Bacterial Vaccines for the Management of Recurrent Urinary Tract Infections: A Systematic Review and Meta-analysis.

BACKGROUND AND OBJECTIVE: Several bacterial immunisations have been developed to reduce the socioeconomic burden of urinary tract infections (UTIs) and the use of prophylactic antibiotics in the management of recurrent UTIs (rUTIs). This systematic review evaluates the effectiveness of vaccinations in preventing rUTIs. METHODS: Medline, Embase, and Web of Science were searched from inception to December 2023. Data were collected from cohort studies with a comparator arm and randomised controlled trials (RCTs) investigating vaccination efficacy in adult rUTI patients according to predefined selection criteria (PROSPERO registration: CRD42022356662). A pooled analysis took place for RCTs, with a subgroup analysis for vaccine types and booster regimens. Other studies were synthesised narratively. The risk of bias was assessed using Cochrane Risk-of-Bias tools. The Grading of Recommendations, Assessment, Development, and Evaluations framework evaluated the quality of evidence. KEY FINDINGS AND LIMITATIONS: Fourteen comparative studies were selected, including 2822 patients across five vaccination types. The pooled risk ratio of eight placebo-controlled studies of the percentage of patients UTI free in the short term (6-12 mo) was 1.52 (95% confidence interval [CI] 1.05-2.20) with a number needed to treat of 6.45 (95% CI 2.80-64.80). There is substantial heterogeneity and a slight risk of a publication bias. CONCLUSIONS AND CLINICAL IMPLICATIONS: There is limited evidence to suggest that vaccinations are effective at reducing UTI recurrence in adult female patients in the short term. Owing to low quality of evidence, the literature requires further long-term RCTs with large sample sizes utilising standardised definitions for conclusive evidence of the long-term efficacy of vaccination in rUTI prevention. PATIENT SUMMARY: We explored whether vaccines could help stop urinary tract infections (UTIs) from happening again. The latest information shows that these vaccines are safe and may help lower the chances of women getting UTIs again for about 6-12 mo.

Summary Paper on Underactive Bladder from the European Association of Urology Guidelines on Non-neurogenic Male Lower Urinary Tract Symptoms.

BACKGROUND AND OBJECTIVE: The European Association of Urology (EAU) Guidelines Panel on non-neurogenic male lower urinary tract symptoms (LUTS) aimed to develop a new subchapter on underactive bladder (UAB) in non-neurogenic men to inform health care providers of current best evidence and practice. Here, we present a summary of the UAB subchapter that is incorporated into the 2024 version of the EAU guidelines on non-neurogenic male LUTS. METHODS: A systematic literature search was conducted from 2002 to 2022, and articles with the highest certainty evidence were selected. A strength rating has been provided for each recommendation according to the EAU Guideline Office methodology. KEY FINDINGS AND LIMITATIONS: Detrusor underactivity (DU) is a urodynamic diagnosis defined as a contraction of reduced strength and/or duration, resulting in prolonged bladder emptying and/or failure to achieve complete bladder emptying within a normal time span. UAB is a terminology that should be reserved for describing symptoms and clinical features related to DU. Invasive urodynamics is the only widely accepted method for diagnosing DU. In patients with persistently elevated postvoid residual (ie, >300 ml), intermittent catheterization is indicated and preferred to indwelling catheters. Alpha-adrenergic blockers are recommended before more invasive techniques, but the level of evidence is low. In men with DU and concomitant benign prostatic obstruction (BPO), benign prostatic surgery should be considered only after appropriate counseling. In men with DU and no BPO, a test phase of sacral neuromodulation may be considered. CONCLUSIONS AND CLINICAL IMPLICATIONS: The current text represents a summary of the new subchapter on UAB. For more detailed information, refer to the full-text version available on the EAU website (https://uroweb.org/guidelines/management-of-non-neurogenic-male-luts). PATIENT SUMMARY: The European Association of Urology guidelines on underactive bladder in non-neurogenic adult men are presented here. Patients must be fully informed of all relevant options and, together with their treating physicians, decide on the most optimal management for them.

Can we predict and manage persistent storage and voiding LUTS following bladder outflow resistance reduction surgery in men? ICI-RS 2023.

AIMS: Lower urinary tract symptoms (LUTS) persist in up to 50% of patients after bladder outflow resistance reduction surgery (BORRS) in men. Our think tank aims to address the predictive factors for persistent LUTS after BORRS and to propose the recommendations for future research to enable improved better patient counseling and selection by more accurate prediction of treatment outcome. METHODS: A think tank of ICI-RS gathered in 2023, Bristol, UK, to discuss the pre and postsurgical clinical and urodynamic evaluation of men undergoing BORRS and whether it is possible to predict which men will have persistent LUTS after BORRS. RESULTS: Our think tank agrees that due to the multifactorial, and still not fully understood, etiology of male LUTS it is not possible to precisely predict in many men who will have persistent LUTS after BORRS. However, severe storage symptoms (overactive bladder, OAB) in association with low volume and high amplitude detrusor overactivity and low bladder capacity in preoperative urodynamics, increase the likelihood of persistent OAB/storage symptoms after BORRS. Furthermore, patients who are clearly obstructed and have good bladder contractility on preoperative pressure flow studies do better postoperatively compared to their counterparts. However, the benefit of pressure flow studies is decreased in patients who do not acceptably void during the study. Poor voiding after BORRS may occur due to persistent obstruction or detrusor underactivity. CONCLUSION: Future research is needed to increase our understanding of why male LUTS persist after surgery, and to enable better patient selection and more precise patient counseling before BORRS.

What is the best first choice oral drug therapy for OAB?

AIMS: The management of overactive bladder (OAB) involves lifestyle changes and conservative measures in the first instance with the use of liquid/dietary advice, weight loss, and bladder training. Thereafter oral pharmacotherapy is instigated in symptomatic patients. Antimuscarinics and beta 3 agonists form the main classes of drug therapy in this field. Views on what is the best first line OAB treatment is changing based on recent evidence and adverse event profiles of these medications. METHODS: At the ICI-RS meeting 2023, Bristol, UK this topic was discussed and debated as a proposal. The following article summarizes the concepts presented that day as well as the interactive discussion that took place thereafter. RESULTS: OAB guidelines are moving in many circumstances to an either antimuscarinic or beta 3 agonist approach based on patient factors. Several studies have raised concerns on the long-term impact of antimuscarinics, in relation to cognition, dementia, cardiovascular events, and mortality all related to antimuscarinic load. Neither antimuscarinics nor beta 3 agonists have good persistence and adherence rates in the medium to long term. Several barriers also exist to prescribing including guidelines recommending utilizing drugs with the lowest acquisition cost and "step therapy." A newer approach to managing OAB is personalized therapy in view of the many possible etiological factors and phenotypes. These concepts are highlighted in this article. CONCLUSIONS: Current oral pharmacotherapy in managing OAB is limited by adverse events, adherence and persistence problems. Both antimuscarinics and beta 3 agonists are efficacious but most clinical trials demonstrate significant placebo effects in this field. Personalizing treatment to the individual seems a logical approach to OAB. There is a need for better treatments and further studies are required of existing treatments with high quality longer term outcomes.

Can we predict whether a man with acute or chronic urinary retention will void after bladder outflow resistance reduction surgery? ICI-RS 2023.

AIMS: To address the predictive factors of a successful voiding after bladder outflow resistance reduction surgery (BORRS) in men presenting with acute or chronic urinary retention (UR). METHODS: A think tank (TT) of ICI-RS was gathered in 2023, Bristol, UK, to discuss several aspects of the problem, such as the pathophysiology of UR, the clinical and urodynamic evaluation of men with UR and whether it is possible to predict which men will be able to successfully void after treatment with contemporary surgical options. RESULTS: The TT agreed that successful voiding after BORRS depends on several factors but that a strong recommendation cannot be made regarding preoperative evaluation and whether there are predictive factors of success because of the heterogeneity of patients and methodology in published trials. The diagnosis of obstruction in men with UR may be challenging when there is apparent reduced detrusor contraction during urodynamic studies. Even in the absence of bladder contractility there is documentation of such cases that have voided adequately after BORRS. Still, detrusor underactivity and inadequate relief of prostatic obstruction are the main causes of an unsuccessful voiding after BORRS. Conventional resection and enucleation methods remain the most successful surgeries in relieving UR in men, whereas the efficacy of minimally invasive surgical treatments needs to be assessed further. CONCLUSION: Research is needed to understand the pathophysiology of UR and the predictors of successful voiding after different types of BORRS in men with UR.

Predicting Prostate Surgery Outcomes from Standard Clinical Assessments of Lower Urinary Tract Symptoms To Derive Prognostic Symptom and Flowmetry Criteria.

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.

Evaluation of new treatments for benign prostatic obstruction: ICI-RS 2023.

AIMS: To address how invasive therapies for benign prostatic obstruction (BPO) have been evaluated, what their effect is on BPO, if they can prevent progression to BPO and how new therapies need to be evaluated before implementation into clinical practice. METHODS: The think tank conducted a literature review and looked at the previous and current American Urological Association, European Association of Urology and the International Consultation on Urological Diseases guidelines to see what procedures have been used to treat BPO. They then assessed whether trials have been conducted before implementation of the procedures and whether they have been compared to a "gold" standard treatment. The use of urodynamics has also been addressed in the think tank in relation the clinical trials as well as terminology. RESULTS: Guidelines vary in the use of terminology when it comes to BPO with some continuing to use the term benign prostatic hyperplasia (BPH). There are several procedures for example, TUNA, which have become obsolete although continues to be mentioned in the guidelines until recently. Majority of procedures have been introduced without comparing to "gold" standard treatment and without any long-term data. There continues to be many unknowns with regard to the success of some of the BPO procedures and why some of the adverse events develop. CONCLUSION: There needs to be more robust long-term clinical trials conducted of new BPO therapies, with men who have both lower urinary tract symptoms and urinary retention, before introduction into clinical practice.

Practice Variation in the Management of Adult Hydroceles: A Multinational Survey.

Background: Although hydrocele is one of the most common urologic pathologies, it is seldom studied, and the major urologic associations have no guidelines for the management of adult hydroceles. Objective: To characterize international practice variation in the treatment of adult hydroceles. Design setting and participants: An international survey was conducted addressing the management of hydroceles among urologists in Belgium, Denmark, Finland, Iceland, Japan, and the Netherlands from September to December 2020. We invited a random sample of 170 urologists from each country (except Iceland). Outcome measurements and statistical analysis: Urologists' treatment options, factors relevant for decision-making, expected patient satisfaction, and outcomes after aspiration versus surgery were assessed. Results and limitations: Of the 864 urologists contacted, 437 (51%) participated. Of the respondents, 202 (53%) performed both hydrocelectomies and aspiration, 147 (39%) performed hydrocelectomies only, and 30 (8%) performed aspiration only. In Belgium (83%), the Netherlands (75%), and Denmark (55%), urologists primarily performed hydrocelectomies only, whereas in Finland (84%), Japan (61%), and Iceland (91%), urologists performed both hydrocelectomies and aspiration. Urologists favored hydrocelectomy for large hydroceles (78.8% vs 37.5% for small), younger patients (66.0% for patients <50 yr vs 41.2% for ≥70 yr), patients with few or no comorbidities (62.3% vs 23.1% with multiple comorbidities), and patients without antithrombotic agents (53.5% vs 36.5% with antithrombotic agents). Most urologists considered patient satisfaction to be highest after hydrocelectomy (53.8% vs 9.9% after aspiration) despite believing that hydrocelectomy is more likely to cause complications (hematoma 77.8% vs 8.8% after aspiration). Estimates varied between countries. Conclusions: We found a large variation in the treatment of adult hydroceles within and between countries. Optimization of hydrocele management globally will require future studies. Patient summary: Our international survey shows that treatment of adult hydrocele varies considerably within and between countries.

Can we define the optimal postvoid residual volume at which intermittent catheterization should be recommended, and are there other measures that could guide an intermittent catheterization protocol: ICI-RS 2023.

AIMS: The postvoid residual (PVR) volume of urine in the bladder is widely used in clinical practice as a guide to initiate treatment, including clean-intermittent self-catheterization (CISC). It is often believed that an elevated PVR causes complications such as recurrent urinary tract infections (UTI) and renal failure. However, evidence for this is limited and identifying alternative measures to guide treatment decisions may optimize patient care. At the International Consultation on Incontinence Research Society (ICI-RS) meeting in 2023 a Think Tank addressed the question of whether we can define the optimal PVR at which CISC should be recommended, and whether there are other measures that could guide a CISC protocol. METHODS: The Think Tank conducted a literature review and expert consensus meeting focusing on current limitations in defining and measuring PVR, and highlighting other measures that may optimize selection for, and persistence with, CISC. RESULTS: There is no consensus on the threshold value of PVR that is considered "elevated" or "significant." There is a lack of standardization on terminology, and the normal range of PVR in different populations of different ages remains to be well-studied. The measurement of PVR is influenced by several factors, including intraindividual variation, timing and method of measurement. Furthermore, the evidence linking an elevated PVR with complications such as UTI and renal failure is mixed. Other measures, such as bladder voiding efficiency or urodynamic parameters, may be better at predicting such complications, and therefore may be more relevant at guiding a CISC protocol. CONCLUSIONS: There is a lack of high quality evidence to support PVR as a predictor for complications of UTI or renal failure. Threshold values for normal PVR in different populations are unknow, and so threshold values for "elevated" or "significant" PVR cannot be determined. Other factors, such as urodynamic findings, may be better at predicting complications and therefore guiding management decisions, and this remains to be studied. Areas for further research are proposed.

How Can We Understand Patients' Values, Preferences, and Expectations in Urology?

Understanding patients' values and preferences is essential for patient-centred care. Qualitative research provides a broader understanding from a patient perspective at different time points across the patient's life. Quantitative methods quantify specific preferences and answer specific questions that have been informed by qualitative work.

Medical Treatment Incidence and Persistence After Surgical Relief of Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Obstruction: A Critical Analysis of the Literature.

CONTEXT: The incidence and risk factors for persisting pharmacotherapy following surgical treatment of benign prostatic obstruction (BPO) remain unclear. OBJECTIVE: To evaluate the evidence on persisting pharmacotherapy of lower urinary tract symptoms (LUTS) following surgical treatment of BPO. EVIDENCE ACQUISITION: A systematic review of the literature was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses checklist (PROSPERO ID CRD42022310598). PubMed and EMBASE databases were searched in February 2022, with an updated search in October 2022. Studies evaluating pharmacotherapy in men aged >18 yr following surgical treatment of BPO were included. EVIDENCE SYNTHESIS: Overall, ten nonrandomized studies and one post hoc analysis of two randomized controlled trials were included. The incidence of persisting medical treatment or medical retreatment varied strongly between time points and investigated surgical techniques. Among the investigated techniques, most data were available for transurethral resection of the prostate (TURP). Persistence of pharmacotherapy after TURP at 6 mo ranged from 8.7% to 57% for the use of alpha-blockers. The use of 5-alpha reductase inhibitors after TURP ranged from 5.5% at 6 mo to 19% at 6-24 mo, whereas the use of antimuscarinics ranged from 3.4% to 28.1% at 6 mo. Data on initiation of pharmacotherapy after TURP also differed between study and type of medication. At 12 yr, the use of alpha-blockers after TURP ranged from 12% to 38%. The risk factors associated with medication after BPO surgery were age, history of diabetes mellitus, history of cerebrovascular accident, preoperative medication use, as well as surgical techniques other than laser enucleation of the prostate. CONCLUSIONS: Pharmacotherapy for LUTS is common after BPO surgery. The outcomes following different surgical techniques are heterogeneous, with limited data from randomized controlled trials. Future studies on surgical treatment of BPO should include the use of LUTS-related pharmacotherapy after BPO surgery as a secondary endpoint. PATIENT SUMMARY: In the present systematic review, we investigated the risk of ongoing or novel therapy with drugs following surgery for benign prostate enlargement. We found that a non-negligible proportion of men will need to take drug therapy after surgery. Certain risk factors can be identified, which are associated with a higher risk of drug therapy after surgery.

Competitive Inoculation as an Effective Prophylaxis Against Recurrent Urinary Tract Infections: A Systematic Review.

Urinary tract infection (UTI) is a common condition defined as the presence of bacteria within the urine above a certain threshold (usually >100,000 m/L). The lifetime risk in women is estimated to be 50%, of whom 25% will develop recurrence within 6 months. Unfortunately, the use of antibiotics to treat and manage recurrent UTI (rUTI) is a growing problem, due to the burden of growing antibiotic resistance on public health. As such, new approaches to manage rUTI are being investigated and developed. Competitive inoculation via instillation of Escherichia coli 83972 or HU2117 in the bladder is a new prophylactic non-antimicrobial therapy for rUTIs. It utilizes the principle of the protective nature of asymptomatic bacteriuria to prevent recurrence of symptomatic UTIs. However, the effectiveness and safety of this technique remains unclear. This systematic review examined the current outcomes data on competitive inoculation as an effective and safe treatment for rUTI prophylaxis. Based on a limited number of studies, current evidence suggests that competitive inoculation is an effective and safe prophylactic measure against UTIs in a select group of patients with incomplete bladder emptying. However, administration of the technology is both resource and time intensive, and there is strong data demonstrating low successful colonisation rates. Competitive inoculation is an alternative to antibiotics only to rUTI patients with incomplete bladder emptying. There is no evidence to suggest that the technology would be suitable for other subsets of rUTI patients. Further randomized controlled trials should be conducted to improve the evidence base before drawing conclusions for clinical practice, and ideas to improve colonisation rates and simplify the administration process should be explored.

The translational implications of the science behind the overactive bladder and the role of OnabotulinumtoxinA.

Urinary incontinence (UI) is a very common condition that can affect patients of all ages and the commonest cause is an overactive bladder (OAB). Most patients with OAB were treated with pharmacotherapy and major surgery. Over 25 years ago, Dasgupta, Fowler et al. studied the presence and role of C fibres in the human bladder which are highly sensitive to capsaicin, the active ingredient of chillies. When capsaicin was instilled into patients' bladders as a synthetic solution, it was found to be highly effective in some patients. Capsaicin was later replaced by Resiniferatoxin. Both toxins desensitised C-fibres through the capsaicin receptor, TRPV1, without any lasting damage to the bladder itself. The discovery of botulinum toxin and its use in the treatment of OAB represents a major breakthrough, in the treatment of OAB. Another key innovation was the development of technique to administer the drug under local anaesthesia which allowed numerous patients to benefit from treatment who would otherwise have been precluded because of the need for injection under general anaesthetic. After extensive trials over many years Botox (OnabotulinumtoxinA) is now licensed for use in OAB. Compared to other treatments for overactive bladder, OnabotulinumtoxinA is more cost-effective and less invasive. It is thought to have changed the quality of life of an estimated 5 million patients worldwide.

Summary Paper on the 2023 European Association of Urology Guidelines on the Management of Non-neurogenic Male Lower Urinary Tract Symptoms.

CONTEXT: Lower urinary tract symptoms (LUTS) are common, often bothersome, and have multifactorial aetiology. OBJECTIVE: To present a summary of the 2023 version of the European Association of Urology guidelines on the management of male LUTS. EVIDENCE ACQUISITION: A structured literature search from 1966 to 2021 selected the articles with the highest certainty evidence. The Delphi technique consensus approach was used to develop the recommendations. EVIDENCE SYNTHESIS: The assessment of men with LUTS should be practical. A careful medical history and physical examination are essential. Validated symptom scores, urine test, uroflowmetry, and postvoid urine residual, as well as frequency-volume charts for patients with nocturia or predominately storage symptoms should be used. Prostate-specific antigen should be ordered if a diagnosis of prostate cancer changes the treatment plan. Urodynamics should be performed for selected patients. Men with mild symptoms are candidates for watchful waiting. Behavioural modification should be offered to men with LUTS prior to, or concurrent with, treatment. The choice of medical treatment depends on the assessment findings, predominant type of symptoms, ability of the treatment to change the findings, and the expectations to be met in terms of the speed of onset, efficacy, side effects, and disease progression. Surgery is reserved for men with absolute indications, and for patients who fail or prefer not to receive medical therapy. Surgical management has been divided into five sections: resection, enucleation, vaporisation, and alternative ablative and nonablative techniques. The choice of surgical technique depends on patient's characteristics, expectations, and preferences; surgeon's expertise; and availability of modalities. CONCLUSIONS: The guidelines provide an evidence-based approach for the management of male LUTS. PATIENT SUMMARY: A clinical assessment should identify the cause(s) of symptoms and define the clinical profile and patient's expectations. The treatment should aim to ameliorate symptoms and reduce the risk of complications.

Oncological and functional outcomes of organ-preserving cystectomy versus standard radical cystectomy: A systematic review and meta-analysis.

Introduction: Radical cystectomy (RC) is historically considered the gold standard treatment for muscle invasive and high-risk non-muscle invasive bladder cancer. However, this technique leaves the majority of patients of both sexes with poor sexual and urinary function. Organ-sparing cystectomy (OSC) techniques are emerging as an alternative to the standard procedure to preserve these functions, without compromising the oncological outcomes. We present a systematic review and meta-analysis of the published literature. Methods: MEDLINE, Embase and Web of Science were systematically searched for eligible studies on 6 April 2021. Primary outcomes studied were both oncological outcomes, specifically overall recurrence, and functional outcomes, specifically sexual function, and daytime and nighttime continence. Odds ratios (OR) with 95% confidence intervals (95% CI) were calculated. The PROSPERO registration reference number was CRD42018118897. Results: From 13 894 identified abstracts, 19 studies (1886 male and 305 female patients) were eligible for inclusion in this review. These studies included patients who underwent either whole prostate, prostate capsule, seminal vesicle, nerve, uterus, ovary, vagina and fallopian tube sparing techniques. Four studies included only female patients.Thirteen studies reported oncological outcomes, and overall recurrence rate was similar between the two groups (five studies; OR 0.73; 95% CI 0.38-1.40, p = 0.34). Thirteen studies reported on male sexual function. In men, OSC had significantly greater odds of retaining potency (five studies; OR 9.05; 95% CI 5.07-16.16, p < 0.00001). Fourteen studies (13 on males and 1 female) reported urinary outcomes. In men, OSC demonstrated greater odds of daytime (seven studies; OR 2.61; 95% CI 1.74 to 3.92, p < 0.00001) and nighttime continence (seven studies; OR 2.62; 95% CI 1.76 to 3.89, p < 0.00001). Conclusion: In carefully selected patients, OSC allows the potential to provide better sexual and urinary function without compromising oncological outcomes. There remains, however, a paucity of OSC studies in females. Further studies are required to make recommendations based on robust clinical evidence.

A cohort profile of the Graham Roberts study cohort.

Purpose: The Graham Roberts Study was initiated in 2018 and is the first Trials Within Cohorts (TwiCs) study for bladder cancer. Its purpose is to provide an infrastructure for answering a breadth of research questions, including clinical, mechanistic, and supportive care centred questions for bladder cancer patients. Participants: All consented patients are those aged 18 or older, able to provide signed informedconsent and have a diagnosis of new or recurrent bladder cancer. All patients are required to have completed a series of baseline questionnaires. The questionnaires are then sent out every 12 months and include information on demographics and medical history as well as questionnaires to collect information on quality of life, fatigue, depression, overall health, physical activity, and dietary habits. Clinical information such as tumor stage, grade and treatment has also been extracted for each patient. Findings to date: To date, a total of 125 bladder cancer patients have been consented onto the study with 106 filling in the baseline questionnaire. The cohort is made up of 75% newly diagnosed bladder cancer patients and 66% non-muscle invasive bladder cancer cases. At present, there is 1-year follow-up information for 70 patients, 2-year follow-up for 57 patients, 3-year follow-up for 47 patients and 4-year follow-up for 19 patients. Future plans: We plan to continue recruiting further patients into the cohort study. Using the data collected within the study, we hope to carry out independent research studies with a focus on quality of life. We are also committed to utilizing the Roberts Study Cohort to set up and commence an intervention. The future studies and trials carried out using the Roberts Cohort have the potential to identify and develop interventions that could improve the prevention, diagnosis, and treatment of bladder cancer.

Active involvement of nursing staff in reporting and grading complication-intervention events-Protocol and results of the CAMUS Pilot Nurse Delphi Study.

Objectives: The aim of this study is to gain experienced nursing perspective on current and future complication reporting and grading in Urology, establish the CAMUS CCI and quality control the use of the Clavien-Dindo Classification (CDC) in nursing staff. Subjects and Methods: The 12-part REDCap-based Delphi survey was developed in conjunction with expert nurse, urologist and methodologist input. Certified local and international inpatient and outpatient nurses specialised in urology, perioperative nurses and urology-specific advanced practice nurses/nurse practitioners will be included. A minimum sample size of 250 participants is targeted. The survey assesses participant demographics, nursing experience and opinion on complication reporting and the proposed CAMUS reporting recommendations; grading of intervention events using the existing CDC and the proposed CAMUS Classification; and rating various clinical scenarios. Consensus will be defined as ≥75% agreement. If consensus is not reached, subsequent Delphi rounds will be performed under Steering Committee guidance. Results: Twenty participants completed the pilot survey. Median survey completion time was 58 min (IQR 40-67). The survey revealed that 85% of nursing participants believe nurses should be involved in future complication reporting and grading but currently have poor confidence and inadequate relevant background education. Overall, 100% of participants recognise the universal demand for reporting consensus and 75% hold a preference towards the CAMUS System. Limitations include variability in nursing experience, complexity of supplemental grades and survey duration. Conclusion: The integration of experienced nursing opinion and participation in complication reporting and grading systems in a modern and evolving hospital infrastructure may facilitate the assimilation of otherwise overlooked safety data. Incorporation of focused teaching into routine nursing education will be essential to ensure quality control and stimulate awareness of complication-related burden. This, in turn, has the potential to improve patient counselling and quality of care.