Understanding a decade of safety reporting for sacral neuromodulation in the Food and Drug Administration Manufacturer and User Facility Device Experience database.

INTRODUCTION: Over 350 000 sacral neuromodulation (SNM) devices have been implanted since approval by the Food and Drug Administration (FDA) in 1998. SNM technology and clinical applications have evolved, with minimal safety updates after initial trials. We aim to provide an updated overview of real-world SNM safety. These insights will guide informed consent, preoperative counseling, and patient expectation-setting. MATERIALS AND METHODS: The FDA Manufacturer and User Facility Device Experience (MAUDE) database is a repository for medical device safety reports. We performed MAUDE categorical (1/1/98-12/31/10) and keyword (1/1/11-9/30/21) searches for "Interstim." A random sample of 1000 reports was reviewed and categorized by theme. To corroborate our MAUDE database analysis, a legal librarian searched the Public Access to Court Electronic Records (PACER) database, as well as Bloomberg Law's dockets database for all lawsuits related to SNM devices. RESULTS: Our search of the MAUDE database returned 44 122 SNM-related adverse events (AEs). The figure illustrates the prevalence of event categories in the random sample. The largest proportion of reports (25.6%) related to a patient's need for assistance with device use, followed by loss/change of efficacy (19.0%). Interestingly, a fall preceded issue onset in 32% of non-shock pain, 30% of lead/device migration, and 27% of painful shock reports. Our legal search revealed only four lawsuits: one for patient complications after an SNM device was used off-label, one case of transverse myelitis after implant, one for device migration or poor placement, and the fourth claimed the device malfunctioned requiring removal and causing permanent injury. CONCLUSIONS: This review confirms the real-world safety of SNM devices and very low complication rates as seen in the original clinical trials. Our findings indicate that 43.2% (95% confidence interval 40.1%-46.3%) of SNM "complications" are not AEs, per se, but rather reflect a need for improved technical support or more comprehensive informed consent to convey known device limitations to the patient, such as battery life. Similarly, the number of lawsuits is shockingly low for a device that has been in the market for 24 years, reinforcing the safety of the device. Legal cases involving SNM devices seem to relate to inappropriate patient selection-including at least one case in which SNM was used for a non-FDA approved indication-lack of appropriate follow-up, and/or provider inability to assist the patient with utilizing the device after implantation.

Long-term lower urinary tract sequelae following AUS cuff erosion.

AIMS: To examine the rate of lower urinary tract complications (LUTC) and urinary diversion (UD) after artificial urinary sphincter (AUS) explantation with the acute reconstruction of AUS cuff erosion defects. METHODS: We performed a retrospective study of patients who underwent in-situ urethroplasty (ISU) for AUS cuff erosion from June 2007 to December 2020. Outcomes included LUTC (urethral stricture, diverticulum, fistula), AUS reimplantation, and UD. Defect size was prospectively estimated acutely and a subanalysis was performed to determine the impact of erosion severity (small erosions [<33% circumferential defect] and large erosions [≥33%]) on these outcomes. Kaplan-Meier curves were created to compare survival between the two groups. RESULTS: A total of 40 patients underwent ISU for urethral cuff erosion. The median patient age was 76 years old with a median erosion circumference of 46%. The overall LUTC rate was 30% (12/40) with 35% (14/40) of patients requiring permanent UD. Secondary AUS placement occurred in 24/40 (60%) patients with 11/24 (46%) leading to repeat erosion. On subanalysis, small erosion was associated with improved LUTC-free and UD-free survival but not associated with AUS reimplantation. CONCLUSIONS: Lower urinary tract complications are common after AUS cuff erosion and can lead to the need for permanent UD. Patients with larger erosions are more likely to undergo UD and reach this end-stage condition earlier compared to patients with small erosions.

Real-World Application of Pre-Orchiectomy miR-371a-3p Test in Testicular Germ Cell Tumor Management.

PURPOSE: Current serum tumor markers for testicular germ cell tumor are limited by low sensitivity. Growing evidence supports the use of circulating miR-371a-3p as a superior marker for malignant (viable) germ cell tumor management. We evaluated the real-world application of serum miR-371a-3p levels in detecting viable germ cell tumor among patients undergoing partial or radical orchiectomy. MATERIALS AND METHODS: Serum samples were collected from 69 consecutive patients before orchiectomy. Performance characteristics of serum miR-371a-3p were compared with conventional serum tumor markers (⍺-fetoprotein/ß-human chorionic gonadotropin/lactate dehydrogenase) between patients with viable germ cell tumor and those without viable germ cell tumor on orchiectomy pathology. Relative miR-371a-3p levels were correlated with clinical course. The Kruskal-Wallis test and linear and ordinal regression models were used for analysis. RESULTS: For detecting viable germ cell tumor, combined conventional serum tumor markers had a specificity of 100%, sensitivity of 58% and AUC of 0.79. The miR-371a-3p test showed a specificity of 100%, sensitivity of 93% and AUC of 0.978. Median relative expression of miR-371a-3p in viable germ cell tumor cases was more than 6,800-fold higher than in those lacking viable germ cell tumor. miR-371a-3p levels correlated with composite stage (p=0.006) and, among composite stage I cases, independently associated with embryonal carcinoma percentage (p=0.0012) and tumor diameter (p <0.0001). Six patients underwent orchiectomy after chemotherapy and were correctly predicted to have presence or absence of viable germ cell tumor by the miR-371a-3p test. CONCLUSIONS: If validated, the miR-371a-3p test can be used in conjunction with conventional serum tumor markers to aid clinical decision making. A positive miR-371a-3p test in patients after preoperative chemotherapy or with solitary testes could potentially guide subsequent orchiectomy or observation.

Overcoming sociodemographic factors in the care of patients with testicular cancer at a safety net hospital.

BACKGROUND: The objective of this study was to determine whether standardized treatment of germ cell tumors (GCTs) could overcome sociodemographic factors limiting patient care. METHODS: The records of all patients undergoing primary treatment for GCTs at both a public safety net hospital and an academic tertiary care center in the same metropolitan area were analyzed. Both institutions were managed by the same group of physicians in the context of multidisciplinary cancer care. Patients were grouped by care center; clinicopathologic features and outcomes were analyzed. RESULTS: Between 2006 and 2018, 106 and 95 patients underwent initial treatment for GCTs at the safety net hospital and the tertiary care center, respectively. Safety net patients were younger (29 vs 33 years; P = .005) and were more likely to be Hispanic (79% vs 11%), to be uninsured (80% vs 12%; P < .001), to present via the emergency department (76% vs 8%; P < .001), and to have metastatic (stage II/III) disease (42% vs 26%; P = .025). In a multivariable analysis, an absence of lymphovascular invasion (odds ratio [OR], 0.30; P = .008) and an embryonal carcinoma component (OR, 0.36; P = .02) were associated with decreased use of adjuvant treatment for stage I patients; hospital setting was not (OR, 0.67; P = .55). For patients with stage II/III nonseminomatous GCTs, there was no difference in the performance of postchemotherapy retroperitoneal lymph node dissection between the safety net hospital and the tertiary care center (52% vs 64%; P = .53). No difference in recurrence rates was observed between the cohorts (5% vs 6%; P = .76). CONCLUSIONS: Sociodemographic factors are often associated with adverse clinical outcomes in the treatment of GCTs; they may be overcome with integrated, standardized management of testicular cancer.

Trends in Renal Transplantation Rates in Patients with Congenital Urinary Tract Disorders.

PURPOSE: Improved bladder and renal management benefit patients with congenital uropathy and congenital pediatric kidney disease. This may translate to delayed initial renal transplantation in these patients, and improved graft and patient survival. Our primary study purpose was to determine whether patients with congenital uropathy and congenital pediatric kidney disease have demonstrated later time to first transplantation and/or graft survival. MATERIALS AND METHODS: SRTR (Scientific Registry of Transplant Recipients) was analyzed for first renal transplant and survival data in patients with congenital uropathy and congenital pediatric kidney disease from 1996 to 2012. Congenital uropathy included chronic pyelonephritis/reflux, prune belly syndrome and congenital obstructive uropathy. Congenital pediatric kidney disease included polycystic kidney disease, hypoplasia, dysplasia, dysgenesis, agenesis and familial nephropathy. RESULTS: A total of 7,088 patients with congenital uropathy and 24,315 with congenital pediatric kidney disease received a first renal transplant from 1996 to 2012. A significant shift was seen in both groups toward older age at initial renal transplantation in those 18 through 64 years old. In the congenital uropathy group this effect was most facilitated by decreased renal transplantion in patients between 18 and 35 years old (38% in 1996 vs 26% in 2012). The congenital pediatric kidney disease group showed a substantial decrease in patients who were 35 to 49 years old (from 39% to 29%). At 10-year followup the congenital uropathy group showed better graft and patient survival than the congenital pediatric kidney disease group. However, aged matched comparison revealed comparable survival rates in the 2 groups. CONCLUSIONS: Analysis of trends in the last 14 years demonstrated that patients with both lower and upper tract congenital anomalies experienced delayed time to the first renal transplant. Furthermore, patients had similar age matched graft and patient survival whether the primary source of renal demise was the congenital lower or upper tract. These findings may indicate that improved urological and nephrological care are promoting renal preservation in both groups.

Impact of testicular cancer stage on semen parameters in patients before orchiectomy.

OBJECTIVE: To study the impact of testicular cancer composite stage and histology with semen parameters in preorchiectomy cryopreservation samples. METHODS: We retrospectively collected semen parameter data, composite stage, and tumor histology for patients who cryopreserved sperm prior to orchiectomy for testicular cancer between 2006 and 2018. Stage I was considered localized disease, and Stages II and III were considered metastatic disease. The World Health Organization (WHO) 2010 semen parameter criteria was used to characterize lab values as normal or subnormal. Categorical and continuous variables were compared using Fisher's exact and Mann Whitney U tests, respectively. RESULTS: Thirty eight patients with testicular cancer underwent preorchiectomy cryopreservation. The median age (IQR) of our cohort was 27 (23-32). Four patients (11%) had azoospermia. No significant differences were found in these semen parameters between Stage I and Stage II/III patients or between seminoma and NSGCT patients. Per WHO 2010 criteria, 7 patients (18%) had abnormal (below reference range) semen volume, 18 patients (47%) had abnormal total sperm counts, and 9 patients (24%) had abnormal motility percentage. Abnormal semen parameters were not significantly associated with tumor histology or stage. CONCLUSION: To our knowledge, this is the first study to show that semen parameters are similar across all stages of testicular cancer. Prior studies have shown that delaying orchiectomy to cryopreserving sperm does not negative affect oncological outcomes. As a result, regardless of staging or histology, sperm banking should be recommended for patients with both localized and metastatic testicular cancer.

The Impact of Race and Gender on 30-Day Urologic Surgery Complications.

OBJECTIVE: To assess the effect of race and gender on complications after urologic surgeries. MATERIALS AND METHODS: The American College of Surgeons' National Surgical Quality Improvement Program data was utilized for patients undergoing urologic surgeries. Patient demographics and comorbidities were analyzed. Postoperative complications occurring in a 30-day postoperative period were noted and classified per the Clavien-Dindo classification. RESULTS: From 2008-2018, 284,050 patients underwent urologic surgery. The majority were men (80%) and identified as non-Hispanic white (80%). Complications occurred in 12%, including 9% minor, 5% major, and mortality in 0.6%. Univariate analysis found female gender, non-Hispanic black and Native American race, and patient comorbidities (hypertension, diabetes, heart failure, lung disease, chronic kidney disease) to be associated with increased risk of complications. Female gender remained a significant predictor on multivariable logistic regression, and Hispanic race was found to be an independent negative predictor of postoperative complications, although these results did not appear clinically significant. On exclusion of gender-specific urologic surgeries, female gender was associated with higher likelihood of minor complications, but male gender was associated with higher likelihood of major complications or mortality. CONCLUSION: Race was not associated with postoperative complication rate. Patient comorbidities are associated with an increased risk of 30-day postoperative complications. Females were more likely to have minor and males were more likely to major complications. Optimizing patient comorbidities preoperatively is key to improving postoperative outcomes.

Decreased Muscle Mass Prior to and Following Chemotherapy Predicts Morbidity in Testicular Cancer Patients Undergoing Post-Chemotherapy Retroperitoneal Lymph Node Dissection.

INTRODUCTION/BACKGROUND: The importance of nutritional status before oncologic surgery has been demonstrated in several solid malignancies. Testicular cancer primarily effects young men, and therefore clinicians may not consider sarcopenia as a factor in this population. We therefore sought to determine the impact of decreased muscle mass, measured by psoas muscle diameter, on outcomes in patients undergoing post-chemotherapy retroperitoneal lymphadenectomy (PC-RPLND) for metastatic germ cell tumors (mGCTs). MATERIALS AND METHODS: Records of all patients undergoing PC-RPLND for mGCTs at our institution were reviewed. Muscle mass was assessed by measuring cross-sectional area of the psoas muscle on pre-chemotherapy and pre-operative computerized tomography. Psoas Index (PSI) was calculated by adjusting total psoas area for patient height (cm2/m2). Univariate and multivariate analysis was performed to assess the predictive value of sarcopenia for morbidity and mortality following PC-RPLND. RESULTS: From 2014-2019, 95 patients underwent PC-RPLND, of whom 64 patients had both pre-chemo and pre-operative cross-sectional imaging. Prior to chemotherapy, mean PSI was 7.36 cm2/m2, which decreased to 7.06 cm2/m2 (P = .041) following chemotherapy. Patients with Stage III disease had a lower mean PSI than patients with Stage I disease (6.84 cm2/m2 vs 7.46 cm2/m2, P = .047). Patients who suffered post-operative complications had a lower mean PSI (6.39 cm2/m2 vs 7.37 cm2/m2, P = .020). CONCLUSION: Decreased muscle mass was predictive of morbidity in patients undergoing PC-RPLND. Patients with higher disease burden had lower pre-operative muscle mass. Further assessment of pre-operative nutritional status in this population may reduce morbidity following PC-RPLND.

Predictive factors of diagnostic delay and effect on treatment patterns in testicular germ cell tumor patients.

BACKGROUND: Increased time from clinical symptom onset to diagnosis of testicular germ cell tumor (GCT), termed diagnostic delay (DD), is associated with an increased likelihood of metastatic disease at presentation. We assessed the association of patient factors on DD and subsequent treatment patterns. METHODS: The records for patients undergoing orchiectomy at a tertiary care hospital and safety net county hospital between 2006 and 2018 were obtained. Demographic variables, clinical symptoms, and post-diagnosis parameters were queried. Patient factors were assessed for association with DD by using both univariate and multivariable analyses. The effect of the Patient Protection and Affordable Care Act (PPACA) on DD was also studied. RESULTS: 201 patients received orchiectomy, and median DD was 38 days (IQR 14.5-122.5). Patients with metastatic disease had increased DD compared to those with localized disease (76 vs. 31 days, P < 0.001). Increased DD was associated with presentation to the safety net hospital (P = 0.001), non-white (P = 0.025), emergency department presentation (P = 0.025), uninsured (P = 0.01), testicular pain (P = 0.019), and presentation before 2014 (P = 0.047). DD was independently associated with presentation before 2014 (P = 0.004) on multivariate analysis. DD >38 days (i.e., above the median) was associated with increased receipt of adjuvant therapy (P = 0.001). CONCLUSION: PPACA implementation is associated with earlier detection of testicular cancer. Our findings highlight the impact of health care legislation on improving access of care to young men with cancer. Delay in diagnosis can lead to increased stage at presentation and need for adjuvant treatment. Further research to identify and overcome sociodemographic factors associated with diagnostic delay may lead to decreased treatment-related morbidity.

Disparities in Pre-Orchiectomy Sperm Cryopreservation Among Testicular Cancer Patients at a Public Safety Net Hospital and a Private Tertiary Care Center.

OBJECTIVE: To compare pre-orchiectomy sperm cryopreservation use in testicular cancer patients at a private tertiary care academic center and an affiliated public safety-net hospital. METHODS: This was a retrospective cohort study of patients who underwent radical orchiectomy for testicular cancer at a private tertiary-care hospital, which cared primarily for patients with private health insurance, and at a public "safety-net" facility, which cared for patients regardless of insurance status. Clinical and demographic predictors of cryopreservation use prior to orchiectomy were determined by chart review. RESULTS: A total of 201 patients formed the study cohort, 106 (53%) at the safety-net hospital and 95 (47%) at the private hospital. Safety net patients were more likely to be non-White (82% vs 15%, P < 0.001), uninsured (80% vs 12%, P < 0.001), Spanish speaking (38% vs 5.6%, P < 0.001), and to reside in areas in the bottom quartile of income (41% vs 5.6%, P < 0.001). On multivariable analysis, treatment at the private tertiary care center was strongly associated with use of cryopreservation (OR 5.60, 95% CI 1.74 - 20.4, P = 0.005, though the effects of specific demographic factors could not be elucidated due to collinearity. CONCLUSION: Among patients with testicular cancer, disparities exist in use of sperm cryopreservation between the private and safety-net settings. Barriers to the use of cryopreservation in the safety-net population should be sought and addressed.

Validation of testicular germ cell tumor staging in nationwide cancer registries.

INTRODUCTION: Nationwide cancer registries such as the National Cancer Database and Surveillance, Epidemiology, and End Results rely on accurate data from tumor registries to formulate hypotheses and report outcomes and treatment patterns. We evaluated the accuracy of our institutional registry for testicular germ cell tumors by comparing data abstracted by urologists with data abstracted by registry. METHODS: We performed a retrospective review of patients receiving initial diagnosis and treatment for germ cell tumors at our hospital system from 2005 to 2016. We compared coding for American Joint Committee on Cancer TNMS staging, overall composite stage, and first-line treatment between urologists and tumor registry at the time of diagnosis. RESULTS: Paired staging from registry and urologist was available for 80 patients. T, N, M, and S-staging were accurate for 90%, 81%, 94%, and 54% of records, respectively. Composite staging and first-line treatment were concordant for 39% and 90% of patients, respectively. A separate review of 33 Stage IS patients per registry for composite staging revealed 15% concordance. CONCLUSION: Our institutional tumor registry had substantial inconsistencies in accurately staging N stage, S stage, and thus, composite stage for testicular cancer. An educational intervention to improve abstraction by registry led to increased concordance. Assuming similar discrepancies may exist at other institutions and for other cancer types, caution should be used when interpreting staging data in nationwide cancer registries. This sheds light on the need for improved clarification of staging guidelines, dynamic institutional internal auditing, and training reform within cancer registries.

Implementation of a Urology E-Consult Service at a Safety Net County Hospital.

INTRODUCTION: We assess the implementation of an e-consult service at a urology clinic in a safety net county hospital. METHODS: An e-consult system was introduced in 2018 at our institution. All e-consults for January to December 2018 were collected and data analyzed. Patient demographics were recorded. Total consults, clinic referrals, cystoscopy referrals, need to reschedule and need for followup were compared. Time from referral to in-person clinic visit was collected. Reason for e-consult and final visit diagnosis were placed into urological categories and subcategories. RESULTS: In 2018 472 e-consults were received for 454 patients. The majority were men (62.3%) with a median age of 55 years (IQR 44-63). The majority (52%) were Hispanic. Most patients (69.1%) were scheduled for an in-person clinic visit with 23.9% of these patients scheduled for a cystoscopy. Median time from referral to in-person clinic visit was 39.5 days (IQR 33-50). A quarter of the patients did not require further followup after initial in-person consultation. The majority of e-consults were for hematuria (24%), renal pathologies (20%), and benign prostatic hyperplasia and lower urinary tract symptoms (17%). CONCLUSIONS: Implementation of a urology e-consult service is feasible and decreases need for in-person clinic visits.

Penile and Urethral Reconstructive Surgery.

Penile and urethral reconstructive surgical procedures are used to treat a variety of urologic diagnoses. Urethral stricture disease can lead to progressive lower urinary tract symptoms and may require multiple surgical procedures to improve patient's symptoms. Male stress urinary incontinence is associated with intrinsic sphincter deficiency oftentimes associated with radical prostatectomy. Men suffering from urethral stricture disease and stress urinary incontinence should be referred to a urologist because multiple treatment options exist to improve their quality of life.

Two Are No Different Than One: Ureteral Duplication Appears to Have No Effect on Ureteroscopy Outcomes.

INTRODUCTION: Ureteral duplication is the most common ureteral anomaly, occurring in 0.6%-0.7% of the population. Our objective was to compare urolithiasis treatment outcomes in patients with and without ureteral duplication. METHODS: Patients with ureteral duplication who underwent ureteroscopy (URS) were identified in a stone registry at a high-volume, tertiary care center from 1998 to 2015. Preoperative, intraoperative, and postoperative data were collected retrospectively. A 1:1 control cohort of patients without duplication was identified, matched by stone location and size, as well as age, body mass index (BMI), and gender. Clinical data and outcomes were compared between duplication and control groups, between partial and complete duplication groups, and between patients in whom duplication was identified intraoperatively vs known preoperatively. RESULTS: Fifty patients with ureteral duplication who underwent URS were identified and were matched to 50 control patients. Patients with ureteral duplication required longer operative time (55 minutes vs 38.5 minutes, p = 0.022). Ureteral duplication had no effect on stone-free rates or need for additional procedures. High-grade (Clavien 4-5) complications were similar in both groups (4% vs 4%). Location of ureteral duplication and preoperative knowledge of ureteral duplication did not affect operative time or stone-free rates. CONCLUSIONS: Patients with ureteral duplication undergoing URS for urinary stone disease have longer operative times. Preoperative knowledge of ureteral duplication appears to have no significant effect on URS's safety or efficacy. In patients without a prior diagnosis of ureteral duplication, our data suggest that intraoperative detection via endoscopy and fluoroscopy is sufficient to safely and completely treat stone disease.

Predicting success after artificial urinary sphincter: which preoperative factors drive patient satisfaction postoperatively?

BACKGROUND: To determine which preoperative factors drive patient-reported quality of life (QoL) after artificial urinary sphincter (AUS) implantation. METHODS: Men receiving AUS after prostate cancer treatment were identified from a prospectively collected dataset. Preoperative factors were recorded during the initial incontinence consultation. Patients underwent urodynamic testing (UDS) preoperatively at surgeon discretion. Patients were surveyed by telephone postoperatively and given the EPIC Urinary Domain (EPIC-UD) and Urinary Distress Inventory (UDI-6) questionnaires. Differences in postoperative maximum pads per day (MxPPD) and questionnaire scores were compared across preoperative factors, with P¡Ü0.05 indicating statistical significance. RESULTS: Telephone survey was completed by 101 of 238 patients (42%). Median age was 69 [63-75] years, BMI was 29 [26-32] kg/m2. MxPPD was 5 [3-9] preoperatively and 2 [1-3] postoperatively (r=0.255, P=0.011). Postoperative median EPIC-UD was 82 [67-89] and UDI-6 was 22 [11-36]. Postoperative MxPPD was lower in patients who reported being able to store urine before AUS {2 [1-2] vs. 2 [1-4], P=0.046}, and lower with urodynamically-proven detrusor overactivity (DO) {1.5 [1-2] with vs. 2 [1-4] without, P=0.050}. Detrusor pressure at maximum flow was negatively associated with QoL as measured by EPIC-UD score (r=-0.346, P=0.013) and UDI-6 score (r=0.413, P=0.003). Although 41 (41%) patients had a history of radiation, postoperative outcomes did not significantly differ with or without a history of radiation. CONCLUSIONS: Few preoperative factors predict QoL after AUS insertion.

Outcomes of Urethroplasty to Treat Urethral Strictures Arising From Artificial Urinary Sphincter Erosions and Rates of Subsequent Device Replacement.

OBJECTIVE: To evaluate the success of urethroplasty for urethral strictures arising after erosion of an artificial urinary sphincter (AUS) and rates of subsequent AUS replacement. PATIENTS AND METHODS: From 2009-2016, we identified patients from the Trauma and Urologic Reconstruction Network of Surgeons and several other centers. We included patients with urethral strictures arising from AUS erosion undergoing urethroplasty with or without subsequent AUS replacement. We retrospectively reviewed patient demographics, history, stricture characteristics, and outcomes. Variables in patients with and without complications after AUS replacement were compared using chi-square test, independent samples t test, and Mann-Whitney U test when appropriate. RESULTS: Thirty-one men were identified with the inclusion criteria. Radical prostatectomy was the etiology of incontinence in 87% of the patients, and 29% had radiation therapy. Anastomotic (28) and buccal graft substitution (3) urethroplasty were performed. Follow-up cystoscopy was done in 28 patients (median 4.5 months, interquartile range [IQR]: 3-8) showing no urethral stricture recurrences. Median overall follow-up was 22.0 months (IQR: 15-38). In 27 men (87%), AUS was replaced at median of 6.0 months (IQR: 4-7) after urethroplasty. In 25 patients with >3 months of follow-up after AUS replacement, urethral complications requiring AUS revision or removal occurred in 9 patients (36%) and included subcuff atrophy (3) and erosion (6). Mean length of stricture was higher in patients who developed a complication after urethroplasty and AUS replacement (2.2 vs. 1.5 cm, P = .04). CONCLUSION: In patients with urethral stricture after AUS erosion, urethroplasty is successful. However, AUS replacement after urethroplasty has a high erosion rate even in the short-term.

Foley or Fix: A Comparative Analysis of Reparative Procedures at the Time of Explantation of Artificial Urinary Sphincter for Cuff Erosion.

OBJECTIVE: To examine artificial urinary sphincter (AUS) cuff erosion intraoperative management methods: Foley catheter placement, abbreviated urethroplasty (AU), or mobilization with primary urethral anastomosis (PA). We reviewed these options to compare postoperative complications and probability of AUS reimplantation. MATERIALS AND METHODS: Medical records of patients treated for AUS cuff erosion from 2005 to 2015 were retrospectively reviewed. We divided patients into 3 groups based on intraoperative management of the urethra: Foley only, AU, or PA. Patient characteristics, operative times, outcomes, complications, and reimplantation factors were recorded and analyzed. RESULTS: Seventy-five patients with a median age of 77 years (72-83) were treated for AUS cuff erosion. Fifty-two underwent Foley placement, 8 AU, and 15 PA. Mean follow-up was 13 months (0-106). Severe erosions were more common in the PA group than Foley or AU (100% vs 37%, 100% vs 38%, P <.001, P <.001, respectively). Severe erosions treated with Foley were more likely to develop strictures than mild erosions (38% vs 5%, P = .009). Tandem cuff patients treated with Foley were more likely to develop diverticuli than single cuff patients (33% vs 4%, P = .016). There was no difference in probability of reimplantation between PA and Foley or AU (63% vs 69%, 63% vs 33%, P = .748, P = .438, respectively). CONCLUSIONS: Foley catheter placement alone may represent suboptimal management for severe or tandem cuff erosions due to increased risk of urethral complications. Urethral defect management should be determined at the time of explantation by individual patient characteristics and surgeon experience.