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.

Personalised versus non-individualised case-based CME: A randomised pilot study.

The PinPoint Case Platform (PPCP) offers independent online case-based CME. To align with personal learning needs, a functionality of needs assessments ("QuickScan") was developed, directing users to follow personalised case journeys. A randomised study was conducted, comparing its effectiveness, time efficiency and user experience with a format of non-individualised case-based learning. Forty-two residents in urology from five European countries were randomly assigned to follow non-individualised case-based learning (control group) or a needs assessment plus personalised case journeys on different topics in prostate cancer. After performing a pre- and post-assessment, both groups showed a similar increase in test scores (Mann-Whitney U = 247; p = .113), but the time needed for completing the learning exercise was significantly lower in the group with the personalised approach (median: 45 vs 90 minutes; Mann-Whitney U = 97.5; p = .0141). The quality of the two learning methods was similarly well received by both groups. In conclusion, learners who followed personalised case journeys learned similarly effective but more time efficient than non-individualised case-based learners. Future studies should determine if these findings can be extrapolated to board-certified physicians following CME activities.

European Association of Urology Guidelines on Male Urinary Incontinence.

CONTEXT: Urinary incontinence (UI) is a common condition in elderly men causing a severe worsening of quality of life, and a significant cost for both patients and health systems. OBJECTIVE: To report a practical, evidence-based, guideline on definitions, pathophysiology, diagnostic workup, and treatment options for men with different forms of UI. EVIDENCE ACQUISITION: A comprehensive literature search, limited to studies representing high levels of evidence and published in the English language, was performed. Databases searched included Medline, EMBASE, and the Cochrane Libraries. A level of evidence and a grade of recommendation were assigned. EVIDENCE SYNTHESIS: UI can be classified into stress urinary incontinence (SUI), urge urinary incontinence (UUI), and mixed urinary incontinence. A detailed description of the pathophysiology and diagnostic workup has been reported. Simple clinical interventions, behavioural and physical modifications, and pharmacological treatments comprise the initial management for all kinds of UI. Surgery for SUI includes bulking agents, male sling, and compression devices. Surgery for UUI includes bladder wall injection of botulinum toxin A, sacral nerve stimulation, and cystoplasty/urinary diversion. CONCLUSIONS: This 2022 European Association of Urology guideline summary provides updated information on definition, pathophysiology, diagnosis, and treatment of male UI. PATIENT SUMMARY: Male urinary incontinence comprises a broad subject area, much of which has been covered for the first time in the literature in a single manuscript. The European Association of Urology Non-neurogenic Male Lower Urinary Tract Symptoms Guideline Panel has released this new guidance, with the aim to provide updated information for urologists to be able to follow diagnostic and therapeutic indications for optimising patient care.

Reasons to consider prostatic artery embolization.

PURPOSE: Prostatic artery embolization (PAE) has emerged as a truly minimally invasive treatment option for patients with lower urinary tract symptoms presumed secondary to benign prostatic obstruction (LUTS/BPO) over the last few years and is now supported by evidence-based international guidelines. Here, we provide an overview on the profile of PAE based on the most relevant and recent literature. METHODS: A comprehensive review of literature on PAE was conducted on PubMed-Medline. The most relevant literature was summarized narratively. RESULTS: While there is still a lack of long-term data, efficacy and safety data have been published for the short to mid-term. As with any minimally invasive technique, relief of bladder outlet obstruction is less pronounced after PAE compared to more invasive resective techniques. This is likely to be associated with higher re-intervention rates during the longer term. However, due to its beneficial safety profile, PAE represents an interesting option for many patients and could fill a niche between pharmacotherapy and formal surgical intervention. Given its unique treatment approach, i.e. endovascular instead of transurethral, PAE has a clearly different profile compared to other minimally invasive treatments. Performance with local anesthesia with possible continuation of anticoagulant drugs and no upper prostate size limit are the most important advantages of PAE. CONCLUSION: PAE represents a valuable supplement in the treatment armamentarium of LUTS/BPH if patients are selected appropriately.

A Systematic Review of Patients' Values, Preferences, and Expectations for the Diagnosis and Treatment of Male Lower Urinary Tract Symptoms.

CONTEXT: Understanding men's values and preferences in the context of personal, physical, emotional, relational, and social factors is important in optimising patient counselling, facilitating treatment decision-making, and improving guideline recommendations. OBJECTIVE: To systematically review the available evidence regarding the values, preferences, and expectations of men towards the investigation and treatment (conservative, pharmacological, and surgical) of male lower urinary tract symptoms (LUTS). EVIDENCE ACQUISITION: We searched electronic databases until August 31, 2020 for quantitative and qualitative studies that reported values and preferences regarding the investigation and treatment of LUTS in men. We assessed the quality of evidence and risk of bias using the Grading of Recommendation, Assessment, Development and Evaluation (GRADE) and GRADE Confidence in the Evidence from Reviews of Qualitative Research (CERQual) approaches. EVIDENCE SYNTHESIS: We included 25 quantitative studies, three qualitative studies, and one mixed-methods study recruiting 9235 patients. Most men reported urodynamic testing to be acceptable, despite discomfort or embarrassment, as it significantly informs treatment decisions (low certainty evidence). Men preferred conservative and less risky treatment options, but the preference varied depending on baseline symptom severity and the risk/benefit characteristics of the treatment (moderate certainty). Men preferred pharmacological treatments with a low risk of erectile dysfunction and those especially improving urgency incontinence (moderate certainty). Other important preference considerations included reducing the risk of acute urinary retention or surgery (moderate certainty). CONCLUSIONS: Men prefer lower-risk management options that have fewer sexual side effects and are primarily effective at improving urgency incontinence and nocturia. Overall, the evidence was rated to be of low to moderate certainty. This review can facilitate the treatment decision-making process and improve the trustworthiness of guideline recommendations. PATIENT SUMMARY: We thoroughly reviewed the evidence addressing men's values and preferences regarding the management of urinary symptoms and found that minimising adverse effects is particularly important. Further research to understand other factors that matter to men is required.

What Is the Required Certainty of Evidence for the Implementation of Novel Techniques for the Treatment of Benign Prostatic Obstruction?

CONTEXT: A large number of minimally invasive techniques have been developed for the surgical management of male lower urinary tract symptoms (LUTS) presumed to be secondary to benign prostatic obstruction (BPO) over the last 3 decades. Many have not stood the test of time often because they were overpromoted before there were sufficient data. OBJECTIVE: The scope of this paper is to consider whether new devices, for the treatment of male LUTS/BPO, have been implemented prematurely in the past. We also examine the relative certainty of evidence (CoE) that is currently available for newer developing technologies and make recommendations about the CoE that should be demanded in the future before widespread implementation. KEY MESSAGES: This evidence must provide adequate length of follow-up to allow proper information to be provided for patients before treatment choices are made and to be able to create recommendations in high-quality guidelines such as those of the European Association of Urology. It is not just within the domain of LUTS treatments that this is important, other urological devices, such as mesh devices, have been equally "guilty" and likewise devices in most other (surgical) specialities. We believe that there is a need for a set of requirements built around primary randomised controlled trials (RCTs) looking at both efficacy and safety, and secondary studies to confirm the reproducibility and generalisability of the first pivotal studies. Otherwise, there is a danger that a single pivotal study can be overexploited by device manufacturers. Studies that are needed include (1) proof of concept, (2) RCTs on efficacy and safety, as well as (3) cohort studies with a broad range of inclusion and exclusion criteria to confirm both reproducibility and generalisability of the benefits and harms. It is not the purpose of this paper to make judgements about individual treatments but simply to look at different treatments to provide verification for this debate. PATIENT SUMMARY: Many new treatment devices have been developed over the last 20-30 yr, often with inadequate medium- to long-term results. Many have not stood the test of time, but were heavily promoted by manufacturers, the press, and some doctors when they were first released, meaning that many patients had unsatisfactory results. This paper proposes minimum standards for the investigation of new treatments before their widespread promotion to patients.

Management of Urinary Retention in Patients with Benign Prostatic Obstruction: A Systematic Review and Meta-analysis.

CONTEXT: Practice patterns for the management of urinary retention (UR) secondary to benign prostatic obstruction (BPO; UR/BPO) vary widely and remain unstandardized. OBJECTIVE: To review the evidence for managing patients with UR/BPO with pharmacological and nonpharmacological treatments included in the European Association of Urology guidelines on non-neurogenic male lower urinary tract symptoms. EVIDENCE ACQUISITION: Search was conducted up to April 22, 2018, using CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, and World Health Organization International Clinical Trials Registry Platform. This systematic review included randomized controlled trials (RCTs) and prospective comparative studies. Methods as detailed in the Cochrane handbook were followed. Certainty of evidence (CoE) was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. EVIDENCE SYNTHESIS: Literature search identified 2074 citations. Twenty-one studies were included (qualitative synthesis). The evidence for managing patients with UR/BPO with pharmacological or nonpharmacological treatments is limited. CoE for most outcomes was low/very low. Only α1-blockers (alfuzosin and tamsulosin) have been evaluated in more than one RCT. Pooled results indicated that α1-blockers provided significantly higher rates of successful trial without catheter compared with placebo [alfuzosin: 322/540 (60%) vs 156/400 (39%) (odds ratio {OR} 2.28, 95% confidence interval {CI} 1.55 to 3.36; participants=940; studies=7; I2=41%; low CoE); tamsulosin: 75/158 (47%) vs 40/139 (29%) (OR 2.40, 95% CI 1.29 to 4.45; participants=297; studies=3; I2=30%; low CoE)] with rare adverse events. Similar rates were achieved with tamsulosin or alfuzosin [51/87 (59%) vs 45/84 (54%) (OR 1.28, 95% CI 0.68 to 2.41; participants=171; studies=2; I2=0%; very low CoE)]. Nonpharmacological treatments have been evaluated in RCTs/prospective comparative studies only sporadically. CONCLUSIONS: There is some evidence that usage of α1-blockers (alfuzosin and tamsulosin) may improve resolution of UR/BPO. As most nonpharmacological treatments have not been evaluated in patients with UR/BPO, the evidence is inconclusive about their benefits and harms. PATIENT SUMMARY: There is some evidence that alfuzosin and tamsulosin may increase the rates of successful trial without catheter, but little or no evidence on various nonpharmacological treatment options for managing patients with urinary retention secondary to benign prostatic obstruction.

Efficacy and safety of prostate artery embolization for benign prostatic hyperplasia: an observational study and propensity-matched comparison with transurethral resection of the prostate (the UK-ROPE study).

OBJECTIVES: To assess the efficacy and safety of prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) and to conduct an indirect comparison of PAE with transurethral resection of the prostate (TURP). PATIENTS AND METHODS: As a joint initiative between the British Society of Interventional Radiologists, the British Association of Urological Surgeons and the National Institute for Health and Care Excellence, we conducted the UK Register of Prostate Embolization (UK-ROPE) study, which recruited 305 patients across 17 UK urological/interventional radiology centres, 216 of whom underwent PAE and 89 of whom underwent TURP. The primary outcomes were International Prostate Symptom Score (IPSS) improvement in the PAE group at 12 months post-procedure, and complication data post-PAE. We also aimed to compare IPSS score improvements between the PAE and TURP groups, using non-inferiority analysis on propensity-score-matched patient pairs. The clinical results and urological measurements were performed at clinical sites. IPSS and other questionnaire-based results were mailed by patients directly to the trial unit managing the study. All data were uploaded centrally to the UK-ROPE study database. RESULTS: The results showed that PAE was clinically effective, producing a median 10-point IPSS improvement from baseline at 12 months post-procedure. PAE did not appear to be as effective as TURP, which produced a median 15-point IPSS score improvement at 12 months post-procedure. These findings are further supported by the propensity score analysis, in which we formed 65 closely matched pairs of patients who underwent PAE and patients who underwent TURP. In terms of IPSS and quality-of-life (QoL) improvement, there was no evidence of PAE being non-inferior to TURP. Patients in the PAE group had a statistically significant improvement in maximum urinary flow rate and prostate volume reduction at 12 months post-procedure. PAE had a reoperation rate of 5% before 12 months and 15% after 12 months (20% total rate), and a low complication rate. Of 216 patients, one had sepsis, one required a blood transfusion, four had local arterial dissection and four had a groin haematoma. Two patients had non-target embolization that presented as self-limiting penile ulcers. Additional patient-reported outcomes, pain levels and return to normal activities were very encouraging for PAE. Seventy-one percent of PAE cases were performed as outpatient or day cases. In contrast, 80% of TURP cases required at least 1 night of hospital stay, and the majority required 2 nights. CONCLUSION: Our results indicate that PAE provides a clinically and statistically significant improvement in symptoms and QoL, although some of these improvements were greater in the TURP arm. The safety profile and quicker return to normal activities may be seen as highly beneficial by patients considering PAE as an alternative treatment to TURP, with the concomitant advantages of reduced length of hospital stay and need for admission after PAE. PAE is an advanced embolization technique demanding a high level of expertise, and should be performed by experienced interventional radiologists who have been trained and proctored appropriately. The use of cone-beam computed tomography is encouraged to improve operator confidence and minimize non-target embolizations. The place of PAE in the care pathway is between that of drugs and surgery, allowing the clinician to tailor treatment to individual patients' symptoms, requirements and anatomical variation.

Prostatic urethral lift vs transurethral resection of the prostate: 2-year results of the BPH6 prospective, multicentre, randomized study.

OBJECTIVES: To compare prostatic urethral lift (PUL) with transurethral resection of the prostate (TURP) with regard to symptoms, recovery experience, sexual function, continence, safety, quality of life, sleep and overall patient perception. PATIENTS AND METHODS: A total of 80 patients with lower urinary tract symptoms attributable to benign prostatic hyperplasia (BPH) were enrolled in a prospective, randomized, controlled, non-blinded study conducted at 10 European centres. The BPH6 responder endpoint assessed symptom relief, quality of recovery, erectile function preservation, ejaculatory function preservation, continence preservation and safety. Additional evaluations of patient perspective, quality of life and sleep were prospectively collected, analysed and presented for the first time. RESULTS: Significant improvements in International Prostate Symptom Score (IPSS), IPSS quality of life (QoL), BPH Impact Index (BPHII), and maximum urinary flow rate (Qmax ) were observed in both arms throughout the 2-year follow up. Change in IPSS and Qmax in the TURP arm were superior to the PUL arm. Improvements in IPSS QoL and BPHII score were not statistically different between the study arms. PUL resulted in superior quality of recovery, ejaculatory function preservation and performance on the composite BPH6 index. Ejaculatory function bother scores did not change significantly in either treatment arm. TURP significantly compromised continence function at 2 weeks and 3 months. Only PUL resulted in statistically significant improvement in sleep. CONCLUSION: PUL was compared to TURP in a randomised, controlled study which further characterized both modalities so that care providers and patients can better understand the net benefit when selecting a treatment option.

Establishing nurse-led active surveillance for men with localised prostate cancer: development and formative evaluation of a model of care in the ProtecT trial.

OBJECTIVES: To develop a nurse-led, urologist-supported model of care for men managed by active surveillance or active monitoring (AS/AM) for localised prostate cancer and provide a formative evaluation of its acceptability to patients, clinicians and nurses. Nurse-led care, comprising an explicit nurse-led protocol with support from urologists, was developed as part of the AM arm of the Prostate testing for cancer and Treatment (ProtecT) trial. DESIGN: Interviews and questionnaire surveys of clinicians, nurses and patients assessed acceptability. SETTING: Nurse-led clinics were established in 9 centres in the ProtecT trial and compared with 3 non-ProtecT urology centres elsewhere in UK. PARTICIPANTS: Within ProtecT, 22 men receiving AM nurse-led care were interviewed about experiences of care; 11 urologists and 23 research nurses delivering ProtecT trial care completed a questionnaire about its acceptability; 20 men managed in urology clinics elsewhere in the UK were interviewed about models of AS/AM care; 12 urologists and three specialist nurses working in these clinics were also interviewed about management of AS/AM. RESULTS: Nurse-led care was commended by ProtecT trial participants, who valued the flexibility, accessibility and continuity of the service and felt confident about the quality of care. ProtecT consultant urologists and nurses also rated it highly, identifying continuity of care and resource savings as key attributes. Clinicians and patients outside the ProtecT trial believed that nurse-led care could relieve pressure on urology clinics without compromising patient care. CONCLUSIONS: The ProtecT AM nurse-led model of care was acceptable to men with localised prostate cancer and clinical specialists in urology. The protocol is available for implementation; we aim to evaluate its impact on routine clinical practice. TRIAL REGISTRATION NUMBERS: NCT02044172; ISRCTN20141297.

Acute Urinary Retention Rates in the General Male Population and in Adult Men With Lower Urinary Tract Symptoms Participating in Pharmacotherapy Trials: A Literature Review.

Despite proven efficacy, antimuscarinics are not frequently used for treating lower urinary tract symptoms in adult men, due to the perception of an increased risk of acute urinary retention (AUR). Men treated with α-blockers, 5α-reductase inhibitors, or their combinations have lower AUR incidence rates than the general symptomatic population. In the selected study population in this review (men with post-void residuals ≤200 mL), the risk of AUR with antimuscarinics with and/or without α-blockers may be increased during short-term treatment, but if patients do not develop AUR in the first 3 months, their subsequent risk is lower than in the untreated, symptomatic population.

Prospective, randomized, multinational study of prostatic urethral lift versus transurethral resection of the prostate: 12-month results from the BPH6 study.

BACKGROUND: Transurethral resection of the prostate (TURP) is considered the gold standard for male lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). However, TURP may lead to sexual dysfunction and incontinence, and has a long recovery period. Prostatic urethral lift (PUL) is a treatment option that may overcome these limitations. OBJECTIVE: To compare PUL to TURP with regard to LUTS improvement, recovery, worsening of erectile and ejaculatory function, continence and safety (BPH6). DESIGN, SETTING, AND PARTICIPANTS: Prospective, randomized, controlled trial at 10 European centers involving 80 men with BPH LUTS. INTERVENTION: PUL or TURP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The BPH6 responder endpoint assesses symptom relief, quality of recovery, erectile function preservation, ejaculatory function preservation, continence preservation, and safety. Noninferiority was evaluated using a one-sided lower 95% confidence limit for the difference between PUL and TURP performance. RESULTS AND LIMITATIONS: Preservation of ejaculation and quality of recovery were superior with PUL (p<0.01). Significant symptom relief was achieved in both treatment arms. The study demonstrated not only noninferiority but also superiority of PUL over TURP on the BPH6 endpoint. Study limitations were the small sample size and the inability to blind participants to enrollment arm. CONCLUSIONS: Assessment of individual BPH6 elements revealed that PUL was superior to TURP with respect to quality of recovery and preservation of ejaculatory function. PUL was superior to TURP according to the novel BPH6 responder endpoint, which needs to be validated in future studies. PATIENT SUMMARY: In this study, participants who underwent prostatic urethral lift responded significantly better than those who underwent transurethral resection of the prostate as therapy for benign prostatic hyperplasia with regard to important aspects of quality of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT01533038.

Management of the complications of BPH/BOO.

Most men will develop histological BPH if they live long enough. Approximately, half will develop benign prostatic enlargement (BPE) and about half of these will get BOO with high bladder pressures and low flow, this in turn leads to detrusor wall hypertrophy. Many of these men will only have lower urinary tract symptoms (LUTS) but a significant number will also suffer the other complications of BPH. These include urinary retention (acute and chronic), haematuria, urinary tract infection, bladder stones, bladder wall damage, renal dysfunction, incontinence and erectile dysfunction. Recognition of the complications of BPH/BOO early allows more effective management of these complications. This is particularly important for the more serious urinary infections and also for high-pressure chronic retention (HPCR). Complications of LUTS/BPH are very rare in clinical trials because of their strict inclusion and exclusion criteria but are more common in real life practice.

Meta-analysis of functional outcomes and complications following transurethral procedures for lower urinary tract symptoms resulting from benign prostatic enlargement.

CONTEXT: There is a continuous decline in the number of transurethral resections of the prostate (TURP) and an increase use of minimally invasive surgical therapy (MIST) for lower urinary tract symptoms resulting from benign prostatic enlargement. Current results from randomised controlled trials (RCT) and methodologically sound prospective studies suggest that some of the proposed procedures have the potential to replace TURP. OBJECTIVE: To determine the contemporary status of TURP and of the currently most commonly applied transurethral MISTs: (1) bipolar TURP, (2) bipolar transurethral vaporisation of the prostate (bipolar TUVP), (3) holmium laser enucleation of the prostate (HoLEP), and (4) potassium-titanyl-phosphate (KTP) laser vaporisation of the prostate. EVIDENCE ACQUISITION: This meta-analysis was based on a systematic Medline search assessing the period 1997-2009. All RCTs comparing TURP and the most commonly discussed ablative treatments were included. The end points of our analyses were functional outcomes and treatment-related adverse events. EVIDENCE SYNTHESIS: Twenty-seven publications involving 23 different RCTs with a total of 2245 patients provided the highest level of evidence available (level 1b) and were fully assessed. Meta-analysis was conducted with SAS v.9.1.3 (SAS Institute, Cary, NC, USA). Forest plots were produced using the R software. Pooled odds ratios and 95% confidence intervals were calculated between various operative techniques versus TURP. Functional results between the specific transurethral procedures versus TURP were summarised as differences in means. CONCLUSIONS: This meta-analysis demonstrates statistically comparable efficacy and overall morbidity for MISTs versus contemporary TURP. Type, category (minor vs major), and the number of complications (safety profile) vary specifically for each of the different transurethral techniques. We feel that the individual patient's clinical profile should be carefully assessed to identify the most appropriate transurethral technique.