Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia Research Articles

Эффективность и безопасность комбинированной терапии препаратами алфузозин (Алфупрост® МР) и солифенацин (Везигамп) у больных доброкачественной гиперплазией предстательной железы и гиперактивным мочевым пузырем: первые результаты наблюдательного многоцентрового исследования «АВИАТОР».

Introduction. Combination therapy of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) with the use of α1-adrenoblockers and anticholinergic drugs has become the standard of treatment and is widely used in clinical practice. Materials and methods. An observational prospective multicenter study was conducted to evaluate the efficacy and safety of combined alfuzosin (Alfuprost ® MR) 10 mg/day and solifenacin (Vesigamp) 5 mg/day in patients with BPH and overactive bladder (OAB) with moderate and severe symptoms in real outpatient practice. The study included 208 patients with LUTS/BPH 60.7±6.4 years old with the following average indicators: international prostate symptom score (IPSS) – 20.2±4.9 points; obstructive symptoms – 10.8±4.2 and irritative symptoms – 9.4±2.1 (nocturia 2.8±1.0); quality of life (QoL) - 4.8±0.5; the prostate volume is 49.9±12.0 cm3 ; intravesical prostatic protrusion < 10 mm; overactive bladder symptom score (OABSS) – 10.5±2.4; patient perception of intensity of urgency scale (PPIUS) – 2.5±0.7; maximum flow rate (Qmax) – 11.5±2.1 ml/s; average flow rate (Qave) – 6.6±1.5 ml/s; urinary volume (Vcomp) – 204.1±51.4 ml; residual urine (Vres) – 49.7±35.3 ml. Control examinations were performed 1 and 3 months after the start of treatment. Results. The overwhelming number of patients achieved a statistically reliable and pronounced effect on most subjective and objective clinical indicators, which was registered a month after the start of combination treatment and intensified by the third month of follow-up. A significant improvement in LUTS according to IPSS was after 1 and 3 months, respectively: total score -45.5% and -72.3%; irritative symptoms -45.7% and -73.4%; obstructive -45.4% and -72.2%; nocturia -46.4% and -71.4%; QoL -50.0% and -79.1%. A statistically significant decrease in OAB symptoms according to the OABSS questionnaire was -50.5% and -80.9% after 1 and 3 months, respectively, including imperative urinary incontinence -50.0% and -83.3%. There was also a significant decrease in the severity of urgency according to the PPIUS questionnaire: by -52.0% and -88.0%. Combination therapy led to a rapid and significant improvement in the objective parameters of urination after 1 and 3 months, respectively: Qmax - by 32.2% and 52.2%; Qave - by 24.2% and 37.9%; Vcomp - by 4.6% and 6.5% (not significant). Vres decrease by -49.5% and -75.6%. It was not only the improvement in digital uroflowmetry (UFM) indicators, but also in the type of the UFM curves. If, before the start of treatment UFM curves close to normal were observed in only 5.3% of patients, then at the end of study already in 44.2%. Combination therapy demonstrated a high degree of safety, although 26.9% of patients had concomitant diseases. During 3 months of treatment, only 5 adverse events were registered in 5 (2.5%) patients: dry mouth – 4 (2.0%), retrograde ejaculation – 1 (0.5%). Nobody interrupted treatment due to adverse events. There were no episodes of acute urinary retention. The program showed high satisfaction of doctors with the clinical effectiveness of treatment (4.5±0.9 on the Likert scale), as well as satisfaction of both doctors and patients with the tolerability of therapy (4.5±0.9 and 4.5±0.9 on the Likert scale), respectively. Conclusion. This study is original, both in terms of the combination of the used drugs and in terms of its design features. This is the first study of alfuzosin and solifenacin combination treatment in patients with LUTS/BPH with OAB and urgency. Also, this is the first study in which the factor of intravesical prostatic protrusion > 10 mm was applied as a non-inclusion criterion. The therapy demonstrated: high and significant efficacy in relation to LUTS (irritative and obstructive), objective voiding parameters and impact on patient’s quality of life; high adherence to treatment, safety, tolerability and satisfaction with its results by doctors and patients. The effectiveness and safety of treatment in this study was achieved due to the combination of drugs used for the first time, careful selection of patients and exclusion of persons with severe mechanical bladder outlet obstruction from the observation group.

Efficacy and Tolerability of 6-Month Treatment with Tamsulosin Plus the Hexanic Extract of Serenoa repens versus Tamsulosin Plus 5-Alpha-Reductase Inhibitors for Moderate-to-Severe LUTS-BPH Patients: Results of a Paired Matched Clinical Study.

The objective of this subset analysis was to evaluate and compare the efficacy and tolerability of two combination treatments for men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). Data were from a real-world, open-label, prospective, and multicenter study performed in outpatient urology clinics. Men with moderate-to-severe LUTS/BPH received 6-month treatment with tamsulosin (TAM) in combination with either the hexanic extract of S. repens (HESr) or a 5-alpha-reductase inhibitor (5ARI). Changes in urinary symptoms and quality of life were measured using the IPSS and BII questionnaires, respectively. Treatment tolerability was assessed by recording adverse effects (AEs). Patients in the two study groups were matched using iterative and propensity score matching approaches. After iterative matching, data were available from 136 patients (n = 68 treated with TAM + 5ARI, n = 68 with TAM + HESr). After 6 months of treatment, mean (SD) IPSS total score improved by 7.7 (6.3) and 6.7 (5.0) points in the TAM + 5ARI and TAM + HESr groups, respectively (p = 0.272); mean BII total scores improved by 3.1 (2.9) and 2.9 (2.4) points (p = 0.751), respectively. AEs were reported by 26.5% and 10.3% of patients in the same groups, mostly affecting sexual function (p < 0.027). When used in a real-world setting to treat patients with moderate-severe LUTS/BPH, 6-month treatment with TAM + HESr was as effective as TAM + 5ARI, but with better tolerability.

Efficacy and Safety of the Hexanic Extract of Serenoa repens vs. Watchful Waiting in Men with Moderate to Severe LUTS-BPH: Results of a Paired Matched Clinical Study.

We investigated changes in symptoms and quality of life (QoL) in men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) receiving the hexanic extract of Serenoa repens (HESr) and compared results with a matched group on watchful waiting (WW). Data was from a real-world, open-label, prospective, multicenter study. This sub-group analysis included patients with moderate-to-severe symptoms receiving either the HESr 320 mg/daily for six months (HESr) or who remained untreated for LUTS/BPH (WW). Changes in urinary symptoms and QoL were measured by IPSS and BII questionnaires. Two statistical approaches (iterative matching and propensity score pairing) were used to maximize between-group comparability at baseline. Tolerability was assessed in the HESr group. After iterative matching, data for analysis was available for 783 patients (102 WW, 681 HESr). IPSS scores improved by a mean (SD) of 3.8 (4.4) points in the HESr group and by 2.2 (4.5) points in the WW group (p = 0.002). Changes in BII score were 1.8 (2.4) points and 1.0 (2.2) points, respectively (p < 0.001). Three patients (0.9%) treated with the HESr reported mild adverse effects. Moderate-severe LUTS/BPH patients treated for six months with the HESr showed greater improvements in symptoms and QoL than matched patients on WW, with a very low rate of adverse effects.

Efficacy and tolerability of the hexanic extract of Serenoa repens compared to tamsulosin in moderate-severe LUTS-BPH patients

In a subset analysis of data from a 6-month, multicenter, non-interventional study, we compared change in symptoms and quality of life (QoL), and treatment tolerability, in men with moderate to severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) receiving tamsulosin (TAM, 0.4 mg/day) or the hexanic extract of Serenoa repens (HESr, 320 mg/day) as monotherapy. Symptoms and QoL were assessed using the IPSS and BII questionnaires, respectively. Patients in the treatment groups were matched using two statistical approaches (iterative and propensity score matching). Within the iterative matching approach, data was available from a total of 737 patients (353 TAM, 384 HESr). After 6 months, IPSS scores improved by a mean (SD) of 5.0 (4.3) points in the TAM group and 4.5 (4.7) points in the HESr group (p = 0.117, not significant). Improvements in QoL were equivalent in the two groups. TAM patients reported significantly more adverse effects than HESr patients (14.7% vs 2.1%; p < 0.001), particularly ejaculation dysfunction and orthostatic hypotension. These results show that HESr is a valid treatment option for men with moderate/severe LUTS/BPH; improvements in urinary symptoms and QoL were similar to those observed for tamsulosin, but with considerably fewer adverse effects.

Poor clinical guideline adherence and inappropriate testing for incident lower urinary tract symptoms associated with benign prostatic hyperplasia.

Background.The American Urological Association makes recommendations for evaluation and testing for lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) to help primary care providers and specialists identify LUTS/BPH and harmful related conditions including urinary retention and prostate or bladder cancer. Our understanding of provider adherence to these Guidelines is limited to single-site or non-representative settings.Methods.We analyzed two insurance claims databases: the Optum® de-identified Clinformatics® Data Mart database for privately insured males aged 40–64 years (N≈1,650,900 annually) and the Medicare 5% Sample for males aged ≥65 years (N≈546,000 annually). We calculated the annual prevalence of LUTS/BPH and comorbid bladder cancer and bladder stones from 2004–2013. We additionally examined LUTS/BPH incidence and adherence to testing guidelines in a cohort of men newly diagnosed with LUTS/BPH in 2009.Results.While LUTS/BPH prevalence and incidence increased with increasing age, evaluation testing became less common. Urinalysis was the most common testing type but was performed in <60% of incident patients. Serum prostate-specific antigen (PSA) was the second most common test across age groups (range: 15–34%). Prevalence of comorbid bladder cancer (range: 0–4%), but not bladder stones (range: 1–2%), increased with increasing age.Conclusions.Although older men were at greater risk of LUTS/BPH than younger men, they were less likely to undergo testing at diagnosis. Recommended testing with urinalysis was poor despite higher prevalence of bladder cancer in older men and a standard recommendation for urinalysis since 1994. Providers should be more cognizant of AUA Guidelines when assessing LUTS/BPH patients.

Cutoff level of prostate volume to predict the efficacy of α1-D/A adrenoceptor antagonist, naftopidil.

Introduction:In lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) patients, prostate volume (PV) at baseline affects the improvement of International Prostate Symptom Score voiding symptoms (IPSS-VS) by naftopidil (NAF), but not total IPSS (IPSS-TS). To predict the efficacy of NAF, the PV cutoff point was examined using IPSS-VS.Materials and Methods:Seventy-seven patients with LUTS/BPH were administrated with NAF 50 mg/day for 4 weeks. Age, PV, IPSS, IPSS quality-of-life (IPSS-QoL), and maximum flow rate (MFR) were evaluated at baseline, and IPSS, IPSS-QoL, and MFR were evaluated after the treatment (at 4 weeks). Responders and nonresponders were divided by IPSS-VS at 4 weeks, and the PV cutoff point was calculated.Results:At baseline, the mean age and PV were 70.7 ± 8.2 years (range, 54–88 years) and 43.3 ± 24.5 mL (range, 20.6–141.7 mL), respectively. After 4 weeks, area under the receiver operating characteristic curve was largest in the patients with <4 points of IPSS-VS. The best standard value to evaluate the efficacy IPSS-VS at 4 weeks was 4 points for the NAF treatment, and the best PV cutoff point was 37.3 mL (sensitivity 60.5%, specificity 71.9%).Conclusions:PV at baseline was one of the predictive factors which affected the efficacy of NAF for IPSS-VS, and LUTS/BPH patients who had PV more than 37.3 mL indicated poor improvement of IPSS-VS, even if IPSS-TS was improved.

Alpha-1 blocker use increased risk of subsequent renal cell carcinoma: A nationwide population-based study in Taiwan.

Elevated Renal cell carcinoma (RCC) risk has been associated with the use of several antihypertensive medications but has not yet been elucidated in the populations prescribed alpha-1 blockers that are commonly used in the treatment of hypertension and lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS-BPH). The aim of the present study was to investigate the association between alpha-1 blocker use and the risk of developing RCC using a nationwide population-based database in Taiwan. Patients who were treated with alpha-1 blockers for at least 28 days were identified through the Taiwan National Health Insurance Research Database from 2000 to 2010. The unexposed participants were matched with the exposed cases according to age, sex, and index year at a ratio of 3:1. Cox proportional hazards regression, stratified by sex and comorbidities and adjusted for age, was performed to estimate hazard ratios (HRs) for the risk of subsequent RCC. Among 2,232,092 subjects, patients who received alpha-1 blocker treatment had a higher risk of RCC than the unexposed group. Taking into account hypertension and BPH, the adjusted HR was significantly higher in male alpha-1 blocker users who had no BPH and either the presence (HR: 1.63, 95% confidence interval [CI] = 1.22–2.18) or absence (HR: 2.31, 95% CI = 1.40–3.81) of hypertension than in men not receiving these drugs. Taken together, male alpha-1 blocker users who had no comorbidity of BPH exhibited an increased risk for developing RCC independent of hypertension. Further study is warranted to elucidate the underlying mechanisms of this association.

Clinical Benefit of Tamsulosin and the Hexanic Extract of Serenoa Repens, in Combination or as Monotherapy, in Patients with Moderate/Severe LUTS-BPH: A Subset Analysis of the QUALIPROST Study

To investigate whether tamsulosin (TAM) and the hexanic extract of Serenoa repens (HESr) are more effective in combination than as monotherapy in men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). Subset analysis of data from a 6-month, multicenter observational study. Patients received either tamsulosin (0.4 mg/day) or HESr (320 mg/day) alone or in combination. Primary endpoints were change in symptoms and quality of life. Tolerability was also assessed. Seven hundred and nine patients were available for intention to treat (ITT) analysis, 263 treated with tamsulosin, 262 with HESr, and 184 with TAM + HESr. After 6 months, International Prostate Symptom Score (IPSS) scores improved by a mean (standard deviation) of 7.2 (5.0) points in the TAM + HESr group compared to 5.7 (4.3) points with TAM alone and 5.4 (4.6) points with HESr (p < 0.001). Quality of life showed greatest improvement with combination therapy (p < 0.02). Adverse effects were reported by 1.9% of patients receiving HESr, 13.3% receiving TAM, and 12.0% receiving TAM + HESr (p < 0.001). In men with moderate/severe LUTS/BPH, combination treatment with TAM + HESr produced more effective symptom relief and greater improvement in quality of life than with either treatment alone, with acceptable tolerability.

The role of novel minimally invasive treatments for lower urinary tract symptoms associated with benign prostatic hyperplasia.

To provide an update on novel minimally invasive lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) treatments in a non-systematic review. To define potential target populations for the various new minimally invasive treatments. Recent literature, meta-analyses and guideline recommendations for aquablation (AquaBeam® ; PROCEPT BioRobotics, Redwood City, CA, USA), water vapour thermal therapy (Rezūm® ; Boston Scientific, Natick, MA, USA), prostate artery embolisation (PAE), prostatic urethral lift (UroLift® ; NeoTract-Teleflex, Pleasanton, CA, USA) and the temporary implantable nitinol device [i-TIND® (nitinol butterfly-like stent ); Medi-Tate Ltd., Or-Akiva, Israel] were reviewed. Procedures that can be performed on an outpatient basis (Rezūm, PAE, UroLift and i-TIND) are not an alternative for the standard patient requiring BPH surgery. Their effect on urinary flow, post-void residual urine volume or bladder outlet obstruction is less pronounced than that of transurethral resection of the prostate (TURP). Yet, these options appear to be valuable for those patients unfit for surgery, men who want to avoid medical therapy in general, or those who want to avoid sexual side-effects associated with medical therapy or standard BPH surgery (e.g. TURP). Aquablation is the first successfully operationalised robotic resection system, especially for patients with prostates >50g. Nevertheless, long-term data are necessary for all novel, minimally invasive treatments. Better designed clinical trials, a clearer definition of target populations and a more realistic marketing allow a better characterisation of novel minimally invasive therapies for LUTS/BPH. It is hoped that some of these novel devices will stand the test of time, in contrast to the vast majority of their predecessors.

PD29-04 EVOLUTION OF HEALTHCARE COSTS FOR LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Epidemiology & Evaluation (PD29)1 Apr 2020PD29-04 EVOLUTION OF HEALTHCARE COSTS FOR LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA Charles Welliver*, Julia B. Ward, Lydia Feinstein, Kevin C. Abbott, Tamara Bavendam, Ziya Kirkali, Erline Martinez-Miller, Brian R. Matlaga, and Kevin McVary Charles Welliver*Charles Welliver* More articles by this author , Julia B. WardJulia B. Ward More articles by this author , Lydia FeinsteinLydia Feinstein More articles by this author , Kevin C. AbbottKevin C. Abbott More articles by this author , Tamara BavendamTamara Bavendam More articles by this author , Ziya KirkaliZiya Kirkali More articles by this author , Erline Martinez-MillerErline Martinez-Miller More articles by this author , Brian R. MatlagaBrian R. Matlaga More articles by this author , and Kevin McVaryKevin McVary More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000893.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Evolving management of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) has changed the distribution of healthcare spending. Our understanding of recent trends in LUTS/BPH management costs is incomplete given prior studies have been limited to older men, small datasets, and inpatient procedures. We characterized LUTS/BPH-related Medicare and private insurance expenditures over 10 years. METHODS: As part of the Urologic Diseases in America project, we analyzed two insurance claims databases: the Centers for Medicare & Medicaid Services Medicare 5% Sample for male Medicare beneficiaries aged ≥65 years with LUTS/BPH (N≈147,800 annually) and the Optum© de-identified Clinformatics® Data Mart Database (CDM) for privately insured males aged 40-64 years with LUTS/BPH (N≈100,300 annually). Annual LUTS/BPH-related expenditures from 2004-2013 were examined by service location: inpatient, hospital-based outpatient, and physician office. RESULTS: The average annual LUTS/BPH-related expenditures were $305 and $248 per LUTS/BPH patient in CDM and Medicare, respectively. Over the 10-year study period, inpatient care accounted for a decreasing percentage of total dollars spent on managing LUTS/BPH by Medicare (30% to 15%) and private insurance (37% to 15%). Outpatient LUTS/BPH-related expenditures rose for both insurer groups, especially for private insurance (61% to 83%). Expenditures for hospital-based outpatient care rose over the study period and exceeded physician office expenditures from 2007 onward for patients with private insurance, and from 2010 onward for Medicare patients (Figure). CONCLUSIONS: The distribution of healthcare expenditures for LUTS/BPH shifted across practice settings from 2004-2013, with increasing outpatient relative to inpatient expenditures. Hospital-based outpatient expenses exceeded physician office expenses, likely due to increased use of ambulatory surgical procedures for LUTS/BPH. In-office minimally invasive surgical therapies will likely lead to higher physician office costs in the future. Differences in expenditures between the study populations may be due to differential reimbursement practices between private insurance and Medicare. Source of Funding: Funded by the NIH via a contract to Social & Scientific Systems. © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e619-e619 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Charles Welliver* More articles by this author Julia B. Ward More articles by this author Lydia Feinstein More articles by this author Kevin C. Abbott More articles by this author Tamara Bavendam More articles by this author Ziya Kirkali More articles by this author Erline Martinez-Miller More articles by this author Brian R. Matlaga More articles by this author Kevin McVary More articles by this author Expand All Advertisement PDF downloadLoading ...

PD33-06 NATIONAL PRESCRIBING TRENDS IN LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA

INTRODUCTION AND OBJECTIVE: Lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) is a chronic disease causing significant morbidity and quality of life impairment among adult men. Pharmacotherapy is the most common initial intervention, but our current understanding of medication usage trends for LUTS/BPH is incomplete and prior studies have relied on limited datasets that have predominantly focused on older men. We assessed trends in the pharmacological management of LUTS/BPH among a national sample of men with private and Medicare insurance over an 8-year period. METHODS: As part of the Urologic Diseases in America project, two insurance claims databases were analyzed over the 2006-2013 study period: the Centers for Medicare & Medicaid Services Medicare (CMS) 5% Sample for an annual average of 105,180 male Medicare beneficiaries aged ≥65 years with LUTS/BPH and the Optum© de-identified Clinformatics® Data Mart Database (CDM) for an annual average of 104,766 privately insured males aged 40-64 years with LUTS/BPH. The percentage of patients receiving LUTS/BPH-related prescriptions was assessed annually over the study period and stratified by 5-year age groups. RESULTS: Use of prescription medications for LUTS/BPH increased throughout the study period (see Figure). The increase was greater for men with private insurance as compared to Medicare (14% vs 5% increase). The proportion of patients who filled prescriptions increased with increasing age, with up to 67% of LUTS/BPH patients aged 85+ years filling prescriptions in 2013. CONCLUSIONS: Over an 8-year study period, BPH was increasingly managed with pharmacotherapy. This increase was especially pronounced among younger men with private insurance. This analysis is unique in that the utilization of administrative claims data allowed for assessment of prescribing trends across different care delivery settings and among a large national sample of men as young as 40 years of age.Source of Funding: Funded by the NIH via a contract to Social & Scientific Systems.

PD33-04 COMPARISON OF MEDICATION PRESCRIBING FOR LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA AMONG SEXAGENARIANS WITH MEDICARE AND PRIVATE INSURANCE

INTRODUCTION AND OBJECTIVE: Medication use for lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) increases with patient age. However, little is known about prescribing patterns as men in their 60’s transition from private insurance to Medicare coverage. We characterized differences in LUTS/BPH medication prescribing patterns among a large, national sample of 60- to 69-year-olds. METHODS: As part of the Urologic Diseases in America project, two insurance claims databases were analyzed over the 2006-2013 study period: the Centers for Medicare & Medicaid Services Medicare (CMS) 5% Sample for Medicare beneficiaries and the Optum© de-identified Clinformatics® Data Mart Database (CDM) for privately insured adults. We compared patterns for LUTS/BPH prescription fills between privately insured men aged 60-64 years with LUTS/BPH (N≈38,300 annually) and Medicare beneficiaries aged 65-69 years with LUTS/BPH (N≈28,700 annually). CMS data for 2012 was unavailable. RESULTS: Prescribing of any LUTS/BPH medication was higher among Medicare beneficiaries (range: 50-55%) than among privately insured men (range: 41-49%), but there was a greater rise in prescribing over time for the privately insured group (17% vs. 5%). The largest difference in medication use was with α-blocker therapy, which was 20% higher on average in the Medicare group (range: 41-45%) compared to the privately insured group (range: 32-38%). Anticholinergic prescribing was uncommon (6% for Medicare vs. 3-4% for private insurance) and remained relatively steady over the study period. 5αRI prescribing increased up to 2010, then decreased in both groups, with a less pronounced decline among Medicare beneficiaries (9% vs. 14%). Tadalafil prescribing was more common in privately insured patients (5-8%) than among Medicare beneficiaries (0.1-3%). CONCLUSIONS: Overall, there was a rise in LUTS/BPH pharmacotherapy for sexagenarians from 2006-2013, with a greater rise among privately insured enrollees relative to Medicare beneficiaries. The decline in 5αRI prescribing correlates to the FDA “black box” warning on finasteride in 2011. Tadalafil coverage was rarely prescribed to Medicare beneficiaries.Source of Funding: Funded by the NIH via a contract to Social & Scientific Systems.

Information on surgical treatment of benign prostatic hyperplasia on YouTube is highly biased and misleading.

To assess the quality of videos on the surgical treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) available on YouTube, given that such video-sharing platforms are frequently used as sources of patient information and the therapeutic landscape of LUTS/BPH has evolved substantially during recent years. A systematic search for videos on YouTube addressing treatment options for LUTS/BPH was performed in May 2019. Measures assessed included basic data (e.g. number of views), grade of misinformation and reporting of conflicts of interest. The quality of content was analysed using the validated DISCERN questionnaire. Data were analysed using descriptive statistics. A total of 159 videos with a median (range) of 8570 (648-2384391) views were included in the analysis. Only 21 videos (13.2%) were rated as containing no misinformation, 26 (16.4%) were free of commercial bias, and two (1.3%) disclosed potential conflicts of interest. According to DISCERN, the median overall quality of the videos was low (2 out of 5 points for question 16). Only four of the 15 assessed categories (bipolar and holmium laser enucleation of the prostate, transurethral resection of the prostate and patient-based search terms) were scored as having moderate median overall quality (3 points). Most videos on the surgical treatment of LUTS/BPH on YouTube had a low quality of content, provided misinformation, were subject to commercial bias and did not report on conflicts of interest. These findings emphasize the importance of thorough doctor-patient communication and active recommendation of unbiased patient education materials.

PD29-07 DISPARITIES IN BPH PROGRESSION: PREDICTORS OF PRESENTATION TO THE EMERGENCY DEPARTMENT IN URINARY RETENTION

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Epidemiology & Evaluation (PD29)1 Apr 2020PD29-07 DISPARITIES IN BPH PROGRESSION: PREDICTORS OF PRESENTATION TO THE EMERGENCY DEPARTMENT IN URINARY RETENTION Parth M. Patel, Sarah E. Sweigert*, Marc Nelson, Gopal Gupta, Marshall Baker, Francois Modave, and Kevin T. McVary Parth M. PatelParth M. Patel More articles by this author , Sarah E. Sweigert*Sarah E. Sweigert* More articles by this author , Marc NelsonMarc Nelson More articles by this author , Gopal GuptaGopal Gupta More articles by this author , Marshall BakerMarshall Baker More articles by this author , Francois ModaveFrancois Modave More articles by this author , and Kevin T. McVaryKevin T. McVary More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000893.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (LUTS/BPH) is an age-related process that can progress to acute urinary retention (AUR). Currently, no studies have evaluated what groups of patients present to the ED with AUR, the regional distribution, or the socioeconomic and demographic factors therein. We utilized a population-level administrative dataset to retrospectively evaluate patients who presented to the emergency room with AUR secondary to BPH. METHODS: Using the Healthcare Cost and Utilization Project (HCUP) State Emergency Department Databases (SEDD), we conducted a retrospective cohort study of patients who presented to emergency departments in Florida between 2005 and 2015. Male patients above 45 years of age who presented with diagnosis codes for both AUR and LUTS/BPH were considered. Information was collected on age, race/ethnicity, primary insurance, and rural-urban commuting area (RUCA) codes. RESULTS: The mean age for patients presenting with AUR was 72.2 years, 10.6 years older than those presenting for non-urologic complaints (p < 0.001). A significantly higher proportion of AUR patients had Medicare insurance (68.9% versus 41.7%, p < 0.001). Greater proportions of the AUR patients belonged to urban RUCA codes (93.2% versus 91.3%, p < 0.001). On multivariable analysis adjusted for measured confounders, all covariates of interest demonstrated significance. The risk of presenting to the ED for AUR from LUTS/BPH increased with age, with the 75-85 year age-group at the highest risk (OR 15.96, p<0.001). Other factors associated with presentation to the ED with AUR included African-American (OR 1.15, p<0.001) or Hispanic (OR 1.75, p<0.001) race, Medicare (OR 1.27, p<0.001) or private (OR 1.33, p<0.001) insurance, and urban RUCA codes (OR 1.31, p<0.001). CONCLUSIONS: Male patients older than 45 who presented to the ED for AUR with BPH were more likely to be older, of non-white race, have Medicare or private insurance, and live in more urbanized areas. We surmise that African-American and Hispanic patients may be untreated or undertreated for BPH in the outpatient setting, resulting in an increased risk of presentation to the ED with AUR. Source of Funding: None © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e620-e620 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Parth M. Patel More articles by this author Sarah E. Sweigert* More articles by this author Marc Nelson More articles by this author Gopal Gupta More articles by this author Marshall Baker More articles by this author Francois Modave More articles by this author Kevin T. McVary More articles by this author Expand All Advertisement PDF downloadLoading ...

Randomised Clinical Trial of Prostatic Artery Embolisation Versus a Sham Procedure for Benign Prostatic Hyperplasia

BackgroundProstatic artery embolisation (PAE) has been associated with an improvement of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH), but conclusive evidence of efficacy from randomised controlled clinical trials has been lacking. ObjectiveTo assess the safety and efficacy of PAE compared with a sham procedure in the treatment of LUTS/BPH. Design, setting, and participantsA randomised, single-blind, sham-controlled superiority clinical trial was conducted in 80 males ≥45yr with severe LUTS/BPH refractory to medical treatment from 2014 to 2019 in a private clinic, with efficacy assessments at 6 and 12 mo after randomisation. One patient in the PAE group and three in the sham group did not complete the study. InterventionPatients were randomised 1:1 upon successful catheterisation of a prostatic artery to either PAE or a sham PAE procedure without embolisation. After 6 mo, all 38 patients randomised to the sham group who completed the single-blind period underwent PAE, and both groups completed a 6-mo open period. Outcome measurements and statistical analysisAn intention-to-treat analysis of all randomised patients was performed. The coprimary outcomes were the change from baseline to 6 mo in the International Prostate Symptom Score (IPSS) and the quality of life (QoL) score at 6 mo, analysed with analysis of covariance and t test, respectively. Results and limitationsMean age was 63.8±6.0yr, baseline IPSS 26.4±3.87, and QoL score 4.43±0.52. At 6 mo, patients in the PAE arm had a greater improvement in IPSS, with a difference in the change from baseline of 13.2 (95% confidence interval [CI] 10.2–16.2, p<0.0001), and a better QoL score at 6 mo (difference: 2.13; 95% CI 1.57–2.68, p<0.0001) than the patients in the sham arm. The improvements in IPSS and QoL in the sham group 6 mo after they performed PAE were, respectively, 13.6±9.19 (p<0.0001) and 2.05 ± 1.71 (p<0.0001). Adverse events occurred in 14 (35.0%) patients after PAE and in 13 (32.5%) after sham, with one serious adverse event in the sham group during the open period. No treatment failures occurred. Limitations include a single-centre trial, only severe LUTS/BPH, and follow-up limited to 12 mo. ConclusionsThe improvements in subjective and objective variables after PAE are far superior from those due to the placebo effect. Patient summaryClearly superior efficacy of prostatic artery embolisation (PAE) compared with a sham procedure was found in this study, which supports the use of PAE in patients with typical symptoms associated with benign prostatic hyperplasia.

Efficacy and safety of HT080 for lower urinary tract symptoms associated with benign prostatic hyperplasia

Background:Lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) are one of the most common conditions seen in middle-aged and elderly men and threaten their quality of life. Since conventional pharmacotherapy for LUTS/BPH can lead to sexual side effects, herbal therapies are widely used as complementary and alternative treatments worldwide. HT080 is an herbal extract of Cinnamomum cassia and Rosa Laevigata, both of which have been used to treat symptoms typically associated with BPH in traditional Asian medicine. The aims of this trial are to assess whether HT080 can alleviate LUTS/BPH in middle-aged and elderly men, and to investigate the safety of HT080.Methods/design:A double-blind, randomized, placebo-controlled, two-arm parallel group trial will be conducted in men with moderate LUTS/BPH. A total of 100 eligible men aged 40 to 75 years with an International Prostate Symptom Score of 8 to 19 will be randomized in a 1:1 ratio and receive either HT080 (500 mg) or placebo twice a day for 12 weeks. All participants will be evaluated for efficacy and safety at baseline and weeks 6 and 12. The primary endpoint is the change in International Prostate Symptom Score between baseline and week 12. The secondary efficacy variables are uroflowmetry parameters (maximal urinary flow rate and post-void residual volume), serum prostate-specific antigen, testosterone, and dihydrotestosterone levels, the International Index of Erectile Function score, and participant-reported global response assessment scores. The safety assessments include adverse events, laboratory tests results, vital signs, and physical examination.Discussion:This is a first-in human trial designed to investigate the efficacy and safety of HT080 among middle-aged and elderly men with LUTS/BPH. This prospective study with a double-blind randomized design will provide high-quality evidence supporting the use of HT080 for LUTS/BPH.Trial registration:Korean Clinical Research Information Service (KCT0004286) Registered September 6, 2019.

Efficacy and safety of a hexanic extract of Serenoa repens (Permixon® ) for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH): systematic review and meta-analysis of randomised controlled trials and observational studies.

To comprehensively evaluate the efficacy and safety of the hexanic extract of Serenoa repens (HESr, Permixon® ; Pierre Fabre Médicament, Castres, France), at a dose of 320mg daily, as monotherapy for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) and prospective observational studies in patients with LUTS/BPH identified through searches in Medline, Web of Knowledge (Institute for Scientific Information), Scopus, the Cochrane Library, and bibliographic references up to March 2017. Articles studying S.repens extracts other than Permixon were excluded. Data were collected on International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax ), nocturia, quality of life, prostate volume, sexual function, and adverse drug reactions (ADRs). Data obtained from RCTs and observational studies were analysed jointly and separately using a random effects model. A sub-group analysis was performed of studies that included patients on longer-term treatment (≥1year). Data from 27 studies (15 RCTs and 12 observational studies) were included for meta-analysis (total N = 5800). Compared with placebo, the HESr was associated with 0.64 (95% confidence interval [CI] -0.98 to -0.31) fewer voids/night (P < 0.001) and an additional mean increase in Qmax of 2.75mL/s (95% CI 0.57 to 4.93; P = 0.01). When compared with α-blockers, the HESr showed similar improvements on IPSS (weighted mean difference [WMD] 0.57, 95% CI -0.27 to 1.42; P = 0.18) and a comparable increase in Qmax to tamsulosin (WMD -0.02, 95% CI -0.71 to 0.66; P = 0.95). Efficacy assessed using the IPSS was similar after 6months of treatment between the HESr and 5α-reductase inhibitors (5ARIs). Analysis of all available published data for the HESr showed a mean improvement in IPSS from baseline of -5.73 points (95% CI -6.91 to -4.54; P < 0.001). HESr did not negatively affect sexual function and no clinically relevant effect was observed on prostate-specific antigen. Prostate volume decreased slightly. Similar efficacy results were seen in patients treated for ≥1year (n = 447). The HESr had a favourable safety profile, with gastrointestinal disorders being the most frequent ADR (mean incidence of 3.8%). The present meta-analysis, which includes all available RCTs and observational studies, shows that the HESr (Permixon) reduced nocturia and improved Qmax compared with placebo and had a similar efficacy to tamsulosin and short-term 5-ARI in relieving LUTS. HESr (Permixon) appears to be an efficacious and well-tolerated therapeutic option for the long-term medical treatment of LUTS/BPH.

Novel naftopidil derivatives containing methyl phenylacetate and their blocking effects on α1D/1A-adrenoreceptor subtypes

α1-Adrenoceptor (α1-AR) antagonists are considered to be the most effective monotherapy agents for lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). In this study, we synthesized compounds 2–17, which are novel piperazine derivatives that contain methyl phenylacetate. We then evaluated the vasodilatory activities of these compounds. Among them, we found that compounds 2, 7, 12, which contain 2-OCH3, 2-CH3 or 2, 5-CH3, respectively, exhibited potent α1-blocking activity similar to protype drug naftopidil (1). The antagonistic effects of 2, 7, and 12 on the (−)-noradrenaline-induced contractile response of isolated rat prostatic vas deferens (α1A), spleen (α1B) and thoracic aorta (α1D) were further characterized to assess the sub receptor selectivity. Compared with naftopidil (1) and terazosin, compound 12 showed the most desirable α1D/1A subtype selectivity, especially improved α1A subtype selectivity, and the ratios pA2 (α1D)/pA2 (α1B) and pA2 (α1A)/pA2 (α1B) were 17.0- and 19.5-fold, respectively, indicating less cardiovascular side effects when used to treat LUTS/BPH. Finally, we investigated the chiral pharmacology of 12. We found, however, that the activity of enantiomers (R)-12 and (S)-12 are not significantly different from that of rac-12.

002 Simulated Over-the-counter use of Tamsulosin by Men with Urinary Symptoms

Lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) are common in men, however, many remain undertreated. Hence, self-management with over-the-counter (OTC) drugs is helpful. The FDA requires a rigorous approval process for prescription (Rx)-to-OTC switches. Currently, tamsulosin is being evaluated for OTC use in men with bothersome urinary symptoms. In a simulated OTC setting, we assessed the ability of men interested in a self-management option to appropriately follow instructions in a proposed Drug Facts Label (label). We conducted a 6-month, open-label, uncontrolled study of tamsulosin 0.4mg capsules in men who responded to advertisements on an OTC treatment for bothersome urinary symptoms. The label included product purpose, directions for use, and instructions on when to stop use/ask a doctor. Primary endpoint was compliance with “Stop use and ask a doctor if” directions, with 2 a priori performance thresholds (upper bound of 95%CI ≤10% or ≤5%). Secondary endpoint was behavior of men who reported a symptom/condition in the “Ask a doctor before use” section. Pre-mitigated responses comprised as-observed responses from men who failed to heed the “Stop use and ask a doctor if” instruction. These cases were reviewed and the decisions switched to ‘appropriate’ if deemed so by 2 of 3 urologists; post-mitigated (post) responses comprised urologist-reviewed responses.

Efficacy and safety of tadalafil 5 mg once daily in the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia in men aged ≥75 years: integrated analyses of pooled data from multinational, randomized, placebo-controlled clinical studies.

To assess efficacy and safety of tadalafil in men aged ≥75 years with lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) and additional safety in men aged ≥75 years with erectile dysfunction (ED). We conducted an integrated analysis of 12 phase II-III randomized, double-blind and/or open-label extension studies to evaluate short-term (12-26 weeks) efficacy and short- and longer-term (42-52 weeks) safety in men aged <75 years vs men aged ≥75 years. All men received once-daily tadalafil 5 mg or placebo. The efficacy outcome was International Prostate Symptom Score (IPSS). Safety measurements included treatment-emergent adverse events (TEAEs), adverse events (AEs) leading to discontinuation, serious AEs (SAEs), and cardiovascular AEs. All analyses were intention-to-treat. Changes from baseline to efficacy endpoint and differences in changes between treatment groups were estimated as least-squares means using analysis of covariance models. Change in the mean IPSS was significantly different in men aged <75 years vs those aged ≥75 years across tadalafil and placebo groups (treatment-by-age interaction P = 0.034). Tadalafil was not statistically significantly better than placebo in men aged ≥75 years, but effect size varied between studies. Maintenance of efficacy with tadalafil was observed across age groups. Short-term tadalafil safety findings for men aged <75 vs ≥75 years included: TEAEs (52 [33.8%] vs 503 [30.1%]), AEs leading to discontinuation (3 [1.9%] vs 50 [3.0%]), SAEs (4 [2.6%] vs 15 [0.9%]) and cardiovascular AEs (4 [2.6%] vs 30 [1.8%]). Long-term tadalafil safety data did not reveal clinically relevant differences between age groups. Limitations include exclusion of men with serious co-existing conditions and limited sample sizes of men aged ≥75 years. Efficacy with once-daily tadalafil 5 mg in the treatment of LUTS/BPH differed between men aged <75 vs ≥75 years, with significant efficacy in the <75-year age group. The older age group had more concomitant diseases and used more drugs, which may have reduced efficacy. The small sample size precluded uni-/multivariate analyses to assess plausible interference from confounding factors. Tadalafil had a reassuring safety profile and no evidence of increased cardiovascular AEs in aging men.