Artificial Urinary Sphincter Placement Research Articles

Editorial Comment on "Persistent Opioid Use following Artificial Urinary Sphincter Placement: A Large Claims Database Analysis"

Editorial Comment on "Persistent Opioid Use following Artificial Urinary Sphincter Placement: A Large Claims Database Analysis"

Persistent Opioid Use Following Artificial Urinary Sphincter Placement: A Large Claims Database Analysis

ObjectiveTo assess risk of persistent opioid use and emergency department (ED) and office/outpatient visits following post-operative prescriptions of common opioids in patients following artificial urinary sphincter (AUS) implantation using a nationwide claims database. MethodsThe TriNetX US Collaborative Network, which encompasses over 115 million patients from 66 healthcare organizations was used to identify males who underwent first-time AUS placement between 2010-2024. Patients with history of opioid dependence/abuse, opioid use within six months prior to AUS placement, or surgery within 9 months post-operation were excluded. Patients were distributed into two cohorts: those who received opioids post-operatively or those that did not. Cohorts were propensity score matched on demographic characteristics, pain, mental health, and substance-related diagnoses. Primary outcome was risk of persistent opioid use 3-9 months post-operatively. Secondary outcomes included risk of ED or office/outpatient visit 30- and 90- days post-operatively. ResultsEach cohort contained 1,036 patients following application of exclusion criteria and propensity score matching. Post-operative Oxycodone, Hydrocodone, or Codeine had a three-fold increase in risk of persistent opioid use at 3-9 months (15.15% vs. 4.92%, RR=3.08, 95% CI=[2.27-4.17]). Risk of ED or office visits was not significantly lower in patients receiving these opioids. ConclusionOpioid prescriptions following AUS placement increases risk of persistent opioid use without lowering the risk of ED or outpatient visits. These findings highlight the necessity for opioid-sparing approaches to post-operative pain control following AUS placement.

Evaluating the impact of artificial intelligence-based assessment of body composition on primary artificial urinary sphincter placement outcomes.

Sarcopenia, characterized by low muscle mass, and aberrant adiposity changes, including visceral fat accumulation, has been associated with impaired physiologic stress response and wound healing. Artificial urinary sphincter (AUS) placement is the preferred surgical treatment for men with severe post-prostatectomy incontinence. Given the higher rates of maladaptive body composition changes in this older, high comorbidity population, this study explores their impact on AUS outcomes. A retrospective analysis was performed including men who underwent primary AUS placement at the Mayo Clinic from 1999 to 2023 for post-prostatectomy incontinence and had cross sectional imaging available within 12 months prior to AUS implant. Sarcopenia and body composition were assessed from the available computed tomography (CT) scan using an algorithm that measures the area of different tissues at the L3 abdominal cross-section. The study investigated the association between sarcopenia [defined as skeletal muscle index (SMI) <52.4 cm2/m2] and adiposity (defined by total visceral and subcutaneous fat area) with all-cause reoperation, including specific etiologies of device infection/erosion, urethral atrophy, and device malfunction, using Cox proportional hazards models. There were 111 patients who had available imaging within the study timeframe, 61 (55%) of whom were classified as sarcopenic. Follow-up did not differ significantly between the two groups [2.11 (0.53-4.78) vs. 2.52 (0.36-5.80) years, P=0.52]. Sarcopenic patients had a lower body mass index (BMI) (29.1 vs. 32.7 kg/m2; P<0.001). No significant difference in overall device survival was observed between sarcopenic and non-sarcopenic patients (P=0.94) on Cox survival analysis. Sarcopenic patients had higher device infection rates, accounting for 16.7% (3/18) of device failures in the sarcopenic cohort compared to none in the non-sarcopenic cohort. Sarcopenia was prevalent among AUS patients but did not significantly impact overall device survival. These findings suggest that AUS placement may be feasible to perform in well-selected sarcopenic patients.

Workup of residual incontinence after artificial urinary sphincter placement

Workup of residual incontinence after artificial urinary sphincter placement

Patient Perception of Physician Reimbursement by Medicare for Artificial Urinary Sphincter Placement.

Patient perceptions of physician reimbursement commonly differ from actual reimbursement. This study aims to improve health care cost transparency and trust between patients, physicians, and the health care system by evaluating patient perceptions of Medicare reimbursement for artificial urinary sphincter (AUS) placement. We identified patients who underwent AUS placement at a single institution from 2014 to 2023. After obtaining informed consent, we administered a telephone survey to ask patients about their perceptions of Medicare reimbursement for AUS surgery and the amount they felt the physician should be compensated. Sixty-four patients were enrolled and completed the survey. On average, patients estimated Medicare physician reimbursement to be $18,920, 25 times the actual average procedure reimbursement. Once informed that the actual amount was $757.52, 97% of respondents felt that the reimbursement was "somewhat lower" (13%) or "much lower" (84%) than what they considered fair. The average amount that patients felt the physician should be paid was $8,844, 12 times the actual average procedure reimbursement. Fifty-four percent of patients estimated their physician's reimbursement to be higher than what they later reported as being "fair," representing a presurvey belief that their physician was overpaid. Patient perceptions of physician reimbursement for AUS are vastly different than the actual amount paid. The discordance between patient perception and actual reimbursement could impact how patients view health care costs and the relationship with their provider.

Dorsolateral fibromuscular tissue preservation during artificial urinary sphincter placement: Technique description and review

Dorsolateral fibromuscular tissue preservation during artificial urinary sphincter placement: Technique description and review

Timing Considerations for Artificial Urinary Sphincter Implantation Postpelvic Radiotherapy

BackgroundTo explore the optimal timing for placing an artificial urinary sphincter (AUS) post-radiation therapy (RT). MethodsA bi-institutional retrospective review of all patients who underwent their first (virgin) AUS placement after pelvic RT between January 1st 2011 and July 1st 2023. To determine the optimal timeline for device implantation 2-5 years post-RT, we compared hazard ratios (HRs) for device revision/explantation (Rev/Exp) using Kaplan-Meier curves for each year (earlier vs. later than 2/3/4/5 years post-RT).The Pearson correlation coefficient identified trends in Rev/Exp reasons (erosion/infection vs. other). ResultsSeventy-two patients met our inclusion criteria with a median age of 65.5 years (IQR 70-81.25). Fifteen (20.1%) had undergone one or more previous urethral or bladder neck interventions (urethroplasty in one [1.4%], internal urethrotomy in 7 [9.7%], and bladder neck incision in 9 [12.5%]). After a median follow-up of 57.5 months (IQR 13-107), a total of 36 (50%) devices were Rev/Exp, with mechanical failure in 14 (19.4%) and device erosion in 12 (16.7%) being the main reasons. Device survival analysis revealed no significant difference in the risk of device Rev/Exp when implanted earlier versus later than 2, 3, 4,or 5 years post-RT, with p-values of 0.3, 0.3, 0.4, and 0.4, respectively. A constant trend towards higher infection/erosion rates as indication for device Rev/Exp the later the insertion was noticed:R2 = 0.98. ConclusionsDespite a small sample size, our study indicates that implanting an AUS within 5-years after RT shows comparable device lifespan. However, later insertions may have higher removal rates due to erosion/infection. Clinical trial registrationNot applicable

Radiologic feature of complications after artificial urinary sphincter implantation following total prostatectomy.

Incontinence following total prostatectomy for prostate cancer significantly impairs patient's quality of life. In severe cases, implantation of an artificial urinary sphincter (AUS) has shown favorable outcomes, enhancing continence by constricting the bulbous urethra. The AUS system consists of a pressure-maintaining balloon, control pump serving as the operational switch, cuff that constricts the urethra, and tubes and connectors that link these components, maintaining a continuous circuit through an internal pressure medium. Most instances of AUS dysfunction are attributed to circuit leaks leading to a reduction in internal pressure, which is identifiable on imaging by fluid accumulation around the circuit, balloon collapse, control pump deformation, and air within the circuit. When the AUS circuit is uncompromised, dysfunction may arise from issues such as the inability to compress the pump due to pain or displacement outside the scrotum or urinary tract obstruction caused by bladder hemorrhage/hematoma. Imaging plays a pivotal role in the evaluation of urinary tract injuries, hematomas/seromas, and infections associated with AUS placement or replacement. Understanding the function of AUS and its appearance on CT imaging is essential for accurately assessing AUS dysfunction and post-implantation complications, guiding clinical decision-making and improving patient care outcomes.

The fragile urethra: Considerations for high-risk patients undergoing artificial urinary sphincter placement

The fragile urethra: Considerations for high-risk patients undergoing artificial urinary sphincter placement

Historical perspective on the artificial urinary sphincter

ABSTRACT Urinary incontinence imposes significant social and psychological distress. The artificial urinary sphincter (AUS) is the most effective device presently available for treating severe stress urinary incontinence (SUI). The principal reason for AUS placement worldwide is to correct postprostatectomy urinary incontinence in males. The concept of an implantable prosthetic device to address SUI dates back to the 1940s. The history of AUS development is marked by trial and error in an era of more permissible latitude for experimentation. Numerous technological innovations, modifications, setbacks, and lucky happenstance paved the path for the emergence of the current Boston Scientific American Medical Systems (AMS) AUS 800 device we use today. This review article emerges from a systematic examination of archival repositories, scholarly databases, primary source materials, and subsequent qualitative assessments, with the aim of delving into the techno-historical evolution of the AUS.

Prevalence of Cognitive and Manual Dexterity Disorders Among Men Following Artificial Urinary Sphincter Placement.

Cognitive ability and manual dexterity sufficient to operate an artificial urinary sphincter (AUS) are critical for device function and safety. We aimed to define the incidence of cognitive and/or dexterity disorders among men after AUS. We secondarily aimed to assess for association between these disorders and postimplant complications. This is a retrospective cohort study using the SEER (Surveillance, Epidemiology, and End Results)-Medicare linked database (2000-2018). We included men ≥ 66 years diagnosed with prostate cancer between 2001 to 2015 who subsequently underwent AUS placement. We excluded patients with < 1-year continuous fee-for-service Medicare enrollment or cognitive and/or manual dexterity disorder diagnoses prior to AUS implant. Subsequent cognitive/dexterity disorders and implant-related complications were queried using appropriate ICD (International Classification of Diseases)-9/10 and/or CPT (Current Procedural Terminology) codes. Associations between cognitive/dexterity disorders and postimplant complications were assessed using extended Cox proportional hazards modeling. Secondary analysis focused on serious complications (device revision/removal, Fournier's gangrene, urethral erosion). We identified 1560 men who underwent AUS who met inclusion criteria. Median age was 73.0 (IQR 70-77) years. Cumulative incidence function analysis estimated 44% and 17% incidence of cognitive and manual dexterity disorder, respectively, at 15 years post-AUS. Presence of cognitive with/without manual dexterity disorder was associated with increased hazard of any, but not serious, complication during follow-up. A significant proportion of patients develop cognitive and/or manual dexterity disorders following AUS. These data support the need for close longitudinal monitoring after implant.

Artificial Urinary Sphincter Complications: A Narrative Review.

Stress urinary incontinence is a financially burdensome and socially isolating problem and can be experienced by men as a result of radical prostatectomy, radiation therapy, or other urologic surgery. Artificial urinary sphincter (AUS) placement for stress urinary incontinence is considered the 'gold standard' for male stress urinary incontinence. While initially only placed by specialized prosthetic surgeons, changes in urologic training have made implantation of the device by general urologists more widespread. Additionally, even though a minority of urologists place the majority of implants, many urologists may find themselves caring for patients with these devices even if they have never placed them themselves. For this reason, it is paramount that the urologic surgeon implanting the device and those caring for patients with prostheses are familiar with the various perioperative and postoperative complications of AUS implantation. This review discusses the most commonly reported complications of AUS implantation as well as those that are rarely described. Knowledge of these potential complications is necessary in order to care for patients with urologic implants.

Posterior Urethral Reconstruction at the Time of Rectourethral Fistula Repair: Technique and Outcomes

IntroductionRecto-urethral fistulas (RUF) remain a difficult management problem. To assess the impact of posterior urethral stenosis on outcomes following RUF repair, we present a cohort of 23 men who underwent posterior urethroplasty concurrent with RUF repair. MethodsWe identified 130 men who underwent RUF repair at our institution between 2003-2021. Of these, 23 (18%) underwent simultaneous posterior urethroplasty. Fifteen men received prior radiation for prostate cancer. Of the 8 men who were not radiated, 4 had a history of radical prostatectomy, 2 pelvic trauma, and 3 inflammatory bowel disease. All 23 men underwent fecal diversion prior to surgery (median, 6 months pre-operatively), and 20 men suprapubic catheter placement (median, 5.5 months pre-operatively). ResultsRUF repair was performed via perineal approach in 22 cases (96%) and prone Kraske position in 1 (4%). Intra-operatively, 20 men (87%) had urethral stenosis, and 3 (13%) had significant urethral defects due to cavitation and tissue loss. There was stenosis/stricture involving the prostatomembranous urethra in 18 cases (78%) and vesicourethral anastomosis in 5 (22%). Urethroplasty was performed with anastomotic repair in 18 patients (78%) and using a buccal mucosal graft in 5 (22%). Gracilis flap interposition was performed in 21 cases (91%).At a median follow up of 55.7 months (IQR, 23-82 months), 20 men (87%) had successful RUF closure, with 3 patients experiencing RUF recurrence requiring further surgery. Fourteen men (61%) reported postoperative urinary incontinence, with 7 (30%) ultimately undergoing artificial urinary sphincter placement. There were no isolated stricture recurrences requiring instrumentation. ConclusionsPosterior urethral stenosis associated with RUF complicates an already challenging problem. However, most of these patients can be successfully treated concurrent with RUF repair. This series demonstrates that patients with RUF should not be ruled out for restorative reconstructive surgery based on the presence of posterior urethral stenosis.

Prior male sling does not affect outcomes of artificial urinary sphincter.

To investigate the outcomes of artificial urinary sphincter (AUS) placement in patients with post-prostatectomy urinary incontinence (PPUI) with or without a prior male sling. We performed a retrospective chart review of patients who underwent AUS for PPUI from 2007 to 2022. The primary endpoint was to determine the proportion of patients who achieved social continence, defined as self-reported use of 0-1 pad/day. The secondary endpoints were device failure rates and device failure-free survival. The analysis included 210 patients, with 30 (14.3%) having had prior slings and 180 (85.7%) without prior slings. After AUS insertion, 80.0% of patients with prior slings and 76.7% of those without prior slings achieved continence (0-1 pad/day). There were six (20.0%) and 53 (29.4%) device failures in patients with and without prior slings, respectively. The median device failure-free survival was not reached in patients with prior slings and was 8.9 years in patients without prior slings (P = 0.048). Limitations include retrospective nature and small sample size. The efficacy and safety of AUS in patients with prior slings are similar to those without. Prior sling is associated with a longer device failure-free survival. AUS remains a viable option in patients who have persistent PPI after prior slings.

A Full Bladder Is Not Needed for the Male Stress Incontinence Grading Scale.

Our objectives were to evaluate the Male Stress Incontinence Grading Scale to stratify male patients with stress urinary incontinence for either artificial urinary sphincter or sling using a standing cough test and determine if an emptier bladder at the time of assessment carries increased risk of treatment failure. Retrospective chart review of male patients undergoing sling and artificial urinary sphincter placement. The standing cough test score and bladder scan results were documented at initial evaluation. Forty patients underwent sling and 43 underwent naïve artificial sphincter placement. Median follow-up was 7.11 months. Thirty-six/forty slings had complete incontinence resolution or reduction to a safety pad vs 40/43 after sphincter (90% vs 93%, P = .62). Four sling patients (10%) had persistence or recurrence of incontinence. Cough test scores were similar between sling failure (67% grade 0, 33% grade 1) and success groups (83% grade 0, 3% grade 1, 14% grade 2). Bladder scan mean was 18.5 cc in the sling failure (SD 21.1) and 38.0 cc in the success groups (38.3), with 32% of success patients having bladder scans of 0 cc, and 63% of < 50 cc. Mean for sphincter patients was 45 cc (56.9). Ten patients with scan = 0 and 7 patients with scans < 30 cc demonstrated grade 4 incontinence. Cough test is a noninvasive, reliable tool to assess stress urinary incontinence severity. Our data suggest it is reliable even when bladders are nearly empty and can effectively stratify patients for sling vs artificial urinary sphincter with a high rate of success.

Characterizing patient experiences with repeat artificial urinary sphincter revisions through quantitative surveys and qualitative patient interviews.

Artificial urinary sphincter (AUS) placement remains the gold-standard treatment for post-prostatectomy urinary incontinence (PPUI), despite their need for periodic surgical revision. To understand the experiences of patients who undergo repeat AUS revisions. Mixed design including quantitative surveys and qualitative interviews for thematic analysis. Men with ⩾2 revisions were collected from a single-institution, retrospective database of AUS patients. Participants were interviewed about their prostatectomy, incontinence, AUS placement, and revisions. A survey was administered utilizing validated tools (e.g., Decision Regret Scale (DRS), Incontinence Impact Questionnaire-7) for quantitative analysis. Interview transcripts were used for qualitative thematic analysis. Of 26 respondents, 20 completed the interview. Twenty-three men completed the survey. The mean DRS score for prostatectomy was 24 (standard deviation (SD) = 27), indicating low regret. Median Incontinence Impact Questionnaire score was 54 (SD = 27), with 70% of participants describing their PPUI as "severe." Participants experienced a significant decrease in daily pad usage with AUS placement (5.5 pre-AUS vs 1.4 post-AUS, p < 0.0001). Qualitative analysis revealed themes involving prostatectomy urgency, physician-patient relationships, expectation setting, and quality of follow-up. Most participants (96%) were satisfied with their initial AUS placement and endorsed a positive relationship with their urologist. However, 22% of participants were unaware of device limitations, including the need for revision. Some participants (26%) were uncertain of the status of their AUS, while some participants (35%) desired improved follow-up. Initial improvement and positive experiences with urologists motivate patients to undergo AUS repeat revision. Urologists should emphasize the limitations of the AUS before placement and follow up with patients to evaluate their needs for future care.

No-Opioid Discharge Following Artificial Urinary Sphincter Placement Does Not Significantly Increase Health Care System Burden.

Postoperative opioid prescriptions are associated with an increased risk of opioid dependance. While studies on no-opioid discharge strategies have been assessed following many urologic procedures, the effect of no-opioid discharges on health care utilization following artificial urinary sphincter placement is unknown. We performed a single-surgeon retrospective comparison of health care system interactions following artificial urinary sphincter implantation between patients who received an opioid prescription on discharge to those who did not. We identified 101 male patients who underwent 3-piece artificial urinary sphincter placement or revision by 1 provider between 2015 and 2022. All patients were discharged with acetaminophen and ibuprofen; none received intraoperative local anesthetic. Demographic information, preprocedural opioid use, opioid prescriptions following the procedure, postoperative office communications, unplanned office visits, and emergency department (ED) visits were recorded for each patient for 90 days. Forty-five patients (45%) were discharged without an opioid prescription and 56 patients (55%) were discharged with an opioid prescription. No differences in age, race, BMI, operative time, or presence of a preoperative opioid prescription were observed. Discharge without an opioid did not significantly increase the number of office communications (55% vs 40%, P = .11), unplanned office visits (36% vs 23%, P = .19), or ED visits (20 vs 12, P = .41) within 90 days of implantation/revision. Opioids can be omitted from the discharge analgesic regimen following artificial urinary sphincter placement without increasing burden to surgical office staff or local EDs. Providers should consider no-opioid discharges for patients undergoing uncomplicated sphincter placement to limit risk of opioid-related morbidity.

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.

An evaluation of three validated comorbidity indices to predict short-term postoperative outcomes after prosthetic urologic surgery.

Commonly used comorbidity indices include the Charlson Comorbidity Index (CCI), Elixhauser/Van Walraven Index (VWI), and modified frailty index (mFI). This study evaluates whether these indices predict postoperative readmissions and complications after inflatable penile prosthesis (IPP) and artificial urinary sphincter (AUS) placement. We identified adult males who underwent IPP or AUS placement using the State Inpatient and State Ambulatory Surgery and Services Databases for Florida (2010-2015) and California (2010-2011). CCI, VWI, and mFI scores were calculated for each patient. We extracted 30-day emergency department services, 30-day readmissions, 90-day device complications (e.g., removal, replacement, or infection), and 90-day postoperative complications (excluding device complications). Receiver-operating characteristic curves were constructed and areas under the curve (AUC) were compared between the indices using the VWI as the reference model. We considered an AUC < 0.7 to represent poor predictive power. We identified 4242 IPP and 1190 AUS patients. All three indices had AUCs and 95% confidence intervals less than 0.70 for all outcomes following IPP and AUS placement making these indices poor predictors for postoperative outcomes. There were no significant differences in predicting 90-day postoperative complications between the VWI (AUC = 0.59, 95% CI [0.54-0.63]), CCI (AUC = 0.59, 95% CI [0.54-0.63], p = 0.99), and mFI (AUC = 0.60, 95% CI [0.55-0.66], p = 0.53) for IPPs and VWI (AUC = 0.54, 95% CI [0.47-0.61]), CCI (AUC = 0.50, 95% CI [0.43-0.57], p = 0.30), and mFI (AUC = 0.52, 95% CI [0.43-0.60], p = 0.56) for AUS placements. All three comorbidity indices were poor predictors of readmissions and complications following urologic prosthetic surgeries. A better comorbidity index is needed for risk-stratification of patients undergoing these surgeries.

The 51-60 cm H2O Artificial Urinary Sphincter Pressure Regulating Balloon: Indications and Outcomes

To describe the role and long-term outcomes of using the 51-60 cm H2O pressure regulating balloon (PRB) in male patients with an artificial urinary sphincter (AUS). From 2005 to 2021, 90 patients with a variety of urethral risk factors underwent AUS placement with use of the low pressure 51-60 cm H2O PRB to treat stress incontinence. Patient demographics, indication for use of the 51-60 cm H2O PRB, perioperative data, and postoperative outcomes were examined and Pearson's chi squared test and Wilcoxon rank sum test were used to identify associations with future revisions, erosion, and mechanical failure. 90 patients were included in the study. After median follow-up of 46.6 months (range: 6 - 146 months), 4 (4.44%) patients developed an erosion-related complication that required device removal, 4 developed an infection, and 3 underwent surgery for pump relocation. One patient had a reported mechanical failure of unknown source. 30 patients underwent revision surgery to reduce incontinence. Of the 4 patients with erosion, 1 was due to iatrogenic catheterization. The remaining 3 had numerous urethral risk factors. Univariate analysis was performed to identify predictors of cuff erosion, infection, and revision in patients with a 51-60 cm H2O PRB. No significant associations were found including prior pelvic radiation, age at AUS placement, presence of IPP, prior AUS erosion, or previous urethroplasty. The low pressure 51-60 cm H2O PRB can be used in high-risk male patients with urinary incontinence with low rates of complications including erosion, infection, and mechanical failure. While patients may choose to undergo future revisional surgery to improve continence, the 51-60 cm H2O PRB should be considered as the initial PRB in patients with urethral risk factors.