Vibegron Effectively Treats Overactive Bladder in Older Men with Benign Prostatic Hyperplasia

Vibegron can treat symptoms of overactive bladder (OAB) safely and effectively in older adults with benign prostatic hyperplasia (BPH), with comparable benefits to those seen in younger patients, according to an analysis presented at the 2026 Annual Meeting of the American Urological Association (AUA 2026) in Washington, D.C.

Older men with BPH often struggle with persistent storage urinary symptoms that do not respond to first-line pharmacotherapy. Beta 3-adrenergic receptor agonists have emerged as a much-needed alternative treatment for residual OAB symptoms, providing symptom relief without the classic anticholinergic side effects associated with older-generation therapies. 

Vibegron, a selective beta 3-adrenergic receptor agonist, is approved in the United States for the treatment of OAB symptoms such as urge urinary incontinence, urgency, and urinary frequency in men taking first-line medications for BPH. In the phase 3 randomized, placebo-controlled COURAGE trial, treatment with once-daily vibegron 75 mg achieved clinically meaningful improvements in the mean daily number of micturitions and urgency episodes and reduced nocturia and daily urge urinary incontinence episodes, resulting in improved quality of life [Staskin D et al. J Urol 2024; 212(2):256-66]. 

COURAGE enrolled more than 1,000 men aged 45 years or older with symptoms of OAB who were also receiving medical therapy for BPH (alpha-blockers with or without 5-alpha reductase inhibitors). The participants were randomized to receive vibegron or placebo for 24 weeks. Of the 1080 participants included in the COURAGE trial efficacy analyses, 192 were aged 75 years or older (92 received vibegron and 100 received placebo). The two subgroups had similar demographic characteristics and comorbidities. Nevertheless, participants aged 75 years or older were more likely to have tried previous therapies, and had higher rates of preexisting hypertension and urinary incontinence. 

The age-group analysis presented at AUA 2026 showed that men aged 75 years or older experienced clinically meaningful reductions from baseline at weeks 12 and 24 in the average daily number of micturitions, urgency episodes, and nocturia episodes with vibegron compared with placebo. These results were comparable to the outcomes observed in men younger than 75 years. A small improvement was also reported in the frequency of urinary incontinence episodes. 

The analysis showed that vibegron was generally well tolerated in this older population, with a safety profile comparable to that observed in younger men. “The adverse events were very similar to placebo and nothing emerged as a new safety consideration,” said presenting author Sender Herschorn, MD, professor of surgery and urology at the University of Toronto and attending urologist at Sunnybrook Health Sciences Centre. “Contraindications are the same as published previously for vibegron. In this [older-age] group, however, the physician has to decide that the patient is a candidate for the drug and has OAB symptoms while the voiding component is adequately treated by the alpha blocker with or without 5-alpha reductase inhibitors.”

Approximately half (52.1%) of the participants aged 75 years or older who received vibegron had at least one treatment-emergent adverse event. The incidence was similar in the younger group, with 43.5% of men under the age of 75 experiencing at least one treatment-emergent adverse event. The most common adverse events in men aged 75 years or older who were treated with vibegron were hypertension (5.2%), hematuria (4.2%), and upper respiratory tract infections (4.2%).

“Vibegron is a safe alternative for older – and younger – patients with OAB symptoms who are on BPH drugs,” Herschorn concluded. “Surgery for these symptoms alone may be problematic, as surgery is better for voiding rather than storage symptoms.”