Urology Times Podcasts28 Apr 2025

Pearls & Perspectives: Martin Kathrins, MD, on MED3000 and learning from failed trials

In this episode of Pearls and Perspectives from the American Urological Association's (AUA) 2025 Annual Meeting, host Amy Pearlman, MD, reconnects with Martin Kathrins, MD of Mass General Brigham, to discuss his first clinical trial and new developments in the treatment of erectile dysfunction (ED).

In the episode, Kathrins shares his experience leading a pilot study on MED3000 (Eroxon), a topical, over-the-counter treatment for ED. According to Katherins, MED3000, unlike traditional therapies, works through local neural stimulation without biologically active drug ingredients. Originally developed as a placebo, the compound showed unexpected promise and was fast-tracked for wider availability. Kathrins discusses the opportunities—and hurdles—of designing a prospective clinical trial, highlighting the critical support of clinical research coordinators and the logistical challenges of recruiting both patients and partners for participation.

AUA Study from Martin Kathrins, MD

The study led by Kathrins was a 12-week open-label, non-randomized, single-arm trial evaluated the use of MED3000 in patients with ED following bilateral nerve-sparing radical prostatectomy (bnsRP). Eligible participants had normal erectile function prior to surgery, normal baseline testosterone levels, and no history of androgen deprivation therapy, radiation therapy, or biochemical recurrence. After a 4-week washout from other erectogenic aids, patients initiated MED3000 monotherapy and were assessed at 4-week intervals. Patients were encouraged to attempt sexual intercourse at least four times per month.

Outcome measures included the International Index of Erectile Function (IIEF), Self-Esteem and Relationship (SEAR) questionnaire, Expanded Prostate Cancer Index Composite (EPIC), and frequency of climacturia.

Twenty patients were initially enrolled; 19 (mean age 64.6±4.6 years) completed at least one on-treatment assessment, and 17 completed the full 12-week treatment phase. The cohort was predominantly white/non-Hispanic (n=17) with two Black/non-Hispanic participants. Following the washout, ED severity classification was 84% severe, 11% moderate, and 5% mild to moderate.

Across the study, paired t-tests comparing baseline to 4-, 8-, and 12-week scores for the IIEF total score, IIEF-EF domain, SEAR, EPIC total score, EPIC sexual domain, and climacturia frequency revealed no statistically significant changes at any time point. No adverse events were reported.

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During the episode, Kathrins emphasized the importance of reporting these "negative" results, as they help refine clinical guidance, manage patient expectations, and identify the right patient populations for future research.

As the episode progresses, Pearlman and Kathrins also explore broader implications for urologists: with MED300 now available OTC, patients are likely to ask about it, and providers must be ready to counsel them appropriately. Kathrins advises caution, noting that while MED3000 may have a role in the broader ED market—particularly among men without surgical histories—its efficacy for post-prostatectomy patients appears limited based on current data.

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