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Since its FDA approval in 2015, over 220,000 men worldwide have been treated with a polyethylene glycol (PEG) hydrogel spacer for prostate cancer. The factors influencing its widespread use are complex and may vary across different patient, provider, and facility characteristics. This study aims to characterize the use of the PEG hydrogel spacer within a US hospital database for patients with prostate cancer planned to receive definitive radiation therapy over time. A cross-sectional analysis was conducted using the Premier PINC AI™ Healthcare Database, a real-world dataset containing approximately one-fifth of hospital facilities in the US. Men aged ≥18 who received a PEG hydrogel spacer, identified using charge master codes, between 2017 and 2022, were included in the study. Patient and practice characteristics, based on procedural dates during the study period, were identified and reported annually to demonstrate temporal changes over the 6-year period. The chi-square test examined differences in characteristics between 2017 and 2022. In 2017, a total of 693 patients who received PEG hydrogel spacers while 2,510 patients were identified in 2022, reflecting a 262% change. Over 6 years, the Midwest experienced the largest increase in the crude number of patients, while the West had the smallest change. Between 2017-2022, the proportion of White men receiving the spacers increased from 63% to 79%, while the proportion of Black men changed from 25% to 16% (p < 0.001). In 2017, community practices performed 69% of total spacer volume and performed majority of spacers until 2018. Thereafter academic practices became the majority practice, and by 2022 comprised 67% of spacers placed. Urology and radiation oncology have consistently been the primary specialties, accounting for over 95% of spacer procedures. The use of PEG hydrogel spacers has increased in the US irrespective of analyzed patient and practice factors. This growth has comparably increased within both radiation oncology and urology specialties. The slower adoption of spacers specifically in Black patients and community practices requires further investigation into barriers and drivers of this observed disparity. [ABSTRACT FROM AUTHOR]

Increasingly, polyethylene glycol (PEG) hydrogel spacers are being utilized to help reduce rectal toxicity in men undergoing radiotherapy for prostate cancer. Previously published analyses of PEG hydrogel spacers using the Manufacturer and User Facility Device Experience (MAUDE) passive surveillance database have not taken into account the real-world volume of spacers placed as part of standard of care following approval. To contextualize the MAUDE reports for the spacers, we assessed the device-related issues and patient event rates from the database, factoring in a conservative estimate of total spacer units used in the US. The MAUDE database was queried for all medical device reports related to PEG hydrogel spacers using trade and generic names from January 2019 to September 2023 (the "Study Period"). Frequencies of reported device problems or patient events were calculated. We used a conservative estimate of total units sold in the US retrieved from the manufacturer to serve as a proxy for the number of patients receiving the spacers; sales numbers do not directly represent the actual number of patients undergoing spacer procedures. The rates of device issues and patient events were then determined by dividing total reports by total spacer units sold. A total of 1,088 reports were analyzed for PEG hydrogel spacers compared with an estimated 200,000 units sold, resulting in an overall report rate per unit sold of 0.54%, ranging from 0.27% to 0.64% during the Study Period. The most frequently reported device issues were placement/positioning problem (778 reports; 0.39% of total units sold) and 'adverse event without identified device or use problem' (233 reports; 0.12% of total units sold). The most frequently reported AEs indicated 'no clinical signs, symptoms, or conditions' (436 reports; 0.22% of total units sold) and 'pain/discomfort' (300 reports; 0.15% of total units sold). Approximately 60% of the total device issues with placement/positioning problems had 'no clinical signs, symptoms, or conditions' and 'no consequences or impact to patient' (462 reports; 0.23% of total units sold). This analysis shows that with respect to estimated device usage, overall device-related problems and event rates for PEG hydrogel spacers consistently remained below 1%, with a majority having little or no reported clinical consequence. Although still a valuable source of information, given the known limitations of MAUDE, additional real-world evidence may help support making informed decisions involving the incorporation of this technology into prostate cancer treatment to potentially mitigate rectal toxicity in men undergoing radiotherapy for prostate cancer. [ABSTRACT FROM AUTHOR]

We evaluated depression-related health care resource utilization and antidepressant prescription medication utilization among commercially insured men in the United States who underwent inflatable penile prosthesis (IPP) implantation between January 1, 2007 and December 31, 2020, and who received a depression diagnosis in the year preceding the IPP procedure. A total of 11,177 patients received an IPP during the index period, 808 of whom were diagnosed with depression. A statistically significant reduction in overall depression-related health care visits occurred from pre- to post-IPP, decreasing from 4.9 to 3.8, p < .001. In addition, there was a significant reduction in depression-related inpatient visits (0.07 vs. 0.03, p = .02) and office visits (4.25 vs. 3.29, p < .001) from pre- to post-IPP. Of the 678 men who received an antidepressant medication within 1 year prior to their IPP date, 15% stopped antidepressant medication use entirely post-IPP. Among patients with continued antidepressant medication use post-IPP ( n = 574), there was a significant decrease in the number of prescriptions (7.55 vs. 8.09, p < .0001) and refills (7.52 vs. 8.11, p = .0015), with a higher likelihood of discontinuation (17.6% vs. 10.5%, p < .0001) and a lower proportion of days covered (0.79 vs. 0.83, p = .0004) post-IPP compared with pre-IPP. In conclusion, IPP was associated with reduced depression-related health care utilization and antidepressant medication use among recipients. This suggests potential mental health benefits for IPP recipients beyond restoration of erectile function. Comprehensive insurance coverage for IPP, especially for men with depression, may be beneficial to both patients and insurers., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: A.M.M. and S.R. are full-time employees of, and shareholders in, Boston Scientific. Y.E.S. is a graduate student who is working on a Global Health Economics and Market Access project with Boston Scientific. R.R. is a consultant for and grant recipient of Boston Scientific. T.K., R.G., S.N., and F.P. have no relevant disclosures to report.

Introduction: Diffusion of Innovation Theory explains how ideas or products gain momentum and diffuse (or spread) through specific populations or social systems over time. The theory analyzes primary influencers of the spread of new ideas, including the innovation itself, communication channels, time, and social systems. Methods: The current study reviewed published medical literature to identify studies and applications of artificial intelligence (AI) in endourology and used E.M. Rogers' Diffusion of Innovation Theory to analyze the primary influencers of the adoption of AI in endourological care. The insights gained were triaged and prioritized into AI application-related action items or "tips" for facilitating the appropriate diffusion of the most valuable endourological innovations. Results: Published medical literature indicates that AI is still a research-based tool in endourology and is not widely used in clinical practice. The published studies have presented AI models and algorithms to assist with stone disease detection ( n = 17), the prediction of management outcomes ( n = 18), the optimization of operative procedures ( n = 9), and the elucidation of stone disease chemistry and composition ( n = 24). Five tips for facilitating appropriate adoption of endourological AI are: (1) Develop/prioritize training programs to establish the foundation for effective use; (2) create appropriate data infrastructure for implementation, including its maintenance and evolution over time; (3) deliver AI transparency to gain the trust of endourology stakeholders; (4) adopt innovations in the context of continuous quality improvement Plan-Do-Study-Act cycles as these approaches have proven track records for improving care quality; and (5) be realistic about what AI can/cannot currently do and document to establish the basis for shared understanding. Conclusion: Diffusion of Innovation Theory provides a framework for analyzing the influencers of the adoption of AI in endourological care. The five tips identified through this research may be used to facilitate appropriate diffusion of the most valuable endourological innovations.

Objective: To quantify the incremental downstream revenue generated from subsequent treatment of men who received an inflatable penile prosthesis (IPP) to treat erectile dysfunction (ED), compared to men without ED., Methods: The 100% Medicare Standard Analytic Files were used to conduct a retrospective claims analysis of the 5-year revenue generated by patients receiving IPP to treat their ED, compared to a propensity-matched cohort of men without ED. Men aged 65 years or older with ED who underwent IPP implantation (Current Procedural Terminology 54405) in a hospital outpatient setting between January 1, 2016 and December 31, 2021, and who had continuous Medicare Parts A and B enrollment for 12 months pre-index IPP and 5 years post-index IPP discharge date were included in the study. Men without ED but with comparable characteristics were identified and used as a comparator group. Revenue received by hospitals from Medicare was defined as the sum of payments for patient services, other payor-paid amounts, patient deductibles, copayments, and coinsurance. Revenue was inflated to 2022 US dollars. The mean values and their corresponding standard deviations (SD) are reported., Results: After matching, there were 2905 men with ED who received an IPP and 7462 men without ED. The IPP cohort showed a significantly higher 5-year cumulative revenue (mean=$34,571 [SD=$50,234]) compared to the men without ED (mean=$3189 [SD=$11,527]). When stratified by diagnosis type, the differences in revenue were $10,258 for circulatory disease, $2646 for diabetes, $2013 for urology, and $1043 for prostate cancer. Significantly more IPP patients had at least 1 health encounter for these conditions over the 5-year follow-up period than their matched controls (55.0% vs 7.8% for circulatory, 46.7% vs 16.8% for urology, 19.3% vs 3.6% for diabetes, and 19.0% vs 3.0% for prostate cancer)., Conclusion: Men with ED who received IPP generated substantially higher revenue for the healthcare system over a 5-year period, nearly 10 times as much, compared to men without ED, excluding the initial cost of the IPP procedure. The presence of ED, coupled with IPP usage, is associated with significantly increased healthcare revenue across a range of medical conditions compared to men without ED. These findings emphasize the financial implications for advanced ED programs to improve access to necessary care for these patients. Healthcare facilities may leverage these insights to effectively allocate resources to deliver critical healthcare to men with ED., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Abimbola O. Williams, Sirikan Rojanasarot, Alysha M. McGovern, Liesl M. Hargens, Gregory Moore, and Erin Turner are employees of and own stock in Boston Scientific. Paurush Babbar is a Physician at The Urology Group, Cincinnati, Ohio. Andrew Sun is a physician at Urology Partners of North Texas, Arlington, Texas. Dr. Andrew Sun and Dr. Paurush Babbar were not compensated for their participation in this study., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Patient out-of-pocket (OOP) cost represents an access barrier to erectile dysfunction (ED) treatment. We determined OOP cost for men with ED covered by Fee-for-Service Medicare. Coverage policies were obtained from the Medicare Coverage Database for treatments recommended by the 2018 American Urological Association (AUA) guidelines. OOP cost was retrieved from the 2023 Centers for Medicare & Medicaid Services Final Rule. OOP cost for treatments without Medicare coverage were extracted from GoodRx® or literature and inflated to 2022 dollars. Annual prescription costs were calculated using the published estimate of 52.2 yearly instances of sexual intercourse. Medicare has coverage for inflatable penile prostheses (IPP; strong recommendation), non-coverage for vacuum erection devices (VED; moderate recommendation) and phosphodiesterase type-5 inhibitors (PDE5i; strong recommendation), and no policies for intracavernosal injections (ICI; moderate recommendation), intraurethral alprostadil (IA; conditional recommendation), or low-intensity extracorporeal shock wave therapy (ESWT; conditional recommendation). Annual IA prescription is most costly ($4022), followed by ICI prescription ($3947), one ESWT course ($3445), IPP ($1600), PDE5i prescription ($696), and one VED ($213). PDE5i and IPP, both strongly recommended by AUA guidelines, are associated with lower OOP cost. Better understanding of patient financial burden may inform healthcare decision-making., (© 2024. The Author(s).)

Objectives: To investigate the racial and socioeconomic (income) differences in receipt of and time to surgical care for urinary incontinence (UI) and erectile dysfunction (ED) occurring post-radical prostatectomy (RP) and/or radiation therapy (RT)., Materials and Methods: Utilizing the Medicare Standard Analytical Files (SAF), a retrospective cohort study was performed on data of patients diagnosed with prostate cancer (PCa) from 2015 to 2021. Patients who underwent RP and/or RT and who subsequently developed UI and/or ED were grouped into four cohorts: RP-ED, RP-UI, RT-ED and RT-UI. County-level median household income was cross-referenced with SAF county codes, classified into income quartiles, and used as a proxy for patient income status. The rate of surgical care was compared between groups using two-sample t-test and log-rank test. Cox proportional hazards modelling was used to determine covariate-adjusted impact of race on time to surgical care., Results: The rate of surgical care was 6.8, 3.61 3.07, and 1.54 per 100 person-years for the RP-UI, RT-UI, RP-ED, and RT-ED cohorts, respectively. Cox proportional 'time-to-surgical care' regression analysis revealed that Black men were statistically more likely to receive ED surgical care (RP-ED AHR:1.79, 95% CI:1.49-2.17; RT-ED AHR:1.50, 95% CI:1.11-2.01), but less likely to receive UI surgical care (RP-UI AHR:0.80, 95% CI:0.67-0.96) than White men, in all cohorts except RT-UI. Surgical care was highest among Q1 (lowest income quartile) patients in all cohorts except RT-UI., Conclusions: Surgical care for post-PCa treatment complications is low, and significantly impacted by racial and socioeconomic (income) differences. Prospective studies investigating the basis of these results would be insightful., Competing Interests: Support for this research was provided by Boston Scientific, Marlborough, MA. Sirikan Rojanasarot and Alysha McGovern are full‐time employees of Boston Scientific. Oluwafolajimi Adesanya has no conflicts of interest to disclose. Arthur Burnett is a research award recipient from Boston Scientific. Oluwafolajimi Adesanya and Arthur Burnett were not compensated for their participation in this study., (© 2024 The Authors. BJUI Compass published by John Wiley & Sons Ltd on behalf of BJU International Company.)

Background: The significance of geographic barriers to receiving inflatable penile prosthesis (IPP) treatment is uncertain according to the existing medical literature., Aim: To describe the travel patterns of men with erectile dysfunction (ED) in the United States who underwent IPP surgery., Methods: This retrospective cohort study utilized data from the 100% Medicare Standard Analytical Files. Men aged ≥65 years with an ED diagnosis who underwent IPP surgery between January 2016 and December 2021 were identified from the database. Federal Information Processing Series codes from the National Bureau of Economic Research's County Distance Database were used to determine geographic distances from patients' homes to the facilities at which surgery was performed., Outcomes: Evaluations included the proportions of men who traveled outside their county of residence or state for IPP treatment and the average distances in miles traveled., Results: Among 15 954 men with ED undergoing IPP treatment, 56.4% received care out of their county for IPP, at a mean distance of 125.6 miles (range, 3.8-4935.0). Although patients aged ≥80 years were less likely to travel outside their county as compared with men aged 65 to 69 years (48.1% vs 57.1%, P  < .001), if they traveled, they were likely to travel farther (mean, 171.8 vs 117.7 miles; P  < .001). South Dakota had the highest proportion of men traveling outside their county for IPP treatment (91.3%; mean, 514.2 miles), while Vermont had the highest proportion traveling outside their home state (73.7%)., Clinical Implications: By unveiling disparities in access, this study will potentially lead to tailored interventions that enhance patient care and health outcomes., Strengths and Limitations: Strengths include the uniqueness in (1) evaluating the proportions of patients who travel out of their county of residence or home state for IPP treatment and (2) quantifying the average distances that patients traveled. An additional strength is the large sample size due to the retrospective design and database used. The analysis did not capture all Medicare enrollees; however, it did encompass all traditional Medicare enrollees, representing approximately half of all men in the US aged ≥65 years. Limitations include not being generalizable to entire population of the US, as the study examined only Medicare enrollees. In addition, the study period includes the pandemic, which could have affected travel patterns. Furthermore, the coding and accuracy of the data are limitations of using administrative claims data for research., Conclusion: Study findings showed that many men with Medicare and ED traveled from their home geographic location for IPP treatment., Competing Interests: S.R. and K.M. are full-time employees of Boston Scientific, while T.N. and T.W. are not compensated for their participation in this study. T.W., a Urology Professor at the University of Washington, is a paid consultant for or grant recipient from Boston Scientific, Coloplast, Endo, BioTe, and Progyny., (© The Author(s) 2024. Published by Oxford University Press on behalf of The International Society of Sexual Medicine.)

Backgrounds: With an increased prevalence and burden of benign prostatic hyperplasia (BPH), effective and equitable treatment is a priority. Limited data exist evaluating treatment disparities for patients with BPH by race. This study examined the association between race and BPH surgical treatment rates among Medicare beneficiaries., Methods: Medicare claims data were used to identify men newly diagnosed with BPH from January 1, 2010 through December 31, 2018. Patients were followed until their first BPH surgery, a diagnosis of prostate/bladder cancer, termination of Medicare enrollment, death, or end of study. Cox proportional hazards regression compared the likelihood of BPH surgery between men of different races (White vs. Black, Indigenous, and People of Color (BIPOC)), controlling for patients' geographical region, Charlson comorbidity score, and baseline comorbidities., Results: The study included 31,699 patients (13.7% BIPOC). BIPOC men had significantly lower BPH surgery rates (9.5% BIPOC vs. 13.4% White; p=0.02). BIPOC race was associated with a 19% lower likelihood of receiving BPH surgery than White race (HR, 0.81; 95% CI 0.70, 0.94). Transurethral resection of the prostate was the most common surgery for both groups (49.4% Whites vs. 56.8% BIPOC; p=0.052). A higher proportion of BIPOC men underwent procedures in inpatient settings compared to White men (18.2% vs. 9.8%; p<0.001)., Conclusions: Among a cohort of Medicare beneficiaries with BPH, there were notable treatment disparities by race. BIPOC men had lower rates of surgery than White men and were more likely to undergo procedures in the inpatient setting. Improving patient access to outpatient BPH surgical procedures may help address treatment disparities., (© 2023. The Author(s).)