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.

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

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

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.

Determinants and prognostic value of post-operative maximum urethral closure pressure after artificial urinary sphincter in men.

PURPOSE: To evaluate the determinants and prognostic value of post-operative maximum urethral closure pressure (MUCP) after AUS implantation in male patients. METHODS: The charts of all male patients who had an AUS implantation between 2008 and 2018 at a single center were reviewed retrospectively for an exploratory study. A post-operative urethral profilometry was performed systematically as part of routine daily practice over the study period to assess the post-operative MUCP with the AUS consecutively closed (c-MUCP) and opened (o-MUCP). The difference between c-MUCP and the manufacturer's theoretical pressure objective determined by the pressure regulating balloon (PRB) was calculated (diff-th-MUCP). The primary endpoint was social continence at 3 months defined as 0-1 protection/day. RESULTS: Ninety patients were included. The median age was 71 years, and the median follow-up was 50 months. The etiology of incontinence was radical prostatectomy in 84% of cases, and endoscopic prostate surgery in 6.6% of patients. There were 74.4% of patients who were socially continent at 3 months. The c-MCUP was significantly higher in the continent group (53 [42.2, 60.2] vs 62 [58, 70] p = 0.02). The diff-th-MUCP did not differ significantly between the two groups (18 [0, 23] vs 1 [- 2, 7.7] p = 0.29). The c-MUCP was not statistically associated with the risk of revision and/or explantation. CONCLUSION: The MUCP after AUS implantation in male patients often differs from the manufacturer's pressure objective. The postoperative c-MUCP might be significantly associated with functional outcomes suggesting that it might be a valuable tool for treatment decision-making. This should be confirmed by larger studies.

Risk of prolapse and urinary complications in adult spina bifida patients with neurogenic acontractile detrusor using clean intermittent catheterization versus Valsalva voiding.

AIMS: To assess the relative risks of pelvic organ prolapse (POP) and urinary complications in adult spina bifida patients with neurogenic acontractile detrusor voiding with Valsalva versus those using clean-intermittent catheterization (CIC). METHODS: We conducted a retrospective analysis including all spina bifida patients with neurogenic acontractile detrusor with a minimum follow-up of 12 months. Patients were then divided in two groups according to their bladder management: voiding with Valsalva versus CIC. The primary endpoint was any de novo or worsened rectal and/or pelvic organ prolapse (POP) diagnosed during follow-up. The secondary outcome was urinary complications defined as febrile urinary tract infections (UTI) and/or urolithiasis and/or renal failure. RESULTS: Fifty-five patients (50.9% were males) met the inclusion/exclusion criteria: 28 voiding with Valsalva and 27 performing CIC. At baseline, the rates of vaginal prolapse (44.4% vs 50%; P = 0.99), and rectal prolapse/intussusception (25.9% vs 21.4%; P = 0.76) were similar in both groups. After a median follow-up of 80.6 and 65.6 months, respectively (P = 0.29), the rate of de novo or worsened rectal prolapse/intussusception was higher in the Valsalva voiding group than in the CIC group (32.1% vs 3.7%; P = 0.01). De novo or worsened vaginal prolapses were also more common in the Valsalva voiding group, but it did not reach statistical significance (33.3% vs 11.1%; P = 0.29). CONCLUSIONS: Valsalva voiding might be harmful in adult spina bifida patients with neurogenic acontractile detrusor as it may increase the risk of rectal prolapse/intussusception. Overall, the prevalence of POP and rectal prolapse was high in both groups.

Diagnosis and treatment of urinary and sexual dysfunction in hereditary TTR amyloidosis.

PURPOSE: We aimed to review the current knowledge on the epidemiology, diagnosis, and management of urinary and sexual dysfunction in patients with TTR amyloidosis (ATTR). METHODS: We performed a review of the literature, screening for randomized controlled trials, prospective and retrospective series, position papers, and guidelines on urinary and sexual dysfunction in ATTR patients published in PubMed and Embase. RESULTS: Lower urinary tract dysfunction is present in up to 83% of patients with ATTR. Voiding symptoms are the most common, reported in 34.8-87.5% of patients, while urinary tract infections are reported in up to 50%. Urinary incontinence is observed in 16.7-37.5% of the ATTR population, mostly due to decreased urethral resistance. Sexual dysfunction affects over 40% of ATTR patients, with erectile dysfunction and sexual arousal disorder being the most common symptoms in male and female patients, respectively. In addition to a thorough clinical examination, invasive pressure-flow urodynamic testing is a cornerstone in the assessment of ATTR lower urinary tract dysfunction. The most common finding is detrusor underactivity and intrinsic sphincter deficiency. Poor bladder compliance can also be observed in patients, due to amyloid deposits on the bladder wall. Urinary tract imaging may be of interest to rule out upper urinary tract deterioration. Given the paucity of data in the ATTR population, treatment should be tailored to the individual patient. CONCLUSION: Urinary and sexual dysfunction are highly prevalent in ATTR patients. Comprehensive assessment and multidisciplinary management are keys to avoiding upper urinary tract damage and improving patients' quality of life.

Migration of a sacral neuromodulation electrode after vaginal delivery in a female patient with non-obstructive urinary retention.

Sacral neuromodulation (SNM) is a well-established treatment in the management of refractory overactive bladder (OAB), non-obstructive retention, and fecal incontinence. However, the use and management of SNM in pregnant women remains elusive. We present a noteworthy case involving a patient diagnosed with Clara-Fowler syndrome who underwent SNM during the early stages of pregnancy. The sacral neuromodulator remained activated throughout the pregnancy upon patient's request. After vaginal delivery the patient encountered device dysfunction, ultimately attributed to electrode migration. After repositioning of a new electrode in the contralateral sacral root, the patient successfully recovered spontaneous voiding with no post void residual. This case suggests that SNM may not have detrimental effects on pregnancy or fetal development. However, the intricate physiological changes associated with pregnancy and vaginal delivery may contribute to electrode migration, warranting careful consideration in the management of pregnant patients undergoing SNM.

Primary implantation of an artificial urinary sphincter using the perineal and penoscrotal approaches: Functional results and assessment of reoperative procedures.

INTRODUCTION: Artificial urinary sphincter (AUS) is the standard treatment for severe stress urinary incontinence in men. While the perineal access is considered the gold standard, some authors have proposed penoscrotal AUS in order to facilitate the procedure. The main objective of our study was to evaluate the duration of survival without revision surgery (SSRC) according to the surgical approach for primary implantation. MATERIAL AND METHODS: Data from 1179 patients implanted in France between 1991 and 2020 with an AMS 800 AUS were retrospectively analyzed. A total of 762 men were implanted perineally (VP) and 417 penoscrotally (VPS). RESULTS: Median follow-up was 20 vs. 25months respectively. The groups were equivalent overall, apart from the use of anticoagulants (11% VP vs. 6.3% VPS P=0.014). In our population, 54% patients were considered as "dry" in the case of VPS vs. 42% for VP. There was no significant difference in terms of survival time without reoperation, revision, replacement or explantation. In univariate and multivariate analysis, age over 70years was predictive of more reinterventions, whereas the use of a 4.5cm cuff was protective, with hazard ratios of 1.42 (P=0.001) and 0.78 (P=0.04), respectively. CONCLUSION: The penoscrotal approach does not appear to be associated with more complications, has good functional results and no significant difference in reoperation-free survival. A prospective multicenter non-inferiority study could be of interest to confirm our findings.

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.

Efficacy, Safety, and Reoperation-free Survival of Artificial Urinary Sphincter in Non-neurological Male Patients over 75 Years of Age.

Background: Artificial urinary sphincter (AUS) is a gold standard treatment in male stress urinary incontinence but remains poorly used in elderly patients. Objective: To assess the efficacy, safety, and reoperation-free survival of AUS implantation in male patients over 75 yr of age. Design setting and participants: We retrospectively reviewed the charts of all 1233 non-neurological male AUS implantations between 2005 and 2020 at 13 French centers. We compared 330 patients ≥75 yr old (GROUP75+) with 903 patients <75 yr old (GROUP75-) at the time of AUS implantation. Outcome measurements and statistical analysis: Our primary endpoint was social continence at 3 mo defined as the use of one or fewer pad daily. We used Kaplan-Meier analyses to assess reoperation-free survival. We sought factors of erosion using logistic regression. Results and limitations: Early postoperative continence was comparable in both groups (74.4% vs 80.1%, p = 0.114). We observed a higher rate of postoperative complications in GROUP75+ (18.8% vs 12.6%, p = 0.014), but the complications were more frequently of low grade in GROUP75+ (p = 0.025). The overall reoperation-free survival was similar (p = 0.076) after a median follow-up of 2 yr. However, patients in GROUP75+ had poorer explantation-free survival (p < 0.0001). A history of radiotherapy was a predictive factor of erosion (odds ratio [OR] = 5.31, p < 0.01), but age was not (OR = 1.08, p = 0.87). Unfortunately, our dataset did not include a systematic geriatric evaluation. Conclusions: AUS in elderly patients appears to be an effective option to treat stress urinary incontinence. However, we observed more postoperative complications and explantations, although age was not associated with the onset of erosion. A prospective study is required to determine whether a geriatric evaluation would be an effective strategy to select patients before surgery. Patient summary: In this study, we looked at outcomes of artificial urinary sphincter in elderly men in a large population. We found satisfying efficacy but slightly more postoperative complications and device infections.

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.