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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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OBJECTIVE: To evaluate the health status and recovery of women after mid-urethral sling (MUS) revision in response to complications. DESIGN: Cross-sectional study using a questionnaire sent to women from a registry. SETTING: Twenty-two French surgical centres. POPULATION: A total of 287 women from the VIGI-MESH registry responded, having undergone MUS revision for complications. METHODS: Our sample of women were compared against a representative set of French women taken from the Eurostat database. Multivariate analysis was performed to identify clinical predictors for successful MUS revision. A qualitative analysis was carried out on free-text comments. MAIN OUTCOME MEASURES: Health status, defined by the Minimum European Health Module, and recovery, assessed by Patient Global Impression of Improvement. RESULTS: The response rate was 76% (287/378), with 49% of the women (141/287, 95% CI 43%-55%) reporting good health status, which was 8 points lower than that expected from the comparator French set (57%, 95% CI 55%-58%). Overall, 53% (147/275, 95% CI 47%-59%) of the women reported feeling much better after MUS revision. Just over one-third (35%, 95/275, 95% CI 29%-40%) of respondents reported poor health with little or no improvement. Multivariate analysis showed that being operated on for pain at revision was associated with worse self-perceived health than being operated on for exposure (OR 0.6, 95% CI 0.14-0.95); women with pre-existing comorbidity reported a poorer health status following MUS revision (OR 0.22, 95% CI 0.13-0.38). CONCLUSIONS: Our results suggest that half of the women recovered good health status after MUS revision, whereas a proportion appeared to be seriously affected by an MUS complication despite the revision.
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OBJECTIVE: To assess the short-term functional outcomes and morbidity of robotic-assisted cystectomy (RAC) and intracorporeal urinary diversion (ICUD) in patients with lower urinary tract dysfunction (LUTD). METHODS: All consecutive patients who underwent RAC+ICUD for LUTD in a tertiary hospital center, between July 2018 and May 2021 were retrospectively included. Medical records were systematically reviewed and patient, perioperative and postoperative data were collected. A good short-term functional outcome was defined by the combination of a satisfying urostomy equipment (absence of urine leakage and easy appliance of the urostomy bag), the absence of pelvicaliceal system dilatation on sonography, and the absence of renal function decrease at the 2months post-operative consultation. Intraoperative parameters and post-operative complications were collected to assess morbidity. RESULTS: Thirty-five patients were included. Eight (22.8%) patients needed intraoperative conversion to laparotomy. Twenty-five patients (92,5%) met criteria for a good functional outcome 2months post-operatively. The median operative time was 346min (86.5-407.5). The median blood loss was 100mL (100-290) and 5 patients (18.5%) required blood transfusion. The median times to return of bowel function was 3 days (2-4) and the median length of hospital stay was 10 days (10-18). Peri-operative complications were reported in 16 patients (59.2%): 6 (22.2%) minor complications Clavien ≤ II and 10 (37%) major complications Clavien ≥ III. There was no significative decrease of the renal function (mean preoperative creatininemia of 61.2µmol/L (50.5-74.5) vs 64.5µmol/L (47-85.25) postoperatively) CONCLUSION: RAC+ICUD in LUTD can provide good short-term functional outcomes while limiting blood transfusion, time to return of bowel function and the length of hospital stay. These results should be confirmed by larger prospective study.
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Cistectomia , Laparoscopia , Procedimentos Cirúrgicos Robóticos , Derivação Urinária , Humanos , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Procedimentos Cirúrgicos Robóticos/métodos , Cistectomia/métodos , Cistectomia/efeitos adversos , Estudos Retrospectivos , Masculino , Derivação Urinária/métodos , Derivação Urinária/efeitos adversos , Feminino , Pessoa de Meia-Idade , Laparoscopia/métodos , Laparoscopia/efeitos adversos , Idoso , Resultado do Tratamento , Fatores de Tempo , Sintomas do Trato Urinário Inferior/cirurgia , Sintomas do Trato Urinário Inferior/etiologia , Recuperação de Função Fisiológica , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologiaRESUMO
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
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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BACKGROUND: Midurethral slings are the gold standard for treating stress urinary incontinence, but their complications may raise concerns. Complications may differ by the approach used to place them. OBJECTIVE: This study aimed to compare serious complications and reoperations for recurrence after midurethral sling procedures when using the retropubic vs the transobturator route for female stress urinary incontinence. STUDY DESIGN: This analysis was of patients included in the French, multicenter VIGI-MESH register since February 2017 who received a midurethral sling for female stress urinary incontinence either by the retropubic or the transobturator route and excluded patients with single-incision slings. Follow-up continued until October 2021. Serious complications (Clavien-Dindo classification ≥ grade III) attributable to the midurethral sling and reoperations for recurrence were compared using Cox proportional hazard models including any associated surgery (hysterectomy or prolapse) and a frailty term to consider the center effect. Baseline differences were balanced by propensity score weighting. Analyses using the propensity score and Cox models were adjusted for baseline differences, center effect, and associated surgery. RESULTS: A total of 1830 participants received a retropubic sling and 852 received a transobturator sling in 27 French centers that were placed by 167 surgeons. The cumulative 2-year estimate of serious complications was 5.8% (95% confidence interval, 4.8-7.0) in the retropubic group and 2.9% (95% confidence interval, 1.9-4.3) in the transobturator group, that is, after adjustment, half of the retropubic group was affected (adjusted hazard ratio, 0.41; 95% confidence interval, 0.3-0.6). The cumulative 2-year estimate of reoperation for recurrence of stress urinary incontinence was 2.7% (95% confidence interval, 2.0-3.6) in the retropubic group and 2.8% (95% confidence interval, 1.7-4.2) in the transobturator group with risk for revision for recurrence being higher in the transobturator group after adjustment (adjusted hazard ratio, 1.9; 95% confidence interval, 1.2-2.9); this surplus risk disappeared after exclusion of the patients with a previous surgery for stress urinary incontinence. CONCLUSION: The transobturator route for midurethral sling placement is associated with a lower risk for serious complications but a higher risk for surgical reoperation for recurrence than the retropubic route. Despite the large number of surgeons involved, these risks were low. The data are therefore reassuring.
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Slings Suburetrais , Incontinência Urinária por Estresse , Feminino , Humanos , Incontinência Urinária por Estresse/cirurgia , Incontinência Urinária por Estresse/etiologia , Slings Suburetrais/efeitos adversos , Telas Cirúrgicas , Procedimentos Cirúrgicos Urológicos/métodos , ReoperaçãoRESUMO
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.
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Doenças Uretrais , Incontinência Urinária por Estresse , Esfíncter Urinário Artificial , Humanos , Masculino , Esfíncter Urinário Artificial/efeitos adversos , Incontinência Urinária por Estresse/cirurgia , Incontinência Urinária por Estresse/etiologia , Implantação de Prótese/métodos , Reoperação/efeitos adversos , Estudos Retrospectivos , Resultado do Tratamento , Uretra/cirurgiaRESUMO
PURPOSE: This study aimed to seek predictive factors and develop a predictive tool for sacral nerve modulation (SNM) implantation in patients with non-obstructive urinary retention and/or slow urinary stream (NOUR/SS). METHODS: This study was designed as a retrospective study including all patients who have undergone a two-stage SNM for NOUR/SS between 2000 and 2021 in 11 academic hospitals. The primary outcome was defined as the implantation rate. Secondary outcomes included changes in bladder emptying parameters. Univariate and multivariable logistic regression analysis were performed and determined odds ratio for IPG implantation to build a predictive tool. The performance of the multivariable model discrimination was evaluated using the c-statistics and an internal validation was performed using bootstrap resampling. RESULTS: Of the 357 patients included, 210 (58.8%) were finally implanted. After multivariable logistic regression, 4 predictive factors were found, including age (≤ 52 yo; OR = 3.31 CI95% [1.79; 6.14]), gender (female; OR = 2.62 CI95% [1.39; 4.92]), maximal urethral closure pressure (≥ 70 cmH2O; OR: 2.36 CI95% [1.17; 4.74]), and the absence of an underlying neurological disease affecting the lower motor neuron (OR = 2.25 CI95% [1.07; 4.76]). Combining these factors, we established 16 response profiles with distinct IPG implantation rates, ranging from 8.7 to 81.5%. Internal validation found a good discrimination value (c-statistic, 0.724; 95% CI 0.660-0.789) with a low optimism bias (0.013). This allowed us to develop a predictive tool ( https://predictivetool.wixsite.com/void ). CONCLUSION: The present study identified 4 predictive factors, allowing to develop a predictive tool for SNM implantation in NOUR/SS patients, that may help in guiding therapeutic decision-making. External validation of the tool is warranted.
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Terapia por Estimulação Elétrica , Retenção Urinária , Urologia , Humanos , Feminino , Retenção Urinária/terapia , Estudos Retrospectivos , Resultado do Tratamento , Eletrodos ImplantadosRESUMO
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.
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PURPOSE: Stress urinary incontinence (SUI) is a key factor for post-prostatectomy (RP) quality of life. Current international guidelines struggle to find the adequate place for each kind of surgeries. The aim of this systematic review and meta-analysis considering updated evidence is to assess the efficacy and safety of proACT in treating male patients with post-RP SUI. METHODS: A review of the literature was performed by searching the PubMed database. We narrowed included studies with adult male patients with SUI; outcomes included pads or pad weight per day and quality of life (QOL) questionnaires, as well as safety outcomes. RESULTS: 18 studies involving 1570 patients mean age of 68.8 (EC 2.1) were included. The mean follow-up reported was 34.7 months (EC 17.7; median 38.5; range 1-128 months). An average of 60.7% (EC 27) and 40.4% of patients suffered from mild-to-moderate and severe incontinence, respectively. The overall dryness rate was 55.1% (EC 19.3) while respecting the definition of 0-1 pads per day, and the mean dryness rate was 53% (EC 0.2). The mean overall complication rate was 31.2% (EC 18.3%), including an explantation rate of 26.5% (EC 15.3) and a reoperation rate of 22.7% (EC 8.7). The methodological quality of the 18 studies was very heterogeneous. CONCLUSION: Implantation of proACT adjustable balloons is a minimally invasive technique that provides medium outcomes (53%) with a strict definition of dryness (0-1 PPD) and important complication rate (31.2%). Past of irradiation is a negative predictive factor for incontinence.
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Incontinência Urinária por Estresse , Incontinência Urinária , Adulto , Humanos , Masculino , Idoso , Incontinência Urinária por Estresse/etiologia , Incontinência Urinária por Estresse/cirurgia , Qualidade de Vida , Prostatectomia/efeitos adversos , Incontinência Urinária/etiologia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/terapia , Complicações Pós-Operatórias/etiologia , Resultado do TratamentoRESUMO
INTRODUCTION AND OBJECTIVES: Almost two decades after the description of robotic vesicovaginal fistula repair (R-VVF), the literature remains limited. The aims of this study are to report the outcomes of R-VVF and to compare the transvesical versus extravesical techniques. METHODS: We performed an observational, retrospective, multicenter study, including all patients who underwent R-VVF from March 2017 to September 2021 at four academic institutions. All abdominal VVF repair over the study period were performed using a robotic approach. The success of R-VVF was defined as the absence of clinical recurrence. The outcomes of the extravesical versus transvesical techniques were compared. RESULTS: Twenty-two patients were included. The median age was 43 years old (IQR 38-50). Fistulas were supratrigonal and trigonal in 18 and 4 cases respectively. Five patients had undergone previous attempts of fistula repair (22.7%). The fistulous tract was systematically excised, and an interposition flap was used in all but two cases (90.9%). The transvesical and extravesical techniques were used in 13 and 9 cases respectively. There were four postoperative complications, three minor and one major. None of the patients had vesicovaginal fistula recurrence after a median follow-up of 15 months. CONCLUSIONS: The present series, one of the largest R-VVF reported to date, is consistent with the few series already published with a 100% cure rate. Systematic excision of the fistulous tract and the high rate of flap interposition may explain the high success rate. The transvesical and extravesical approaches yielded similar outcomes.
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BACKGROUND: Although sacral neuromodulation (SNM) for overactive bladder (OAB) is an established therapy, there is a lack of high-quality, long-term data on real-life practice. OBJECTIVE: To report on real-life therapeutic effectiveness, quality of life (QoL), disease severity, and safety as well as patient-reported symptom bother after approximately 5 yr of follow-up. DESIGN, SETTING, AND PARTICIPANTS: A total of 291 OAB patients were enrolled at 25 French sites according to local standard of care. Sacral neuromOdUlation with InterStim therapy for intractable lower uriNary tract DySfunctions (SOUNDS) enrolled both de novo and replacement patients, and a total of 229 patients were permanently implanted. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Over the course of the study, patients were followed up six times with two follow-ups in the year after implantation and annually thereafter. Of the patients, 154 completed the final follow-up after a mean of 57.7 ± 3.9 mo. RESULTS AND LIMITATIONS: The mean number of daily leaks in urinary urge incontinence (UI) patients was reduced from 4.4 ± 3.3 at baseline to 1.8 ± 2.6 after 5 yr in de novo and from 5.4 ± 4.9 to 2.2 ± 3.0 in replacement patients (both p < 0.001). Likewise, the number of voids in urinary frequency patients was reduced compared with baseline (de novo: reduced from 12.6 ± 4.0 [baseline] to 9.6 ± 4.3 [5 yr]; replacements: reduced from 11.5 ± 4.3 [baseline] to 9.2 ± 3.1 [5 yr]; both p < 0.05). Complete continence rates after 5 yr were 44% (25/57) in de novo and 33% (5/15) in replacement UI patients, and 68% (39/57) and 67% (10/15) of UI patients were categorized as therapy responders by showing a >50% improvement in leaks. Disease severity (Urinary Symptom Profile domain 2), Numeric Rating Scale-based symptom bother, and disease-specific QoL (Ditrovie) improved significantly in both groups at all visits (p < 0.001). Adverse events related to device or procedure occurred in 51% (140/274) of patients, with 66% (152/229) of the events being classified as minor (Clavien-Dindo grade I and II). Surgical revisions were reported in 39% (89/229), which include permanent explants in 15% (34/229) of patients. CONCLUSIONS: SOUNDS demonstrates the sustained effectiveness and QoL improvements of SNM in OAB patients after 5 yr in real-world conditions while maintaining an acceptable safety profile consistent with literature. PATIENT SUMMARY: This study confirmed that French overactive bladder patients had a sustained symptom and bother reduction, and improvements in quality of life up to 5 yr after sacral neuromodulation device implantation.
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Terapia por Estimulação Elétrica , Bexiga Urinária Hiperativa , Humanos , Qualidade de Vida , Estudos Prospectivos , Resultado do Tratamento , Terapia por Estimulação Elétrica/efeitos adversos , Terapia por Estimulação Elétrica/métodos , Incontinência Urinária de Urgência/terapia , Incontinência Urinária de Urgência/etiologiaRESUMO
INTRODUCTION AND HYPOTHESIS: The objective was to describe the different laparoscopic and vaginal steps of sub-urethral infected mesh explantation as well as an unexpected and unusual complication: a sub-mucosal calcification on the sub-urethral segment of the sling that was not infiltrating the urethra. METHODS: This was carried out at our University Teaching Hospital of Strasbourg. RESULTS: We show the complete removal of an infected retropubic sling in a patient who had already undergone three previous surgeries without resolution of symptoms. This is a difficult case requiring a laparoscopic approach of the space of Retzius, which has been less familiar to surgeons since the advent of the midurethral sling. We show how to approach this space in an inflammatory environment by specifying its anatomical limits. Moreover, a great deal can be learned from the occurrence of an infectious complication after the surgery and the presence of a large calcification on the prosthesis. In this context, we advise a systematic antibiotic treatment to avoid this kind of complication. CONCLUSIONS: Knowing the guidelines and the different surgical steps will help urogynecological surgeons to perform similar procedures in patients requiring removal of retropubic slings for complications such as infection and pain, where conservative management has not been successful. These cases must be discussed in a multidisciplinary meeting, as recommended by the French National Authority for Health, and managed in an expert establishment.
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Laparoscopia , Slings Suburetrais , Incontinência Urinária por Estresse , Feminino , Humanos , Slings Suburetrais/efeitos adversos , Remoção de Dispositivo , Implantação de Prótese , Laparoscopia/efeitos adversos , Vagina/cirurgia , Incontinência Urinária por Estresse/cirurgiaRESUMO
Women's preoperative perceptions of pelvic-floor disorders may differ from those of their physicians. Our objective was to specify women's hopes and fears before cystocele repair, and to compare them to those that surgeons anticipate. We performed a secondary qualitative analysis of data from the PROSPERE trial. Among the 265 women included, 98% reported at least one hope and 86% one fear before surgery. Sixteen surgeons also completed the free expectations-questionnaire as a typical patient would. Women's hopes covered seven themes, and women's fears eleven. Women's hopes were concerning prolapse repair (60%), improvement of urinary function (39%), capacity for physical activities (28%), sexual function (27%), well-being (25%), and end of pain or heaviness (19%). Women's fears were concerning prolapse relapse (38%), perioperative concerns (28%), urinary disorders (26%), pain (19%), sexual problems (10%), and physical impairment (6%). Surgeons anticipated typical hopes and fears which were very similar to those the majority of women reported. However, only 60% of the women reported prolapse repair as an expectation. Women's expectations appear reasonable and consistent with the scientific literature on the improvement and the risk of relapse or complication related to cystocele repair. Our analysis encourages surgeons to consider individual woman's expectations before pelvic-floor repair.
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OBJECTIVE: To describe the outcomes of ileal conduit as a salvage therapy for refractory lower urinary tract dysfunctions (LUTDs) due to multiple sclerosis (MS) in a national neurourology referral center network. METHODS: A retrospective multicenter French study was carried out to identify MS patients who underwent non-continent urinary diversion for refractory LUTDs from January 2010 to December 2015. Multiple sclerosis status, urological history, surgical indication and technique, postoperative complications, renal anatomy and function at last follow-up as well as number of rehospitalizations for urinary tract infections (UTI) were collected. Preoperative and postoperative urinary-related quality of life (urQoL) through the Qualiveen short-form questionnaire (QSF) and patient global impression of improvement (PGI-I) were collected and analyzed. RESULTS: Overall, 10 centers identified 211 patients with a mean age of 54±11 and mean preoperative EDSS (expanded disability status scale) score of 7.3±0.9. The main indication for diversion was MS progression leading to impossible intermittent self-catheterization (55%). Cystectomy was performed either by open (34.6%), laparoscopic (39.3%) or robotic (21.8%) approach (unknown: 4.2%) with cystectomy in all cases. Early complications were reported in 42% of the patients, mainly Clavien I or II grades. There was no difference in GFR (glomerular filtration rate) after surgery. After diversion, patients had fewer hospitalizations for UTI and better urQoL on QSF confirmed by evaluation of PGI-I. CONCLUSION: This study, reporting the largest series of ileal conduit in selected MS patients with end-stage LUTDs, showed significant improvement in symptomatic UTI and quality of life with a low high-grade complication rate.
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Esclerose Múltipla , Neoplasias da Bexiga Urinária , Derivação Urinária , Infecções Urinárias , Urologia , Humanos , Adulto , Pessoa de Meia-Idade , Idoso , Esclerose Múltipla/complicações , Qualidade de Vida , Terapia de Salvação , Derivação Urinária/métodos , Cistectomia/efeitos adversos , Neoplasias da Bexiga Urinária/cirurgia , Estudos Retrospectivos , Infecções Urinárias/etiologiaRESUMO
PURPOSE: New follow-up models of care are needed to ensure long-term comprehensive care for cancer survivors. We investigated the impact of a general practitioner (GP)-led follow-up program for prostate cancer (PCa) and renal cell cancer (RCC) survivors. METHODS: This retrospective monocentric study compared standard urologist-led follow-up to experimental GP-led follow-up within a nurse-led network for PCa and RCC survivors. To assess the safe continuity of follow-up, the number of patients lost to follow-up (LFU) was collected. A microcosting analysis from the French national health system perspective was conducted to describe incremental costs associated with experimental follow-up. A satisfaction survey was conducted to determine participating patient's and GP's satisfaction scores, ranging from 0 to 4 and 0 to 5, respectively. RESULTS: Among the 1274 patients included, 92/753 (12.2%) were LFU during standard follow-up vs 0/521 (0%) during experimental follow-up (p < 0.001). In the latter, the median management delay of suspected recurrence for PCa and RCC survivors was 20 [12-27] and 16 [10.5-31.25] days, and the mean incremental cost on a per-patient basis was 34.68 ± 105.87 and 64.24 ± 93.55, respectively. Patient and GP mean satisfaction scores were 3.6/4 and 3.9/5, respectively. CONCLUSION: The GP-led follow-up of PCa and RCC survivors within a nurse-led network seems to provide safe continuity of follow-up and seems not to be associated with major incremental costs. The surveys indicated high level of patient's satisfaction and encouraging results regarding GP's satisfaction. Randomized clinical trials are needed to confirm these findings and promote larger implementation of this type of follow-up care.
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Sobreviventes de Câncer , Carcinoma de Células Renais , Neoplasias Renais , Assistência ao Convalescente , Seguimentos , Humanos , Rim , Neoplasias Renais/terapia , Masculino , Próstata , Estudos Retrospectivos , SobreviventesRESUMO
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.
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Incontinência Urinária por Estresse , Esfíncter Urinário Artificial , Idoso , Humanos , Masculino , Implantação de Prótese/efeitos adversos , Estudos Retrospectivos , Resultado do Tratamento , Uretra/cirurgia , Incontinência Urinária por Estresse/etiologia , Incontinência Urinária por Estresse/cirurgia , Esfíncter Urinário Artificial/efeitos adversosRESUMO
BACKGROUND: SOUNDS strengthens the evidence basis of sacral neuromodulation (SNM) for overactive bladder (OAB) through real-world data. OBJECTIVE: To analyze diary-based effectiveness, quality of life (QoL), disease severity, symptom bother, and safety data for SNM with the InterStim system up to 3 yr after implantation. DESIGN, SETTING, AND PARTICIPANTS: Twenty-five representative French sites enrolled 291 patients with OAB followed according to the local standard of care. Overall, 229 patients received a de novo or replacement InterStim implant and had four follow-up visits, two within the first yr and annually thereafter. A total of 190 patients completed the fourth follow-up visit after a mean of 33.7 ± 3.7 mo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The effectiveness outcomes measured were changes in daily voids and leaks and the therapy responder rates. Other outcomes included validated QoL data (Ditrovie and EuroQol 5-dimension 5-level questionnaires), disease severity (Urinary Symptom Profile [USP]), symptom bother rated using a numeric rating scale (NRS), and safety data. Follow-up data were compared to baseline results using the Wilcoxon signed-rank test. RESULTS AND LIMITATIONS: Average daily voids and leaks were significantly reduced at all time points up to 3 yr after implantation (p < 0.05) except for voids at 21 mo in the group receiving a replacement device. The therapeutic response for urinary urge incontinence at the fourth follow-up was 72% for the de novo group and 86% for the replacement group. Disease-specific QoL (Ditrovie), OAB-specific symptom severity (USP domain 2), and NRS-rated disease bother were significantly improved at all visits (p < 0.001). Device- or procedure-related adverse events occurred in 49% of patients, with 68% of the events classified as minor (Clavien-Dindo grade I or II). Surgical revisions were performed in 33% of patients, including permanent removal in 13%, over a mean exposure time of 44.4 ± 15.3 mo. CONCLUSIONS: This study confirms the safety and effectiveness of SNM for OAB and improvements in QoL and disease bother in real life. PATIENT SUMMARY: Our study in French patients with overactive bladder showed that disease symptoms and bother were significantly reduced and quality of life was significantly improved over a study duration of approximately 3 yr after implantation of a device to stimulate nerves that control the bladder. This trial is registered at ClinicalTrials.gov as NCT02186041.
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Terapia por Estimulação Elétrica , Bexiga Urinária Hiperativa , Humanos , Bexiga Urinária Hiperativa/diagnóstico , Qualidade de Vida , Estudos Prospectivos , Terapia por Estimulação Elétrica/efeitos adversos , Terapia por Estimulação Elétrica/métodos , Resultado do TratamentoRESUMO
PURPOSE: To assess the efficacy and safety of intradetrusor botulinum toxin type A injections (IBTI) for idiopathic overactive bladder (iOAB) in non-neurological adults with an artificial urinary sphincter (AUS). MATERIALS AND METHODS: We retrospectively selected, in the 11 French centers, members of a collaborative network (GENULF (Groupe d'étude de neuro-urologie de langue francaise)), the patients who had had an artificial urinary sphincter implantation and who had subsequently developed iOAB requiring IBTI. This study was approved by the French association of urology ethics committee (no 2018012). RESULTS: Between 2006 and 2020, 33 patients were included from 5 French centers. Mean follow-up after the first IBTI was 47 months. The average age of the studied population was 68 years, with 70% of females. A complete resolution of symptoms at optimal IBTI dose was experienced by 21 (64%) patients. Seven (21%) patients had partial improvement. Five non-responder patients (15%) had no improvement at all. Maximum cystometric bladder capacity was 240 ml pre-IBTI and 335 ml post IBTI. Discontinuation free survival at 60 months was 50%. Two erosions occurred during the 6 months following an IBTI both in male patients with a perineal implantation. There were four AUS balloon perforations that occurred during the 6 months following an IBTI, all of them in female patients. CONCLUSIONS: IBTI has a good efficacy for the treatment of iOAB in patients with an AUS. However, both patients and practicians must be aware of the risk of rare and usually mild complications.
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Toxinas Botulínicas Tipo A , Fármacos Neuromusculares , Bexiga Urinária Hiperativa , Esfíncter Urinário Artificial , Adulto , Idoso , Toxinas Botulínicas Tipo A/efeitos adversos , Feminino , Humanos , Masculino , Fármacos Neuromusculares/efeitos adversos , Estudos Retrospectivos , Resultado do Tratamento , Bexiga Urinária Hiperativa/tratamento farmacológico , Bexiga Urinária Hiperativa/etiologia , Esfíncter Urinário Artificial/efeitos adversosRESUMO
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.