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

PURPOSE: 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. MATERIALS AND METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.

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.

Outcomes of the Victo™ adjustable artificial urinary sphincter in the treatment of male incontinence.

OBJECTIVES: To report the clinical outcomes of the Victo™ (Promedon, Cordoba, Argentina) adjustable artificial urinary sphincter (AUS) implantation in a cohort of patients with severe urinary incontinence (UI) after prostate surgery. PATIENTS AND METHODS: This study enrolled patients with UI following prostate surgery who underwent a Victo implantation between May 2018 and December 2023. Patients were prospectively evaluated at baseline, and at 3 and 12 months after device activation, and thereafter annually. The 24-h pad-weight test (24hPWT) was used to assess severity of UI, while the Patient Global Impression of Improvement (PGI-I) and patient satisfaction according to a Likert scale were used to measure patient-reported outcomes. RESULTS: A total of 96 patients with a median (interquartile range [IQR]) age of 68 (65-72) years were included in the final analysis. The median (IQR) follow-up was 3 (1-4) years. In all, 10 patients completed the 5-year follow-up. After the treatment, we observed a significant reduction in 24hPWT by the median of 83% (P < 0.001) at 3 months and by a median of 79% (P < 0.001) at 3 years. According to the PGI-I, a total of 87%, 92%, 87%, 81%, 83%, and 50% (five of 10) of patients rated their condition/incontinence as 'very much improved', 'much improved' or 'little improved' at 3 months, 1-, 2-, 3-, 4-, and 5-year follow-up visits, respectively. The proportion of patients, who were 'very satisfied' or 'satisfied' with the treatment outcome was 79%, 80%, 75%, 69%, 80%, and 60% (six of 10) at 3 months, 1-, 2-, 3-, 4-, and 5-years, respectively. There were a total of 13 (14%) device failures during the follow-up period. CONCLUSION: In conclusion, our data suggest that Victo AUS significantly reduces the severity of UI after prostate surgery and provides a reasonably high patient-reported satisfaction with treatment outcomes at mid-term follow-up.

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.

Robotic female artificial urinary sphincter implantation vs. male artificial urinary sphincter implantation for non-neurogenic stress urinary incontinence.

PURPOSE: Previous studies suggested better functional outcomes and longer device survival for female artificial urinary sphincter (AUS) implantation compared to male AUS implantation. We hypothesized that the adoption of robotic approaches for female implantation might have influenced these comparisons. This study aimed to compare the outcomes of robotic female AUS and male AUS implantation for non-neurogenic stress urinary incontinence (SUI). METHODS: We retrospectively reviewed charts of male patients who had AUS implantation and female patients who underwent robotic AUS implantation for non-neurogenic SUI between 2010 and 2022 at a single center. Prior AUS implantations were exclusion criteria. The primary endpoint was continence status at 3 months, categorized as complete resolution of SUI (0 pad), improved SUI (1pad), or unchanged SUI (>1pad). RESULTS: After excluding 79 patients, 171 were included: 70 women and 101 men. Operative time was shorter in males (126.9 vs. 165.5 min; p < 0.0001). Postoperative complication rates were similar (17.3% vs. 22.9%; p = 0.38). Continence status at 3 months and last follow-up favored females. The ICIQ-SF decrease at 3 months was greater in females (-7.2 vs. -4.6; p < 0.001). The 5-year estimated explantation-free survival was similar (78.6% vs. 73.7%; p = 0.94) as was the revision-free survival (67.4% vs. 61.7%; p = 0.89). Multivariate analysis showed that female gender was associated with better continence at last follow-up (OR = 4.3; p = 0.03). CONCLUSION: Robotic female AUS implantation is associated with better functional outcomes than male AUS implantation, with similar morbidity and survival rates.

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.

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.

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.

In silico assessment of the reliability and performance of artificial sphincter for urinary incontinence.

BACKGROUND: The standard artificial urinary sphincter (AUS) is an implantable device for the treatment of urinary incontinence by applying a pressure loading around the urethra through an inflatable cuff, often inducing no-physiological stimulation up to tissue degenerative phenomena. A novel in silico approach is proposed to fill the gap of the traditional procedures by providing tools to quantitatively assess AUS reliability and performance based on AUS-urethra interaction. METHODS: The approach requires the development of 3D numerical models of AUS and urethra, and experimental investigations to define their mechanical behaviors. Computational analyses are performed to simulate the urethral lumen occlusion by AUS inflation under different pressures, and the lumen opening by applying an intraluminal pressure progressively increased under the AUS action (Abaqus Explicit solver). The AUS reliability is evaluated in terms of tissue stimulation by the mechanical fields potentially responsible for vasoconstriction and tissue damage, while the performance by the intraluminal pressure that causes the lumen opening for a specific occlusive pressure, showing the maximum urethral pressure for which continence is guaranteed. RESULTS: The present study implemented the procedure considering the gold standard AMS 800 and a novel patented AUS. Results provided the comparison between two sphincteric devices and the evaluation of the influence of different building materials and geometrical features on the AUS functionality. CONCLUSIONS: The approach was developed for the AUS, but it could be adapted also to artificial sphincters for the treatment of other anatomical dysfunctions, widening the analyzable device configurations and reducing experimental and ethical efforts.

Treatment strategies for revision surgery of artificial urinary sphincter: A review.

Artificial urinary sphincters (AUS) are an effective treatment for male stress urinary incontinence (SUI). However, infection, erosion, mechanical failure, atrophy, and balloon deterioration cause device malfunction in approximately half of patients by 10 years after implantation. Many patients desire to regain urinary continence and require revision surgery (RS), including device removal and simultaneous or delayed implantation. Patients for whom RS is considered should be examined physically and by interview for signs of infection. Urethral erosion should be assessed using cystoscopy. If there is infection or erosion, all devices should be removed first, and a new device should be implanted several months later. During the RS, after strong adhesion around the urethra, transcorporal cuff implantation is a safe choice. Device removal and simultaneous implantation can be performed in the absence of infection or erosion. If a long time has passed since device implantation, the entire device should be replaced due to device aging and deterioration; however, if the time is short, only the defective component need be replaced. Intraoperative assessment of urethral health is necessary for device removal and implantation. If the urethra is healthy, a new cuff can be placed in the same position as the old cuff was removed from; however, if the urethra is unhealthy, the cuff can be implanted in a more proximal/distal position, or a transcorporal cuff implant may be chosen. This article reviews the literature on diagnostic and treatment strategies for recurrent SUI in male patients with AUS and proposes a flowchart for AUS revision.

Urethral Stricture Formation After Artificial Urinary Sphincter Cuff Erosion Is Uncommon in the Absence of Pelvic Radiation.

PURPOSE: Reported rates of urethral stricture development after artificial urinary sphincter erosion are highly variable. We hypothesized that the risk of stricture is commensurate with the degree of erosion. MATERIALS AND METHODS: We reviewed our prospectively maintained quality improvement database for all patients with artificial urinary sphincter erosion from 2011 to 2022. The incidence of postoperative stricture development was compared to the severity of erosion using a graded scale: 1, <25% circumference; 2, 25%-50% circumference; 3, >50% and <100% circumference; and 4, 100% circumference. From 862 artificial urinary sphincter surgeries, 102 erosion cases were identified, and 63 with documented erosion severity were included for analysis. Additional analysis was performed on 28 cases without documented erosion severity for validation. RESULTS: Within the main cohort, urethral stricture developed in 22 (34.9%) patients. The incidence of stricture did not vary by grade of erosion (P = .73) and was not significantly higher in men with grade 4 erosion vs lower-grade erosions (32.7% vs 50.0%, P = .34). Radiation exposure was associated with a 41.1% higher incidence of stricture (P < .01) and nearly every stricture occurred in the setting of prior radiation (21 of 22; 95.5%). In the validation group, 10 (35.7%) developed stricture, mostly in the setting of radiation (8 of 10; 80%). Overall, 29 of 32 (90.6%) cases of stricture involved a history of radiation. CONCLUSIONS: Artificial urinary sphincter erosion does not lead to urethral stricture formation in most cases and is not associated with degree of erosion. Those who develop strictures nearly always have a history of pelvic radiation.

Retrospective Multicenter Observational Study of Immediate Voiding at End of Urinary Sphincter Surgery (REMOVE).

PURPOSE: Patients may remain catheterized after artificial urinary sphincter surgery to prevent urinary retention, despite a lack of evidence to support this practice. Our study aims to evaluate the feasibility of outpatient, catheter-free continence surgery using a multi-institutional database. We hypothesize that between catheterized controls and patients without a catheter, there would be no difference in the rate of urinary retention or postoperative complications. MATERIALS AND METHODS: We conducted a retrospective review of patients undergoing first-time artificial urinary sphincter placement from 2009-2021. Patients were stratified by postoperative catheter status into either no-catheter (leaving the procedure without a catheter) or catheter (postoperative indwelling catheter for ∼24 hours). The primary outcome, urinary retention, was defined as catheterization due to subjective voiding difficulty or documented postvoid residual over 250 mL. RESULTS: Our study identified 302 catheter and 123 no-catheter patients. Twenty (6.6%) catheter and 9 (7.3%) no-catheter patients developed urinary retention (P = .8). On multivariable analysis, controlling for age, cuff size, radiation history and surgeon, there was no statistically significant association between omitting a catheter and urinary retention (OR: 0.45, 95% CI: 0.13-1.58; P = .2). Furthermore, at 30 months follow-up, Kaplan-Meier survival analysis revealed that device survival was 70% (95% CI: 62%-76%) vs 69% (95% CI: 48%-82%) for the catheter and no-catheter group, respectively. CONCLUSIONS: In our multi-institutional cohort, overall retention rates were low (7%) in groups with a catheter and without. Obviating postoperative catheterization facilitates outpatient incontinence surgery without altering reoperation over medium-term follow-up.

Artificial Urinary Sphincter Cuff Downsizing Improves Continence and Patient Satisfaction in Cases of Sub-cuff Atrophy.

PURPOSE: The management of artificial urinary sphincter sub-cuff atrophy remains controversial, and clinical outcomes are underreported. We intend to examine the impact of cuff downsizing in cases of isolated sub-cuff atrophy. MATERIALS AND METHODS: We reviewed our prospectively collected, institutionally approved quality improvement database for this study from 2011 to 2022. Institutional Review Board approval was obtained for the analysis. Sub-cuff atrophy in patients with post-prostatectomy incontinence was diagnosed with a clinical presentation of recurrent urinary leakage, serial pelvic films, cystoscopy, and patient evaluation. Outcomes were assessed with pad use, subjective measures, and American Urological Association Symptom Score scores. RESULTS: During the study interval, 871 encounters for artificial urinary sphincter placement were identified, 229 for revision or replacement, of which cuff downsizing for isolated cases of sub-cuff atrophy occurred in 34. Downsizing took place after a median of 6.5 years after initial artificial urinary sphincter placement. Of the patients, 97% reported subjective improvement and 93% experienced a decrease in daily incontinence pad use, with a mean±SD decrease of 2.2±1.45 pads (P < .01). American Urological Association Symptom Score bother scores decreased from pre-downsizing values by a mean±SD of 1.5±1.4 (P = .01). After a median follow-up of 1.8 years after downsizing, 24 (70.6%) of downsized cuffs remained in place, 2 (5.9%) were further downsized, 2 (5.9%) required replacement for mechanical failure, 4 (11.8%) underwent removal for erosion, and 2 (5.9%) underwent replacement for a herniated pressure regulating balloon. CONCLUSIONS: When diagnosed using objective criteria, cuff downsizing improves continence and patient satisfaction in cases of sub-cuff atrophy.

Bladder Neck Contractures Stabilize After Placement of the Artificial Urinary Sphincter.

PURPOSE: For male cancer survivors, the combination of stress urinary incontinence and recurrent bladder neck contracture presents a management dilemma with poor consensus. Our objective was to assess the impact of artificial urinary sphincter placement on bladder neck contracture recurrence among prostate cancer survivors with stress urinary incontinence and bladder neck contracture. MATERIALS AND METHODS: Men electing artificial urinary sphincter placement at our institution undergo synchronous bladder neck contracture treatment if indicated. An institutional database was queried for men with stress urinary incontinence and ≥1 intervention for bladder neck contracture. Records were divided according to whether an artificial urinary sphincter was ever placed. The impact of artificial urinary sphincter placement on bladder neck contracture recurrence was assessed using a multivariable conditional survival analysis, with survival defined as the recurrence-free interval following bladder neck contracture intervention. The proportional hazards assumption was assessed on the basis of Schoenfeld residuals. RESULTS: The analytic cohort consisted of 118 in the artificial urinary sphincter group and 88 in the non-artificial urinary sphincter group. Patients in both groups underwent a median of 2 (range 1-8) bladder neck contracture interventions over the entire course of their care, encompassing 445 total bladder neck contracture interventions. The artificial urinary sphincter group was on average 2.6 years younger (P = .02) and had a higher pack-year smoking history (P < .01). The presence of an artificial urinary sphincter was associated with a 61% lower bladder neck contracture re-intervention rate (HR 0.39, P < .01, CI 0.30-0.50) at any time when accounting for number of prior bladder neck contracture interventions and bladder neck contracture risk factors. CONCLUSIONS: Artificial urinary sphincter placement is associated with a lower rate of bladder neck contracture re-intervention. Artificial urinary sphincter placement should not be delayed or avoided due to the presence of bladder neck contracture.

The role of transcorporal cuff placement in high-risk and ultra-high-risk patients: are they actually helpful?

PURPOSE: To assess the incidence of artificial urinary sphincter (AUS) explant in high-risk patients and to evaluate the relationship between transcorporal cuff (TCC) placement and explant risk in this population. METHODS: We retrospectively reviewed all AUS insertions performed on high-risk patients by a single surgeon from 2010 to 2020. "High-risk" was defined as having ≥ 1 urethral risk factor: pelvic radiation, urethroplasty, recalcitrant urethral/bladder neck stenosis, urethral stenting, or previous AUS erosion/infection. Patients with ≥ 2 factors were "ultra-high-risk." Time-to-event analyses were used to assess all-cause-, infection/erosion-related-, and mechanical failure-related explant-free survival. Subgroup analyses were performed for patients with a history of radiation and urethral dissection. RESULTS: The final cohort included 68 men, mean age of 67 years (SD 11), and 77 AUS cuffs. Mean follow-up was 32 months (IQR 6-50). 29% of cuffs (n = 22) were transcorporal. 32 cuffs (42%) were explanted. All-cause explant-free survival was 64% at 1 year and 52% at 2 years. Classification as "ultra-high-risk" was not associated with explant risk (all p-values > 0.05). TCC placement was associated with an increased risk of explant for infection/erosion across all patients (HR 2.74, p = 0.03) and in radiated patients (n = 50; HR 4.1, p = 0.04), but not in patients with prior urethral dissection (n = 52; HR 1.98, p = 0.21). CONCLUSION: High-risk patients have a high rate of AUS explant and TCC placement may not be protective in this population. TCC placement was associated with an increased risk of infection/erosion in radiated patients, but not in those with a history of open urethral surgery.

Robotic-assisted artificial urinary sphincter revisions for women suffering from non-neurogenic stress incontinence: a single center experience.

PURPOSE: Patients with artificial urinary eventually need surgical revision. Unfortunately, in women, this requires another invasive abdominal intervention. Robotic-assisted revision may provide a less invasive and more acceptable approach for sphincter revision in women. We wanted to determinate the continence status after robotic-assisted artificial urinary sphincter revision among women with stress incontinence. We also examined postoperative complications and the safety of the procedure. METHODS: The chart of the 31 women with stress urinary incontinence who underwent robotic-assisted AUS revision at our referral center from January 2015 to January 2022 were reviewed retrospectively. All patients underwent a robotic-assisted artificial urinary sphincter revision by one of our two expert surgeons. The primary outcome was to determinate the continence rate after revision and the secondary outcome aimed to evaluate the safety and feasibility of the procedure. RESULTS: Mean patients age was 65 years old, and the mean time between the sphincter revision and previous implantation was 98 months. After a mean follow-up of 35 months, 75% of the patients were fully continent (0-pad). Moreover, 71% of the women were back to the same continence status as with the previously functional sphincter, while 14% even have an improved continence status. Clavien-Dindo grade [Formula: see text] 3 and overall complications occurred in 9% and 20.5% of our patients, respectively. This study is mainly limited by its retrospective design. CONCLUSION: Robotic-assisted AUS revision carries satisfying outcome in terms of continence and safety.

Which revision strategy is the best for non-mechanical failure of male artificial urinary sphincter?

PURPOSE: Persistence or recurrence of stress urinary incontinence (prSUI) after artificial urinary sphincter (AUS) implantation may be secondary to non-mechanical failure (NOMECA). It have for long been assumed to result from urethral atrophy. Its existence is now debated. As the pathophysiology of NOMECA is not elucidated, the most appropriate management remains unclear. We aimed to compare the several revision techniques for NOMECA of AUS in men. METHODS: NOMECA was defined as prSUI, with normally functioning device, no erosion, infection or fluid loss. Exclusion criteria were neurogenic SUI, revision or explantation for other causes. From 1991 to 2022, 143 AUS revisions for NOMECA, including 99 cuff DOWNSIZING, 10 cuff repositioning (RELOC), 13 TANDEM-CUFF placement, 18 cuff changing (CHANGE), three increasing balloon pressure (BALLOON-UP), were performed in 10 centers. BALLOON-UP patients weren't included in comparative analysis due to small sample size. All components could be changed during the revision. Patients were also categorized in COMPLETE-CHANGE vs. PARTIAL-CHANGE of the device. RESULTS: The three-months complete continence rate was 70.8% with a significant difference between RELOC and DOWNSIZING groups (p = 0.04). COMPLETE CHANGE was significantly associated with complete continence status at three months in multivariate analysis (83.3% vs. 63.3%, OR = 2.7; CI 95% [1.1-7.1], p = 0.03). Estimated five-year reoperation-free and explantation-free survival were respectively 63.4% and 75.9% (p = 0.16; p = 0.30). Those were significantly longer in COMPLETE-CHANGE vs PARTIAL-CHANGE (82.2% vs. 69.6%, p = 0.03); (71.2% vs. 58.2%, p = 0.047). CONCLUSIONS: AUS revision for prSUI due to NOMECA yields satisfactory outcomes regardless of the technique used. We observed better functional outcomes when repositioning the new cuff. COMPLETE-CHANGE may improve functional outcomes, explantation-free and reoperation-free survivals.

Trends over 20 years of antimicrobial prophylaxis for artificial urinary sphincter surgery.

INTRODUCTION AND OBJECTIVE: Perioperative antimicrobial prophylaxis is crucial for prevention of prosthesis and patient morbidity after artificial urinary sphincter (AUS) placement. While antibiotic guidelines exist for many urologic procedures, adoption patterns for AUS surgery are unclear. We aimed to assess trends in antibiotic prophylaxis for AUS and outcomes relative to American Urological Association (AUA) Best Practice guidelines. METHODS: The Premier Healthcare Database was queried from 2000 to 2020. Encounters involving AUS insertion, revision/removal, and associated complications were identified via ICD and CPT codes. Premier charge codes were used to identify antibiotics used during the insertion encounter. AUS-related complication events were found using patient hospital identifiers. Univariable analysis between hospital/patient characteristics and use of guideline-adherent antibiotics was done via chi-squared and Kruskal-Wallis tests. A multivariable logistic mixed effects model was used to assess factors related to the odds of complication, specifically the use of guideline-adherent versus nonadherent regimens. RESULTS: Of 9775 patients with primary AUS surgery, 4310 (44.1%) received guideline-adherent antibiotics. The odds of guideline-adherent regimen use increased 7.7% per year with 53.0% (830/1565) receiving guideline-adherent antibiotics by the end of the study period. Patients with guideline-adherent regimens had a decreased risk of any complication (odds ratio [OR]: 0.83, 95% confidence interval [CI]: 0.74-0.93) and surgical revision (OR: 0.85, 95% CI: 0.74-0.96) within 3 months; however, no significant difference in infection within was noted (OR: 0.89, 95% CI: 0.68-1.17) within 3 months. CONCLUSIONS: Adherence to AUA antimicrobial guidelines for AUS surgery appears to have increased over the last two decades. While guideline-adherent regimens were associated with decreased risk of any complication and surgical intervention, no significant association was found with risk of infection. Surgeons appear to be increasingly following AUA recommendations for antimicrobial prophylaxis for AUS surgery, however, further level 1 evidence should be obtained to demonstrate conclusive benefit of these regimens.

Long-term device survival after a first implantation of AMS800™ for stress urinary incontinence: Comparison between men and women.

PURPOSE: The artificial urinary sphincter is the reference treatment for stress urinary incontinence in men, but it remains rarely used in women. This study aimed to compare long-term device survival between women and men, after the first implantation of an AMS800™ artificial urinary sphincter (Boston Scientific) for the treatment of a non-neurogenic stress urinary incontinence. MATERIALS AND METHODS: This retrospective cohort study included all patients with nonneurogenic stress urinary incontinence who underwent surgery in a large-volume university hospital between 2000 and 2013. The primary outcome was the overall survival of the device, defined as the absence of any repeated surgery (revision or explantation) during follow-up. Men and women were matched 3:1 according to age and year of implantation. Differences were analyzed using a Cox model accounting for matching and applying time intervals because hazards were not proportional over time. Sensitivity analyzes were performed, excluding firstly a population with a history of radiotherapy and secondly a population with more than one previous surgery for urinary incontinence. RESULTS: A total of 107 women were matched to 316 men. Median follow-up was 6.0 years (Q1-Q3 1.8-9.4): 7.0 years (Q1-Q3 3.1-10.3) for women and 5.1 years (Q1-Q3 1.3-9.1) for men. During the follow-up, 56 patients had an explantation of the device: 44 men (13.9%) and 12 women (11.2%), and 113 had a revision: 85 men (26.9%) and 28 women (26.1%). Men have a significantly higher risk of explantation or revision than women between 6 months and 8 years after implantation (hazard ratio 2.12 [1.29-3.48]). Before 6 months and after 8 years, there were no significant differences. Both sensitivity analyses found consistent results. CONCLUSIONS: This study suggests that device survival seems better in women after the first 6 months.

Long-term results of artificial urinary sphincter implantation for urinary incontinence due to intrinsic sphincter deficiency in children.

PURPOSE: To report long-term results of artificial urinary sphincter implantation for urinary incontinence due to intrinsic sphincter deficiency in children. MATERIALS AND METHODS: This retrospective monocentric study included all patients who underwent artificial urinary sphincter (AMS 800) implantation before 18 years of age between 1986 and October 2018 for intrinsic sphincter deficiency. The primary outcome was the continence rate at the last follow-up, defined by the daily use of 0 pads. The secondary outcome was the overall survival of the device, defined as the absence of any repeated surgery (revision or explantation) during follow-up. Reoperation-free, revision-free, and explantation-free device survival rates were estimated using the Kaplan-Meier method. RESULTS: Thirty-six patients with a median age of 12 years (interquartile range [IQR]: 10-14) were included (15 females, 21 males). The median follow-up was 18.7 years (IQR: 9-26). The main underlying condition was spinal dysraphism (n = 24; 67%). The median time to the first reoperation was 9 years (IQR: 3.75-14.7). At the last follow-up, survival rates without revision were 84%, 71%, 55%, and 33% at 5, 10, 15, and 20 years, respectively. Survival rates without explantation were 91%, 84%, 80%, and 72% at 5, 10, 15, and 20 years, respectively. At the last follow-up, 29 patients had a functional device. The overall continence rate was 88%. All patients who had their device still in place were continent at the last follow-up. CONCLUSION: The artificial urinary sphincter is an effective long-term treatment for urinary incontinence related to intrinsic sphincter deficiency in children, providing a high rate of continence, even if associated with a high rate of reoperation.