Comparing the lifespan of virgin artificial urinary sphincters in radiated patients: transcorporal vs. standard placement.

PURPOSE: To compare the lifespan of first transcorporal cuff (TC) placement of an artificial urinary sphincter (AUS) versus standard placement (SP) in patients with prior radiotherapy (RT) for prostate cancer (PCa). METHODS: We reviewed first (virgin) AUS placements from two high-volume care centers between 1/2011 and 1/2021, including PCa patients with RT history. AUS lifespan was assessed via the hazard ratio of device explantation and/or revision within a ten-year timeframe for the TC vs. SP approaches. Chi-square, Fisher's exact, and t-tests compared clinicodemographic variables. Kaplan-Meier curve compared TC and SP lifespan. RESULTS: 85/314 men with AUS met inclusion criteria, with 38.8% (33/85) in the TC group and 61.2% (52/85) in the SP group. Median ages were 69.8 (IQR = 65.2-73.6) and 67.1 (61.6-72.9), respectively, p = 0.17. Over a median follow up of 51.9 (15.8-86.1) and 80.4 (28.1-128.3) months for the TC and SP, overall, 12 (36.4%) TC devices were removed (four [12.1%] due to mechanical failures; eight [24.2%] erosions, and two [6.1%] infections) vs. 29 (55.8%) in the SP group (14 [26.9%] mechanical failures; 11 [21.1%] erosions, and five [9.6%] infections). No statistically significant differences were observed between the two approaches, with HR = 0.717, 95% CI 0.37-1.44, p = 0.35. The calculated device survival probabilities for the TC vs. SP at one, five, and 10 years were 78.8% vs. 76.9%, 69.3% vs. 58.7%, and 62.1% vs. 46.7%, respectively. CONCLUSIONS: TC cuff insertion for the first AUS implantation in pre-radiated patients showed to be comparable to SP when it comes to device survival, with comparable complication rates. Current guidance for approach selection is primarily based on patient selection and surgeon preference.

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

INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

[Urinary stress incontinence in men: diagnostic workup and modern surgical treatment]. / Belastungsinkontinenz des Mannes: sinnvolle Diagnostik und moderne operative Therapie.

Radical prostatectomy is the most common cause of urinary stress incontinence in male patients. The exact pathophysiology is not clearly defined but probably due multifactorial. Thorough preoperative diagnostic workup before surgical therapy appears to be crucial for good postoperative results. Various systems are available. The artificial urinary sphincter continues to be considered standard procedure with a high success rate, even in patients with more complex situations and severe urinary incontinence. However, there are also relevant complication and revision rates. Modern alternatives include various sling systems. The adjustable sling systems consist of a cushion that is placed against the urethral bulb and leads to a permanent increase in urethral resistance, which can be readjusted in different ways depending on the system implanted. The adjustable sling systems also seem to be an alternative in patients with a prior history of radiation therapy. The AdVance XP sling (Boston Scientific, Marlborough, MA, USA) is a fixed sling that corrects the postoperative hypermobility of the posterior urethra after radical prostatectomy and, thus, leads to a longer functional urethral length. Good long-term results after AdVance XP implantation are only possible in selected patients.

Manual Dexterity Predictors of Artificial Urinary Sphincter Success.

OBJECTIVE: To determine better in-office measures for artificial urinary sphincter outcomes, we investigated the ability of preoperative timed peg-transfer, pinch strength, grip strength, and Disabilities of the Arm Shoulder and Hand Outcome questionnaire in predicting postoperative satisfaction, confidence, and ease of use of artificial urinary sphincter placement for stress urinary incontinence. MATERIALS AND METHODS: A timed 9-hole peg test, pinch and grip strength assessment, and upper extremity questionnaire were administered during the preoperative visit before sphincter placement. In addition to standard preoperative workup, short-form International Consultation of Incontinence Questionnaire and physician handshake were recorded. Activation occurred 6 weeks after surgery along with assessment of adequacy of pump placement. Three months from surgery a repeat incontinence questionnaire and a survey measuring satisfaction, difficulty of use, and confidence were given. Correlation between preoperative assessment variables and the postoperative questionnaire was assessed. RESULTS: Thirty-nine patients were included. Average age and body mass index were 68.8 years and 28.8 kg/m2, respectively. Prior prostatectomy accounted for 92.3% of patients, and 46.2% had prior pelvic radiation. Postoperatively, 59.0% of patients were very satisfied; 64.1% of patients reported no difficulty of use; 53.8% felt confidence within 1 day; and 66.7% had much better bladder control. Average pad improvement count was 5.3. Pinch test was associated with satisfaction (P = .011) while peg test was associated with confidence (P = .049). Handshake and upper extremity questionnaire were not significant. CONCLUSION: The pinch and 9-hole peg transfer tests are cost-effective and easily performed adjuncts that could be used during artificial urinary sphincter evaluation for patients with unclear manual functional status.

Eighteen years of experience in laparoscopic implantation of artificial urinary sphincter in women with intrinsic sphincter deficiency.

INTRODUCTION AND OBJECTIVES: Artificial urinary sphincter (AUS) is a treatment option for women with stress urinary incontinence (SUI) after failure of previous surgery or as a primary procedure in severe intrinsic sphincter deficiency (ISD). The aim of the study was to assess the long-term efficacy and risk factors for surgical revision and definitive explantation of AUS laparoscopic implantation in female patients. METHODS: A retrospective review of all women submitted to AUS implantation between April 2005 and March 2023 was conducted. The AUS was implanted via transperitoneal laparoscopic approach, by two experienced surgeons. The primary endpoint was postoperative continence. Continence was defined as no leakage and no pad usage or leakage and/or pad usage with no impact on social life and failure as leakage and/or pad usage impacting social life. As secondary outcomes, clinical predictive factors for AUS revision and definitive explantation were evaluated. RESULTS: In the last 18 years, females with a mean age of 68±12 years-old were submitted to laparoscopic implantation of AUS. Early overall complication rate was 16%, but only one case was Clavien-Dindo ≥3. After a median follow-up of 67 months, 22.2% of the patients needed a device revision, the majority due to mechanical device dysfunction. AUS definitive explantation was performed in 16%, mainly due to urethral/vaginal erosion (9.9%) and infection (6.2%). Patients with age ≥70 years and follow-up ≥10 years significantly predisposed for device revision. At the time of the last follow-up, 72% of the patients were keeping the urinary continency. CONCLUSIONS: Laparoscopic AUS implantation in females is an effective treatment for SUI due to ISD. Meanwhile, adequate patient selection, multidisciplinary evaluation and careful expectation management are essential to achieving good results, concerning their significant complication rate.

Neurological sphincter deficiency: is there a place for artificial urinary sphincter?

PURPOSE: Neurogenic stress urinary incontinence (N-SUI) is a condition with serious impact on the quality of life. There are several treatment modalities of which the artificial urinary sphincter (AUS) stands out as the most suitable technique for addressing sphincter insufficiency. In this article, the purpose is to describe practical considerations, outcomes, and complications of the artificial urinary sphincter in neurological sphincter deficiency in both males and females. METHODS: A narrative review of the current literature. RESULTS: The outcomes of AUS are reasonably good in patients with NLUTD, the surgical technique is discussed as well as the limitations and special considerations in this complex and heterogeneous patient population. CONCLUSION: The available evidence suggests that its efficacy and functional durability may be lower in patients with neurogenic lower urinary tract dysfunction (NLUTD) compared to those without neurological deficits. However, studies have shown that AUS can still provide effective and safe continence outcomes in both male and female patients, with long-term device survival rates ranging from several years to over a decade.

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

OBJECTIVE: 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. PATIENTS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Characterizing and Quantifying Material Fatigue of the Artificial Urinary Sphincter Pressure Regulating Balloon.

OBJECTIVE: To characterize and quantify changes in elastic properties and in vivo pressure characteristics of pressure regulating balloons (PRB) over time, we conducted an analysis of the mechanical characteristics of the PRB after removal from patients for revision surgery. METHODS: Pressure and elasticity characteristics of new and used 61-70 cm H2O PRBs were analyzed. Pressure-volume curves were generated using commercially available urodynamics equipment. PRB pressures were measured at a standard fill volume (23 cc). Elastance was calculated by the slope of the tangent line at the inflection point of the pressure-volume curve. Tests were repeated 5 times per PRB and intraclass correlations were used to gauge test-retest reliability. Regression models were used for continuous variables based on data distribution. RESULTS: Twenty-seven used PRBs were analyzed after excluding 3 for alternative pressure ratings and 2 for occult pinpoint leaks. Time from artificial urinary sphincter placement to removal ranged from 0.02-17.6 years (median 8.4, interquartile range (IQR) 5.7-10.0). The mean pressure of all extracted PRBs: 58.8 cm H=O (± 7.4), 17 (62.9%) below the standard operating range. Each year of use in-vivo was associated with 1.09 cm H2O pressure loss on linear regression (P <.01 CI -1.52 to -0.65). PRB pressures were not significantly different according to indication for removal (1-way analysis of variance (ANOVA) P = .11). Loss of elastance was non-linear, decreasing by 1.9% per year on Poisson regression (P <.01, CI -0.03 to -0.01). When accounting for PRB age, PRB pressure was independently associated with detrusor overactivity. CONCLUSION: In PRBs tested for pressure-volume characteristics, increasing PRB age was associated with decreased pressure and elasticity.

A robot-assisted laparoscopic revision of an artificial urinary sphincter in a patient with spinal cord injury.

This step-by-step article demonstrates our approach to robot-assisted laparoscopic revision of a bladder neck sited artificial urinary sphincter (AUS) for a spinal cord injured patient. The bladder neck location of an AUS in the spinal cord injured demographic is ideal to minimise urethral complications and urinary tract infections, whilst the transabdominal approach reduces the risk of wound breakdown that can occur via the typical perineal incision for AUS insertion. The accompanying video will guide viewers as to our minimally invasive technique for cuff revision in the event of secondary surgery for recurrent urinary incontinence.

Androgens and Urethral Health: How Hypogonadism Affects Postoperative Outcomes of Patients Undergoing Artificial Urinary Sphincter or Inflatable Penile Prosthesis Placement.

OBJECTIVE: To determine the role of androgens in penile and urethral health, we sought to understand what impact hypogonadism may have on artificial urinary sphincter (AUS) and inflatable penile prosthesis (IPP) outcomes. We hypothesize that patients with hypogonadism are at increased risk of reinterventions, complications, and infections. METHODS: We queried the TriNetX Global Database in March 2023 for patients receiving an AUS or IPP, looking at lifetime reintervention, complication, and infection rates. We conducted multiple comparisons: (1) eugonadal patients against hypogonadal patients, (2) hypogonadal patients on testosterone replacement therapy (TRT) against hypogonadal patients not on TRT, and (3) hypogonadal patients on TRT against eugonadal patients. RESULTS: Hypogonadal patients undergoing AUS had more complications (33.5% vs 28.3%), higher reintervention rates (27.7% vs 24.3%) and higher infection rates (7.3% vs 6.8%), albeit none reaching significance. Hypogonadal patients undergoing IPP had significantly higher infection rates (6.3% vs 4.4%, RR 1.5 (1.04, 2.04)) and reintervention rates (14.9% vs 11.9%, RR 1.3 (1.04, 1.61)), but not complication rates (21.9% vs 18.9%). When comparing patients with hypogonadism on TRT vs off TRT, there was not a significant difference in reinterventions, or complications, in AUS and IPP patients, but there were significantly more infections in IPP patients (7.0% vs 3.9%, RR 1.9 (1.002, 3.5)). CONCLUSION: Hypogonadal patients have more reinterventions, complications, and infections following urologic implant surgery, to varying levels of significance. TRT may not be completely protective to improve tissue health but with many limitations that should be explored in further research.

Robot-assisted Periprostatic Artificial Urinary Sphincter Implantation in Men with Neurogenic Stress Urinary Incontinence: Description of the Surgical Technique and Comparison of Long-term Functional Outcomes with the Open Approach.

BACKGROUND: Periprostatic artificial urinary sphincter implantation (pAUSi) is a rare yet relevant indication for male neurogenic stress urinary incontinence (SUI). OBJECTIVE: To describe the surgical technique of robot-assisted pAUSi (RApAUSi) and compare the long-term functional results with the open pAUSi (OpAUSi). DESIGN, SETTING, AND PARTICIPANTS: Data of 65 consecutive men with neurogenic SUI undergoing pAUSi between 2000 and 2022 in a tertiary centre were collected retrospectively. SURGICAL PROCEDURE: Thirty-three patients underwent OpAUSi and 32 underwent RApAUSi. OpAUSi cases were performed by a single surgeon, experienced in functional urology and prosthetic surgery. RApAUSi cases were performed by the same surgeon together with a second surgeon, experienced in robotic surgery. MEASUREMENTS: Outcome measures were achievement of complete urinary continence, intra- and postoperative complications, and surgical revision-free survival (SRFS). RESULTS AND LIMITATIONS: RApAUSi showed superior results to OpAUSi in terms of median (interquartile range) operative time (RApAUSi: 170 [150-210] min vs OpAUSi: 245 [228-300] min; p < 0.001), estimated blood loss (RApAUSi: 20 [0-50] ml vs OpAUSi: 500 [350-700] ml; p < 0.001), and median length of hospital stay (LOS; RApAUSi: 5 [4-6] d vs OpAUSi: 11 [10-14] d; p < 0.001). Clavien-Dindo grade ≥3a complications occurred more frequently after OpAUSi (RApAUSi: 1/32 [3%] vs OpAUSi: 10/33 [30%]; p = 0.014). Achievement of complete urinary continence (zero pads) was comparable between the groups (RApAUSi: 24/32 [75%] vs OpAUSi: 24/33 [73%]; p = 0.500). The median follow-up periods were 118 (50-183) and 56 (25-84) mo for OpAUSi and RApAUSi, respectively (p < 0.001). A tendency towards longer SRFS was observed in the RApAUSi group (p = 0.076). The main study limitation was its retrospective nature. CONCLUSIONS: RApAUSi is an efficient alternative to OpAUSi, resulting in shorter operative times, less blood loss, fewer severe complications, and a shorter LOS with similar functional results and need for revision surgery. PATIENT SUMMARY: Compared with open periprostatic artificial urinary sphincter implantation (pAUSi), robot-assisted pAUSi leads to faster recovery and similar functional results, with fewer postoperative complications.

Immediate and Long-term Outcomes of Lateral Retroperitoneal Pressure Regulating Balloon Placement During Artificial Urinary Sphincter Implantation.

OBJECTIVE: To 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). METHODS: A retrospective chart review was performed on all patients that underwent primary AUS placement between 2006 and 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. RESULTS: Five hundred forty-one 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 54.8months (range: 1-181months), 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 nonbothersome, but palpable reservoir. Lastly, there were 2 incidents (0.4%) of mechanical failure caused by a leak in the PRB. CONCLUSION: Due 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.

Longitudinal deterioration in lower urinary tract symptoms after artificial urinary sphincter implantation in patients with a history of pelvic radiation therapy.

OBJECTIVES: To evaluate longitudinal changes in lower urinary tract symptoms (LUTS) after artificial urinary sphincter (AUS) implantation in patients undergoing radiation therapy (RT) in comparison to those in non-irradiated patients. METHODS: This retrospective study included 20 and 51 patients with and without a history of pelvic RT (RT and non-RT group, respectively) who were treated with primary AUS implantation for post-radical prostatectomy incontinence between 2010 and 2020. Longitudinal changes in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), the International Prostate Symptom Score (IPSS), and the Overactive Bladder Symptom Score (OABSS) were calculated with a linear mixed model. RESULTS: In the RT and non-RT group, 18 (90%) and 48 (94%) patients achieved social continence, defined as daily pad use ≤1 at 1 month after activation of AUS, respectively (p = .555). During the mean follow-up of 38 months, ICIQ-SF, IPSS, and OABSS significantly improved after AUS implantation in both the RT and non-RT groups. In the RT group, ICIQ-SF, IPSS, and OABSS subsequently deteriorated with a slope of 0.62/year (p = .010), 0.55/year (p = .025), and 0.30/year (p = .007), respectively. In the non-RT group, no significant longitudinal changes in subsequent IPSS and OABSS were observed, although ICIQ-SF significantly deteriorated (0.43/year, p = .006). Comparing between the groups, the slopes of IPSS and OABSS were significantly greater in the RT group than in the non-RT group (p < .001, and .015, respectively). CONCLUSIONS: Longitudinal deterioration in LUTS that improved immediately after AUS implantation was observed in patients with a history of pelvic RT, but not in patients without a history of pelvic RT.

Robust voltage-controlled transcutaneous energy transfer system for artificial anal sphincter.

BACKGROUND: The artificial anal sphincter (AAS) system has gained significant attention as a solution for treating fecal incontinence (FI). It relies on transcutaneous energy transfer (TET) as its primary energy source. However, changes in posture or biological tissue can cause misalignment of the coil, resulting in unstable power reception. Inadequate power affects charging efficiency, while excessive power leads to excessive heating at the receiver side. Consequently, achieving safe and constant voltage charging for the AAS becomes a complex challenge. METHODS: To maintain a consistent charging voltage and overcome the issue of variations in load and coil coupling strength, this article proposes a wireless charging control system that utilizes an LCC-S-type resonant network and phase shift to adjust the transmitting voltage based on feedback charging voltage in real time. In particular, the PI controller and neural network are introduced to change the phase-shift angle swiftly. The dynamic performance is then evaluated under different misalignments and presented with comparative results. RESULTS: The results indicate that the multilayer perceptron control system outperforms the PI. Under the complex misalignment disturbance, the average error of receiver side load voltage is only 0.007 V, with an average settling time of 960 ms. Additionally, the average temperature at the receiver side is 40.4°C. CONCLUSION: The experiments demonstrate that the proposed system effectively addresses the misalignment issue in TET during the charging, ensuring constant voltage charging at the receiver side and thermal safety.

How older men live with stress urinary incontinence: Patient experience and navigation to treatment.

OBJECTIVES: To explore the context in which older men navigate treatment for stress urinary incontinence (SUI) following prostate surgery by characterizing lived experience of men with symptomatic SUI. SUBJECTS/PATIENTS AND METHODS: Mixed method study using surveys and semistructured interviews to examine a cohort of men who underwent evaluation for treatment of postprostatectomy SUI. RESULTS: Thirty-six men were interviewed after consultation for SUI and 31 had complete quantitative clinical data. Twenty-six underwent surgery and 10 chose no surgical intervention. In qualitative interviews, respondents experienced substantial decline in quality of life due to incontinence citing concerns associated with use of pads and worrying about incontinence. Most patients reported "workarounds"-efforts to mitigate or manage incontinence including Kegels, physical therapy, and garments. Participants also reported lifestyle changes including less strenuous physical activity, less sexual activity, and/or fewer social gatherings. Patients then described a "breaking point" where incontinence workarounds were no longer sufficient. After seeking evaluation, men described challenges in exploring treatment for SUI, including access to care and provider knowledge of treatment options. CONCLUSION: In a novel study of patients living with SUI a predictable lived experience was observed that culminated in a desire for change or "breaking point." In all men, this led to treatment-seeking behaviors and for many it led to SUI intervention. Despite effective treatments, patients continue to meet barriers gaining access to SUI evaluation and treatment.

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

OBJECTIVE: To describe the role and long-term outcomes of using the 51-60cm H2O pressure regulating balloon (PRB) in male patients with an artificial urinary sphincter (AUS). METHODS: From 2005-2021, 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. RESULTS: Ninety patients were included in the study. After median follow-up of 46.6months (range: 6-146months), 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. Thirty 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 inflatable penile prosthesis (IPP), prior AUS erosion, or previous urethroplasty. CONCLUSION: 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.