Acute Autonomic Nervous System Response to Direct Sacral Nerve Root Stimulation in Lower Urinary Tract Dysfunction: A New Approach to Understand the Mechanism of Action of Sacral Nerve Modulation.

PURPOSE: Our goal was to assess acute autonomic nervous system (ANS) response to direct sacral nerve root (SNR) stimulation in the context of lower urinary tract dysfunction. MATERIALS AND METHODS: In this retrospective monocentric study, patients undergoing 2-stage sacral nerve modulation for overactive bladder, nonobstructive urinary retention, or chronic bladder pain syndrome between March 2022 and June 2023 were analyzed. A standardized stimulation protocol was applied during the lead implantation, each of the 4 contact points being sequentially stimulated at the amplitude required to elicit anal motor response. Stimulations were labeled as StimA, StimB, StimC, and StimD, ordered by ascending order of minimum amplitude required for anal motor response. Heart rate variability parameters were collected using PhysioDoloris Monitor, and computed through the time-domain (standard deviation of normal-to-normal intervals [SDNN], root mean square of successive differences), the frequency-domain (low frequency, high frequency) and the graphical (Analgesia Nociception Index [ANI]) methods. RESULTS: Fifty patients were analyzed, including 35 females. Twelve patients had an underlying neurological disease. Efficacy was deemed achieved in 54% of patients. SDNN variability significantly increased during StimA to StimC, while maximum SDNN significantly increased only during StimA. ANI variability significantly increased during all 4 stimulations, while maximum ANI significantly increased only during StimA. CONCLUSIONS: Direct stimulation of SNR is responsible for a significant increase in ANS and relative parasympathetic nervous system activity, with a greater effect observed when the stimulation was delivered closer to the SNR. These results shed light on potential mechanisms underlying sacral nerve modulation, particularly regarding the treatment of ANS dysregulation in lower urinary tract dysfunction.

Response to tibial and sacral nerve modulation in overactive bladder: Is there any correlation?

OBJECTIVES: To assess the correlation between the response to transcutaneous tibial nerve stimulation (TTNS) and subsequent response to sacral nerve modulation (SNM) to treat overactive bladder (OAB). MATERIALS AND METHODS: All patients who consecutively received TTNS followed by a two-stage SNM between January 2016 and June 2022 to treat OAB in two university hospital centers were included. The response to each therapy was evaluated with success defined by a 50% or greater improvement in one or more bothersome urinary symptoms from baseline. The primary endpoint was the statistical relationship between the response to TTNS and the response to SNM, assessed by logistic regression. Secondary endpoints were the statistical relationship between the response to TTNS and the response to SNM when controlling for gender, age (<57 years vs. >57 years), presence of an underlying neurological disease, and presence of DO, adding the factor and interaction to the previous regression model. RESULTS: Among the 92 patients enrolled in the study, 68 of them were women (73.9%), and the median age was 57.0 [41.0-69.0] years. The success was reported in 22 patients (23.9%) under TTNS and 66 patients (71.7%) during the SNM test phase. There was no statistical correlation between response to TTNS and response to SNM in the overall population (confidence interval: 95% [0.48-4.47], p = 0.51). Similarly, there was no statistical correlation when controlling for age <57 years or ≥57 years, with p = 1.0 and p = 0.69, respectively. No statistical study could be conducted for the other subpopulations due to small sample sizes. CONCLUSION: The response to TTNS does not predict the response to SNM in the treatment of OAB. TTNS and SNM should be considered as separate therapies, and the decision-making process for OAB treatment should take this into account.

Improved emptying performance with a new micro-hole zone catheter in adult male intermittent catheter users: A comparative multi-center randomized controlled cross-over study.

AIMS: To confirm the improved performance of the micro-hole zone catheter (MHZC) compared to a conventional eyelet catheter (CEC) in male users of clean intermittent catheterizations (CICs). METHODS: Male self-catheterizing subjects, who used hydrophilic sleeved soft/flexible CIC as the only bladder emptying method, were enrolled into a multi-center, randomized, cross-over study performed across six European sites. Subjects tested the MHZC, featuring a drainage zone with 120 micro-holes and a CEC with two eyelets. The study consisted of four study visits (V0-V3), during which endpoints related to catheter performance (urinary flow-stops, bladder emptying, and intra-catheter pressure) were measured and two 4-week test periods at home (T1 and T2) where dipstick hematuria and user perception between catheters were evaluated. RESULTS: Seventy-three male subjects with non-neurogenic and neurogenic bladder dysfunction (3:2) were enrolled. On average, catheterizations with the MHZC led to close to mean zero flow-stops compared to ≥1 flow-stops with the CEC, during both HCP- and self-led catheterizations (both p < 0.001). Residual urine at first flow-stop was significantly reduced for the MHZC compared to CEC (p = 0.001 and p = 0.004, for HCP- and self-led catheterizations, respectively). This was substantiated by a significantly smaller pressure peak at first flow-stop, a proxy for minimized mucosal suction (both HCP- and self-led catheterizations, p < 0.001). After home-use catheterizations, dipstick hematuria was comparable between catheters, whereas catheterizations were associated with significantly improved perception in favor of MHZC regarding bladder emptying, less blocking sensation, and improved hygienic catheterization compared to the CEC. CONCLUSION: This study confirmed the evidence of improved bladder emptying with the MHZC compared to a CEC without the need to reposition the catheter. The MHZC therefore offers an enhanced benefit for the dependent CIC user securing complete bladder emptying in an uninterrupted free flow and reducing the need to reposition the catheter during emptying.

Intravesical injections of botulinum neurotoxin A to treat overactive bladder and/or detrusor overactivity related to multiple sclerosis: 5-Year continuation rate and specific risk factors for discontinuation-A study from the neuro-urology committee of the French Association of Urology.

BACKGROUND: While intravesical injections of botulinum neurotoxin A (BoNT-A) are currently recommended for patients experiencing refractory neurogenic overactive bladder and/or detrusor overactivity (OAB/DO), it is unclear how much this therapy is effective and sustainable in the long-term in patients with multiple sclerosis (MS). OBJECTIVES: To assess the mid-term continuation rate of BoNT-A injections to treat neurogenic OAB/DO in MS patients and to investigate MS-specific risk factors for discontinuation. METHODS: This retrospective study involved 11 French university hospital centers. All MS patients who received BoNT-A to treat neurogenic OAB/DO between 2008 and 2013 and were subsequently followed up for at least 5 years were eligible. RESULTS: Of the 196 MS patients included, 159 (81.1%) were still under BoNT-A 5 years after the first injection. The combination of the Expanded Disability Status Scale (EDSS < 6 or ⩾ 6) and of the MS type (relapsing-remitting vs progressive) predicted the risk of discontinuation. This risk was 5.5% for patients with no risk factor, whereas patients presenting with one or two risk factors were 3.3 and 5.7 times more likely to discontinue, respectively. CONCLUSION: BoNT-A is a satisfying mid-term neurogenic OAB/DO therapy for most MS patients. Combining EDSS and MS type could help predict BoNT-A discontinuation.

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.

Development of a predictive tool for sacral nerve modulation implantation in the treatment of non-obstructive urinary retention and/or slow urinary stream: a study from the Neuro-Urology Committee of the French Association of Urology.

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.

Adjustable Continence Therapy (ACT®) balloons to treat female stress urinary incontinence: effectiveness, safety and risk factors of failure and complication.

INTRODUCTION AND HYPOTHESIS: To assess the effectiveness, safety and risk factors of failure and complications associated with Adjustable Continence Therapy (ACT®) balloons as a treatment for female stress urinary incontinence (SUI). METHODS: In the present multicentric retrospective study, all women implanted with ACT® balloons between 2000 and 2018 were considered eligible. Effectiveness and safety were assessed at 1 year, and risk factors for failure and complications were sought. The effectiveness was categorized into three distinct groups: Success = maximum 1 pad/day and patient's impression of improvement using a numerical rating scale (NRS) ≥ 8/10; Improvement = decrease of daily pad use and NRS ≥ 5/10; Failure = increase or stability of daily pad use or NRS < 5/10. The intra- and postoperative surgical complications were collected. RESULTS: Over the study period, 281 women were included. Among them, 104 (37.0%), 94 (33.5%) and 83 (29.5%) were categorized as success, improvement, and failure, respectively. Intra-, early and late postoperative complications occurred in 13 (4.6%), 35 (12.5%) and 75 (26.7%) women, respectively. Most early surgical complications were minor according to the Dindo-Clavien classification. Of women that presented a late postoperative surgical complication, 64 (22.8%) underwent an explantation performed under local or general anesthesia without associated sequalae. CONCLUSIONS: The short-term effectiveness associated with ACT® balloons, their minimally invasive implantation and the frequent but easily manageable and sequelae-free complications suggest that they should be part of the therapeutic arsenal for female SUI.

Incidence and safety outcomes associated with active stone removal procedures (ASRP): a comparison between neurological and non-neurological patients using the French National Health Data Base.

PURPOSE: To compare the incidence and the safety outcomes associated with active stone removal procedure (ASRP) between neurological and non-neurological patients. MATERIALS AND METHODS: The present study was conducted using the data issued from the French National Health Data Base. All patients that have been hospitalized to undergo an ASRP between January 1 2012 and December 31 2018 were included and allocated to four neurological groups (multiple sclerosis, spinal dysraphism, paraplegia, tetraplegia) and one non-neurological group. The primary outcome was the rate of patients hospitalized at least once to undergo an ASRP over the study period. The secondary outcomes included the type of ASRP performed, the length of hospital stay, the rates of post-operative UTI, of early re-admission and re-treatments. Multivariate logistic regression was used to estimate odd ratios, the four neurological groups being compared to the non-neurological group. RESULTS: During the study period, 45,745,055 patients were hospitalised, with 151,850 of them presenting with an underlying neurological disease. Among the non-neurological patients, 0.89% underwent an ASRP, while 1.39% neurological patients did. Neurological patients presented with a lower rate of ESWL associated with a higher rate of PCNL, while the length of hospital stay, the rate of post-operative UTI, of early re-admission and of re-treatment were systematically increased (p < 0.001), when compared to non-neurological patients, regardless of the type of ASRP considered. CONCLUSIONS: The results presented here confirm and clarify the incidence and the safety outcomes associated with ASRP within the neurological population and advocate for the emergence of a dedicated research field focusing on neuro-urolithiasis.

Efficacy and safety of intradetrusor botulinum toxin injections for idiopathic overactive bladder syndrome in patients with an artificial urinary sphincter.

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.

Prioritization of risk situations in neuro-urology: guidelines from Association Française d'Urologie (AFU), Association Francophone Internationale des Groupes d'Animation de la Paraplégie (A.F.I.G.A.P.), Groupe de Neuro-urologie de Langue Française (GENULF), Société Française de Médecine Physique et de Réadaptation (SOFMER) and Société Interdisciplinaire Francophone d'UroDynamique et de Pelvi-Périnéologie (SIFUD-PP).

PURPOSE: The current health crisis has drastically impacted patient management in many fields, including neuro-urology, leading to a mandatory reorganization. The aim of this work was to establish guidelines regarding the prioritization and optimal timing of each step of neurogenic lower urinary tract dysfunction management. METHODS: A steering committee included urologists and physical medicine and rehabilitation practitioners. Based on a literature review and their own expertise, they established a comprehensive risk-situation list and built a risk scale, allowing multiple other experts to score each clinical situation. New recommendations were generated using a Delphi process approach. RESULTS: Forty-nine experts participated in the rating group. Among the 206 initial items, 163 were selected and divided into four domains, diagnosis and assessment, treatment, follow-up, and complications, and two sub-domains, general (applicable for all neurological conditions) and condition-specific [varying according to the neurological condition (spinal cord injury, multiple sclerosis, brain injury, Parkinsonism, dysraphism, lower motor neuron lesions)]. The resulted guidelines are expert opinions established by a panel of French-speaking specialists, which could limit the scalability of this work. CONCLUSIONS: The present multidisciplinary collaborative work generates recommendations which complement existing guidelines and help clinicians to reorganize their patients' list in the long term with a personalized medicine approach, in the context of health crisis or not.

Impact of COVID-19 pandemic on functional urology procedures in France: a prospective study.

PURPOSE: To evaluate the impact of COVID-19 pandemic on functional urology procedures in France. METHODS: A prospective study was conducted within 11 secondary and tertiary referral centers in France. Patients aged > 18 years who were diagnosed with a functional urology disease before the national lockdown (March 17th, 2020) and who required a surgery were included. Study period went from March 17th to September 30th 2020. The included interventions were listed according to the guidelines for functional urology enacted by the French Association of Urology and delay of reoperation was compared to the guidelines' delay. The primary outcome was the number of procedures left unscheduled at the end of the study period. Descriptive statistics were performed. RESULTS: From March 17th 2020 to September 3 rd 2020, 1246 patients with a previous diagnosis of a functional urological disease requiring a surgery were included. The mean follow-up was 140.4 days (± 53.4). Overall, 316 interventions (25.4%) were maintained whereas 74 (5.9%) were canceled, 848 (68.1%) postponed and 8 patients (0.6%) died. At the end of the follow-up, 184 patients (21.7%) were still not rescheduled. If the intervention was postponed, the mean delay between the initial and final date was 85.7 days (± 64.4). CONCLUSION: Overall, more than two thirds of interventions had to be postponed and the mean delay between the initial and final date was about three months.

Adjustable continence therapy (ACT®) balloons to treat neurogenic and non-neurogenic female urinary incontinence.

AIMS: To compare efficacy and safety between neurogenic and non-neurogenic women after adjustable continence therapy (ACT®) balloons implantation to treat stress urinary incontinence (SUI) due to intrinsic sphincter deficiency. METHODS: In the present retrospective multicentric study, all neurogenic and non-neurogenic women implanted with ACT® balloons between 2000 and 2018 were considered for inclusion. Efficacy was compared 1 year after implantation, and women were allocated in three different groups as follows. Success: maximum 1 pad per day and patient's impression of improvement assessed using a numeral rating scale (NRS) ≥8/10. Improvement: decrease of daily pad use and/or NRS ≥5/10. Failure: increase or stability of daily pad use or NRS <5/10. Overall surgical complications and explantations were compared 1 year after implantation. RESULTS: Among the 277 included women, 51 presented with a neurologic underlying disease. Mean age at implantation was 68.5 years. There was no significant difference in efficacy between neurogenic and non-neurogenic women with a success rate of 39.2% and 36.3%, respectively (p = 0.69). Similarly, improvement rate was reported to be 31.4% and 33.6%, in neurogenic and non-neurogenic women, respectively (p = 0.92). The overall surgical complications rate (24% vs. 34.5%, p = 0.15) and the explantation rate (19.6% vs. 28.8%, p = 0.18) were not significantly different. CONCLUSION: ACT balloons may be proposed to treat mixed or SUI in females with ISD. Efficacy and safety profiles appear to be similar in both neurogenic and non-neurogenic patients.

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 interventions to prevent lower urinary tract dysfunction after spinal cord injury: a systematic review.

STUDY DESIGN: Systematic review. OBJECTIVES: To synthetise the available scientific literature reporting early interventions to prevent neurogenic lower urinary tract dysfunction (NLUTD) after acute supra-sacral spinal cord injury (SCI). METHODS: The present systematic review is reported according to the PRISMA guidelines and identified articles published through April 2021 in the PubMed, Embase, ScienceDirect and Scopus databases with terms for early interventions to prevent NLUTD after SCI. Abstract and full-text screenings were performed by three reviewers independently, while two reviewers performed data extraction independently. An article was considered relevant if it assessed: an in-vivo model of supra-sacral SCI, including a group undergoing an early intervention compared with at least one control group, and reporting clinical, urodynamic, biological and/or histological data. RESULTS: Of the 30 studies included in the final synthesis, 9 focused on neurotransmission, 2 on the inflammatory response, 10 on neurotrophicity, 9 on electrical nerve modulation and 1 on multi-system neuroprosthetic training. Overall, 29/30 studies reported significant improvement in urodynamic parameters, for both the storage and the voiding phase. These findings were often associated with substantial modifications at the bladder and spinal cord level, including up/downregulation of neurotransmitters and receptors expression, neural proliferation or axonal sprouting and a reduction of inflammatory response and apoptosis. CONCLUSIONS: The present review supports the concept of early interventions to prevent NLUTD after supra-sacral SCI, allowing for the emergence of a potential preventive approach in the coming decades.

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.

Artificial urinary sphincter implantation in non-neurogenic men: a place for out-patient surgery.

OBJECTIVE: To assess feasibility, safety and risk factors for failure associated with out-patient surgery for artificial urinary sphincter (AUS) implantation/revision in non-neurogenic men. MATERIALS: In the present retrospective monocentric study conducted between May 2016 and March 2020, 81 patients undergoing AUS implantation or revision during an out-patient surgery were included. The primary outcome was the success rate of out-patient surgery. Success was assessed using two distinct definitions, a narrow definition, where success was defined as a one-day hospitalization and the absence of any unscheduled consultation or re-hospitalization within the 3 days following surgery, a broad definition, where success was defined as a one-day hospitalization and the absence of any unscheduled re-hospitalization within the 3 days following surgery. In parallel, risk factors for failure of out-patient surgery, as well as efficacy and safety were assessed. RESULTS: Eighty-one patients were enrolled, with a mean age of 71.2 years ± 5.9. Out-patient surgery was successfully completed in 58 men (71.6% [95% CI 60.5-81.1]) and in 76 men (93.8% [95% CI 86.2-97.9]) according to the narrow and the broad definition, respectively. After multivariate analysis, anticoagulant therapy (OR 25.97 [95% CI 4.44-152.04]) and low socio-professional status (OR 22.1 [95% CI 3.701-131.95]) were statistically associated with failure of out-patient surgery. The continence rate after a 90-day follow-up was 79%. CONCLUSION: AUS implantation/revision in non-neurogenic men could be safely proposed in out-patient surgery. Special attention may however be paid to patients undergoing anticoagulant therapy or belonging to a low socio-professional category. TRIAL REGISTRATION NUMBER: DEC20-173 (French National Commission for Data Protection and Liberties).

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.

Randomized clinical trials assessing third-line therapies to treat non-neurogenic overactive bladder syndrome: a review about methodology.

INTRODUCTION AND HYPOTHESIS: Using similar methodologies and outcome measures is crucial to allow pertinent literature reviews and meta-analyses. Therefore, this scoping review aims to compare methodologies of randomized clinical trials (RCTs) assessing the efficacy of third-line therapies to treat non-neurogenic OAB: intradetrusor onabotulinumtoxinA (BoNTA) injections, sacral neuromodulation (SNM) and posterior tibial nerve stimulation (PTNS). METHODS: A literature search was conducted using the PubMed search database. Using filters, the search was limited to RCTs conducted on humans and written in English or French since 2000 which evaluated BoNTA injections, SNM and/or PTNS. RCTs focusing on pediatric or neurogenic OAB were excluded. For each included RCT, methodology was assessed using a standardized form investigating the study design, clinical outcomes and urodynamic outcomes. Inclusion criteria, sex ratio, blinding strategies, treatment arms, primary outcomes and delays for reevaluation were assessed. Availability of clinical and urodynamic outcomes was reported at baseline, 3 months and 6 months. RESULTS: Thirty-one RCTs were included in the final synthesis. The most frequent main outcome measure was change in the number of urinary incontinence episodes in 35.5% and in the number of voids per day in 25.8%. Bladder diaries were lacking in 12.9%, 32.3% and 80.1% at baseline, 3 and 6 months, respectively, while 26% of studies reported the results of urodynamic studies at any point. CONCLUSION: Heterogeneity in study designs and data collection was pointed out between RCTs assessing the efficacy of third-line therapies to treat non-neurogenic OAB. We therefore advocate for the development of specific research guidelines focusing on OAB-related therapies.

Intradetrusor Injections of Botulinum Toxin A in Adults with Spinal Dysraphism.

PURPOSE: The aim of the current study was to determine the outcomes of botulinum toxin A intradetrusor injections in adult patients with spina bifida. MATERIALS AND METHODS: All patients with spinal dysraphism who underwent intradetrusor injections of botulinum toxin A from 2002 to 2016 at a total of 14 centers were retrospectively included in analysis. The primary end point was the global success of injections, defined subjectively as the combination of urgency, urinary incontinence and detrusor overactivity/low bladder compliance resolution. Univariate and multivariate analysis was performed to seek predictors of global success. RESULTS: A total of 125 patients were included in study. The global success rate of the first injection was 62.3% with resolution of urinary incontinence in 73.5% of patients. All urodynamic parameters had improved significantly by 6 to 8 weeks compared to baseline, including maximum detrusor pressure (-12 cm H2O, p <0.001), maximum cystometric capacity (86.6 ml, p <0.001) and compliance (8.9 ml/cm H2O, p = 0.002). A total of 20 complications (3.6%) were recorded for the 561 intradetrusor botulinum toxin A injections, including 3 muscular weakness complications. The global success rate of the first injection was significantly lower in patients with poor compliance (34.4% vs 86.9%, OR 0.08, p <0.001). On multivariate analysis poor compliance was associated with a lower global success rate (OR 0.13, p <0.001). Female gender (OR 3.53, p = 0.01) and patient age (OR 39.9, p <0.001) were predictors of global success. CONCLUSIONS: Intradetrusor botulinum toxin A injections were effective in adult patients with spina bifida who had detrusor overactivity. In contrast, effectiveness was much lower in adult patients with spina bifida who had poor bladder compliance. The other predictors of global success were female gender and older age.