Evolution of healthcare costs for lower urinary tract symptoms associated with benign prostatic hyperplasia.

PURPOSE: With the ubiquity of lower urinary tract symptoms due to benign prostatic hyperplasia (LUTS/BPH) in older men, costs related to this highly prevalent disease are likely significant but not well defined. With this study, we hoped to define costs related to LUTS/BPH care. METHODS: We utilized the Optum© de-identified Clinformatics® Data Mart Database (CDM) for privately insured male enrollees aged 40-64 years with LUTS/BPH (N ≈ 100,300 annually) and the Centers for Medicare and Medicaid Services Medicare 5% Sample for male beneficiaries aged 65 + years with LUTS/BPH (N ≈ 147,800 annually). Annual LUTS/BPH-related expenditures from 2004 to 2013 were age standardized and calculated overall and by age and service location. RESULTS: The Medicare cohort demonstrated a 23% increase in total costs over the study period with a 28% decrease in CDM costs. Decreases in inpatient hospital charges (45% for Medicare, 55% for CDM) were offset by increasing hospital-based outpatient fees (120% for Medicare, 87% for CDM). Overall, we estimated a total cost of at least $1.9 billion for treatment of men with LUTS/BPH for 2013. Per person expenditures increased with age within cohorts with an average per-person cost of $269 (CDM) and $248 (Medicare) in 2013. CONCLUSION: The distribution of healthcare expenditures for LUTS/BPH shifted across practice settings from 2004 to 2013, with increasing outpatient relative to inpatient expenditures. Total direct costs for LUTS/BPH in 2013 were at least $1.9 billion, not accounting for indirect costs or certain unmeasured populations.

A comprehensive analysis of clinical, quality of life, and cost-effectiveness outcomes of key treatment options for benign prostatic hyperplasia.

Treatment options for men with moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) have variable efficacy, safety, and retreatment profiles, contributing to variations in patient quality of life and healthcare costs. This study examined the long-term cost-effectiveness of generic combination therapy (CT), prostatic urethral lift (PUL), water vapor thermal therapy (WVTT), photoselective vaporization of the prostate (PVP), and transurethral resection of the prostate (TURP) for the treatment of BPH. A systematic literature review was performed to identify clinical trials of CT, PUL, WVTT, PVP, and TURP that reported change in International Prostate Symptom Score (IPSS) for men with BPH and a prostate volume ≤80 cm3. A random-effects network meta-analysis was used to account for the differences in patient baseline clinical characteristics between trials. An Excel-based Markov model was developed with a cohort of males with a mean age of 63 and an average IPSS of 22 to assess the cost-effectiveness of these treatment options at 1 and 5 years from a US Medicare perspective. Procedural and adverse event (AE)-related costs were based on 2021 Medicare reimbursement rates. Total Medicare costs at 5 years were highest for PUL ($9,580), followed by generic CT ($8,223), TURP ($6,328), PVP ($6,152), and WVTT ($2,655). The total cost of PUL was driven by procedural ($7,258) and retreatment ($1,168) costs. At 5 years, CT and PUL were associated with fewer quality-adjusted life years (QALYs) than WVTT, PVP, and TURP. Compared to WVTT, the incremental cost-effectiveness ratios (ICERs) for both TURP and PVP were above a willingness-to-pay threshold of $50,000/QALY (TURP: $64,409/QALY; PVP: $87,483/QALY). This study provides long-term cost-effectiveness evidence for several common treatment options for men with BPH. WVTT is an effective and economically viable treatment in resource-constrained environments.

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 nonrepresentative 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 to 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.

Assessment of Frailty and Association With Progression of Benign Prostatic Hyperplasia Symptoms and Serious Adverse Events Among Men Using Drug Therapy.

Importance: Benign prostatic hyperplasia (BPH) in older men can cause lower urinary tract symptoms (LUTS), which are increasingly managed with medications. Frailty may contribute to both symptom progression and serious adverse events (SAEs), shifting the balance of benefits and harms of drug therapy. Objective: To assess the association between a deficit accumulation frailty index and clinical BPH progression or SAE. Design, Setting, and Participants: This cohort study used data from the Medical Therapy of Prostatic Symptoms trial, which compared placebo, doxazosin, finasteride, and combination therapy in men with moderate-to-severe LUTS, reduced urinary flow rate, and no prior BPH interventions, hypotension, or elevated prostate-specific antigen. Enrollment was from 1995 to 1998, and follow-up was through 2001. Data were assessed in February 2021. Exposures: A frailty index (score range, 0-1) using 68 potential deficits collected at baseline was used to categorized men as robust (score ≤0.1), prefrail (score 0.1 to <0.25), or frail (score ≥0.25). Main Outcomes and Measures: Primary outcomes were time to clinical BPH progression and time to SAE, as defined in the parent trial. Adjusted hazard ratios (AHRs) were estimated using Cox proportional hazards regressions adjusted for demographic variables, treatment group, measures of obstruction, and comorbidities. Results: Among 3047 men (mean [SD] age, 62.6 [7.3] years; range, 50-89 years) in this analysis, 745 (24%) were robust, 1824 (60%) were prefrail, and 478 (16%) were frail at baseline. Compared with robust men, frail men were older (age ≥75 years, 12 men [2%] vs 62 men [13%]), less likely to be White (646 men [87%] vs 344 men [72%]), less likely to be married (599 men [80%] vs 342 men [72%]), and less likely to have 16 years or more of education (471 men [63%] vs 150 men [31%]). During mean (SD) follow-up of 4.0 (1.5) years, the incidence rate of clinical BPH progression was 2.2 events per 100 person-years among robust men, 2.9 events per 100 person-years among prefrail men (AHR, 1.36; 95% CI, 1.02-1.83), and 4.0 events per 100 person-years among frail men (AHR, 1.82; 95% CI, 1.24-2.67; linear P = .005). Larger point estimates were seen among men who received doxazosin or combination therapy, although the test for interaction between frailty index and treatment group did not reach statistical significance (P for interaction = .06). Risk of SAE was higher among prefrail and frail men (prefrail vs robust AHR, 1.81; 95% CI, 1.48-2.23; frail vs robust AHR, 2.86; 95% CI, 2.21-3.69; linear P < .001); this association was similar across treatment groups (P for interaction = .76). Conclusions and Relevance: These findings suggest that frailty is independently associated with greater risk of both clinical BPH progression and SAEs. Older frail men with BPH considering initiation of drug therapy should be counseled regarding their higher risk of progression despite combination therapy and their likelihood of experiencing SAEs regardless of treatment choice.

The rising worldwide impact of benign prostatic hyperplasia.

OBJECTIVES: To describe the trend in the impact of lower urinary tract symptoms attributed to benign prostatic hyperplasia (LUTS/BPH) on a global scale using the Global Burden of Disease (GBD) database. MATERIALS AND METHODS: Using the GBD database, worldwide data aggregated from registries and health systems from 1990 to 2017 were filtered for LUTS/BPH diagnoses. Calculation of years lived with disability (YLD) were compared with other urological diseases. YLD were calculated by a standardized method using assigned disability weights. The GBD-defined sociodemographic index (SDI) was used to assess impact of LUTS/BPH by global SDI quintile. RESULTS: Global Burden of Disease data over the 1990-2017 study period were summarized and global numbers and trends noted with other urological diseases for comparison. A total of 2 427 334 YLD were attributed to BPH in 2017 alone, almost three times more than those attributed to the next highest urological disease, prostate cancer (843 227 YLD). When stratified by SDI quintile, a much lower impact of BPH was found in the bottom three quintiles, despite this subset representing 66.9% of the 2017 world population. CONCLUSIONS: Lower urinary tract symptoms attributed to benign prostatic hyperplasia exert a rapidly rising human burden far exceeding other urological diseases. As the population ages and men in a lower SDI enjoy increased life expectancy and decreased competing mortalities, a continually accelerating wave of LUTS/BPH can be forecast. These epidemiological trends have serious implications for the future allocation of resources and the global urological workforce.

Penile Prosthesis Implantation and Timing Disparities After Radical Prostatectomy: Results From a Statewide Claims Database.

BACKGROUND: Many patients with erectile dysfunction (ED) after radical prostatectomy (RP) improve with conservative therapy but some do not; penile prosthesis implantation rates have been sparsely reported, and have used nonrepresentative data sets. AIM: To characterize rates and timing of penile prosthesis implantation after RP and to identify predictors of implantation using a more representative data set. METHODS: The Healthcare Cost and Utilization Project State Inpatient and State Ambulatory Surgery databases for Florida from 2006 to 2015 were used. Patients undergoing RP (2006-2012) were tracked longitudinally for penile prosthesis implantation. Patient and clinical data were analyzed using multivariable logistic regression. OUTCOMES: The primary outcome was risk-adjusted predictors of prosthesis implantation, and the secondary outcome was predictors of the highest quartile of time between RP and penile prosthesis. RESULTS: Of 29,288 men who had RP, 1,449 (4.9%) patients underwent subsequent prosthesis. The mean time from RP to prosthesis was 2.6 years (median: 2.1; interquartile range [IQR]: 1.2-3.5). Adjusted predictors of prosthesis implantation included open RP (odds ratio [OR]: 1.5, P < .01), African American race (OR: 1.7, P < .01) or Hispanic ethnicity (OR: 3.2, P < .01), and Medicare (OR: 1.4, P < .01) insurance. Oler patients (age >70 years; OR: 0.7, P < .01) and those from the highest income quartile relative to the lowest (OR: 0.8, P < .05) were less likely to be implanted. Adjusted predictors of longer RP-to-implantation time (highest quartile: median: 4.7 years; IQR: 3.9-6.0 years) included open RP (OR: 1.78, P < .01), laparoscopic RP (OR: 4.67, P < .01), Medicaid (OR: 3.03, P < .05), private insurance (OR: 2.57, P < .01), and being in the highest income quartile (OR: 2.52, P < .01). CLINICAL IMPLICATIONS: These findings suggest ED treatment healthcare disparities meriting further investigation; upfront counseling on all ED treatment modalities and close monitoring for conservative treatment failure may reduce lost quality of life years. STRENGTHS & LIMITATIONS: This study is limited by its use of administrative data, which relies on accurate coding and lacks data on ED questionnaires/prior treatments, patient-level cost, and oncologic outcomes. Quartile-based analysis of income and time between RP and prosthesis limits the conclusions that can be drawn. CONCLUSION: Less than 5% of post-RP patients undergo penile prosthesis implantation, with open RP, Medicare, African American race, and Hispanic ethnicity predicting post-RP implantation; living in the wealthiest residential areas predicts lower likelihood of implantation compared to the least wealthy areas. Patients with the longest time between RP and prosthesis are more likely to live in the wealthiest areas or have undergone open/laparoscopic RP relative to robotic RP. Bajic P, Patel PM, Nelson MH, et al. Penile Prosthesis Implantation and Timing Disparities After Radical Prostatectomy: Results From a Statewide Claims Database. J Sex Med 2020;17:1175-1181.

A novel metric for treatment durability in clinical trials of minimally invasive treatments for benign prostatic hyperplasia.

Introduction: Clinical trial manuscripts commonly report results of individual endpoints. However, durability of a medical treatment may be difficult to determine when evaluating endpoint outcomes individually. We reviewed pivotal trial manuscripts of two minimally invasive benign prostatic hyperplasia (BPH) treatments and estimated the rate of treatment durability using a composite, symptom-centric metric.Methods: Data were derived from published pivotal trial reports of two minimally invasive BPH treatments - water vapor thermal therapy (WVTT) and prostatic urethral lift (PUL). We estimated the risk of medical or surgical retreatment using life-table methods, and the number of patients achieving the minimal clinically important difference (MCID) for the International Prostate Symptom Score (IPSS) using z-score methods. Treatment durability was defined as a MCID on the IPSS at the 4-year follow-up visit while free from medical or surgical retreatment.Results: Comparing WVTT to PUL, the rate of medical or surgical retreatment was 10.6% vs. 31.8%, the IPSS MCID was achieved in 82.2% vs. 79.5%, and treatment durability rates were 71.8% vs. 51.7%.Conclusions: Utilization of a composite treatment durability metric derived from endpoints commonly reported in the BPH literature may allow patients and their providers to make better informed treatment decisions.

Trends in Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia, 2004 to 2013: the Urologic Diseases in America Project.

PURPOSE: Our current understanding of recent trends in the management of lower urinary tract symptoms associated with benign prostatic hyperplasia is incomplete, particularly in younger men. The 2018 Urologic Diseases in America Project attempted to fill this gap by analyzing multiple large administrative claims databases which include men of all ages and permit longitudinal followup. To our knowledge we report these findings for the first time in the scientific literature. MATERIALS AND METHODS: The 2 data sources used in this study included the de-identified Optum® Clinformatics® Data Mart database for men 40 to 64 years old and the Medicare 5% Sample for men 65 years old or older. To assess trends in lower urinary tract symptoms/benign prostatic hyperplasia related medication prescriptions and surgical procedures from 2004 to 2013 we created annual cross-sectional cohorts and a longitudinal cohort of patients with incident lower urinary tract symptoms/benign prostatic hyperplasia and 5 years of followup. RESULTS: The use of medications related to lower urinary tract symptoms/benign prostatic hyperplasia increased with age, particularly among men 40 to 60 years old. While medication use increased with time, surgical procedures decreased. Increasing age correlated with a higher rate of surgical procedures in the longitudinal cohort. Younger men were more likely to elect treatments of lower urinary tract symptoms/benign prostatic hyperplasia which reportedly optimize sexual function. CONCLUSIONS: Medication use increased and surgery decreased during the study period. Treatment approaches to lower urinary tract symptoms/benign prostatic hyperplasia varied greatly by patient age. While the minority of men in the fifth and sixth decades of life required treatment, a sharp increase in treatment use was seen between these decades. Younger men were more likely to elect less invasive surgical options. Future studies of lower urinary tract symptoms/benign prostatic hyperplasia should focus on age specific treatment selection.

30-day all-cause hospital readmission after cystectomy: no worse for rural Medicare residents.

OBJECTIVE: To evaluate rural/urban disparities in 30-day all-cause hospital admission after cystectomy. MATERIALS AND METHODS: We used the SEER-Medicare database to identify all Medicare beneficiaries who underwent radical cystectomy (ICD-9 codes 57.7, 57.71, 57.79, and 68.8) between the years 1991 and 2009, yielding a total sample size of 15,572. Our primary outcome was 30-day hospital readmission rate. Rural Urban Continuum Codes were used to designate county-level rural status based on patient residence. Location of surgery was not a variable considered in this analysis. A multivariable regression model was constructed with demographic and clinical variables as covariates. RESULTS: A total of 2,003 rural and 2,904 urban patients (31.1% vs. 31.8%, P = 0.33) were readmitted within 30 days of discharge. In the multivariable model, older age, unmarried status, lower socioeconomic status, higher Charlson comorbidity score, shorter index admission hospital stay, and discharge to a skilled nursing facility were associated with higher odds of readmission. The variables for gender, race, cancer stage, tumor grade, and type of urinary diversion were not significant. The odds ratio for readmission was not significant for patients from rural counties in the final model. CONCLUSIONS: Rural Medicare residents were not at higher risk for 30-day all-cause hospital readmission after cystectomy after accounting for various demographic and clinical variables.

Undertreatment of erectile dysfunction: claims analysis of 6.2 million patients.

INTRODUCTION: Prior research conducted on treatment of erectile dysfunction (ED) has been derived from surveys involving relatively small populations of men. There are needs for large population-based studies in this area. Our study addresses that need. AIM: The aim of this study was to characterize ED treatment among a large population of men. METHODS: Patients ≥30 years in commercial insurance dataset with diagnosis code for ED during 12-month period ending June 2011 were identified. Men were considered "treated" if prescription was filled for phosphodiesterase type 5 inhibitor (PDE5i), injection or urethral prostaglandins, or androgen replacement (ART) during study period. "Untreated" patients received the diagnosis but did not fill prescription. Statistical analyses were used to compare prescription frequency with clinical characteristics, including age and comorbidities. MAIN OUTCOME MEASURES: ED treatment rates among large population of insured men, treatment types employed, patient demographics, associated medical comorbidities of this population, and prescriber details were the main outcome measures. RESULTS: Only 25.4% of 6,228,509 men with ED were treated during study period. While PDE5is were the most commonly prescribed medical therapy (75.2%), ART was utilized as monotherapy or in combination therapy in 30.6% of men. ART was significantly (P < 0.0001) more frequently used in men <40 and >65 years. Although ED frequency was associated with increased age and number of comorbidities, men >60 years were significantly (P < 0.0001) less likely to be treated compared with men aged 40-59 years. Additionally, treatment frequency did not vary as a function of number of comorbidities. However, compared with men with prostate cancer, men with comorbid hypogonadism, sleep disorders, benign prostatic hyperplasia, or components of metabolic syndrome were (P < 0.0001) more likely to be treated. CONCLUSIONS: Despite high prevalence of ED with age and comorbidities, most men continue receiving no treatment. Although benefits of medical intervention for ED are well-recognized, many barriers to treatment continually exist including physician, patient and partner preference and knowledge.

Ensuring comprehensive assessment of urinary problems in prostate cancer through patient-physician concordance.

OBJECTIVES: To examine the concordance between clinicians and men diagnosed with prostate cancer on a clinician-derived pathophysiological classification of the following self-reported urinary complications: storage (irritative), voiding (obstructive), and leakage/incontinence. MATERIALS AND METHODS: Fourteen urology experts classified 37 urinary function questionnaire items into 3 primary conceptual dimensions (e.g., storage [irritative], voiding [obstructive] and urinary leakage/incontinence) that would best reflect each item's content. In addition, 218 patient participants provided responses to the 37 items. Using classifications by experts to develop the conceptual framework, the structure was tested using confirmatory factor analyses with patient data. RESULTS: Expert consensus was achieved in the classification of 31 out of 37 items. Using the 3-factor conceptual framework and patient data, the fit indices for the overall correlated factor model suggested an acceptable overall model fit. The analyses of the separate domains showed acceptable fit for the storage/irritative domain and the leaking/incontinence domain. The dimensionality of the voiding/obstructive domain was too difficult to estimate. CONCLUSIONS: Our analysis found items that conceptually and psychometrically support 2 constructs (leaking/incontinence and storage/irritative). The consistency of this support between the groups suggests a clinical relevance that is useful in treating patients. We have conceptual support for a third hypothesis (voiding/obstructive), although there were too few items to assess this psychometrically. Relative motivating factors of bother and urinary complaints were not addressed and remain an unmet need in this field.

Nationwide emergency department visits for priapism in the United States.

INTRODUCTION: The epidemiology of priapism is not well characterized. A small number of studies based on inpatient data or small population samples have estimated the incidence to range from 0.34 to 1.5 cases per 100,000 males. AIM: To estimate the current epidemiology and impact on resource utilization of priapism in the United States (US). MAIN OUTCOME MEASURES: Rate of emergency department encounters for priapism in the US. METHODS: Emergency department (ED) visits for priapism were analyzed using discharge data from the Nationwide Emergency Department Sample (NEDS), Healthcare Cost and Utilization Project (HCUP). Priapism encounters were identified by ICD9 code. Priapism encounters were analyzed for patient and hospital characteristics, associated diagnoses, and hospital charge. Established weighting in the sample was used to calculate nationwide estimates. RESULTS: A total of 8,738 ED encounters for priapism were identified between 2006 and 2009 in the NEDS. This translated to an estimated 39,964 encounters out of a total of 496,195,793 ED visits, or 8.05 per 100,000 ED visits (95% confidence interval [CI] 7.59-8.51). 21.1% of patients had a concurrent diagnosis of sickle cell disease (SCD). 72.1% of all patients were discharged home from the ED, while only 49.6% of patients with SCD were discharged home. A concurrent diagnosis of SCD was associated with an odds ratio (OR) of 3.84 (95% CI 3.65-4.05) for admission to the hospital when controlling for age, region, hospital and payer type. The mean hospital charge was $1,778 per encounter if discharged home and $41,909 per encounter if admitted. The estimated mean total annual charge for priapism was $123,860,432 with 86.8% of charges attributed to inpatient admissions. CONCLUSIONS: Our estimate of the rate of ED visits for priapism was significantly higher than prior estimates with a SCD concurrence rate lower than previously estimated.

Identifying patients with benign prostatic hyperplasia through a diagnosis of, or treatment for, erectile dysfunction.

OBJECTIVE: Erectile dysfunction (ED) and lower urinary tract symptoms (LUTS) associated with benign prostate hyperplasia (BPH) are highly correlated. This study examined rates of screening, diagnosis, and treatment of BPH/LUTS among men seeking care for ED. RESEARCH DESIGN AND METHODS: This was a retrospective US claims data analysis (1999-2004) evaluating men > or = 40 years old with a new diagnosis of or prescription medication for ED. Multivariate analyses were used to examine times to screening, diagnosis, and treatment. RESULTS: 81 659 men with ED were identified (mean age 57 years). The baseline prevalence of recorded BPH was 1.5%. During the follow-up period (mean 2.2 years), 7.6% had documented BPH. Time to screening was shorter among patients seeing urologists (121.1 days) compared with those seeing primary-care physicians (282.2 days). Controlling for demographic and clinical characteristics, patients who saw a urologist were more likely to be screened (OR: 2.4, p < 0.0001), diagnosed with BPH (OR: 1.8, p < 0.0001), and treated (OR: 1.3, p < 0.0001), relative to patients seeing other providers. Men aged 75 and over were 43% less likely to be screened (p < 0.0001), but 5.4 times more likely to be diagnosed with BPH (p < 0.0001) and 5.3 times more likely to be treated (p < 0.0001) compared with men aged 40-49. CONCLUSIONS: Screening for BPH appears less likely for men with ED who do not see a urologist. When screening does occur, it takes much longer with non-specialty providers. Patient age and provider specialty are key factors associated with screening, diagnosis, and treatment of BPH among men with ED.