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Androgens not only play an important role in the development and function of the prostate but they are also intimately involved in the development and progression of prostate cancer (PCa). Within the prostate, testosterone is converted to the more potent androgen dihydrotestosterone (DHT) via the action of 5[alpha]-reductase enzymes. DHT is the primary prostatic androgen and promotes the growth and survival of normal, hyperplastic and malignant prostate tissues. Throughout the different stages of PCa [prostatic intraepithelial neoplasia (PIN), localised, recurrent, and metastatic] there is an increase in expression of 5[alpha]-reductase enzymes, particularly in localised high-grade carcinoma. Specifically inhibiting 5[alpha]-reductase may reduce the production of DHT in the prostate while maintaining other endogenous hormone levels. Clinical studies have shown significant PCa risk reduction by blocking this pathway with 5[alpha]-reductase inhibitors (5ARIs). However, this comes at a risk, albeit low, with sexual side effects, gynaecomastia and cardiac failure. In addition, one study has shown a slight, but significant, risk of high-grade PCa. The currently available evidence does not support the routine use of 5[alpha]-reductase inhibitors to prevent PCa in the general population. It could, however, be considered as an individual option for high-risk or concerned patients with appropriate education from the prescribing provider. [ABSTRACT FROM AUTHOR]

Aims: Overactive bladder (OAB) is common in men and may exist concomitantly with benign prostatic hyperplasia (BPH) and obstruction. We present a subanalysis of results from men with OAB in a 6-month, open-label study of treatment with the oxybutynin transdermal system (OXY-TDS). Broad entry criteria were incorporated to yield a clinically representative population.Methods: All participants received OXY-TDS 3.9 mg/day. Effectiveness was assessed by changes in scores on validated questionnaires, which included the single-item Patient Perception of Bladder Condition (PPBC), the King's Health Questionnaire (KHQ) and the Beck Depression Inventory-II (BDI-II).Results: The proportion of men (n=369; mean age=69.6 years) who reported that their bladder condition caused moderate, severe or many severe problems (PPBC>or=4) improved from 77.3% at baseline to 38.1-53.6% in subsequent months. Mean KHQ scores decreased significantly (p12 (associated with a diagnosis of depression) decreased from 23.9% to 17.9% (p=0.0055). Men with a history of 'prostate problems' or use of 'BPH medication' (32.2%) had KHQ domain changes that were similar (p>or=0.1016) to those of other men. Most men (76.2%) reported no treatment-related adverse events; two men (0.5%) experienced symptoms of mild urinary retention, but neither required catheterisation.Conclusions: Oxybutynin transdermal system treatment of men with OAB was effective and well tolerated, regardless of history of prostate condition. [ABSTRACT FROM AUTHOR]

Consider interstitial cystitis (IC) when a patient presents with urinary frequency and urgency and/or pelvic pain and no other cause of the symptoms can be identified. Symptom surveys, such as the Pelvic Pain and Urgency/Frequency scale and the O'Leary-Sant symptom and problem indices, can facilitate diagnosis. Rule out diseases that have similar symptoms, such as urinary tract infection, and order a urinalysis to screen for hematuria and bacteriuria. The potassium sensitivity test and the anesthetic bladder challenge may also help with the diagnosis. Avoidance of potassium-rich foods and stress reduction may ameliorate symptoms. Oral pentosan polysulfate sodium and intravesical dimethyl sulfoxide have been approved by the FDA for the treatment of IC. Symptoms may be slow to respond to therapy; thus, close follow-up (every month for the first 3 months of treatment and every 3 months there-after) is recommended. Referral to a gynecologist or urologist may be necessary if symptoms do not respond to behavioral or pharmacologic approaches within 6 months. [ABSTRACT FROM AUTHOR]

Prostate cancer represents a significant health risk to aging men, in which diagnostic challenges to the identification of aggressive cancers remain unmet. Prostate cancer screening is driven by the prostate-specific antigen (PSA); however, in men with benign prostatic hyperplasia (BPH) due to an enlarged prostate and elevated PSA, PSA's screening utility is diminished, resulting in many unnecessary biopsies. To address this issue, we previously identified a cleaved fragment of Filamin A (FLNA) protein (as measured with IP-MRM mass spectrometry assessment as a prognostic biomarker for stratifying BPH from prostate cancer and subsequently evaluated its expanded utility in Caucasian (CA) and African American (AA) men. All men had a negative digital rectal examination (DRE) and PSA between 4 and 10 ng/mL and underwent prostate biopsy. In AA men, FLNA serum levels exhibited diagnostic utility for stratifying BPH from patients with aggressive prostate cancer (0.71 AUC and 12.2 OR in 48 men with BPH and 60 men with PCa) and outperformed PSA (0.50 AUC, 2.2 OR). In CA men, FLNA serum levels also exhibited diagnostic utility for stratifying BPH from patients with aggressive prostate cancer (0.74 AUC and 19.4 OR in 191 men with BPH and 109 men with PCa) and outperformed PSA (0.46 AUC, 0.32 OR). Herein, we established FLNA alone as a serum biomarker for stratifying men with BPH vs. those with high Gleason (7-10) prostate cancers compared to the current diagnostic paradigm of using PSA. This approach demonstrates clinical actionability of FLNA alone without the requirement of prostate volume measurement as a test with utility in AA and CA men and represents a significant opportunity to decrease the number of unnecessary biopsies in aggressive prostate cancer diagnoses.

Introduction: To promote comprehensive care of patients throughout the androgen deprivation therapy (ADT) prescribing process, the Prostate Cancer 360 (PC360) Working Group developed monitoring and management recommendations intended to mitigate or prevent ADT-associated adverse events., Methods: The PC360 Working Group included 14 interdisciplinary experts with a dedicated clinical interest in prostate cancer and ADT management. The working group defined challenges associated with ADT adverse event management and then collaboratively developed comprehensive care recommendations intended to be practical for ADT prescribers., Results: The PC360 Working Group developed both overarching recommendations for ADT adverse event management and specific recommendations across 5 domains (cardiometabolic, bone, sexual, psychological, and lifestyle). The working group recommends an interdisciplinary, team-based approach wherein the ADT prescriber retains an oversight role for ADT management while empowering patients and their primary and specialty care providers to manage risk factors. The PC360 recommendations also emphasize the importance of proactive patient education that involves partners or other support providers. Recommended monitoring and assessment tools, risk factor management, and patient counseling points are also included for the 5 identified domains, with an emphasis on lifestyle and behavioral interventions that can improve quality of life and reduce the risk for ADT-associated complications., Conclusions: Comprehensive care of patients receiving ADT requires early and ongoing coordinated management of a variety of health domains, including cardiometabolic, bone, sexual, psychological health. Patient education and primary care provider involvement should begin prior to ADT initiation and continue throughout treatment to improve patient and partner quality of life.

Introduction and Hypothesis: Data from a large US population-based, cross-sectional, epidemiological study (the EpiNP Study) were used to assess the symptoms and bother experienced by women with nocturnal polyuria (NP)., Methods: Consenting participants recruited from an online panel completed the baseline EpiNP survey online (Lower Urinary Tract Symptoms Tool and urological comorbidities). All reporting ≥2 voids/night and a random sample of 100 respondents, each reporting 0 or 1 void/night were asked to complete a 3-day web-based bladder diary recording time, volume, and urgency rating of each void. NP was calculated by the proportion of urine production that occurred during nocturnal hours using a Nocturnal Polyuria Index (NPI33) threshold of >0.33 or nocturnal urine production of >90 ml/h (NUP90). The frequency of participants reporting LUTS and bother was determined by age and NP: idiopathic NP, NP associated with overactive bladder (NPOAB), NP associated with comorbidities (NPCom), and no NP (did not meet NP criteria)., Results: A total of 5,290 women completed the baseline survey. Mean age (range) was 54.9 (30-95) years; 1,841 (34.8%) reported ≥2 nocturnal voids. The prevalence of LUTS increased across the lifespan; however, bother associated with each LUTS decreased with increasing age. The percentage of women rating bother by nocturia episodes ≥2 "> somewhat" ranged from 40.3% to 68.3%, with bother ratings highest in the NPOAB and No NP groups., Conclusions: NP is prevalent in women with considerable bother and is often associated with other urinary symptoms. Multifactorial causes and potential treatments of NP should be considered, particularly at a later age., (© 2023. The International Urogynecological Association.)

Background: Overactive bladder (OAB) is defined as urinary urgency accompanied by frequency and nocturia, with or without urge urinary incontinence (UUI). Vibegron, a selective β 3 -adrenergic receptor agonist approved in the US in December 2020, demonstrated efficacy in reducing symptoms of OAB and was safe and well tolerated in the 12-week EMPOWUR trial and its 40-week, double-blind extension trial. The goal of the COMPOSUR study is to evaluate vibegron in a real-world setting to assess patient treatment satisfaction, tolerability, safety, duration of treatment, and persistence., Methods: This is a 12-month, prospective, observational, real-world study, with an optional 12-month extension to 24 months, in the US assessing adults ≥ 18 years old starting a new course of vibegron. Patients must be previously diagnosed with OAB with or without UUI, symptomatic for ≥ 3 months before enrollment, and receive prior treatment with an anticholinergic, with mirabegron, or with a combination of an anticholinergic and mirabegron. Enrollment is performed by the investigator following exclusion and inclusion criteria guided by US product labeling, reinforcing a real-world approach. Patients complete the OAB Satisfaction with Treatment Questionnaire (OAB-SAT-q) monthly and the OAB Questionnaire short form (OAB-q-SF) and Work Productivity and Activity Impairment Questionnaire (WPAI:US) at baseline and monthly for 12 months. Patients are followed up via phone call, in-person visits, or telehealth (ie, virtual) visits. The primary endpoint is patient treatment satisfaction as determined by the OAB-SAT-q satisfaction domain score. Secondary endpoints include percent positive responses to individual OAB-SAT-q questions, additional OAB-SAT-q domain scores, and safety. Exploratory endpoints include adherence and persistence., Discussion: OAB leads to a significant decrease in quality of life, as well as impairment of work activities and productivity. Persistence with OAB treatments can be challenging, often due to lack of efficacy and adverse effects. COMPOSUR is the first study to provide long-term, prospective, pragmatic treatment data for vibegron in the US and the resultant effect on quality of life among patients with OAB in a real-world clinical setting. Trial registration ClinicalTrials.gov identifier: NCT05067478; registered: October 5, 2021., (© 2023. The Author(s).)

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., (© 2023 Wiley Periodicals LLC.)

Background: The prevalence of nocturnal polyuria (NP), which is passing large volumes of urine during the main sleep period, has been investigated primarily in middle-aged to older men. There is thus a gap in the NP evidence base for women and for younger individuals., Objective: To estimate the prevalence of nocturia due to NP in the USA., Design, Setting, and Participants: This large epidemiologic study used a US population-representative sample of men and women aged ≥30 yr to assess the prevalence of NP (NCT04125186)., Outcome Measurements and Statistical Analysis: Consenting participants completed an online survey (Lower Urinary Tract Symptoms Tool and comorbidities). All who reported two or more voids per night and 100 random respondents each reporting no or one void per night were asked to complete a 3-d bladder diary. Two NP definitions were used: nocturnal urine production >90 ml/h (NUP90) and Nocturnal Polyuria Index >0.33 (NPI33). Crude and population-adjusted prevalence results were calculated from completed diaries for the following subgroups by sex and age: idiopathic NP; NP with overactive bladder (NP-OAB) or bladder outlet obstruction (NP-BOO; men only); NP associated with other comorbidities; and no NP (did not meet the NPI33 or NUP90 definition)., Results and Limitations: Among the 10,190 respondents who completed the survey, the mean age was 54.4 yr (range 30-95); 3,339 reported two or more nocturnal voids and 1,763 completed the 3-d diary (response rate 49.3%). The adjusted overall NP prevalence was 31.5% among men and 38.5% among women using the NPI33 definition, and 23.8% among men and 18.1% among women using NUP90. The adjusted idiopathic NP prevalence was lower among men (NPI33: 5.2%; NUP90: 1.4%) than among women (NPI33: 9.8%; NUP90: 4.0%). The prevalence of idiopathic NP decreased with age as NP associated with other possible causes increased with age in men (most common, BOO) and women (most common, OAB)., Conclusions: This is the first population-based study of NP prevalence to include men, women, and young adults. NP is common; a multifactorial etiology should be considered, particularly as age increases., Patient Summary: In this population-based US study, we examined the frequency of nighttime urination among men and women aged ≥30 y and older. We found that nighttime urination is common among men and women. Many conditions can lead to increased nighttime urination as people age., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

Purpose: Prevalence data on nocturnal polyuria (NP), nocturia caused by overproduction of urine during sleep, is primarily limited to men and varies by NP definition. This U.S.-representative epidemiological study of men and women ≥30 years old assessed the prevalence of NP., Materials and Methods: Consenting participants completed the baseline EpiNP (Epidemiology of Nocturnal Polyuria) survey (eg Lower Urinary Tract Symptoms Tool, comorbidities). All reporting ≥2 voids/night and a target of 100 random respondents reporting 0 or 1 void/night were asked to complete 3-day bladder diaries. NP was defined as nocturnal polyuria index (NPI) >0.33 (NPI33) and nocturnal urine production >90 ml/hour (NUP90). Extrapolated prevalence was stratified by sex and subgroups: idiopathic (without underlying causes), associated with overactive bladder (NPOAB), bladder outlet obstruction (NPBOO; men) and comorbidities. Voided volumes and timing, including first uninterrupted sleep period, were assessed by subgroup., Results: A total of 10,190 individuals completed the baseline survey; mean age (range) was 54.4 (30-95). A total of 3,938 individuals were invited to complete the diary; 1,763 (49.3%) completed 3-day bladder diaries. Urine production (maximum nighttime volume, total volume, nocturnal urine production, nocturia index) was higher in both men and women with idiopathic NP and comorbidities. The median number of nighttime voids was greatest for NPBOO in men and NPOAB in women. Bother associated with nighttime voiding differed by NP subgroup but was highest in NPBOO for men (NPI33: 69.6%; NUP90: 71.1%) and NPOAB for women (NPI33: 67.5%; NUP90: 66.0%)., Conclusions: This population-based NP prevalence study including men and women characterizes NP subgroups and provides insights into nocturia treatment by emphasizing factors influencing urine production versus factors influencing bladder capacity.

Background: Overactive bladder (OAB) is characterized by urgency and frequency with (OAB wet) or without (OAB dry) urge urinary incontinence (UUI). In the phase 3 EMPOWUR trial, vibegron-a selective β 3 -adrenergic receptor agonist for the treatment of OAB-significantly improved daily number of urgency episodes and micturitions vs. placebo ( P  < 0.01). These post hoc analyses aimed to compare the efficacy of vibegron vs. placebo in OAB dry and wet populations., Methods: Patients were randomly assigned 5:5:4 to receive once-daily vibegron 75 mg, placebo, or tolterodine 4 mg extended release, respectively, for 12 weeks. Baseline criteria for OAB dry included an average of ≥8 micturitions, ≥3 urgency episodes, and <1 UUI episode per diary day and for OAB wet included an average of ≥8 micturitions and ≥1 UUI episode per diary day. Change from baseline in mean daily number of urgency episodes and micturitions was assessed in both populations., Results: Of the 1463 patients included in the full analysis set, 336 (23%) had OAB dry (vibegron, N  = 123; placebo, N  = 115; and tolterodine, N  = 98), and 1127 (77%) had OAB wet (vibegron, N  = 403; placebo, N  = 405; and tolterodine, N  = 319). Vibegron was associated with significant reductions (95% CIs of the least squares mean differences [LSMD] does not include 0) from baseline at week 12 vs. placebo in mean daily urgency episodes for the dry (LSMD [95% CI], ‒1.0 [‒2.0, ‒0.1]) and wet (‒0.6 [‒1.0, ‒0.1]) populations. Vibegron was associated with significant reductions from baseline at week 12 vs. placebo in mean daily micturitions for the dry (LSMD [95% CI], ‒0.8 [‒1.5, ‒ 0.1]) and wet (‒0.5 [‒0.8, ‒0.1]) populations. There were no significant differences in either outcome between tolterodine and placebo for either the dry or wet populations in this study., Conclusions: In this subgroup analysis from the EMPOWUR trial, vibegron was associated with significant reductions compared with placebo in urgency episodes and micturitions in both the OAB dry and wet populations, suggesting that vibegron is similarly efficacious for these endpoints in patients with and without UUI. This trial is registered with NCT03492281., Competing Interests: DS is an advisor for Astellas, Urovant Sciences, and UroCure; a meeting participant, lecturer, and investigator for Astellas and Urovant Sciences; and holds other interests in UroCure. JF is an investigator for Urovant Sciences, an investigator and speaker for Astellas Pharma and Pfizer Inc., and a speaker for Tolmar Inc. SV is a consultant and speaker for Urovant Sciences, a principal investigator for Clinical Research Consulting, and holds academic positions at Sacred Heart University and the University of Bridgeport. MK has received grant and/or research study funding from Allergan, Amphora, Astellas, Axonics, Boston Scientific, Coloplast, Cook Myosite, Dignify Therapeutics, EBT Medical, FemPulse, Ipsen, Taris, and Uro1 and is a consultant for Allergan, Astellas, Boston Scientific, Coloplast, Laborie, and Urovant Sciences. DKN is a consultant for Urovant Sciences. MR is a consultant and speaker for Urovant Sciences; a consultant and speaker for Astellas Pharma; and a consultant for Ferring. DDS, RJ, and PNM were employees of Urovant Sciences at the time the work was conducted., (Copyright © 2022 David Staskin et al.)

Introduction: Reductions in bothersome symptoms of overactive bladder (OAB) demonstrate improvement in clinical trials, but patient perception of meaningfulness of such improvement is lacking. In the 12-week phase 3 EMPOWUR trial, vibegron significantly reduced average daily number of micturitions, urgency episodes, and urge urinary incontinence (UUI) episodes vs placebo (P < 0.01 each). This analysis assessed meaningfulness of reductions in clinical endpoints observed in EMPOWUR using patient perception of improvement., Methods: An anchor-based approach using Patient Global Impression of Change (PGI-C) applied to phase 2 data allowed predefining phase 3 responder definitions. To confirm in phase 3, median change from baseline at week 12 in average daily number of micturitions, urgency episodes, and UUI episodes was generated for each PGI-C category and pooled across treatments. Based on predefined meaningful responder definitions, percentages of patients achieving ≥ 15% reduction in micturitions (post hoc), ≥ 50% reduction in urgency episodes (predefined), and ≥ 75% (predefined) and ≥ 90% (post hoc) reduction in UUI episodes were determined for patients receiving vibegron or placebo., Results: Across treatments, for micturitions, urgency episodes, and UUI episodes, median change from baseline to week 12 increased with greater subjective improvement based on PGI-C scores, and median reductions pooled across treatment groups were higher than the responder definitions that patients perceived as improved. Significantly more patients receiving vibegron vs placebo achieved ≥ 15% reduction in micturitions (56.3% vs 44.6%, respectively), ≥ 50% reduction in urgency episodes (39.5% vs 32.8%), ≥ 75% reduction in UUI episodes (49.3% vs 32.8%), and ≥ 90% reduction in UUI episodes (35.2% vs 23.5%) at week 12 (P < 0.05 each)., Conclusion: Significantly more patients treated with vibegron vs placebo in EMPOWUR achieved meaningful reductions in micturitions, urgency episodes, and UUI episodes that were associated with patient-perceived improvement. Results of these analyses support the meaningfulness of reductions in clinical endpoints observed in the 12-week EMPOWUR trial., Clinical Trials Registration: ClinicalTrials.gov identifier, NCT03492281., (© 2021. The Author(s).)

Background: Overactive bladder (OAB) syndrome has a diverse etiology that disrupts quality of life domains in affected patients. OAB is significantly under-recognised and undertreated, especially in the primary care setting. In order to educate primary care providers about OAB recognition, evaluation and management, we created a virtual live-streamed and enduring education program., Methods: We evaluated the impact of education on provider knowledge and self-efficacy via qualitative interviews with a sample of education participants. We analysed participant responses via constant comparative method, an iterative approach that allows for exploration of a priori issues and identification of emergent themes., Results: We identified four key themes: (a) taking OAB seriously; (b) variations in therapy; (c) patient motivation; and (d) education value. Participants were proactive about screening for and managing OAB and recognised urgency as a key symptom; some participants used diagnostic tests that are not are not considered necessary in the workup of uncomplicated OAB patients. Participants varied in their descriptions of initial approaches to treatment and most participants described a longer-than-recommended follow-up window to monitor patients. Some participants characterised patients as looking for a "quick fix" in ways that could lead to provider inaction in relation to behavioural/lifestyle interventions. Overall, participants felt that the education validated their current practice and provided new knowledge about evaluation, initiating behavioural treatment, and combination therapy., Conclusions: Participant responses were congruent with education messages, which likely reflect their "readiness to learn". The rationale for diagnostic tests and evidence on the effectiveness of behavioural regimens represent ongoing areas of unmet educational need., (© 2020 The Authors. International Journal of Clinical Practice published by John Wiley & Sons Ltd.)

Objective: To determine whether patients with interstitial cystitis have elevated levels of toxic urinary cations, to identify and quantify these cationic metabolites, and to assess their cytotoxicity., Methods: Isolation of cationic fraction was achieved by solid phase extraction using an Oasis MCX cartridge on urine specimens from interstitial cystitis patients and controls. C 18 reverse phase high-performance liquid chromatography was used to profile cationic metabolites, and they were quantified by the area under the peaks and normalized to creatinine. Major cationic fraction peaks were identified by reverse phase high-performance liquid chromatography and liquid chromatography-mass spectrometry. HTB-4 urothelial cells were used to determine the cytotoxicity of cationic fraction and of individual metabolites., Results: The reverse phase high-performance liquid chromatography analysis was carried out on cationic fraction metabolites isolated from urine samples of 70 interstitial cystitis patients and 34 controls. The mean for controls versus patients was 3.84 (standard error of the mean 0.20) versus 6.71 (0.37) mAU*min/µg creatinine, respectively (P = 0.0001). The cationic fraction cytotoxicity normalized to creatinine for controls versus patients in mean percentage was -7.79% (standard error of the mean 3.32%) versus 20.03% (standard error of the mean 2.75%; P < 0.0005). The major toxic cations were 1-methyladenosine, 1-methylguanine, N 2 ,N 2 -dimethylguanosine and L-tryptophan., Conclusions: These data confirm significant elevation of toxic cations in the urine of interstitial cystitis patients. These toxic cations likely represent a primary cause of interstitial cystitis, as they can injure the bladder mucus and initiate an epithelial leak., (© 2020 The Japanese Urological Association.)

Background: From the primary care perspective, many urologists and oncologists appear to be ignoring an FDA warning to assess patients' cardiovascular (CV) risk before instituting androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonists. A growing body of data suggest an association between ADT and CV/cardiometabolic risk, particularly for GnRH agonists., Methodology: The author examined available evidence regarding CV side effects with GnRH agonists and antagonists to determine what urologists, medical oncologists, primary care physicians (PCPs) and patients need to know about these risks., Results: Data are inconclusive and somewhat conflicting-for example, both low testosterone and testosterone replacement have been associated with elevated CV risk. But the distinction between GnRH agonists and antagonists is becoming clearer, as agonists appear to be more strongly linked with CV risk, perhaps due to the transient testosterone surge they cause upon administration. Moreover, adverse CV events associated with GnRH agonists can emerge relatively quickly, within weeks to months. Conversely, two studies show that GnRH antagonists may significantly reduce CV risk compared to GnRH agonists., Conclusions: Both GnRH agonists and antagonists carry some degree of CV risk. Although the risk appears to be lower with GnRH antagonists, urologists and oncologists should communicate with PCPs to determine patients' baseline CV risk levels before implementing ADT with either type of agent., (© 2019 John Wiley & Sons Ltd.)

Purpose Guidelines are limited for genetic testing for prostate cancer (PCA). The goal of this conference was to develop an expert consensus-driven working framework for comprehensive genetic evaluation of inherited PCA in the multigene testing era addressing genetic counseling, testing, and genetically informed management. Methods An expert consensus conference was convened including key stakeholders to address genetic counseling and testing, PCA screening, and management informed by evidence review. Results Consensus was strong that patients should engage in shared decision making for genetic testing. There was strong consensus to test HOXB13 for suspected hereditary PCA, BRCA1/2 for suspected hereditary breast and ovarian cancer, and DNA mismatch repair genes for suspected Lynch syndrome. There was strong consensus to factor BRCA2 mutations into PCA screening discussions. BRCA2 achieved moderate consensus for factoring into early-stage management discussion, with stronger consensus in high-risk/advanced and metastatic setting. Agreement was moderate to test all men with metastatic castration-resistant PCA, regardless of family history, with stronger agreement to test BRCA1/2 and moderate agreement to test ATM to inform prognosis and targeted therapy. Conclusion To our knowledge, this is the first comprehensive, multidisciplinary consensus statement to address a genetic evaluation framework for inherited PCA in the multigene testing era. Future research should focus on developing a working definition of familial PCA for clinical genetic testing, expanding understanding of genetic contribution to aggressive PCA, exploring clinical use of genetic testing for PCA management, genetic testing of African American males, and addressing the value framework of genetic evaluation and testing men at risk for PCA-a clinically heterogeneous disease.

Purpose: The influence of cardiovascular risk factors/comorbidities on response to oral once-daily tadalafil 5 mg was explored in men with lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH)., Methods: This post hoc analysis pooled data from four double-blind studies in which 1498 men with > 6-mo history of LUTS/BPH were randomised and received either once-daily placebo (n = 746) or tadalafil 5 mg (n = 752) for 12 weeks. Descriptive statistics were reported for changes in total International Prostate Symptom Score (IPSS), IPSS voiding and storage subscores, and IPSS quality-of-life (QoL) index. Treatment group differences by baseline clinical and cardiovascular factors and medical therapies were examined using analysis of covariance., Results: Tadalafil was effective in men with LUTS/BPH and cardiovascular risk factors/comorbidities except for patients receiving > 1 antihypertensive medication. Placebo-adjusted least squares (LS) mean improvements in total IPSS were -1.2 (95% CI: -2.5 to -0.0) in men taking > 1 antihypertensive medication vs. -3.3 (95% CI: -4.4 to -2.1) in men taking one medication (interaction p = 0.020). In addition, placebo-adjusted LS mean improvements in total IPSS were -0.2 (95% CI, -2.1 to 1.7) in men who reported use of diuretics vs. -2.8 (95% CI, -3.7 to -1.9) in men who reported taking other antihypertensive medications vs. -2.3 (95% CI, -3.2 to -1.5) in men who reported not using any antihypertensive drug (p-value for interaction = 0.053)., Conclusions: Once-daily tadalafil 5 mg improved LUTS/BPH, regardless of severity, in men with coexisting cardiovascular risk factors/comorbidities, except for patients with history of > 1 drug for arterial hypertension. Use of diuretics may contribute to patients' perception of a negated efficacy of tadalafil on LUTS/BPH. Comorbidities should be considered when choosing the optimal medicine to treat men with LUTS/BPH., (© 2015 John Wiley & Sons Ltd.)

Testosterone deficiency (TD) afflicts approximately 30% of men ages 40-79 years, with an increase in prevalence strongly associated with aging and common medical conditions including obesity, diabetes, and hypertension. There appears to be a strong relationship between TD and metabolic syndrome, though the relationship is not certain to be causal. Several studies have suggested that repletion of testosterone in deficient men with these comorbidities may indeed reverse or delay their progression. While testosterone repletion has been largely thought of in a sexual realm, we discuss its potential role in general men's health concerns: metabolic, body composition, and its association with decreased all-cause mortality. Recent guidelines and studies have suggested variable prevalence statistics and expanded uses of testosterone repletion in certain populations with both biochemical and clinical signs of testosterone deficiency. Yet, this is not done without risk. A recent randomized placebo-controlled trial of testosterone repletion in elderly frail men with limited mobility has suggested potential negative cardiovascular risks in this older, sicker group of men. Two more recent retrospective studies of variable clinical design and interpretation suggest testosterone poses an increased cardiovascular risk in older men than 65 years and younger men with heart disease. This review examines these and other studies, with practical recommendations for the diagnosis of testosterone deficiency and repletion in middle aged and older men, including an analysis of treatment modalities and areas of concern and uncertainty.

In the primary care office the evaluation of prostate related lower urinary tract symptoms (BPH-LUTS) in the male can be confusing. Are the symptoms, in fact, from the prostate or is there another etiology such as the bladder or medical conditions causing or contributing to the problems? If the cause is the prostate, how does the physician choose from the multitude of available treatment options and when is referral appropriate? The prevalence of BPH-LUTS is high and commonly encountered by the primary care physician (PCP). An understanding of the normal prostate is essential to identifying the patient when symptoms do occur. Then the evaluation and treatment of the affected patient can occur effectively and efficiently in the PCP setting. In this article we present the background information needed for the PCP to provide this evaluation of the patient with BPH-LUTS. We explain the various treatment options that are best suited for the individual which are based on symptom severity, sexual dysfunction and risk of progression. We also identify follow up parameters and reasons for referral.

An association between erectile dysfunction (ED) and cardiovascular disease has long been recognized, and studies suggest that ED is an independent marker of cardiovascular disease risk and even further, a marker for the burden of both obstructive and non-obstructive coronary artery disease. Therefore, the primary care physician (PCP) must assess the presence or absence of ED in every man > 39 years of age, especially if that man is asymptomatic of signs and symptoms of coronary artery disease. Assessment and management of ED may help identify and reduce the risk of future cardiovascular events, particularly in younger middle-aged men. The initial ED evaluation should distinguish between predominantly vasculogenic ED and ED of other etiologies. For men believed to have predominantly vasculogenic ED, we recommend that initial cardiovascular risk stratification be based on the Framingham Risk Score. Management of men with ED who are at low risk for cardiovascular disease should focus on risk factor control; men at high risk, including those with cardiovascular symptoms, should be referred to a cardiologist. Intermediate risk men should undergo noninvasive evaluation for subclinical atherosclerosis. A growing body of evidence supports the use of selected prognostic markers to further understand cardiovascular risk in men with ED, particularly CT calcium scoring. In conclusion, we support cardiovascular risk stratification and risk factor management in all men with vasculogenic ED.

The evaluation and treatment of overactive bladder (OAB) starts in the primary care office and can be accomplished efficiently, effectively and, most importantly, safely. With appropriate knowledge of the disease and an understanding of what to look for the primary care physician (PCP) can readily make the empiric diagnosis and initiate treatment. The key for the PCP is to be able to distinguish the uncomplicated patient from the complicated one and know when to refer, if necessary. It is also essential to be able to able to identify confounding conditions that could either be the cause of the symptoms or, in fact, make them worse. The algorithm presented in this paper describes a simplified, yet complete, approach to the patient presenting with lower urinary tract symptoms (LUTS) consistent with OAB. In the paper, we explain the disease itself, its prevalence and impact, the evaluation as well as the different treatment modalities that are available for the patient. Appropriate follow up, therapy adherence techniques and referral recommendations are also discussed.

Patients with urologic conditions may present to a primary care physician (PCP) in the emergency department or in the PCP's office. Some conditions are true emergencies that require immediate surgical intervention. Others may require medical treatment or possibly simply reassuring the patient that there is no serious medical problem. Sometimes the diagnosis can be easily made, whereas other times the PCP needs to be able to rule out serious causes for a presenting problem and execute a guideline-recommended patient work up, to make a final diagnosis. Sometimes recommended diagnostic tests may not be readily available. When a PCP believes that a patient may have a serious urologic condition and is unsure of the appropriate patient management strategy, then he or she must quickly refer the patient to a urologist. This article describes common urology-related issues-hematuria, prostate-specific antigen (PSA) test interpretation, phimosis and paraphimosis, acute scrotal pain and masses in the child and adult, urinary tract infection, renal colic, and castration-treatment-induced bone loss. It provides insights into decision-making processes for patient management of some urologic conditions, and information about managing sequelae and side effects of long term treatment. It includes practical diagnostic suggestions and patient management strategies based on the authors' years of urologic clinical practice experience.

The primary care provider is in an optimal position to identify and care for the patient affected by prostate-related lower urinary tract symptoms (BPH-LUTS). This assessment can be readily accomplished with a good history and only a few simple, in-office tests. In some instances, the primary care provider may believe that they do not have the experience, comfort level or time to perform an adequate evaluation of the problem. Therefore, in this article, we describe the function of the lower urinary tract, as well as the rationale behind the medical history, examination and tests needed in order to diagnose and treat, or refer, the patient presenting with BPH-LUTS. We will also update the literature-based STEP (simplified treatment of the enlarged prostate) approach, which was initially published in 2009, to include recently described therapeutic options.

Aim: To assess whether participation in a series of continuing medical education-certified activities presenting complicated case scenarios resulted in evidence-based decision making for patients with chronic comorbid conditions., Methods: A series of interactive live workshops and online case studies presented evidence-based, practical information addressing the care of patients with multiple chronic diseases to primary care physicians. Clinical case vignettes were used to assess workshop participant knowledge and competence. Results were compared with those of matched non-participant controls. Online participants were surveyed to evaluate immediate knowledge gains from the activity., Results: Overall, physician workshop participants were 27% more knowledgeable of evidence-based treatment decisions. Participants were more likely to refer a patient with rheumatoid arthritis to a rheumatologist (57% vs. 36%; p = 0.035) and showed better recognition of medications that can contribute to overactive bladder symptoms (36% vs. 18%; p = 0.043) compared with non-participant controls. Non-significant differences in favour of participants included evidence-based decisions regarding the management of osteoporosis, attention deficit hyperactivity disorder in adults and type 2 diabetes mellitus in adolescents. Online participants demonstrated significant knowledge gains (p < 0.001) on 17 of 18 assessment questions across all therapeutic areas., Discussion: Chronic comorbid conditions afflict a sizable minority of patients. However, specific recommendations and education surrounding patient management are often overlooked because of the inherent difficulty of treating this group. Highly interactive educational activities can improve participant knowledge and competency in treating these patients by providing an opportunity to interact with faculty experts, receive immediate feedback and practice new skills., Conclusion: Interactive educational activities that discuss complicated case scenarios can improve participant application of evidence-based medicine for patients with multiple chronic comorbidities., (© 2013 John Wiley & Sons Ltd.)

Bladder conditions, including UTI, UI, and bladder cancer, are highly prevalent and affect a wide range of populations. There are a variety of modifiable behavioral and lifestyle factors that influence bladder health. Some factors, such as smoking and obesity, increase the risk or severity of bladder conditions, whereas other factors, such as pelvic floor muscle exercise, are protective. Although clinical practice may be assumed to be the most appropriate ground for education on behavioral and lifestyle factors that influence bladder health, it is also crucial to extend these messages into the general population through public health interventions to reach those who have not yet developed bladder conditions and to maximize the prevention impact of these behaviors. Appropriate changes in these factors have the potential for an enormous impact on bladder health if implemented on a population-based level., (Published 2013. This article is a U.S. Government work and is in the public domain in the USA.)

Results are reported from the first two adequate trials of the PDE-5 inhibitor vardenafil using a stopwatch to precisely measure erection duration in men with ED. Two randomized, multicenter, double-blind, placebo-controlled trials were conducted: a crossover 4-week treatment in men with ED (ENDURANCE) and a parallel group, 12-week treatment in men with ED and dyslipidemia (the dyslipidemia study). Stopwatch-assessed duration of erection leading to successful intercourse measured by Sexual Encounter Profile question-3 (SEP-3) was the primary end point in ENDURANCE and one of the secondary end points in the dyslipidemia study. Other efficacy end points included responses to SEP-2, SEP-3 and International Index of Erectile Function-Erectile Function (IIEF-EF) domain scores. Adverse events were recorded. Duration of erection (least squares mean ± s.e.) leading to successful intercourse was statistically superior in men receiving vardenafil versus placebo (12.8 ± 1.0 versus 5.5 ± 1.0 min; p<0.001 in ENDURANCE and 10.0 ± 0.8 versus 3.4 ± 0.8; p<0.001 in the dyslipidemia study), with a difference of 7.4 and 6.6 min, respectively, between treatment groups. Results for SEP-2, SEP-3 and IIEF-EF domain scores were consistent across studies and with stopwatch-assessed measures for duration of erection. Vardenafil was well tolerated. Duration of erection leading to successful intercourse is an important indicator of the efficacy of ED treatment. The stopwatch approach offers an alternative, precise and reproducible measure of efficacy. We propose this approach as a potential new paradigm for assessing the efficacy of ED treatments.

There is a high prevalence of hypogonadism in the older adult male population and the proportion of older men in the population is projected to rise in the future. As hypogonadism increases with age and is significantly associated with various comorbidities such as obesity, type 2 diabetes, hypertension, osteoporosis and metabolic syndrome, the physician is increasingly likely to have to treat hypogonadism in the clinic. The main symptoms of hypogonadism are reduced libido/erectile dysfunction, reduced muscle mass and strength, increased adiposity, osteoporosis/low bone mass, depressed mood and fatigue. Diagnosis of the condition requires the presence of low serum testosterone levels and the presence of hypogonadal symptoms. There are a number of formulations available for testosterone therapy including intramuscular injections, transdermal patches, transdermal gels, buccal patches and subcutaneous pellets. These are efficacious in establishing eugonadal testosterone levels in the blood and relieving symptoms. Restoration of testosterone levels to the normal range improves libido, sexual function, and mood; reduces fat body mass; increases lean body mass; and improves bone mineral density. Testosterone treatment is contraindicated in subjects with prostate cancer or benign prostate hyperplasia and risks of treatment are perceived to be high by many physicians. These risks, however, are often exaggerated and should not outweigh the benefits of testosterone treatment.

We propose a simple and practical approach to the identification, evaluation and treatment of lower urinary tract symptoms (LUTS) resulting from an enlarging and obstructive prostate. The proposed Simplified Treatment for Enlarged Prostate (STEP) plan is a logical guide to patient management by the primary care provider (PCP). Symptoms of enlarged prostate (EP) are common and may frequently progress into a condition with profound adverse effects on quality of life. Despite the high prevalence, EP is underdiagnosed and undertreated. This situation may result from patient- and provider-related issues. Assessment of symptoms of EP should be initiated with a discussion of LUTS. Evaluation includes a focused history, physical examination and selected laboratory tests. Certain factors put the symptomatic patient at risk for disease progression; however, not all factors can be readily evaluated in the PCP setting. The serum prostate-specific antigen (PSA) level acts both as an indicator of prostatic size and a screening tool for prostatic cancer, and thereby provides an important tool for PCPs. The STEP plan is a logical guide to patient management. Step 1, watchful waiting, is appropriate in patients with symptoms that are not bothersome. If symptoms cause bother, the initiation of an alpha-blocker (AB) in step 2, provides relatively rapid symptom improvement. Patients with bothersome symptoms and a PSA > or = 1.5 ng/ml are at risk for progression and consideration should be given to combination treatment with an AB and a 5alpha-reductase inhibitor (step 3). Patients with refractory symptoms should be referred to a urologist (step 4). Identification, evaluation and management of EP are within the domain of the primary care setting. The STEP approach provides a simple and practical framework for PCPs to manage most men with symptoms of EP.

Objectives: Overactive bladder syndrome (OAB) is a urinary condition that often exerts detrimental effects on an individual's quality of life (QoL). A once-daily, extended-release (ER) formulation of the quaternary amine trospium chloride has recently been developed for the treatment of OAB. The pooled health-related QoL (HRQoL) data from two multicenter, parallel-group, double-blind Phase III studies with trospium chloride ER 60 mg were analyzed., Methods: Subjects aged>or=18 years with urinary urgency, frequency, and an average of >or=1 urge urinary incontinence episode per day on a 3-day bladder diary were randomized (1:1) to receive once-daily trospium 60 mg ER or placebo for 12 weeks. HRQoL was assessed at baseline and at Week 12 using the King's Health Questionnaire (KHQ) and the OAB questionnaire (OAB-q)., Results: Overall, 1165 subjects were randomized (trospium ER, n=578; placebo, n=587). Trospium ER produced significantly greater improvements from baseline than placebo in seven of the nine KHQ domains. At Week 12, the improvement in mean OAB-q HRQoL total score (from approximately 52 at baseline) was significantly greater with trospium ER than with placebo (+25.8 vs. +20.7; P=0.0003). Improvements from baseline were seen with trospium ER on all eight of the OAB-q symptom bother scales., Conclusions: Once-daily trospium 60 mg ER improved the QoL of subjects with OAB, as assessed using the KHQ and the OAB-q, in two large Phase III clinical trials.

Background: Trospium chloride is an antimuscarinic agent with a hydrophilic polar quaternary amine structure that is minimally metabolised by hepatic cytochrome P450 and is actively excreted in the urine, each of which confers a potential benefit with regard to efficacy and tolerability., Purpose: We analysed pooled data from two identically designed phase III trials of a once-daily, extended-release (XR) formulation of trospium chloride (trospium XR 60-mg capsules) in subjects with overactive bladder syndrome (OAB)., Methods: Adults with OAB of > or = 6 months' duration with urinary urgency, frequency and > or = 1 urge urinary incontinence (UUI) episode/day were enrolled in these multicentre, parallel-group, double-blind trials. Participants were randomised (1 : 1) to receive trospium XR 60 mg or placebo for 12 weeks. Primary efficacy variables were changes in urinary frequency and the number of UUI episodes/day. Adverse events (AEs) were recorded throughout., Results: In total, 1165 subjects were randomised (trospium XR, 578; placebo, 587). At baseline, subjects averaged 12.8 toilet voids/day and 4.1 UUI episodes/day. Compared with placebo, subjects treated with trospium XR had significantly greater reductions from baseline in the mean number of toilet voids/day (-1.9 vs. -2.7; p < 0.001) and UUI episodes/day (-1.8 vs. -2.4; p < 0.001) at week 12. The most frequent AEs considered possibly related to study treatment were dry mouth (trospium XR, 10.7%; placebo, 3.7%) and constipation (trospium XR, 8.5%; placebo, 1.5%). Notably, rates of central nervous system (CNS) AEs were lower with trospium XR vs. placebo (dizziness: 0.2% vs. 1.0%; headache: 1.4% vs. 2.4%)., Conclusions: Treatment with trospium XR resulted in statistically significant improvements in both of the dual primary and all of the secondary outcome variables. Trospium XR demonstrated favourable rates of AEs, particularly CNS AEs (numerically lower than with placebo) and dry mouth (lower than previously reported with trospium immediate-release, although not compared in a head-to-head study).

Despite its high prevalence, chronic pain is suboptimally treated in approximately one half of affected patients. Failure to recognise and manage comorbid physical and psychosocial impairments may contribute to the perpetuation of chronic pain. Knowledge of the potential advantages and disadvantages of available analgesic medications will permit informed selection of the appropriate medication for the individual chronic pain patient. Ultimate therapeutic goals will also influence analgesic medication selection. For the patient with chronic pain requiring analgesic treatment for an extended period of time, long-acting analgesics are recommended. Theoretically, these agents will provide sustained analgesia by minimising the end-of-dose pain that is often seen with short-acting medications, with improved patient convenience and a potential for reduced risk of adverse events. The extended-release formulation of tramadol (tramadol ER) has proven efficacy in chronic pain conditions such as osteoarthritis and low back pain, as well as a favourable tolerability profile. In addition, tramadol ER has been shown in clinical trials to improve pain-related sleep disturbances and physical function in patients with chronic pain from osteoarthritis and low back pain.

Several studies with modern antimuscarinics have used a flexible-dosing strategy. We reviewed data from several studies with solifenacin, darifenacin and oxybutynin extended-release that evaluated the impact of dose flexibility on clinical management. A strategy based on patient-requested dose increases was found to be consistently effective in improving the symptoms of overactive bladder. Patients requesting a dose increase often had more severe symptoms at baseline than those who did not request a dose increase, and these patients derived most benefit from the increased dose. Specialists and family doctors should encourage open discussion with their patients about requesting dose titration so as to meet patients' individual needs.

Objective: The ENDURANCE study evaluated the efficacy of vardenafil, a phosphodiesterase type 5 (PDE5) inhibitor, in men with erectile dysfunction (ED), by measuring the duration of erection leading to successful intercourse using a stopwatch as the assessment instrument., Methods: This was a randomised, multicentre, double-blind, placebo-controlled, crossover study consisting of a 4-week treatment-free run-in phase after which patients were randomised to either fixed-dose vardenafil 10 mg or placebo (to be administered 60 min prior to intercourse) and entered the first of the two 4-week double-blind treatment periods, separated by a 1-week washout. The primary efficacy end-point was the stopwatch-assessed duration of erection, which was defined as the time from erection perceived hard enough for penetration until withdrawal from the partner's vagina leading to successful intercourse as measured by Sexual Encounter Profile Question 3 (SEP-3). Secondary efficacy end-points included SEP-2 and SEP-3 success rates, the erectile function domain of the International Index of Erectile Function, global assessment questionnaire, change from baseline in duration of erection and duration of erection not leading to successful intercourse. Safety was assessed by adverse events (AEs), laboratory samples, vital signs and ECGs., Results: Of the 191 men included in the safety population, 40% had moderate ED and 33% had severe ED at baseline. The duration of erection (least squares mean +/- SE) leading to successful intercourse was longer with vardenafil than with placebo (12.81 +/- 1.00 min vs. 5.45 +/- 1.00 min; p < 0.001). The differences recorded for all secondary end-points were statistically significant in favour of vardenafil compared with placebo (p < 0.001), with the exception of duration of erection not leading to successful intercourse. Vardenafil was well tolerated in this study; the majority of AEs being mild-to-moderate in intensity., Conclusion: Vardenafil 10-mg therapy provided a statistically superior duration of erection leading to successful intercourse in men with ED compared with placebo.

Aims: Lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) are a common problem in ageing men and are accompanied by sexual dysfunction (SD) in 40-70% of men evaluated in large-scale epidemiological studies. One year after the 2003 American Urological Association (AUA) guideline on BPH management was published, a survey of US urologists (UROs) and primary care physicians (PCPs) was conducted to ascertain physician knowledge of the AUA guideline and practice patterns regarding LUTS/BPH diagnosis, treatment and association with SD., Methods: A 19-question qualitative survey, sponsored by the American Foundation of Urologic Disease, was mailed April 2004 to 7500 UROs and 17,500 PCPs, with responses collected until May 2004., Results: A total of 788 surveys were returned (437 UROs; 351 PCPs). Only 62% of PCPs were aware of and only 41% of PCPs used the AUA-Symptom Index/International Prostate Symptom Score (AUA-SI/IPSS) to assess LUTS compared with 97% and 81% of UROs respectively. Alpha-blocker monotherapy was the treatment of choice for both UROs and PCPs. Compared with UROs, PCPs reported higher rates of SD in association with LUTS or BPH (37% vs. 27%) and BPH pharmacotherapy (27% vs. 21%). UROs and PCPs reported higher rates of SD side effects [ejaculatory dysfunction (EjD) and erectile dysfunction (ED)] for tamsulosin (EjD: UROs 22%, PCPs 12%; ED: UROs 7%, PCPs 10%) and doxazosin (EjD: UROs 14%, PCPs 10%; ED: UROs 7%, PCPs 12%) than for alfuzosin (EjD: UROs 6%, PCPs 4%; ED: UROs 4%, PCPs 5%)., Conclusions: The results suggest that many PCPs are not using the AUA-SI/IPSS to assess LUTS in their ageing male patients. Both UROs and PCPs appear to be underestimating the prevalence of SD in men with LUTS/BPH relative to prevalence rates reported in large-scale epidemiological studies.