increased rate of urethral atrophy.

Dorsolateral fibromuscular tissue preservation during artificial urinary sphincter cuff placement is associated with low infection and erosion rates.

To present a modified technique in artificial urinary sphincter (AUS) placement that is associated with low rates of erosion and infection in a high-risk population. After Institutional Review Board approval, we identified patients who underwent primary AUS placement using the modified technique between January 2007 and November 2015. Our modification consists of preserving the dorsolateral fibromuscular tissue surrounding the bulbar urethra and horizontally transecting the ventral bulbospongiosus muscle during urethral cuff placement. Preoperative variables such as radiotherapy (RT) and bladder neck contractures were recorded. Effectiveness and complications including infections, erosions, and re-operations were recorded at follow-up. The new technique was used on 208 patients: 40% had a history of RT, including 15% who had had a salvage radical prostatectomy; 26% had had previous bladder neck contractures. No patients developed infection. Overall, erosion occurred in six (2.9%) patients and spontaneous erosions occurred in two (0.9%) during the study period. In all, 21 patients underwent re-operation for device failure. The probability of re-operation for 'any' reason was 7% (95% confidence interval [CI] 4-12%) at 1 year. The 1-year social continence rate was 74% (95% CI 67-81%). Preservation of dorsolateral fibromuscular tissue during AUS placement is an effective means to achieve a low risk of erosions. Our modified technique is safe with low infection and erosion rates, whilst maintaining good functional outcomes despite a high-risk population.

Can time to failure predict the faulty component in artificial urinary sphincter device malfunctions?

Artificial urinary sphincter malfunctions can occur in any of the individual components. Preoperative identification of the malfunctioning component can be valuable for patient counseling and surgical planning. The optimal strategy for repair of failed artificial urinary sphincter components is debated given the relative rarity of the situation. The aim of the present study was to evaluate the relationship of time to failure with failed artificial urinary sphincter component and to compare our outcomes of specific component versus complete device replacement. From 1983 to 2011, 1805 artificial urinary sphincter procedures were carried out at Mayo Clinic (Rochester, Minnesota, USA), of which 1072 patients underwent primary artificial urinary sphincter placement. Clinical variables, including time to failure, were evaluated for association with component failure. Bootstrap analysis was used to estimate the differences in time to reach a fixed percentage of component failure. A total of 115 patients experienced device failure at a median follow up of 4.2 years. Urethral cuff, abdominal reservoir, scrotal pump and tubing malfunction occurred in 53 (4.9%), 26 (2.4%), 11 (1%) and 25 (2.3%) patients, respectively. Increasing age at the time of primary surgery was protective of cuff malfunction (hazard ratio 0.97, P = 0.04). Time to 3% urethral cuff failure outpaced other component failures (P < 0.05). Secondary failure-free rates after whole device versus specific component revisions were comparable (P = 0.38). Clinical predictors for artificial urinary sphincter failure continue to be difficult to establish. Although single component versus entire device replacement have similar outcomes, if pursuing single component revision, we recommend cuff-first interrogation in devices in place for >3 years, as this represents the most likely component to fail.

Evaluating Success Rates After Artificial Urinary Sphincter Placement: A Comparison of Clinical Definitions

To assess success rates of primary artificial urinary sphincter (AUS) implantation using various objective, subjective, or retreatment definitions. We identified 309 male patients who underwent primary AUS placement at the Mayo Clinic from 2010 to 2016. Of those, 214 had not undergone repeat surgery, were sent a mailed survey, and 148 of 214 (69.2%) responded. Eleven definitions of success were evaluated among responders. Associations between the definitions and patient-reported success were assessed via logistic regression and c-statistic. Treatment success rates were highly variable depending on the definition used (14.8%-86.7%). Median follow-up was 24 months (interquartile range [IQR] 8, 40), during which 72% did not undergo reoperation. Among survey respondents, 87% felt at least "much better," and 47% reported surgery was "very successful." Roughly 15% reported zero pad use. Patient-reported success was most strongly associated with the Patient Global Impression of Improvement (PGI-I) score (odds ratio [OR] 0.07, 95% confidence interval [CI] 0.02-0.19; P <.0001; c = 0.88). The largest difference in Michigan Incontinence Symptom Index (M-ISI) score between treatment successes and failures was noted when success was defined by PGI-I as well (success group M-ISI 11 vs failure group M-ISI 24.15; OR 0.48, 95% CI 0.37-0.63; P <.0001; c = 0.97). In terms of pad count, use of a security pad or less was most closely associated with patient-reported success (OR 0.18, 95% CI 0.10-0.35; P <.0001; c = 0.75). The "success rate" after primary AUS implantation varies widely depending on the definition used. Although most patients report that surgery was beneficial, zero pad count was less common. Among definitions evaluated, the PGI-I had the strongest association with patients' evaluation of surgical success.

The impact of incontinence etiology on artificial urinary sphincter outcomes.

PurposeTo evaluate the impact of incontinence etiology on artificial urinary sphincter (AUS) device outcomes.Materials and MethodsWe identified 925 patients who underwent primary AUS placement from 1983 to 2011. The etiology of incontinence was categorized as radical prostatectomy alone, radical prostatectomy with radiation, benign prostate resection, and those with cryotherapy as a salvage prostate cancer treatment. Hazard regression and competing risk analyses were used to determine the association of the etiology of incontinence with device outcomes.ResultsThe distribution of the 4 etiologies of incontinence included: 598 patients (64.6%) treated with prostatectomy alone, 206 (22.2%) with prostatectomy and pelvic radiation therapy, 104 (11.2%) with benign prostate resection, and 17 (1.8%) with prior cryotherapy. With a median follow-up of 4.9 years (interquartile range, 1.2–8.8 years), there was significant difference in the cumulative incidence of device infection/urethral erosion events between the four etiologies (p=0.003). On multivariable analysis, prior cryotherapy (reference prostatectomy alone; hazard ratio [HR], 3.44; p=0.01), older age (HR, 1.07; p=0.0009) and history of a transient ischemic attack (HR, 2.57; p=0.04) were associated with an increased risk of device infection or erosion. Notably, pelvic radiation therapy with prostatectomy was not associated with an increased risk of device infection or erosion (reference prostatectomy alone, p=0.30).ConclusionsCompared to prostatectomy alone, prior treatment with salvage cryotherapy for recurrent prostate cancer was associated with an increased risk of AUS infection/erosion, whereas radiation (in addition to prostatectomy) was not.

The impact of androgen deprivation on artificial urinary sphincter outcomes.

BackgroundAndrogen deprivation therapy (ADT) causes systemic tissue atrophy. It is unclear if this tissue atrophy adversely impacts artificial urinary sphincter (AUS) outcomes. We sought to evaluate the effect of ADT on adverse AUS outcomes.MethodsWe retrospectively identified 518 men undergoing primary AUS placement at our institution between 1998 and 2014. Rates of device explant for infection/erosion, mechanical failure, and urethral atrophy in men with >6 months of ADT use within 2 years prior to AUS placement were compared to ADT naive men.ResultsFifty of the patients (50/518, 9.7%) had >6 months of ADT use within 2 years prior to AUS placement while 442 were ADT naive. Multivariable survival analysis of AUS events by competing risks failed to show any effect of ADT on device explantation for infection/erosion (HR 1.12, P=0.68), replacement for mechanical failure (HR 0.92, P=0.77), or urethral atrophy (HR 0.77, P=0.46).ConclusionsThis study did not show evidence supporting differences in adverse AUS outcomes between men with ADT use and ADT naive men.

Artificial urinary sphincters for male stress urinary incontinence: current perspectives.

The artificial urinary sphincter (AUS), which has evolved over many years, has become a safe and reliable treatment for stress urinary incontinence and is currently the gold standard. After 4 decades of existence, there is substantial experience with the AUS. Today AUS is most commonly placed for postprostatectomy stress urinary incontinence. Only a small proportion of urologists routinely place AUS. In a survey in 2005, only 4% of urologists were considered high-volume AUS implanters, performing >20 per year. Globally, ~11,500 AUSs are placed annually. Over 400 articles have been published regarding the outcomes of AUS, with a wide variance in success rates ranging from 61% to 100%. Generally speaking, the AUS has good long-term outcomes, with social continence rates of ~79% and high patient satisfaction usually between 80% and 90%. Despite good outcomes, a substantial proportion of patients, generally ~25%, will require revision surgery, with the rate of revision increasing with time. Complications requiring revision include infection, urethral atrophy, erosion, and mechanical failure. Most infections are gram-positive skin flora. Urethral atrophy and erosion lie on a spectrum resulting from the same problem, constant urethral compression. However, these two complications are managed differently. Mechanical failure is usually a late complication occurring on average later than infection, atrophy, or erosions. Various techniques may be used during revisions, including cuff relocation, downsizing, transcorporal cuff placement, or tandem cuff placement. Patient satisfaction does not appear to be affected by the need for revision as long as continence is restored. Additionally, AUS following prior sling surgery has comparable outcomes to primary AUS placement. Several new inventions are on the horizon, although none have been approved for use in the US at this point.

The Impact of Diabetes Mellitus and Obesity on Artificial Urinary Sphincter Outcomes in Men

To evaluate the impact of diabetes and obesity on artificial urinary sphincter (AUS) outcomes. From 1987 to 2011, men with available diabetes and body mass index (BMI) information (568 of 954) undergoing primary AUS placement at our institution were evaluated. The incidence of all-cause reintervention, mechanical failure, atrophy, and erosion or infection was assessed using the Kaplan-Meier method. Multivariable analyses evaluated the association between clinical characteristics and AUS outcomes. In total, 90 (16%) men had diabetes. Median follow-up among alive men without AUS event was 5.9 years. Diabetics had a greater 5-year incidence of erosion/infection (13% vs 8%; P = .025). On multivariable analysis, diabetes was independently associated with an increased risk of erosion/infection (hazard ratio [HR] = 2.26; P = .02); whereas greater BMI was associated with a reduced risk of erosion or infection (obese: HR = 0.39; P = .02; overweight: HR = 0.57; P = .07). Accordingly, in diabetics, greater average postoperative glucose level (176 mg/dL vs 153 mg/dL; P = .04) and use of nonantibiotic coated devices (13 of 62 vs 1 of 28; P = .035) was associated with a greater incidence of erosion or infection. There was no difference in social continence (≤1 pad/day) (45% vs 57%; P = .29) or high-level satisfaction (95% vs 90%; P = .43) among diabetics vs nondiabetics. However, with greater BMI (<25, 25 to <30, and ≥30), there was a decrease in ≤1 pad/day usage (62% vs 61% vs 49%; P = .02). We found that the presence of diabetes was independently associated with a 2.3-fold increased risk of AUS erosion or infection. These findings warrant the consideration of additional periprocedural measures to reduce the risk of this devastating complication.

Outcomes of artificial urinary sphincter placement in octogenarians.

To evaluate the impact of patient age on device outcomes among patients undergoing primary artificial urinary sphincter. A total of 1081 male patients who underwent primary artificial urinary sphincter placement from 1983 to 2011 were analyzed, including 91 men (8%) who were aged >80 years at the time of surgery. Revisions and explanations were compared between men stratified by decade of life. Hazard ratios adjusting for competing risks were used to determine the association with age and artificial urinary sphincter device outcomes (infection/erosion, urethral atrophy and malfunction), while overall device failure was estimated using Kaplan-Meier and Cox regression analysis. Patients aged >80 years were more likely to have coronary disease (P = 0.009), diabetes mellitus (P = 0.04), hypertension (P = 0.002) and lower body mass index (P < 0.0001). On multivariable analysis, patients aged >80 years were significantly more likely to experience device erosion or infection compared with a reference of patients aged <60 years (hazard ratio 4.13; P = 0.046), whereas there was no difference in those patients aged 60-70 years or 70-80 years compared with the reference group (P = 0.56 and 0.45). There was no significant difference in overall device survival between the age-stratified groups (P = 0.26). Although overall artificial urinary sphincter device survival is similar, patients aged >80 years are more likely to experience erosion or infection compared with younger patients. Despite this, the overall device failure rate is low, and artificial urinary sphincter might be considered for appropriately selected and counseled octogenarians.