INTRODUCTION:Artificial intelligence (AI) is poised to improve the diagnosis and management of lower urinary tract dysfunction (LUTD). Its effective deployment requires prioritization, regulatory oversight, rigorous validation, and clinician and patient engagement. METHODS:The Think Tank at the International Consultation on Incontinence-Research Society (ICI-RS) 2025 evaluated key considerations for successful AI implementation into LUTD clinical care. The topics included clinical triage framework, regulatory and legal principles, levels of evidence required for validation, and clinician and patient engagement to guide development. The group developed a narrative of the pressing matters related to AI implementation and a list of proposed research questions, which, when addressed, will help shape the future of the field. RESULTS:LUTD topics that should be prioritized for AI implementation include high-burden conditions with high unmet need such as neurogenic LUTD, bladder outlet obstruction, and overactive bladder. Regulatory frameworks such as the EU AI Act and the U.S. "Software as a Medical Device" and its associated guidance promote safety, transparency, and accountability. AI solutions should be as rigorously evaluated as other clinical devices or drug agents. Patient and clinician engagement are paramount to ensure innovation aligns with the pressing needs of patients and clinicians. CONCLUSIONS:AI's integration into LUTD care requires cross-disciplinary collaboration, prospective validation, and legal and ethical frameworks. AI must be developed and implemented with a strong focus on transparency, trust, and patient-centered care. CLINICAL TRIAL REGISTRATION:This study is not a clinical trial and thus does not warrant registration as such.
The UPSTREAM and FUTURE trials found no added benefit from routine urodynamics (UDS) in men with presumed benign prostatic obstruction or women with overactive bladder symptoms unresponsive to initial therapy. However, these population-based studies were not powered to evaluate specific subgroups for which a higher degree of diagnostic certainty could have led to better outcomes. This consensus paper argues that UDS is essential in selected cases for which comprehensive clinical assessment alone may be insufficient. A selective approach to UDS will ensure that patients receive the most accurate diagnosis and appropriate treatment.
Currently, in vitro testing examines the cytotoxicity of biomaterials but fails to consider how materials respond to mechanical forces and the immune response to them; both are crucial for successful long-term implantation. A notable example of this failure is polypropylene mid-urethral mesh used in the treatment of stress urinary incontinence (SUI). The mesh was largely successful in abdominal hernia repair but produced significant complications when repurposed to treat SUI. Developing more physiologically relevant in vitro test models would allow more physiologically relevant data to be collected about how biomaterials will interact with the body. This study investigates the effects of mechanochemical distress (a combination of oxidation and mechanical distention) on polypropylene mesh surfaces and the effect this has on macrophage gene expression. Surface topology of the mesh was characterised using SEM and AFM; ATR-FTIR, EDX and Raman spectroscopy was applied to detect surface oxidation and structural molecular alterations. Uniaxial mechanical testing was performed to reveal any bulk mechanical changes. RT-qPCR of selected pro-fibrotic and pro-inflammatory genes was carried out on macrophages cultured on control and mechanochemically distressed PP mesh. Following exposure to mechanochemical distress the mesh surface was observed to crack and craze and helical defects were detected in the polymer backbone. Surface oxidation of the mesh was seen after macrophage attachment for 7 days. These changes in mesh surface triggered modified gene expression in macrophages. Pro-fibrotic and pro-inflammatory genes were upregulated after macrophages were cultured on mechanochemically distressed mesh, whereas the same genes were down-regulated in macrophages exposed to control mesh. This study highlights the relationship between macrophages and polypropylene surgical mesh, thus offering more insight into the fate of an implanted material than existing in vitro testing.
BACKGROUND:This pooled analysis of randomized controlled studies investigated the safety and efficacy of onabotulinumtoxinA in male and female patients with overactive bladder (OAB). METHODS:Data were pooled from four similarly designed trials in North America and Europe. Adults with idiopathic OAB for ≥6 months inadequately managed by at least one anticholinergic were randomized 1:1 or 2:1 to receive onabotulinumtoxinA 100 U or matched placebo in Cycle 1 and could request open-label retreatment with onabotulinumtoxinA 100 U at ≥12 weeks. Efficacy outcomes at Week 12 included the primary endpoint of mean urinary incontinence (UI) episodes per day and other variables, such as the proportion of patients with ≥50% reduction in daily UI episodes. Safety was assessed by monitoring treatment-emergent adverse events (TEAEs). Analyses by sex were descriptive. Males were further analyzed by benign prostatic hyperplasia (BPH) diagnosis status. RESULTS:In the pooled population (N = 1564), there were 194 males (12.4%) and 1370 females (87.6%). Mean number of baseline UI episodes per day was 4.9 in males and 5.5 in females. At Week 12, numerically greater mean reductions from baseline in number of daily UI episodes were observed with the onabotulinumtoxinA 100 U group (females: -3.0; males: -2.2) versus placebo (females: -1.1; males: -1.3). Achievement of ≥50% reduction in daily UI episodes was numerically greater with onabotulinumtoxinA 100 U (females: 64.8%; males: 61.2%) versus placebo (females: 30.6%; males: 44.8%), and numerically higher in males without BPH (onabotulinumtoxinA: 65.1%; placebo: 50.9%) versus with BPH (onabotulinumtoxinA: 54.3%; placebo: 36.6%). A total of 34.7% of males and 39.4% of females experienced at least one TEAE in the first 12 weeks during treatment Cycle 1. Urinary tract infection rate was 13.1% in females and 4.2% in males; incidence of hematuria was 6.8% in males and 1.1% in females. Incidence of urinary retention (defined as incomplete emptying, requiring catheterization) was 2.7% in females and 4.7% in males. CONCLUSION:OnabotulinumtoxinA 100 U was efficacious and well tolerated in men and women with OAB, including in males with and without BPH. No new safety findings were identified when data were analyzed by sex.
The failure of polypropylene mesh is marked by significant side effects and debilitation, arising from a complex interplay of factors. One key contributor is the pronounced physico-mechanical mismatch between the polypropylene (PP) fibres and surrounding tissues, resulting in substantial physical damage, inflammation, and persistent pain. However, the primary cause of sustained inflammation due to polypropylene itself remains incompletely understood. This study comprises a comprehensive, multi-pronged investigation to unravel the effects of implantation on a presumed inert PP mesh in sheep. Employing both advanced and conventional techniques to discern the physical and chemical transformations of the implanted PP. Our analyses reveal a surface degradation and oxidation of polypropylene fibres after 60 days implantation, persisting and intensifying at the 180-day mark. The emergence and accumulation of PP debris in the tissue surrounding the implant also increased with implantation time. We demonstrate observable physical and mechanical alterations in the fibre surface and stiffness. Our study shows surface alterations which indicate that PP is evidently less chemically inert than was initially presumed. These findings underscore the need for a re-evaluation of the biocompatibility and long-term consequences of using PP mesh implants.
Purpose of review There is a long history of implantation of absorbable and nonabsorbable materials to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP). The focus of this review is to review the development of new materials for use in the surgical management of both pelvic conditions following an unacceptable level of severe complications in the use of polypropylene mesh (PPM). We discuss current concepts relating to the development of new materials with particular reference to our experience with polyurethane mesh. Recent findings Our review highlights the strategies that manufacturers and researchers are employing to improve PPM using collagen gels and stem cells, or to find alternatives. We conclude that current preclinical safety testing is inadequate, and the field requires better in vivo testing. Specifically, we highlight novel techniques demonstrating the degradation of polypropylene potentially elucidating the link between PPM degradation and induction of inflammation leading to adverse side effects. Summary This field badly needs innovation in developing new materials and in testing these to ensure materials will benefit patients. A collaboration between materials scientists and clinicians is needed to facilitate the translation of basic research and preclinical testing into patient benefit for the treatment of SUI and POP.
AIMS:Insights into the role of the urethra in maintaining continence and in normal voiding have been provided with advances in imaging techniques. Also, functional urethral testing is used to understand which treatments are optimal for women with functional bladder outlet obstruction (BOO), but which testing is better for which treatment? This review aims to describe our current understanding of female urethral function and dysfunction and to provide future research directions for treating functional female urethral disorders. MATERIALS AND METHODS:This is a consensus report of the proceedings of a research proposal discussed at the annual International Consultation on Incontinence-Research Society (ICI-RS), 6th-8th June 2024 (Bristol, UK): "Do we need to re-focus on functional female urethral disorders in lower urinary tract dysfunction? ICI-RS 2024". RESULTS:Regarding female urethral nomenclature, it was agreed that the same terminology should be used in the orientation of the female urethra as in the male. Also, functional MRI and computer modeling could aid further understanding of urethral function in women with voiding dysfunction and OAB symptoms. As for functional urethral assessment, options include video-urodynamics with leak point pressure (LPP) testing, urethral pressure profilometry (UPP), and striated urethral sphincter electromyography (EMG). Future testing may include the use of modalities (borrowed from cardiologic assessment of vascular structures such as resistive measures obtained with ultrasound) for the purpose of assessing urethral closure. UPP testing has limitations in measurement and reproducibility in assessing urethral pressure. Urethral sphincter EMG is difficult to perform and reproduce. LPP also has limitations related to testing and to patient effort, in addition to being influenced by factors such as bladder volume and compliance. When performing urethral surgery, it is imperative to dissect in tissue planes that preserve urethral function. Regarding therapeutic modalities for the treatment of functional female urethral dysfunction, conservative management includes pelvic floor muscle training with or without biofeedback, electrical stimulation, and extracorporeal magnetic stimulation. Furthermore, there was a robust discussion on the use of cognitive-behavioral therapy to address psychological comorbidities, thereby improving female LUTD. The evidence supporting long-term pharmacologic treatment of female urethral LUTD remains scarce. As for invasive management options, the evidence supporting the use of botulinum toxin in female LUTD is limited. Finally, the very existence of BNO and the validity of its diagnosis was discussed. Furthermore, bladder neck incision as a treatment of BNO was debated, and the indications for this procedure include a therapeutic decision balancing benefit to complications. CONCLUSION:Improving the treatment of female functional storage and voiding disorders depends on optimal urethral function assessment. Functional MRI to better understand urethral function, expanding the use of UPP testing, LPP testing, and emerging modalities while maintaining urethral function during female urethral surgery, and addressing psychological comorbidities whilst pursuing both conservative and invasive options (for refractory symptoms) are all important considerations in treating functional female urethral disorders.
Background: Patients with overactive bladder may cycle through different antimuscarinic medications even though there is limited evidence to support this approach. Objective: To describe treatment patterns and the associated health care resource utilisation (HCRU) according to antimuscarinic cycling groups. Design, setting, and participants: The CYCLe AntiMuscarinics in ENgland (CYCLAMEN) study was a retrospective observational investigation that used primary care records from the Clinical Practice Research Datalink GOLD database linked to Hospital Episode Statistics secondary care data. Eligible patients (>= 18 yr) were prescribed their first antimuscarinic between January 2014 and December 2017. Patients were categorised into groups prescribed one, two, or three or more (groups 1-3) consecutive unique antimuscarinics over 18 mo. Outcome measurements and statistical analysis: The HCRU rate and costs were calculated for the period of continuous antimuscarinic therapy (first antimuscarinic treatment episode) and the 18-mo follow-up period. Treatment sequence patterns were displayed using sunburst plots and Kaplan-Meier analysis was used to assess time on treatment. Results and limitations: Overall, 35 369 patients were included, of whom 31 760 (89.8%) received one antimuscarinic (group 1), 3182 (9.0%) received two (group 2), and 427 (1.2%) received three or more (group 3). The most common initial antimuscarinics were solifenacin (13 628 patients, 42.9%) in group 1, and oxybutynin in group 2 (1267 patients, 39.8%) and group 3 (200 patients, 46.8%). The median duration of the first antimuscarinic treatment episode was 57 d and <20% of patients were receiving any antimuscarinic after 18 mo. The number of primary care visits and mean costs increased across groups. The reasons for cycling could not be identified in this study. Conclusions: Approximately 10% of patients underwent sequential cycling with two or more antimuscarinics. Furthermore, as the majority discontinued treatment within 18 mo, there is a need to improve the management of these patients in the clinical care setting. Patient summary: We investigated treatment patterns and health care use for patients with overactive bladder who were prescribed at least one antimuscarinic drug (AMD), which are drugs that reduce some of the impulses passing from the bladder to the brain. Around 10% of patients accessing primary health care in England received more than one sequential AMD. Most patients discontinued treatment, which may indicate inadequate management of their condition. Prescription of a higher number of AMDs was associated with higher health care costs. (c) 2023 The Authors. Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article under the CC BY license (http://creativecommons. org/licenses/by/4.0/).
The concept that “the bladder is an unreliable witness” highlights the non-disease-specific nature of lower urinary tract symptoms (LUTS), which can arise regardless of anatomical differences between genders. This non-specificity has led to the broader classification of symptoms under LUTS, which include storage, voiding, and post-micturition symptoms. Overactive bladder (OAB) is characterised by urgency, often accompanied by frequency, nocturia, and, in some cases, incontinence. The symptoms of OAB do not always correlate with urodynamically proven idiopathic detrusor overactivity (IDO), indicating that afferent nerve activity plays a significant role. The complexity of bladder control involves a neural network spanning the brain, spinal cord, and peripheral ganglia. Current therapies, such as anticholinergics and beta-3 agonists, target both motor and sensory pathways, with emerging evidence suggesting that sensory modulation is crucial for effective treatment. Research using animal models has provided insights into the pharmacological mechanisms underlying bladder function, although these models have limitations in replicating human conditions. The importance of the sensory ‘web’ within the bladder’s mucosal and interstitial cell network is emphasised, as it significantly influences bladder compliance and sensory signalling. Recent advances, including the use of Onabotulinum toxin A and sacral neuromodulation, highlight the therapeutic potential of targeting sensory pathways in managing OAB symptoms.
BACKGROUND:Following the severe complications widely reported in some women following polypropylene suburethral mesh implantation for the treatment of stress urinary incontinence, it has become clear that careful preclinical study in an appropriate animal model is essential. The preclinical model described here allows the postoperative clinical and histochemical assessment of material implanted in the sheep vagina and represents a model that allows prediction of the potential vaginal tissue responses to suburethral mesh implantation before implantation into humans. OBJECTIVES:To develop and evaluate a relevant preclinical animal model to mimic suburethral implantation of support materials for stress urinary incontinence. MATERIAL:Fourteen parous ewes of 30-40 kg were used. Under general anesthetic, animals were placed in the lithotomy position. A 12-French Foley catheter was inserted. The ventral vaginal wall was longitudinally incised. The space between the vaginal wall and the urethra was developed, with lateral retropubic dissection. Either a standard transvaginal polypropylene tape (seven animals) or a fascia mimetic microfibre spun polyurethane tape (seven animals) were inserted using an introducer either via a suprapubic (seven animals) or a transvaginal approach (seven animals) into the suburethral and retropubic space. The incisions were closed, and the catheter was removed. A betadine vaginal pack was placed and removed after 24 h. Postoperatively, the animals were observed carefully for pain and complications and allowed access to water and food under continuous veterinary supervision adhering to USA-approved protocols. RESULTS:On the second postoperative day, all the animals passed urine freely and had regular bowel motions. No procedure related complications were observed. CONCLUSION:This is the first large animal model which has been designed for suburethral implantation. and which can be effectively used for the preoperative evaluation of novel materials designed for suburethral implantation. We believe that this technique in this large animal model accurately reproduces the surgical technique used to treat stress urinary incontinence in women. It provides a new and effective in vivo model for the objective evaluation of new materials to treat female stress incontinence.
Clean intermittent self-catheterisation (CISC) is a very common and largely well-tolerated intervention for people with neurological and urological voiding dysfunction; however, catheter-associated urinary tract infections (CAUTIs) are a troublesome and potentially major complication. The main risk factors predisposing to CAUTI associated with CISC are poor patient compliance, failure to achieve complete bladder emptying resulting in residual urine, and microtrauma during catheterisation, potentially weakening the bladder’s defences against UTI. An innovative development in the design of CISC catheters is Micro-hole Zone Technology (MHZT) used in the novel Luja™ CISC catheter, which aims to overcome some of the problems associated with conventional CISC catheters. Through a narrative review of the literature undertaken by a multi-disciplinary panel of experts, specialists and patient advocate, who reviewed all major factors contributing to CAUTI and the potential benefits of MHZT catheters over conventional two-eyelet CISC catheters (CECs). MHZT catheters potentially confer the following advantages over CECs in male and female patients: (1) more effective bladder drainage in one continuous flow; (2) reduced risk of blockages by preventing the occlusion of the catheter end-eyelets by bladder mucosa; (3) reduced risk of bladder mucosal microtrauma; and (4) reduced intra-catheter pressure if any flow stop occurs, hence minimising the unpleasant dragging sensation. These benefits are likely to improve the patient’s comfort, quality of life and compliance. However, the panel acknowledged the lack of robust clinical data as to whether MHZT catheters reduced the incidence of CAUTI. Hence, comparative studies between MHZT and CECs are needed before definitive conclusions can be drawn.
Inflammatory and fibrotic responses to polypropylene mesh led to the withdrawal of this practice for treatment of stress urinary incontinence and pelvic organ prolapse in women in some countries. Improved material testing has been urged. We report poor responses of polypropylene mesh to repeated mechanical distension and macrophage interrogation. These results from preclinical in vitro testing show the potential of this approach for testing and improving materials before their introduction into the clinic.
Introduction and Hypothesis In the setting of recurrent female urethral stricture, urethroplasty offer the best chance of cure. However, which approach (dorsal or ventral) and which tissue (buccal mucosa, vaginal graft, vaginal flap) remain areas of controversy. In this article and accompanying video, we describe female urethroplasty with a supraurethral approach using a buccal mucosa graft. Methods A stricture of 3 cm in length was observed in the mid urethra. A supraurethral semi-lunar incision was made and dissection was performed up to the stricture. A dorsal urethrotomy was performed and a 3 × 2 cm oral mucosal graft was harvested from the left cheek. The mucosal graft was anastomosed to both urethral edges with running sutures. The graft was fixed to the supraurethral tissue with quilting sutures. A urethral catheter and a suprapubic catheter were left in place for 3 weeks. Results Following removal of the catheters, the patient was able to void satisfactorily with no incontinence. No complications were observed in the urethral area or at the graft harvest site. Conclusions Buccal mucosa graft urethroplasty with a supraurethral approach is a reliable method in the treatment of female urethral stricture.
BACKGROUND:Assessment of male lower urinary tract symptoms (LUTS) needs to identify predictors of symptom outcomes when interventional treatment is planned. OBJECTIVE:To develop a novel prediction model for prostate surgery outcomes and validate it using a separate patient cohort and derive thresholds for key clinical parameters. DESIGN, SETTING, AND PARTICIPANTS:From the UPSTREAM trial of 820 men seeking treatment for LUTS, analysis of bladder diary (BD), International Prostate Symptom Score (IPSS), IPSS-quality of life, and uroflowmetry data was performed for 176 participants who underwent prostate surgery and provided complete data. For external validation, data from a retrospective database of surgery outcomes in a Japanese urology department (n = 227) were used. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:Symptom improvement was defined as a reduction in total IPSS of ≥3 points. Multiple logistic regression, classification tree analysis, and random forest models were generated, including versions with and without BD data. RESULTS AND LIMITATIONS:Multiple logistic regression without BD data identified age (p = 0.029), total IPSS (p = 0.0016), and maximum flow rate (Qmax; p = 0.066) as predictors of outcomes, with area under the receiver operating characteristic curve (AUC) of 77.1%. Classification tree analysis without BD data gave thresholds of IPSS <16 and Qmax ≥13 ml/s (AUC 75.0%). The random forest model, which included all clinical parameters except BD data, had an AUC of 94.7%. Internal validation using the bootstrap method showed reasonable AUCs (69.6-85.8%). Analyses using BD data marginally improved the model fits. External validation gave comparable AUCs for logistic regression, classification tree analysis, and random forest models (all without BD; 70.9%, 67.3%, and 68.5%, respectively). Limitations include the significant number of men with incomplete baseline data and limited assessments in the external validation cohort. CONCLUSIONS:Outcomes of prostate surgery can be predicted preoperatively using age, total IPSS, and uroflowmetry data, with prognostic thresholds of 16 for IPSS and 13 ml/s for Qmax. PATIENT SUMMARY:This study identified key preoperative factors that can predict outcomes of prostate surgery for bothersome urinary symptoms, including which patients are at risk of a poor outcome.
Childbirth contributes to common pelvic floor problems requiring reconstructive surgery in postmenopausal women. Our aim was to develop a tissue-engineered vaginal wound model to investigate wound healing and the contribution of estradiol to pelvic tissue repair. Partial thickness scalpel wounds were made in tissue models based on decellularized sheep vaginal matrices cultured with primary sheep vaginal epithelial cells and fibroblasts. Models were cultured at an airliquid interface (ALI) for 3 weeks with and without estradiol-17β [E2]. Results showed that E2 significantly increased wound healing and epithelial maturation. Also, E2 led to collagen reorganization after only 14 days with collagen fibers more regularly aligned and compactly arranged Additionally, E2 significantly downregulated α-SMA expression which is involved in fibrotic tissue formation. This model allows one to investigate multiple steps in vaginal wound healing and could be a useful tool in developing therapies for improved tissue healing after reconstructive pelvic floor surgery.
OBJECTIVES:To explore the impact of nocturnal polyuria (NP) on health-related quality of life (HRQoL), work productivity, mental health, fatigue, bother, and daytime sleepiness.MATERIALS AND METHODS:This large-scale, US population-representative epidemiologic study was conducted in two parts: a web-based survey and 3-day bladder diary. Consenting participants completed the baseline Epidemiology of NP (EpiNP) survey online (Lower Urinary Tract Symptoms [LUTS] Tool, comorbidities, burden, and multiple HRQoL measures). Participants who reported ≥2 voids/night, and a random sample of 100 respondents each reporting 0 or 1 void/night, were sent urine measurement containers and asked to complete the 3-day bladder diary. NP was defined as Nocturnal Polyuria Index >0.33 (NPI33) or nocturnal urine production >90 ml/h (NUP90). Five subgroups were created: Idiopathic NP (NP with no underlying cause), NP associated with symptoms of overactive bladder (NPOAB) or bladder outlet obstruction (NPBOO; men only), NP associated with other comorbidities (NPCOM; e.g., diabetes, hypertension, heart disease, sleep apnea), and no NP (did not meet NP criteria).RESULTS:A total of 4893 men and 5297 women completed the EpiNP survey; mean age was 54.4 (SD = 14.7). Significantly greater patient burden (p < 0.0001) was evidenced in the nocturia group (≥2 voids/night) versus no nocturia group (0-1 void/night) on daily impact of nocturia, LUTS Bother, prostate symptoms (men only), work productivity, physical and mental health component scores, depression, fatigue, and daytime sleepiness. NP subgroup analyses showed men in the NPBOO group and women in the NPOAB group reported the greatest impact on LUTS bother, fatigue, physical health, work productivity impairment, daytime sleepiness, and depression (women only).CONCLUSION:This was the first large-scale, epidemiologic study to explore the impact of different forms of NP on patients' HRQoL. Findings demonstrate that NP associated with other urologic or comorbid conditions appears to have greater patient burden than idiopathic NP, in particular for women.