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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.
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INTRODUCTION: The Operated Male-to-Female Sexual Function Index (oMtFSFI) questionnaire is the first scoring system developed to assess sexual function after gender-affirming vulvo-vaginoplasty, and was initially developed and validated in Italian. The aim of this study was to provide linguistic validation of the questionnaire in French through several steps including use of the questionnaires across a series of patients who had undergone gender-affirming vulvo-vaginoplasty between 2020 and 2022 at two French academic centers. METHOD: The French version of the oMtFSFI questionnaire was obtained through a double translation (Italian to French) and a back-translation (French to Italian), validated by a scientific committee, and cognitively assessed by a panel of expert patients. The questionnaire was then distributed to transgender male to female patients who had undergone genital gender affirming surgery at two French academic centers. RESULTS: The oMtFSFI score consists of 18 questions exploring 7 domains (genital self-image, desire, arousal, lubrication, orgasm, satisfaction, sexual pain). Among the sixty-four patients who responded to the questionnaire, 16 patients (25%) reported abstaining from sexual activity involving vaginal penetration at the time of the study were excluded. The mean total score was 37, corresponding to mild to moderate sexual dysfunction and 60.4% of the patients reported normal overall sexual function. The level of sexual satisfaction was normal for 68.8% of the patients and the genital self-image was normal for 52.1%. Most of the patients (79.2%) reported at least mild dyspareunia and 10.4% had critical sexual dysfunction. Surgery improved gender dysphoria in 96.7% of patients. There was a strong correlation between the overall oMtFSFI score and the happiness Visual Analog Scale (VAS) (P<0.001) as well as with the quality of life VAS (P<0.001). CONCLUSION: The French version of the oMtFSFI questionnaire is the only scoring system specifically developed to assess sexual function after vulvo-vaginoplasty in transgender women linguistically validated in French. Its validation in French language makes it an interesting tool for research and clinical practice.
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BACKGROUND AND OBJECTIVE: Symptomatic benefit and urodynamic obstruction relief represent relevant outcomes of therapies for lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH). We summarized evidence from studies concurrently assessing variations in terms of symptoms severity and invasive urodynamic measures of obstruction following medical and surgical therapies for LUTS/BPH. METHODS: We performed a systematic review of PubMed, Scopus, and Web of Science in June 2023. KEY FINDINGS AND LIMITATIONS: We identified 29 publications: 14 (872 patients) and 15 (851 patients) studies addressing medical and surgical therapies, respectively. The mean percentage total International Prostate Symptom Score (IPSS) improvements ranged from -2.5% to 56.3% and from 35.1% to 82.1% following medical and surgical therapies, respectively. The corresponding mean percentage Bladder Outlet Obstruction Index (BOOI) improvements ranged from 7.8% to 53.5% and from 22.4% to 138.6%, respectively. Holmium laser enucleation of the prostate (HoLEP) provided IPSS improvements in the higher range and the greatest BOOI reduction. CONCLUSIONS AND CLINICAL IMPLICATIONS: Globally, based on available evidence, more pronounced symptomatic benefits are observed following treatments providing greater deobstructive effect. In detail, patients undergoing surgery exhibit greater IPSS and BOOI improvements than those receiving medical therapy. PATIENT SUMMARY: Treatments for lower urinary tract symptoms suggestive of benign prostatic hyperplasia providing greater urodynamic improvements also provide greater symptomatic benefit. Surgical procedures provide greater symptomatic and urodynamic outcomes than medical therapies. Maximal obstruction relief, together with symptomatic benefits in the higher ranges, is observed following holmium laser enucleation of the prostate.
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BACKGROUND AND OBJECTIVE: Our aim was to report the first clinical trial of TENSI+, a new device for transcutaneous posterior tibial nerve stimulation (TNS) for treatment of overactive bladder (OAB). METHODS: A prospective, multicentre clinical trial was conducted in adults with OAB in seven French centres. The main exclusion criteria were prior percutaneous or transcutaneous TNS or invasive OAB treatment, current antimuscarinic use, 24-h polyuria, known bladder disease, postvoid residual volume >150 ml, and pelvic organ prolapse stage >2. Patients self-administered daily TTNS sessions of 20 min with TENSI+ at home after education by a specialized nurse. A bladder diary, Urinary Symptom Profile and OAB-q questionnaires, and Patient Global Impression of Improvement (PGI-I) scores were evaluated at baseline and 3 and 6 mo. The primary endpoint was efficacy, based on PGI-I and variations in bladder diary parameters. Success was defined as a PGI-I score ≤3 and any improvement ≥30% in bladder diary parameters. KEY FINDINGS AND LIMITATIONS: The study included 78 patients (13 males). Nine patients had neurological disease, 21 had previously tried antimuscarinics, and 41 had wet OAB at baseline. At 3 mo, 65/78 patients had a full analysis set. Treatment was successful in 44/65 patients (67%), with 25/65 (38%) reporting both an objective improvement and high satisfaction. All OAB-related endpoints were significantly improved, except bladder capacity and total voided volume per 24 h. At 6 mo, only five of 44 patients had interrupted their treatment. No factor predictive of success was identified. Two adverse events (pain at stimulation site and/or pelvic pain) were reported and spontaneously resolved without treatment interruption. CONCLUSIONS AND CLINICAL IMPLICATIONS: TENSI+ is a safe and effective TTNS treatment option for OAB management. PATIENT SUMMARY: TENSI+ is a new device for nerve stimulation in patients with overactive bladder. Patients use the device at home every day. In our short-term trial, TENSI+ use improved symptoms in 67% of patients. Further evaluation over a longer period of time is needed.
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PURPOSE: To compare the outcomes of patients undergoing robotic YV plasty for bladder neck contracture (BNC) vs. vesico-urethral anastomotic stricture (VUAS). METHODS: A retrospective study included male patients who underwent robotic YV plasty for BNC after endoscopic treatment of BPH or VUAS between August 2019 and March 2023 at a single academic center. The primary assessed was the patency rate at 1 month post-YV plasty and during the last follow-up visit. RESULTS: A total of 21 patients were analyzed, comprising 6 in the VUAS group and 15 in the BNC group. Patients with VUAS had significantly longer operative times (277.5 vs. 146.7 min; p = 0.008) and hospital stay (3.2 vs. 1.7 days; p = 0.03). Postoperative complications were more common in the VUAS group (66.7% vs. 26.7%; p = 0.14). All patients resumed spontaneous voiding postoperatively. Five patients (23.8%) who developed de novo stress urinary incontinence had already an AUS (n = 1) or required concomitant AUS implantation (n = 3), all of whom were in the VUAS group (83.3% vs. 0%; p < 0.0001). The proportion of patients improved was similar in both groups (PGII = 1 or 2: 83.3% vs. 80%; p = 0.31). Stricture recurrence occurred in 9.5% of patients in the whole cohort, with no significant difference between the groups (p = 0.50). Long-term reoperation was required in three VUAS patients, showing a statistically significant difference between the groups (p = 0.05). CONCLUSION: Robotic YV plasty is feasible for both VUAS and BNC. While functional outcomes and stricture-free survival may be similar for both conditions, the perioperative outcomes were less favorable for VUAS patients.
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Contratura , Procedimentos Cirúrgicos Robóticos , Estreitamento Uretral , Obstrução do Colo da Bexiga Urinária , Humanos , Masculino , Bexiga Urinária/cirurgia , Constrição Patológica/etiologia , Constrição Patológica/cirurgia , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Estudos Retrospectivos , Obstrução do Colo da Bexiga Urinária/cirurgia , Obstrução do Colo da Bexiga Urinária/complicações , Contratura/cirurgia , Estreitamento Uretral/etiologia , Estreitamento Uretral/cirurgia , Prostatectomia/efeitos adversosRESUMO
INTRODUCTION: Neurogenic detrusor overactivity (NDO) has a major impact on patients' quality of life and can lead to upper urinary tract complications. Intradetrusor botulinum toxin type A injections are administered as second-line treatment to these patients following the failure of anticholinergic agents. The aim of the DETOX 2 study is to propose a consensus definition of the failure of intradetrusor botulinum toxin injections for NDO in patients presenting spinal cord injury, spina bifida, or multiple sclerosis (MS) with self-catheterization. METHOD: This study followed the method adopted by the French National Authority for Health for recommendations by consensus. Based on a review of the literature and a preliminary survey, a steering committee compiled a questionnaire and selected a rating group comprising 16 experts from the Neuro-Urology Committee of the French Urology Association (cnuAFU) and Genulf. The experts were asked to complete the online questionnaire. At the end of the first round, all participants came together to discuss any disagreements and a second-round online questionnaire was completed to reach a consensus. RESULTS: Thirteen of the 16 experts approached completed both rounds of questionnaires. A strong consensus was reached for two proposals (median score = 9/10) which were therefore included in the definition from the first round: at least one repeat injection of the same botulinum toxin at the same dose must be given to rule out failure on technical grounds and a duration of efficacy <3 months must be considered a failure. At the end of round 2, a relative consensus was reached regarding the clinical criterion defining failure (median score = 7/10) and the urodynamic criterion of failure (median score = 8/10). An additional proposal was selected during this second round on the need for a voiding diary (median score = 8/10). CONCLUSION: The first consensus definition of failure of an intradetrusor injection of TB-A for NDO has been achieved with this study: persistence of detrusor overactivity with maximum detrusor pressures >40 cm H2O and/or a compliance issue and/or persistence of urinary incontinence and/or urgency and/or a number of daily self-catheterizations >8/day and/or efficacy <3 months. This study will help to standardize research on the failure of the intradetrusor botulinum toxin for NDO in clinical practice and clinical research.
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Toxinas Botulínicas Tipo A , Fármacos Neuromusculares , Bexiga Urinaria Neurogênica , Bexiga Urinária Hiperativa , Incontinência Urinária , Humanos , Toxinas Botulínicas Tipo A/uso terapêutico , Fármacos Neuromusculares/uso terapêutico , Qualidade de Vida , Resultado do Tratamento , Bexiga Urinaria Neurogênica/etiologia , Bexiga Urinária Hiperativa/tratamento farmacológico , Incontinência Urinária/complicações , UrodinâmicaRESUMO
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.
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Terapia por Estimulação Elétrica , Eletrodos Implantados , Migração de Corpo Estranho , Retenção Urinária , Humanos , Feminino , Gravidez , Retenção Urinária/terapia , Retenção Urinária/etiologia , Adulto , Migração de Corpo Estranho/terapia , Terapia por Estimulação Elétrica/instrumentação , Terapia por Estimulação Elétrica/métodos , Complicações na Gravidez/terapia , Parto Obstétrico , Plexo LombossacralRESUMO
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.
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OBJECTIVE: To assess the current knowledge of French urology residents and fellows about neurogenic lower urinary tract dysfunction and their management in patients with spina bifida. MATERIAL AND METHOD: A 7-question questionnaire, covering the responder's experience and the various stages in the neuro-urological management of spina bifida, was drafted by an expert urologist. Responses were collected within 5days of being e-mailed to members of the Association française des urologues en formation (AFUF), and a descriptive analysis was carried out. RESULTS: Of the 448 members, 155 completed the questionnaire. Of the participants, 83.8% said they knew the definition of spina bifida, and 76.8% had already had to care for a spina bifida patient. Of the participants, 48.4% correctly estimated the number of spina bifida patients in France. Neurogenic lower urinary tract dysfunction to look for and the specificities of management seemed to have been acquired by a majority of respondents (correct response rates of 70.7% and 75.4%, respectively), unlike the extra-urological aspects (53.9%), and the choice of examinations useful for the initial work-up and follow-up (55.8%). CONCLUSION: While the expected neurogenic lower urinary tract dysfunction and the specificities of therapeutic management of spina bifida patients appear to be well known to urologists in training, knowledge of extra-urological symptoms and the choice of examinations could be improved. These results could be used to adjust the teaching given to French urologists in training on the urological management of spina bifida patients. LEVEL OF EVIDENCE: Grade 4.