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Aims: Sacral neuromodulation (SNM) and percutaneous tibial nerve stimulation (PTNS) are strongly recommended by international guidelines bodies for complex lower urinary tract dysfunctions. However, treatment failure and the need for rescue programming still represent a significant need for long-term follow-up. This review aimed to describe current strategies and future directions in patients undergoing such therapies., Materials and Methods: This is a consensus report of a Think Tank discussed at the Annual Meeting of the International Consultation on Incontinence - Research Society (ICI-RS), June 6-8, 2024 (Bristol, UK): "Is our limited understanding of the effects of nerve stimulation resulting in poor outcomes and the need for better 'rescue programming' in SNM and PTNS, and lost opportunities for new sites of stimulation?", Results: Rescue programming is important from two different perspectives: to improve patient outcomes and to enhance device longevity (for implantable devices). Standard SNM parameters have remained unchanged since its inception for the treatment of OAB, nonobstructive urinary retention, and voiding dysfunction. SNM rescue programming includes intermittent stimulation (cycling on), increased frequency and changes in pulse width (PW). The effect of PW setting on SNM outcomes remains unclear. Monopolar configurations stimulate more motor nerve fibers at lower stimulation voltage; hence, this could be an option in patients who failed bipolar stimulation in the long term. Unfortunately, there is little evidence for rescue programming for PTNS. However, the development of implantable devices for intermittent stimulation of the tibial nerve may increase long-term adherence to therapy and increase interest in alternative programming. There has been recent promising neurostimulation targeting the pudendal nerve (PNS), especially in BPS/IC. More recently, preliminary data addressed the benefits of high-frequency bilateral pudendal nerve block for DESD and adaptive PNS on both urgency and stress UI in women., Conclusion: The exploration of rescue programming and new stimulation sites remains underutilized, and there are opportunities that could potentially expand the therapeutic applications of nerve stimulation. By broadening the range of target sites, clinicians may be able to tailor treatments according to individual patient needs and underlying conditions, thereby improving overall outcomes. However, further studies are still needed to increase the level of evidence, potentially allowing for an individualized treatment both in patients who are candidates for electrostimulation and in those who have already received surgical implants but seek a better outcome., (© 2024 Wiley Periodicals LLC.)

Background: Modeling studies using large datasets from men with lower urinary tract symptoms/benign prostate enlargement (LUTS/BPE) can predict changes in International Prostate Symptom Score (IPSS) and risk of acute urinary retention/surgery under different treatment regimens and according to predictors (baseline characteristics) that commonly define risk of progression. We assessed the impact of treatments on different symptom types (storage, voiding, and nocturia), quality of life (QoL; IPSS Q8), and BPH Impact Index [BII])., Methods: Generalized least squares models were used to predict each outcome. Data from the CombAT study were used to predict outcomes for active treatments (dutasteride, tamsulosin, combination therapy). Predictors included: age; IPSS total, storage, voiding, nocturia and QoL (IPSS Q8) scores; BII; prostate volume; maximum urine flow rate (Qmax), prostate-specific antigen, postvoid residual urine (PVR); alpha-blocker usage within 12 months. Data from phase III dutasteride monotherapy studies were used to predict placebo outcomes. Results were visualized using an interactive web-based tool ( www.bphtool.com )., Results: Combination therapy provided greater predicted benefit than either monotherapy for all five outcomes for most patient profiles within the CombAT inclusion criteria. PVR and corresponding subscores were significant predictors of change in both storage and voiding subscores. Alpha-blocker use within 12 months, age (storage subscore), and Qmax (voiding subscore) were also significant predictors. PVR, age, Qmax, and nocturia score were significant predictors of change in nocturia. PVR, Qmax, previous alpha-blocker use, total IPSS, and QoL (IPSS Q8) score were significant predictors of change in QoL (IPSS Q8) score. For BII, significant predictors were PVR, age, total IPSS, and BII score. The multivariable effect of covariates and treatments is best visualized through the interactive web-based tool., Conclusions: This predictive modeling study informs our understanding of how risk factors for disease progression interact and affect treatment impact on different symptom types and QoL scores., (© 2023. The Author(s).)

Post-prostatectomy urinary incontinence (PPUI) is an important issue in the urological practice and imposes a negative effect on quality of life (QoL). Despite recent technological advances, PPUI remains a common complication and the artificial urinary sphincter (AUS) is regarded as the most effective long-term surgical treatment for moderate-to-severe stress urinary incontinence. Success rates for AUS as defined by a continence status of zero to one pad per day range from 59% to 90%. One potential downside of the AUS is the need for periodic revisions in a number of patients. Revision and explantation rates due to mechanical failure, urethral atrophy, infection and erosion vary considerably among studies with reports of 8-45% and 7-17%, respectively. These complications can be classified into different categories, including recurrent or refractory incontinence, erosion and/or infection, and other complications. This review article aims to describe the main AUS-related complications and their management strategies. Diagnostic work-up strategies are explored to facilitate timely identification and management of these complications. Additionally, emerging technologies and future directions in AUS development are discussed, highlighting potential advancements to mitigate complications and enhance device performance. This review consolidates current knowledge and provides insights for clinicians to manage the complexities associated with AUS therapy effectively., Competing Interests: Conflicts of Interest: Both authors have completed the ICMJE uniform disclosure form (available at https://tau.amegroups.com/article/view/10.21037/tau-22-830/coif). The series “50 Years Anniversary of the Modern Artificial Urinary Sphincter” was commissioned by the editorial office without any funding or sponsorship. M.A.A. is a member of the Coloplast Continence Advisory Board, and received fees from Medtronic (proctor for sacral neuromodulation) and from Boston Scientific (proctor for AMS800 implants). S.H.M.d.A is a member of the Coloplast Continence Advisory Board. The authors have no other conflicts of interest to declare., (2024 Translational Andrology and Urology. All rights reserved.)

Background: Evidence shows that intermittent catheterisation (IC) for bladder emptying is linked to urinary tract infections (UTIs) and poor quality of life (QoL)., Aim: To investigate the association between UTI risk factors and QoL and patient-reported UTIs respectively., Methods: A survey was distributed to IC users from 13 countries., Findings: Among 3464 respondents, a significantly poorer QoL was observed when experiencing blood in the urine, residual urine, bowel dysfunction, recurrent UTIs, being female, and applying withdrawal techniques. A lower UTI risk was found when blood was not apparent in urine (RR: 0.63; 95% CI: 0.55-0.71), the bladder was perceived empty (RR: 0.83; 95% CI: 0.72-0.96), not having bowel dysfunction (RR: 0.86; 95% CI: 0.76-0.98), and being male (RR: 0.70; 95% CI: 0.62-0.79)., Conclusion: This study underlines the importance of risk factors and their link to QoL and UTIs, highlighting the need for addressing symptoms before UTIs become problematic., Competing Interests: Declaration of interest: Andrei Krassioukov, Charalampos Konstantinidis, Emmanuel Chartier-Kastler, Marcio Augusto Averbeck, Michael Kennelly, and Nikesh Thiruchelvam are all part of the Coloplast Neurourology Advisory Board. This study was conducted and funded by Coloplast, where Malene Landauro, Lotte Jacobsen, Rikke Vaabengaard, and Sabrina Islamoska are employed

Objective: To assess the efficacy of vaginal electrical stimulation (VS) versus transcutaneous tibial nerve electrical stimulation (TTNS) in women with overactive bladder syndrome (OAB)., Material and Methods: Sixty-nine patients were randomized to receive 12 sessions of VS versus TTNS, or no treatment (control group-CG), over 6 weeks. OAB impact according to international consultation on incontinence questionnaire overactive bladder module (ICIQ-OAB), symptoms discomfort scores and voiding diaries were evaluated at baseline, 6 weeks and 1-month post-treatment., Results: Both TTNS (mean difference = -4.2; 95% confidence interval [CI] = -6.5 to -1.9) and VS (-3.8; -6.0 to -1.6) were associated with significant reduction of ICIQ-OAB scores, as well as discomfort sensation (-3.9; -6.2 to -1,7; p < 0.001 for the TTNS and -2.8; -5.0 to -0.6; p = 0.01 for the VS) at 6 weeks when compared to CG (p < 0.001). ICIQ-OAB score remained low only in the TTNS group when compared to the CG (-3.6; -6.0 to -1.2/p = 0.00) 1 month after treatment. Discomfort symptoms improved in both active groups when compared to CG (TTNS [-3.2; -5.2 to -1.2; p < 0.001] and VS groups [-2.6; -4.7 to -0.6; p = 0.01]). No statistically differences were found in primary outcomes comparing TTNS and VS Secondary analysis showed significant improvement in urinary urgency incontinence episodes (UUI) in both TTNS and VS, but CG. UUI episodes were still reduced in the VS group and urgency in the TTNS group 1-month post-treatment., Conclusion: Short-term interventions (6 weeks) of TTNS and VS were both effective in treating women with OAB. TTNS provided residual effects at one-month postintervention on ICIQ-OAB score., (© 2023 Wiley Periodicals LLC.)

Objective: To estimate the cost-effectiveness of single-use hydrophilic-coated intermittent catheters (HCICs) versus single-use uncoated intermittent catheters (UICs) for urinary catheterization., Methods: The evaluation took a UK national health service (NHS) perspective. The population of interest were people using intermittent catheters, with either a spinal cord injury or multiple sclerosis. A Markov model was developed that estimated costs and clinical evidence over the lifetime of a hypothetical cohort and applied health-related quality - of - life estimates. Model inputs were sourced from published evidence, including a network meta-analysis to inform the treatment effect (reduction in catheter-associated urinary tract infections [CAUTIs]), and were supported by expert opinion. The model outputs included per-patient lifetime costs, quality-adjusted life years (QALYs), and the incremental cost effectiveness ratio (ICER). Event counts were also produced., Results: Using HCICs instead of UICs could prevent seven CAUTI events per patient over a lifetime horizon (1.8 requiring secondary care). Overall, lifetime use of HCICs is £3,183 more expensive than use of UICs per patient. However, for these additional costs, 0.55 QALYs are gained. The ICER is £5,755 per additional QALY gained. Key drivers of the model results were identified and subject to sensitivity analyses. The results were found to be robust to parameter uncertainty., Conclusion: HCICs are likely to be a cost-effective alternative to UICs, a result driven by substantial reductions in the number of CAUTIs. Their adoption across clinical practice could avoid a substantial number of infections, freeing up resources in the NHS and reducing antibiotic use in urinary catheter users.

Neurogenic lower urinary tract dysfunction (NLUTD), the abnormal function of the lower urinary tract in the context of neurological pathology, has been the subject of multiple efforts worldwide for the development of clinical practice guidelines. These guidelines are based on the same body of evidence, and are therefore subject to the same gaps. For example, sexual and bowel dysfunction in the context of NLUTD, optimal renal function assessment in those who are non-ambulatory or with low muscle mass, optimal upper tract surveillance timing, and modification of diagnostic and treatment modalities for low-resource nations and communities are inadequately addressed. In addition, many aspects of the conclusions and final recommendations of the guidelines are similar. This duplicative work represents a large expenditure of time and effort, which we believe could be focused instead on evidence gaps. Here, we call for a global unified approach to create a single, resource-independent, comprehensive guidance on NLUTD, neurogenic sexual, and neurogenic bowel dysfunction. Targeted research addressing the evidence gaps should be called for and pursued. This will allow for focus to shift to filling the gaps in the evidence for future guidelines.

Background: It is unclear how cumulative multivariable effects of clinically relevant covariates impact response to pharmacological treatments for lower urinary tract symptoms (LUTS)/benign prostatic enlargement (BPE)., Objective: To develop models to predict treatment response in terms of International Prostate Symptom Score (IPSS) and the risk of acute urinary retention (AUR) or BPE-related surgery, based on large data sets and using as predictors baseline characteristics that commonly define the risk of disease progression., Design, Setting, and Participants: A total of 9167 patients with LUTS/BPE at risk of progression in three placebo-controlled dutasteride trials and one comparing dutasteride, tamsulosin, and dutasteride + tamsulosin combination therapy (CT) were included in the analysis to predict response to placebo up to 24 mo and active treatment up to 48 mo., Outcome Measurements and Statistical Analysis: Predictors included age, IPSS, total prostate volume (PV), maximum urinary flow rate (Q max ), prostate-specific antigen, postvoid residual urine (PVR), α-blocker usage within 12 mo, and randomised treatment. A generalised least-squares model was developed for longitudinal IPSS and a Cox proportional-hazards model for time to first AUR/surgery., Results and Limitations: The vast majority of patients benefit from dutasteride or CT when compared with tamsulosin alone. The predicted IPSS improvement with dutasteride or CT increased with greater PV and severity of symptoms at baseline. The tamsulosin effect was lower with greater baseline PV and tended to decrease over time. Predicted AUR/surgery risk was greater with tamsulosin versus CT or dutasteride; this risk increased with larger PV, higher PVR, and lower Q max (all at baseline). An educational interactive web-based tool facilitates visualisation of the results (www.bphtool.com). Limitations include: the placebo and active-treatment predictions are from different studies, the lack of similar studies for external validation, and the focus on a population at risk of progression from the 4-yr CombAT study., Conclusions: Predictive modelling based on large data sets and visualisation of the risk for individual profiles can improve our understanding of how risk factors for disease progression interact and affect response to different treatments, reinforcing the importance of an individualised approach for LUTS/BPE management., Patient Summary: We used data from previous studies to develop statistical models for predicting how men with lower urinary tract symptoms or benign prostate enlargement and at risk of disease complications respond to certain treatments according to their individual characteristics., (Copyright © 2022 The Author(s). Published by Elsevier B.V. All rights reserved.)

Background: Urinary Tract Infections (UTIs) are among the most severe complications for users of intermittent catheterisation (IC), with numerous risk factors contributing to their occurrence. The aim of this study was to develop a tool to assess UTI risk factors among IC users in a systematic way that considers the perspective of the individual user., Methods: The Design Thinking Process was used to guide the development of the content and format of the tool. The UTI Risk Factors model by Kennelly et al. was used as a basis for developing the content. Insights on the appropriate content and format were collected via the Coloplast Nurse Advisory Boards and by conducting a qualitative evidence synthesis on user perspectives and practices in relation to UTIs., Results: The literature search identified a total of 3544 articles, out of which 22 met the inclusion criteria. Additionally, three rounds of meetings were conducted with approximately 90 nurses from the Nurse Advisory Boards across Europe. The qualitative evidence synthesis showed that users describe their UTI symptoms in different terms and that personal needs and priorities impact their adherence and catheter selection. Furthermore, some users lack relevant and updated knowledge about IC and UTIs. The nurses described that correct UTI diagnosis is essential. They pointed that they would assess the user's general condition, adherence, technique, and catheter type as potential areas of risk factors and emphasised the importance of adequate support for users. The study resulted in the development of the UTI assessment tool for intermittent catheter users, which comprises three elements: a guide for healthcare professionals, a dialogue board, and a notepad. The tool starts with a confirmation of the UTI incidence, and then assesses risk factors via questions on health, adherence, technique, and catheter, and concludes with a support section., Conclusions: The UTI assessment tool for intermittent catheter users is designed to help healthcare professionals assess UTI risk factors in a systematic way, while engaging users and taking their perspective into account. By identifying the relevant risk factors, the use of this tool has the potential to reduce the occurrence of UTIs for the individual IC user., (© 2022. The Author(s).)

Context: The role of urodynamic studies (UDSs) in the diagnosis of lower urinary tract symptoms (LUTS) is crucial. Although expert statements and guidelines underline their value for clinical decision-making in various clinical settings, the academic debate as to their impact on patient outcomes continues., Objective: To summarise the evidence from all randomised controlled trials assessing the clinical usefulness of UDS in the management of LUTS., Evidence Acquisition: For this systematic review, searches were performed without language restrictions in three electronic databases until November 18, 2020. The inclusion criteria were randomised controlled study design and allocation to receive UDS or not prior to any clinical management. Quality assessment was performed by two reviewers independently, using the Cochrane Collaboration's tool for assessing the risk of bias. A random-effect meta-analysis was performed on the uniformly reported outcome parameters., Evidence Synthesis: Eight trials were included, and all but two focused on women with pure or predominant stress urinary incontinence (SUI). A meta-analysis of six studies including 942 female patients was possible for treatment success, as defined by the authors (relative risk 1.00, 95% confidence interval: 0.93-1.07), indicating no difference in efficacy when managing women with UDS., Conclusions: Although UDSs are not replaceable in diagnostics, since there is no other equivalent method to find out exactly what the lower urinary tract problem is, there are little data supporting its impact on outcomes. Randomised controlled trials have focussed on a small group of women with uncomplicated SUI and showed no added value, but these findings cannot be extrapolated to the overall patient population with LUTS, warranting further well-designed trials., Patient Summary: Despite urodynamics being the gold standard to assess lower urinary tract symptoms (LUTS), as it is the only method that can specify lower urinary tract dysfunction, more studies assessing the clinical usefulness of urodynamic studies (UDSs) in the management of LUTS are needed. UDS investigation is not increasing the probability of success in the treatment of stress urinary incontinence., (© 2022 The Authors.)

Aim: To summarize available data focused on diagnosis and management of urethral stricture in men with neurogenic lower urinary tract dysfunction by a systematic review of the literature., Materials and Methods: A systematic review of the literature was carried out through an extensive electronic database search performed in PubMed/MEDLINE and Scopus databases for full texts, and International Continence Society, American Urology Association, and European Association of Urology abstracts for citations related to urethral structure. This review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis., Results: A total of 316 articles were identified, 48 of which were selected for this review. Different strategies are currently being used for the management of urethral strictures, such as clean intermittent catheterization (CIC) which reduces stricture by up to 68%; direct vision internal urethrotomy which shows lower rates of renarrowing; urethroplasty which shows a success rate up to 70%; urinary diversion is the treatment of choice when reconstruction is not possible., Conclusions: Further studies are needed in this population because of the heterogeneity of the outcomes and the lack of a standardized definition and classification of this population., (© 2022 Wiley Periodicals LLC.)

Purpose: This study examined and compared efficacy, safety, satisfaction, and complications of the retropubic Safyre™ sling and a retropubic hand-made synthetic sling (HMS) in a short-, mid- and long-term follow-up., Methods: We retrospectively reviewed a prospectively maintained database of women who underwent Safyre™ or HMS between March 7ths 2005 and December 27ths, 2017. Patients had first assessment (7-10 days), second (40-45 days), and third (sixth month) postoperatively. Between September and December 2018, patients who completed at least one year of surgery, received a telephone call. Follow-up compared quartiles of follow-up time to determine complications (Clavien-Dindo), success rates (International Consultation on Incontinence Modular Questionnaire for Urinary Incontinence Short Form - ICIQ-UI SF), and patient satisfaction., Results: Three hundred fifty-one patients underwent surgery and 221 (63%) were evaluated after a median of 78.47 (± 38.69) months, 125 (55%) in the HMS, and 96 (45%) in the Safyre™ group. Higher intraoperative bladder injury was observed with Safyre™ (0% vs. 4.2%, p=0.034), and a tendency for urinary retention, requiring indwelling urinary catheter over 24 hours (2.4% vs. 8.3%, p=0.061). Both HMS (p<0.001) and Safyre™ (p<0.001) presented improvements on ICIQ-UI SF. There were no differences in satisfaction, subjective cure rates, ICIQ-UI SF, or complications between groups., Conclusions: Both HMS and Safyre™ have similar satisfaction and subjective cure rates, with marked ICIQ-UI SF score improvement. Higher rates of intraoperative bladder injury were seen in patients who received Safyre™ retropubic sling., Competing Interests: None declared., (Copyright® by the International Brazilian Journal of Urology.)

Purpose: We sought to systematically review the literature on the use of botulinum toxin (BTX-A) injections in the bladder to treat overactive bladder (OAB) in men., Materials and Methods: A systematic review was performed to identify clinical trials on efficacy and safety of BTX-A injections in the detrusor for treatment of OAB in men published from inception to October 2020. Quality assessment was performed using the Cochrane Collaboration's tool for assessing risk of bias and study characteristics were extracted by two reviewers independently., Results: After screening 75 abstracts, 12 trials were included in the qualitative synthesis, of which 6 were conducted exclusively in men (mean age: 66.7 years). Only two were randomized controlled studies and the remaining were observational studies, mostly case series. Total number of participants in each study ranged from 28 to 146. Therapeutic response to intravesical BTX-A injection was assessed differently across the studies, which used quality-of-life symptom questionnaires and voiding diary parameters. Urodynamics findings were reported separately for men before and after intravesical injection of BTX-A in two studies only. Pooling of outcome data was possible with adverse events reported after BTX-A by seven studies, which showed urinary tract infection, urinary retention, increased postvoid residual, de novo interstitial cystitis, and hematuria rates of 29.8%, 20.0%, 37.3%, 28.3%, and 12.4%, respectively., Conclusions: Limited information regarding the efficacy and safety of BTX-A bladder injections for male OAB from relatively low evidence is available. Further research is needed to better understand the risk-benefit profile of BTX-A in the male population., (© 2022 Wiley Periodicals LLC.)