Prevalence and Risk Factors of Artificial Urinary Sphincter Revision in Nonneurological Male Patients.

PURPOSE: The main objective of this study was to assess the prevalence and risk factors of male artificial urinary sphincter (AUS) mechanical failures and nonmechanical failures. MATERIALS AND METHODS: The charts of all male patients who underwent AUS implantation between 2004 and 2020 in 16 centers were retrospectively reviewed. Patients with neurogenic stress urinary incontinence (SUI) were excluded as well as revisions/explantations due to infections and/or erosions. The causes of revision were divided into mechanical failures (fluid loss or malfunction from any components of the AUS), nonmechanical failures (urethral atrophy, recurrence/persistence of SUI despite normally functioning device) and other (pump malposition, balloon herniation, hematoma, pain). Failure-free survival analysis was performed both for general and specific causes of revision. Predictors of mechanical and nonmechanical failures were determined by Cox proportional hazards model. RESULTS: A total of 1,020 patients met the inclusion criteria. After a median followup of 20 months, the estimated 5-year and 10-year overall revision-free survival was 60% and 40%, respectively. There were 214 AUS revisions: 59 (27.6%) for mechanical failures, 121 (56.5%) for nonmechanical failures and 34 (15.9%) other causes of revision. In multivariable Cox regression analysis, larger cuff size was the only predictor of overall revisions (HR=1.04 [1.01-1.07]; p=0.01) and revision for nonmechanical failure (HR=1.05 [1.02-1.09]; p=0.004). CONCLUSIONS: Half of the male AUS patients underwent device revision within the first 10 years after implantation. Nonmechanical failures are the primary cause of AUS revision in nonneurological men. Larger cuff size appears to be the main determinant of AUS revision risk.

Multi-institutional Outcomes and Associations After Excision and Primary Anastomosis for Radiotherapy-associated Bulbomembranous Urethral Stenoses Following Prostate Cancer Treatment.

OBJECTIVE: To evaluate the outcomes of excision and primary anastomosis (EPA) for radiation-associated bulbomembranous stenoses using a multi-institutional analysis. The treatment of radiation-associated urethral stenosis is typically complex owing to the adverse impact of radiation on adjacent tissue. METHODS: An IRB-approved multi-institutional retrospective review was performed on patients who underwent EPA for bulbomembranous urethral stenosis following prostate radiotherapy. Preoperative patient demographics, operative technique, and postoperative outcomes were abstracted from 1/2007-6/2018. Success was defined as voiding per urethra without the need for endoscopic treatment and a minimum follow-up of 12 months. RESULTS: One hundred and thirty-seven patients from 10 centers met study criteria with a mean age of 69.3 years (50-86), stenosis length of 2.3 cm (1-5) and an 86.9% (119/137) success rate at a mean follow-up 32.3 months (12-118). Univariate Cox regression analysis identified increasing patient age (P = .02), stricture length (P <.0001) and combined modality radiotherapy (P = .004) as factors associated with stricture recurrence while body mass index (P = .79), diabetes (P = .93), smoking (P = .62), failed endoscopic treatment (P = .08) and gracilis muscle use (P = .25) were not. On multivariate analysis, increasing patient age (H.R.1.09, 95%CI 1.01-1.16; P = .02) and stenosis length (H.R.2.62, 95%CI 1.49-4.60; P = .001) remained associated with recurrence. Subsequent artificial urinary sphincter was performed in 30 men (21.9%), of which 25 required a transcorporal cuff and 5 developed cuff erosion. CONCLUSIONS: EPA for radiation-associated urethral stenosis effectively provides unobstructed instrumentation-free voiding. However, increasing stenosis length and age are independently associated with surgical failure. Patients should be counseled that further surgery for incontinence may be necessary.

Outcomes of laparoscopic artificial urinary sphincter in women with stress urinary incontinence: mid-term evaluation.

PURPOSE: Although artificial urinary sphincter (AUS) has become an established treatment for moderate to severe stress urinary incontinence (SUI), implantation can be challenging. This study aimed to review the outcomes of laparoscopic AUS (LAUS) implantation and revision in women presenting with SUI. METHODS: We reviewed the files of female patients presenting with moderate to severe SUI treated with LAUS implantation from October 2007 to July 2017. Surgeries were performed by one surgeon experienced in open AUS implantation and starting LAUS implantation. The primary endpoint was postoperative urinary continence, which was divided into three categories: complete continence, improved continence, and unchanged incontinence. The secondary outcomes were complications, explantation-free and revision-free time. RESULTS: A total of 49 women (mean age 64 years, range 40-80) had LAUS implantation. Among the 42 patients (85.7%) with an AUS in place at the last follow-up, 25 (59.5%) were fully continent, 16 (38.1%) had improved continence, and 1 (2.4%) had unchanged incontinence. At the last follow-up, 29 (59.2%) patients had their initial AUS and 13 (26.5%) had at least one reintervention. There were 9 (18.4%) intraoperative complications and 25 (51%) postoperative complications, of which 9 (18.4%) were Clavien⩾3. After a median follow-up of 4 years, 9 (18.4%) explantations and 11 (22.5%) revisions occurred. The average period without explantation or revision was 3.7 and 3.1 years, respectively. CONCLUSION: Our study shows that the laparoscopic approach for AUS implantation is an efficient treatment option for women with moderate to severe SUI.

Cadaveric Laboratory Simulation Training of Male Stress Urinary Incontinence Treatment Improves Trainee Knowledge and Confidence.

OBJECTIVE: To assess whether a focused, simulation training course can improve trainee surgical knowledge and confidence in the treatment of male stress urinary incontinence. MATERIALS AND METHODS: Urology residents participated in a prosthetic education course as part of the 2018 SUPS and SMSNA annual meeting. The course included didactic lectures and a hands-on cadaveric laboratory. Participants completed questionnaires before and after the lab (2 weeks and 6 months) to assess procedural knowledge and confidence. Analysis of lab responses was performed using the Wilcoxon signed rank test for matched pairs. RESULTS: Thirty-two residents (median age 29, range 27-34) participated in the course. The majority were postgraduate year 4 (63%) or postgraduate year 5 (20%). Most participants reported minimal AUS or sling experience with 50% and 94% reporting less than 5 cases, respectively. Overall score from the knowledge assessment improved significantly between the pre-lab versus 2-week post-lab (P = .02) and pre-lab versus 6-month post-lab (P = .01). Similarly, procedural confidence improved between pre-lab vs 2-week post-lab (P < .001) and pre-lab versus 6-month post-lab (P < .001). Knowledge and confidence assessments were not different between year of residency training or pre-lab experience. CONCLUSIONS: Simulation training improves knowledge and confidence in prosthetic surgery for male stress incontinence. In the current climate of reduced exposure and limited availability of prosthetic educators, simulation courses can provide much needed educational value.

Female neurogenic stress urinary incontinence.

PURPOSE OF REVIEW: The aim of this article is to look into recent updates on the management of neurogenic stress urinary incontinence (NSUI) in adult females. RECENT FINDINGS: Recently, a small number of studies have investigated different surgical modalities in treatment of NSUI in adult females including artificial urinary sphincter (AUS), suburethral tapes (SUT) and adjustable slings and urethral bulking agents. Up to 70% of neurogenic patients who received AUS implants are continent and have not required surgical revision over a 20-year follow-up period. However, the risk for explantation of AUS may be twice as high in neurogenic patients compared with nonneurogenic patients. SUT have success and improvement in quality of life rates of up to 52 and 68%, respectively. However, complications may be as high as 24%. Early data on adjustable slings may suggest up to 80% continence with low complication rates. SUMMARY: AUS can provide satisfactory continence levels with acceptable rates of revision and explantation. SUT are effective but more than half of patients may require additional procedures. Adjustable slings could be a promising option. Further high-quality studies with careful attention to methodology and standardization of both definitions used and outcome reporting are required to help us reach safe conclusions.

The Changing Face of Artificial Urinary Sphincter Use in France: The Future is Female.

Analyzing concurrently data from the manufacturer and from a national comprehensive administrative claim database (PMSI)we found that, overall, the total number of AUS implanted (male+female) increased from 2012 to 2017 (+8.8%). This growth was driven by a strong increase in the number of female implants from 2015 to 2017 (+28.9%). Meanwhile, the number of AUS implanted in male patients remained roughly stable and the total number of anti-incontinence surgery in men (slings+AUS) decreased steadily over the period studied.

Use of Surgery for Post-Prostatectomy Incontinence.

PURPOSE: Stress urinary incontinence following radical prostatectomy is common and potentially debilitating. Surgical therapy with a urethral sling or an artificial urinary sphincter is an effective option with high patient satisfaction in men in whom conservative measures fail to treat post-prostatectomy incontinence. We sought to characterize the contemporary utilization of surgical therapy of post-prostatectomy incontinence using an all payer database. MATERIALS AND METHODS: We used the Healthcare Cost and Utilization Project databases for Florida from 2006 to 2015 and identified men who underwent radical prostatectomy between 2006 and 2012 using ICD procedure codes. Patients were tracked longitudinally for placement of an ambulatory or inpatient urethral sling, or an artificial urinary sphincter between 2006 and 2015. Patient and clinical data were extracted and analyzed with descriptive statistics. A multivariable logistic regression model was constructed to determine risk adjusted predictors of subsequent incontinence surgery. RESULTS: During the study period 29,287 men underwent radical prostatectomy, of whom 1,068 (3.6%) were treated with subsequent incontinence surgery a median of 23.5 months after prostatectomy. On multivariate analysis risk factors for incontinence surgery included age groups 61 to 70 years (OR 1.25, p=0.008) and 71 to 80 years (OR 1.34, p=0.022), Medicare insurance (OR 1.33, p <0.005) and an increased Charlson Comorbidity Index (OR 1.13 per unit increase, p <0.005). CONCLUSIONS: Of patients who underwent radical prostatectomy 3.6% subsequently underwent stress urinary incontinence surgery. Post-prostatectomy incontinence surgery is likely under performed and delayed in performance based on the previously reported prevalence of severe post-prostatectomy incontinence and the natural history of symptoms. Efforts to increase prompt repair of refractory or severe incontinence can greatly improve patient quality of life after radical prostatectomy.

Low Serum Albumin Correlates With Adverse Events Following Surgery for Male Urinary Incontinence: Analysis of the American College of Surgeons National Surgical Quality Improvement Project.

OBJECTIVE: To investigate the incidence and risk factors associated with artificial urinary sphincter (AUS) and male urethral sling placement (MUS), revision, and removal. METHODS: We identified CPT codes of patients undergoing AUS and sling placement, revision, and removal in the American College of Surgeons National Surgery Quality Improvement Program database. Bivariate analysis was used to compare preoperative parameters against adverse events of interest (Length of stay (LOS) >1, readmission, reoperation, other postoperative complications, and death). Variables that were significant or neared significance (P <.1) in the univariate analysis were entered into multivariable logistic regression models. Multivariable models were used to estimate the probability of adverse events. RESULTS: About 2792 patients underwent surgical treatment for stress urinary incontinence in the American College of Surgeons National Surgery Quality Improvement Program database from 2008 to 2016. Increased length of stay was the most common adverse event (12.7%), followed by other postoperative complications (4.9%), readmission (4%), reoperation (2.3%), and death (0.3%). We noted an association between perioperative adverse events and preoperative hypoalbuminemia. Patients with preoperative hypoalbuminemia compared with patients with normal preoperative serum albumin had an increase predicted probability of LOS >1 day (42% vs 10%), readmission (10% vs 4%), reoperation (6% vs 2%), other postoperative complications (18% vs 4%) after adjusting for other factors. CONCLUSION: Surgical treatment for stress urinary incontinence is well tolerated with acceptable levels of perioperative adverse events. Low serum albumin (<3.5 ng/dL) was associated with perioperative adverse events. These data may affect preoperative decision making and direct future quality improve efforts at the highest risk patients to help minimize perioperative morbidity and mortality.

Effects of Smoking Status on Device Survival Among Individuals Undergoing Artificial Urinary Sphincter Placement.

Smoking is an established risk factor for wound complications. There is limited data on the impact of smoking on artificial urinary sphincter (AUS) outcomes. Thus, the aim of this study was to assess AUS device survival outcomes based on smoking status. From 1985 to 2014, 1,270 patients underwent AUS placement with 728 having smoking status available for review. Smoking status was categorized as never, prior, and active smokers. Kaplan-Meier analysis was performed to evaluate differences in survival, including overall device and erosion/infection-free survival. Hazard regression analysis was utilized to determine the association between smoking and device outcomes. Of the 728 patients in the study, 401 had a history of smoking with 41 active smokers and 360 never smokers at the time of AUS implant. When compared with nonsmokers, past smokers had a higher rate of hypertension and prior transient ischemic attack. Clinical comorbidities were similar between nonsmokers and active smokers. On univariate analysis, patient age, history of transient ischemic attack, diabetes, and coronary artery disease were significantly associated with infection/erosion rate, but prior or active smoking statuses were not. Likewise, when comparing smokers (past or active) with lifelong nonsmokers, there was no significant difference in 1- and 5-year overall device survival. There was no evidence for adverse AUS outcomes in current or past smokers compared with nonsmokers. Given the established risk of perioperative complications secondary to smoking, the recommendation should still be to counsel patients to quit prior to undergoing AUS placement. External validation of these findings is needed.

AdVance sling use decreasing relative to artificial urinary sphincters.

INTRODUCTION: To evaluate the percent of AdVance male sling usage relative to artificial urinary sphincters (AUS) over a 9 year period since its introduction in order to assess trends across the United States. MATERIALS AND METHODS: As a surrogate for procedures performed, we reviewed device utilization trends of the AdVance sling and AUS broken down by American Urological Association (AUA) section. ANOVA testing between years was used to determine purchasing trends with p values of < 0.05 considered statistically significant. RESULTS: Relative to AUS, AdVance sling percentage significantly increased from 36% in 2007 to 48% in 2008 (p = 0.032). Sling percentage then remained stable over the next 3 years from 2008-2011 with no significant percent change between years (p = NS). Compared with 2008-2011, AdVance usage decreased in 2012 to 29% (p = 0.002) and remained stable at this decreased relative level through 2015 (p = NS, difference between years 2012-2015). Comparing incontinence procedures across AUA sections, the Southeast section performed the highest percentage of male stress urinary incontinence procedures, including 27% of all AdVance slings and 25% of all artificial sphincters. CONCLUSION: Proportion of AdVance sling usage relative to AUS increased after its introduction through 2008. Usage remained stable at an increased level for the next3 years. More recent years have found decreased AdVance usage and a resurgence of the artificial urinary sphincter. Reasons for these trends remain speculative.

Comparison of complication rates related to male urethral slings and artificial urinary sphincters for urinary incontinence: national multi-institutional analysis of ACS-NSQIP database.

PURPOSE: Male stress urinary incontinence (SUI) can significantly diminish quality of life and lead to embarrassment and social withdrawal. Surgical therapies, such as male urethral slings and artificial urinary sphincters (AUS), are considered effective and safe treatments for male SUI. Our objective is to evaluate 30-day complications in patients undergoing male slings and AUS placement from a national multicenter database. METHODS: Data from the American College of Surgeons National Surgical Quality of Improvement Program for 2008-2013 were used to identify patients who underwent male slings and AUS implantation. Trained coders abstracted complication data from the patient record independent of the surgical team. We compared 30-day postoperative complications for male slings and AUS. We examined the relationship between patient factors and complication rates for each procedure type. RESULTS: Overall, 1205 incontinence surgeries in men were identified: 597 male sling placements and 608 AUS implantations. Male sling placement had a lower 30-day postoperative complication rate compared to AUS (2.8 vs. 5.1 %, p = 0.046). Compared to AUS, male sling was associated with fewer urinary tract infections (0.3 vs. 2.0 %, p = 0.020) and return trips to the operating room (1.0 vs. 3.0 %, p < 0.001). Patients with higher BMI were more likely to have a complication, while age, race and Charlson comorbidity index were not associated with higher or lower complication rates. CONCLUSIONS: Complications rates for both male sling and AUS are low. Male sling is associated with a lower rate of complications than AUS. These findings allow for better patient perioperative counseling regarding 30-day perioperative complications.

Male Sling and Artificial Urethral Sphincter for Male Stress Urinary Incontinence Among Certifying American Urologists.

OBJECTIVE: To examine case volume characteristics among certifying urologists performing male sling and artificial urinary sphincter (AUS) procedures to evaluate practice patterns in male stress urinary incontinence (SUI). MATERIALS AND METHODS: Six-month case log data of certifying urologists (2003-2013) were obtained from the American Board of Urology. Cases specifying Current Procedural Terminology code for male sling, AUS, and removal or revision of either procedure in males ≥18 years were analyzed. RESULTS: Among 1615 urologists (568 certifying and 1047 recertifying) logging at least 1 male incontinence procedure, 2109 (48% of all procedures) male sling and 2284 (52%) AUS cases were identified. The mean age of patients undergoing AUS was 74.9 years and the mean age of patients undergoing sling procedures was 67.3 years (P <.001). An increase in male incontinence procedures from 2003 to 2013 was demonstrated. The rate of male sling procedure increased from 32.7% of incontinence surgeries in 2004 to 45.5% in 2013 (P <.001). Academically affiliated urologists are 1.5 times more likely to perform AUS than male sling for SUI (P <.001). Median number of slings performed was 2 (range 1-40), with 32.7% placing slings exclusively. A small group of certifying urologists (3.4%) accounted for 22% of all male slings placed. This same cohort logged 10.2% of all AUS performed. Surgical management of male SUI varies widely across states (P <.001), with slings performed between 21% and 70% of the time. CONCLUSION: Overall the number of male incontinence procedures has increased over time, with a growing proportion of male slings. Most slings and AUS cases are performed by a small number of high-volume surgeons.

International variation in artificial urinary sphincter use.

OBJECTIVE: To analyze international trends in artificial urinary sphincter (AUS) use, indications for placement, and application by gender. METHODS: We conducted a retrospective review of data derived from patient information forms sent to American Medical Systems. There were 86 140 unique cases from March 1975 through December 2008, including all indications. RESULTS: AUS use increased worldwide from 1975 (90 procedures) through 2008 (4818 procedures). In 2008, patients with postprostatectomy incontinence (PPI) accounted for 61% (2907/4751) of AUS use compared to 12% (8/66) in 1975. Artificial urinary sphincter annual implant rates in women were much lower than in men, decreasing from 298 procedures in 1990 to 67 in 2008. Artificial urinary sphincter implants in the United States for men alone accounted for the majority (62%, 2995/4818) of worldwide artificial urinary sphincter use in 2008. Conversely, artificial urinary sphincter use has recently started declining in other areas, including South America and Canada. Frequency of artificial urinary sphincter surgery varied dramatically from less than 0.01 per 100 000 population in Brazil to 0.99 in the United States. Of surgeons performing artificial urinary sphincter implants in 2008, case volumes in and outside of the United States were similarly low: 56% in the United States and 52% outside the United States performed only 1 artificial urinary sphincter implant, whereas 76% in the United States and 73% outside the United States did fewer than 3. CONCLUSION: Artificial urinary sphincter use has continued to increase internationally over the study period, especially for patients with PPI. However, artificial urinary sphincter use exhibits considerable regional variation, and most surgeons performed very low annual case volumes of implants.

Temporal trends in adoption of and indications for the artificial urinary sphincter.

PURPOSE: The introduction of the artificial urinary sphincter represented a significant advance in treating urinary incontinence. We examined temporal trends in artificial urinary sphincter use, focusing on adoption of the device with time, individual surgeon volume, indications for placement and differences in application by gender. MATERIALS AND METHODS: Data on artificial urinary sphincter related operations performed in the United States from 1975 and thereafter were provided by the manufacturer. Surgical and demographic data on each patient were recorded and analyzed on an annual basis at 5-year intervals to determine the number of procedures performed as well as individual surgeon volume. Indications for implantation or revision were also studied and recorded in 5-year increments. RESULTS: Artificial urinary sphincter use increased dramatically from 11 cases in 1975 to 3,762 in 2005. Most increased volume was due to an increase in device use in men with little growth in use in women. More than 90% of surgeons who participated in artificial urinary sphincter surgery performed 5 or fewer related cases per year (median 1 to 2) in most years. The annual proportion of revision surgeries stabilized after an initial increase. The most prevalent indication for initial implantation in men from 1985 and thereafter was incontinence after radical prostatectomy. In women neurogenic disease was consistently the most common indication for placement. CONCLUSIONS: Artificial urinary sphincter use has increased dramatically in the United States since 1975 and it now appears to be stable. Placement is primarily performed in men with incontinence after radical prostatectomy. Only a small minority of surgeons perform a high volume of artificial urinary sphincter cases.

Current use of the artificial urinary sphincter and its long-term durability: a nationwide survey in Japan.

OBJECTIVES: Although the artificial urinary sphincter (AUS) is one of the most effective surgical treatments for severe urinary incontinence, little is known about its use in Japan. A nationwide survey was done to determine contemporary trends in AUS use and its long-term durability. METHODS: Data on AUS units sold in Japan were provided directly by Takai Hospital Supply Co., Ltd., Tokyo, Japan, and a survey form was sent to all 44 institutes where AUS implantation had been carried out. The survey included various demographic and preoperative variables, surgical variables, and postoperative outcomes. RESULTS: Between 1994 and 2007, a total of 100 AUS devices had been provided in Japan. Of the 44 institutes, 24 responded to the survey, and a total of 64 patients were enrolled in the study. Post-urological surgery incontinence accounted for 81.3% of the indications. During the mean follow-up of 50 months, mechanical failure occurred in four (6.2%), and the device was removed in 13 (20.3%) due to infection (14.0%), erosion (4.7%), or urination difficulty (1.5%). Of the 58 patients evaluated, 91.4% reported social continence. Five- and 10-year failure-free rates were 74.8% and 70.1%, respectively. On multivariate analysis, operative time was an independent predictor of treatment failure (P = 0.0334). CONCLUSIONS: Considering recent trends in prostate surgery, the AUS may be significantly underused in Japan. Although excellent long-term durability has been achieved, a learning effect appears to be evident. The Japanese urological community needs to provide appropriate patients with this treatment option.

[FlowSecure artificial urinary sphincter for the treatment of stress urinary incontinence after radical prostatectomy]. / El esfínter urinario FlowSecure en el tratamiento de la incontinencia urinaria de esfuerzo post prostatectomía radical.

OBJECTIVES: To diffuse the concept and implantation surgical technique of a new prosthesis for the treatment of stress urinary incontinence, the Flow Secure artificial urinary sphincter. METHODS: The prosthesis is a single silicone piece filled with saline solution which has the following parts: (1) Pressure regulation reservoir, (2) assistance reservoir for stress situations, (3) control pump with self-sealant port and (4) a cuff. One of the main characteristics is the self-sealant port enables pressure adjustment depending of the clinical needs of the patient as many times as necessary. RESULTS: The surgical technique is simple and the level of continence achieved excellent. The only complication inherent to the Flow Secure design is perforation of the cuff during the act of pressurization, but it has been corrected by designing a new control pump which can not be punctured. Self limited scrotal edema/hematoma are frequent; they can be avoided minimizing the time of trocar use. The remainder complications are common with the AMS 800 and other implantable prosthesis. CONCLUSIONS: Despite midterm good results, we need to wait for a greater number of patients with the Flow Secure sphincter and longer follow up to determine the definitive role of this prosthesis for the treatment of urinary incontinence.