Risk Factors for Artificial Urinary Sphincter Explantation and Erosion in Male Nonneurological Patients.

PURPOSE: This study was performed to assess the risk factors for artificial urinary sphincter (AUS) explantation in a large multicenter cohort. METHODS: We retrospectively reviewed the medical records for all 1,233 implantations of the AMS-800 AUS device in male nonneurological patients from 2005 to 2020 across 13 French centers. Patients with neurological conditions were excluded from the study. To identify factors associated with explantation-free survival, survival analysis was performed. Explantation was defined as the complete removal of the device, whereas revision referred to the replacement of the device or its components. RESULTS: The study included 1,107 patients, of whom 281 underwent AUS explantation. The median survival without explantation was 83 months. The leading causes of explantation were infection and erosion. Univariate analysis revealed several significant risk factors for explantation: age above 75 years (34.6% in the explanted group vs. 25.8% in the nonexplanted group, P=0.007), history of radiotherapy (43.5% vs. 31.3%, P=0.001), and anticoagulant use (15% vs. 8.6%, P<0.001). In logistic regression analysis, the only significant risk factor was previous radiotherapy (odds ratio [OR], 2.05; P<0.05). Cox proportional hazards analysis revealed 2 factors associated with earlier explantation: transcorporal cuff implantation (hazard ratio [HR], 2.67; P=0.01) and the annual caseload of the center (HR, 1.08; P=0.02). When specifically examining explantation due to erosion, radiotherapy was the sole factor significantly associated with the risk of erosion (OR, 2.47; P<0.05) as well as earlier erosion (HR, 1.90; P=0.039). CONCLUSION: In this series, conducted in a real-world setting across multiple centers with different volumes and levels of expertise, the median survival without AUS explantation was 83 months. This study confirms that radiotherapy represents the primary independent risk factor for AUS erosion in male nonneurological patients.

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.

Impact of radiation therapy on artificial urinary sphincter implantation in male patients: A multicenter study.

AIMS: To evaluate the impact of an history of radiation therapy on the outcomes of artificial urinary sphincter (AUS) implantation in male patients. METHODS: The charts of all patients who underwent AUS implantation for stress urinary incontinence (SUI) after prostate surgery in thirteen centers between 2004 and 2020 were retrospectively reviewed. We excluded patients with neurogenic SUI. Continence rates and incidence of complications, revision and cuff erosion were evaluated. The outcomes in irradiated men were compared to those of non irradiated men. RESULTS: A total of 1277 patients who had an AUS met the inclusion criteria with a median age of 70 years, of which 437 had an history of prior radiotherapy. There was no difference in comorbidities. In irradiated patients, postoperative social continence, urethral atrophy and infection rates were respectively 75.6%, 2.4% and 9.5% and 76.8%, 5.4%, and 5.8% in nonirradiated men (respectively, p = 0.799, p = 0.128, p = 0.148). There were more urethral erosion in irradiated male patients. After a mean follow up of 36.8 months, the explantation free survival was poorer in irradiated patients (p = 0.001). CONCLUSION: These data suggest that pelvic radiotherapy before AUS adversely affect device survival with and increased greater occurrence of infection-erosion and therefore of explantation.

Early Efficacy and Safety Outcomes of Artificial Urinary Sphincter for Stress Urinary Incontinence Following Radical Prostatectomy or Benign Prostatic Obstruction Surgery: Results of a Large Multicentric Study.

BACKGROUND: Artificial urinary sphincter (AUS) is the gold standard for the management of moderate to severe stress urinary incontinence (SUI) in the male population. While outcomes of this device in postprostatectomy incontinence (PPI) are widely described, those obtained for incontinence after benign prostatic obstruction (BPO) surgery remains poorly explored. OBJECTIVE: To compare continence outcomes after AUS implantation in a PPI population with those obtained in men incontinent after BPO surgery. DESIGN, SETTING, AND PARTICIPANTS: A retrospective review of all cases of AUS implantation between 2005 and 2020 in 16 different French centers was conducted. Only patients with primary implantation whose indication was moderate to severe SUI after prostatectomy or BPO surgery were included (excluding those with a history of radiation therapy, brachytherapy, cystectomy, high-intensity focused ultrasound therapy, or neurogenic disease). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was the rate of social continence (zero or one pad per day) at 3 mo. Complications were also noted within 90 d of implantation. RESULTS AND LIMITATIONS: A total of 417 patients were included in the PPI group and 50 in the BPO surgery group. Social continence rates at 3 mo were similar between the groups (79% vs 72%, p = 0.701). Complication rate was significantly higher in the BPO group (8% vs 18%, p = 0.044). The same was found for the Clavien-Dindo type 2 complication rate (20.6% vs 44.4%, p = 0.026). The retrospective nature and lack of precise definition of incontinence are the main limitations of this study. CONCLUSIONS: This multicentric study strengthens the position of AUS as gold standard for SUI after radical prostatectomy. Comparable efficacy results were found for incontinence after BPO surgery, with nevertheless a higher rate of complications. PATIENT SUMMARY: Artificial urinary sphincter represents the gold standard for the treatment of moderate to severe stress urinary incontinence. Efficacy results are comparable between postprostatectomy incontinence and incontinence after benign prostatic obstruction surgery.

Transcorporal vs. bulbar artificial urinary sphincter implantation in male patients with fragile urethra.

PURPOSE: To compare transcorporal vs bulbar artificial urinary sphincter (AUS) implantation in men with fragile urethra and to investigate the risk factors of AUS explantation in this population. METHODS: The charts of all male patients who had an AUS implantation between 2004 and 2020 in 16 centers were reviewed retrospectively. The primary endpoint was device explantation-free survival. Only patients with a fragile urethra were included in the present analysis. Fragile urethra was defined as a urethra carrying a high risk of cuff erosion because of prior radiotherapy and/or history of AUS explantation and/or history of urethral stricture surgery. The patients were divided in two groups according to the implantation site: bulbar vs transcorporal. RESULTS: 464 patients were included for analysis. 88 patients underwent a transcorporal AUS implantation and 376 underwent a bulbar AUS implantation. Explantation-free survival was similar in both groups (estimated 5-year explantation free survival rates 55.3% vs. 58.4%; p=0.98). In the subgroup of patients with a history of previous AUS explantation, transcorporal approach tended to bring longer explantation-free survival (2-year explantation-free survival: 61.9% vs. 58.2%; p=0.096). In multivariate analysis, the only risk factor of shorter explantation-free survival was the history of previous AUS explantation (HR=2.65; p=0.01). CONCLUSIONS: Transcorporal AUS implantation was not associated with longer explantation-free survival. History of previous AUS explantation was the only risk factor associated with shorter explantation-free survival and this subgroup of patients may be the only one to draw benefits of transcorporal AUS implantation.