Citations

Abstract Introduction Intralesional Collagenase Clostridium Histolyticum (CCH; Xiaflex; Endo Pharmaceuticals, Dublin, Ireland) is the only FDA-approved intralesional therapy to treat bothersome penile curvature in men with Peyronie’s Disease (PD). Clinicians who administer CCH must be certified through a risk evaluation and management strategy (REMS) program. However, provider availability is highly dependent on geography and many patients must travel great distances to undergo evaluation and treatment with CCH by an experienced injector. Objective The goal of the current study is to describe the landscape of certified CCH injectors with respect to location and clinical background/training. Methods Patients are currently able to use an online “locate a specialist” tool through Endo Pharmaceuticals to identify clinicians in their local geographic area who are certified to administer CCH. Using this tool, a list of all providers who offer CCH injections was compiled throughout the continental United States. Pertinent information that was gathered included geographic location, type of provider or level of training [Medical Doctor (MD), Doctor of Osteopathic Medicine (DO), Physician Assistant (PA), Nurse Practitioner (NP), and Registered Nurse (RN)], and gender of providers. This information was compared to state population data (United State Census Bureau) to determine per capita coverage. Results A total of 1947 Xiaflex providers were identified: 1749 Doctors of Medicine (MD; 90%), 115 Doctor of Osteopathic Medicine (DO; 6%), 60 Physician Assistants (PA; 3%), 21 Nurse Practitioners (NP; 1%), and 1 Registered Nurse (RN; 0.05%). Out of the 1947 providers, only 95 (4.9%) were women. Most women administering Xiaflex were MDs (73%), followed by PAs (12%), NP and DOs (7%), and RN (1%). Xiaflex providers were available in all states except for Hawaii and Alaska. Providers were distributed throughout the United States with the average provider per capita ratio of 230,240. Wyoming, Washington D.C., Rhode Island, and Georgia had the best provider per capita at <10,000 while New Mexico had the worst provider per capita ratio at 2,117,522. Conclusions Our results show significant variation in certified CCH injector availability for patients across the United States. < 5% of all certified clinicians are female and 4% were advanced practice providers. Further work is needed to characterize and remedy gender disparities amongst providers, and ensure greater access for patients who desire an FDA-approved non-surgical treatment for their PD-associated curvature. Disclosure No

ABSTRACT Introduction Vasectomy reversal (VR) is rarely covered by insurance, creating a market similar to cosmetic surgery with direct marketing to patients. While cost is an immediate concern for patients, surgeon training and experience are essential for a successful outcome. Patients considering VR are likely to seek information online regarding providers and the nature of the procedure. Objective In this study, we reviewed the characteristics of providers marketing VR online, as well as the comprehensiveness of their website content. Additionally, we sought to determine differences in VR practice patterns between academic and private practices. Methods We identified VR practices operating within the top 50 populous metropolitan areas in the USA. Practice websites were reviewed to obtain information such as educational background of providers, use of operating microscope, ability to perform vasoepididymostomy (VE), surgical volume, and out-of-pocket cost. Based on the information available from practice websites, providers were assigned a non-validated “REVERSAL score” out of 12, based on 8 domains (Risks disclosure; provider's Educational background; ability to perform VE; Expense disclosure; success Rate disclosure; Surgical volume disclosure; disclosure of Alternatives to VR; and Level of magnification used for VR) (Table). Descriptive statistics were used to compare the results between academic and private practices. Results 107 providers were identified (29 academic and 78 private). All but 2 were male, and similarly all but 2 had Doctor of Medicine (M.D.) degree. Review of practice websites allowed us to obtain complete information (REVERSAL score of 12) on only one provider (academic), with the majority (66%) of providers achieving REVERSAL score of ≤6. Providers with formal fellowship training in andrology, microsurgery, and/or infertility achieved higher REVERSAL scores compared to those without (6.9 ± 2.4 vs. 4.8 ± 2.4, p < 0.01). Academic providers were more likely to have completed pertinent fellowship training compared to private practice providers (97% vs. 44%, p < 0.05). Only 14% of academic providers disclosed procedure cost online, compared to 40% of private practice providers (p < 0.05). There was a trend toward increased use of online advertisements by private practice providers (22% vs. 10%, p = 0.07), and increased reference to literature success rates by academic providers (59% vs. 41%, p = 0.10). Among the 35 providers who disclosed pricing online, mean cost of VR was $5,990 ± 1,935. There was a non-significant trend toward increased cost with academic practices compared to private practices ($7,337 ± 1,103 vs. $5,765 ± 1,964, p = 0.09). There was significant reduction in cost when comparing non-urologists vs. urologists ($3,584 ± 1,554 vs. $6,591 ± 1,518, p < 0.01), and when comparing providers without pertinent fellowship training to those with ($5,405 ± 2,000 vs. $6,769 ± 1,590, p < 0.05). Conclusions There is significant lack of transparency in publicly available information from VR practices, both academic and private. Practices should implement measures to improve the dissemination of information to the general public, so that patients may more easily compare various providers. Disclosure Work supported by industry: no. A consultant, employee (part time or full time) or shareholder is among the authors (Coloplast, AMS).