Sender Herschorn, BSc, MDCM, FRCSC, on vibegron efficacy in older men with OAB and BPH

Vibegron (Gemtesa) demonstrated efficacy and a favorable safety profile in men aged 75 years and older with persistent overactive bladder (OAB) symptoms receiving pharmacotherapy for benign prostatic hyperplasia (BPH), according to a subgroup analysis of the phase 3 COURAGE trial (NCT03902080) presented at the 2026 American Urological Association (AUA) Annual Meeting.¹ In this video, Sender Herschorn, BSc, MDCM, FRCSC, discusses the background and key findings from the study.

Herschorn is a professor of surgery/urology at the University of Toronto.

The COURAGE trial was a phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating once-daily vibegron 75 mg vs placebo in men aged 45 years and older with OAB symptoms despite stable treatment with an α-blocker with or without a 5α-reductase inhibitor for BPH. Herschorn explained that the original trial, published in 2024, demonstrated significant improvements across multiple primary and secondary urinary symptom end points with the addition of vibegron. The subgroup analysis presented at AUA sought to determine whether older age, and the bladder changes that accompany aging, influenced treatment response by comparing outcomes in men aged 75 years and older with those younger than 75 years.

Among the 1080 participants included in the efficacy analyses, 192 were aged 75 years or older, including 92 who received vibegron and 100 who received placebo. Patients aged 75 years and older had higher rates of preexisting hypertension, urinary incontinence, and prior OAB therapies than younger participants. Herschorn noted that although the subgroup analysis was not powered for statistical comparisons, numerical trends suggested that treatment benefits were generally consistent across age groups. Clinically meaningful reductions in daily micturitions, urgency episodes, and nocturia episodes were observed with vibegron vs placebo at both 12 and 24 weeks in the older subgroup, comparable overall with results seen in men younger than 75 years. Herschorn added that improvements in nocturia and urgency urinary incontinence appeared somewhat less pronounced in the older cohort but remained clinically beneficial. He also noted that the magnitude of benefit observed with vibegron compared favorably with prior add-on studies evaluating other β3-adrenergic agonists and anticholinergic therapies in similar patient populations.

Regarding safety, Herschorn emphasized that no new safety concerns emerged in the older population. Treatment-emergent adverse events (TEAEs) were similar between vibegron and placebo regardless of age, supporting the agent's tolerability in older adults. Among men aged 75 years and older receiving vibegron, 52.1% experienced at least 1 TEAE (vs 43.5% among men younger than 75 years), with hypertension (5.2%), hematuria (4.2%), and upper respiratory tract infection (4.2%) reported most frequently. Overall, Herschorn concluded that efficacy and safety were largely maintained in patients aged 75 years and older.

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