Abstract
Abstract Introduction While penile prosthesis implantation (PPI) is a recommended treatment option per the American Urological Association for men with erectile dysfunction (ED), there are a limited number of urologists performing PPI procedures in the US. Objective This study quantified the number of US men with ED and projected the number of potential candidates for PPI in 2022. Methods An excel-based disease-impact model was constructed using a top-down estimation approach based on two age groups for ED: 18-64 and ≥65 years old. The starting US male population was extracted from the 2022 US Census after the removal of age-specific mortality rates obtained from the National Vital Statistics Reports. Only men who subscribed to public or private health insurance were included in the model using insurance status data from the US Census. ED prevalence rates were obtained from administrative claims data analyses (IBM® MarketScan® Commercial Database [18-64 years] and 5% Medicare Standard Analytical Files [≥65 years]) using relevant International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis codes to calculate a base-case estimate of men with ED. To quantify the number of PPI candidates, the rate of men with ED but without ED treatment was obtained from the claims data and combined with the proportion of men with moderate-to-severe ED obtained from published research. The ED prevalence obtained from the administrative claims data analyses reflects a documented diagnosis of ED, which may underestimate the actual US prevalence of ED. Therefore, scenario analyses were conducted using patient-reported ED prevalence data obtained from a literature search of Medline. Results Using the ED prevalence obtained from the administrative claims data analyses, an estimated 8.3% of insured men (8,882,548 aged 18-64 and 1,419,992 aged ≥65) had a diagnosis of ED from 124,318,519 eligible US men aged ≥18 in 2022. The base-case estimate using claims data for the untreated ED rate and published literature for the proportion with moderate-to-severe ED showed 17.1% of men with an ED diagnosis claim could benefit from PPI (1,759,248 men aged ≥18). The literature review for the scenario analyses identified 11 publications from 2000 to 2020 with patient-reported ED prevalence. ED prevalence was assessed using different methods: International Index of Erectile Function (IIEF; 3 publications, 27.3%), Massachusetts Male Aging Study (MMAS)-derived questionnaire (3 publications, 27.3%), and other patient self-reported questionnaires (5 publications, 45.5%). Patient self-reported ED prevalence across all ages ranged from 5.1% to 70.2%. Applying the patient self-reported ED prevalence range to the scenario analyses, it was found that as many as 13,436,363 men in the US with ED could benefit from PPI. Conclusions From this disease-impact model, the estimated number of US men with ED is 124,318,519 as of 2022. Between 1.7 and 13.4 million of these men could potentially benefit from PPI. Ensuring sufficient penile prosthesis implanters could mitigate the potential physical, emotional, and social burden of untreated ED. Disclosure Yes, this is sponsored by industry/sponsor: Boston Scientific Clarification Industry initiated, executed and funded study Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific
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