Vibegron scores high among patient preferences as a treatment option for overactive bladder

Real-world results from a phase 4 study presented at the 2025 Annual Meeting of the American Urological Association (AUA 2025) in Las Vegas, Nevada showed that individuals treated with vibegron for overactive bladder (OAB) symptoms continued to adhere to therapy after 12 months and were satisfied with the levels of symptom relief achieved with this medication.

The American Urological Association recommends two classes of oral pharmacotherapy for the management of urinary symptoms associated with OAB: anticholinergics and beta-3 adrenergic receptor agonists. Although anticholinergic medications have shown efficacy in the treatment of OAB, more than half of patients treated with these agents discontinue therapy within 6 months, largely due to bothersome side effects [Yeowell G et al. BMJ Open. 2018;8(11): e021889]. Moreover, the potential risk of developing dementia, which remains a concern with the long-term use of anticholinergic agents, has shifted prescription trends in favor of beta-3 adrenergic receptor agonists.

Vibegron has received regulatory approval in the United States for the treatment of OAB with symptoms of urinary frequency, urgency, and urge urinary incontinence. The landmark phase 3, randomized, placebo-controlled COURAGE trial showed that once-daily vibegron 75 mg achieved significant improvements in daily micturitions, urgency episodes, nocturia episodes, and episodes of urge urinary incontinence over 24 weeks of treatment compared with placebo [Staskin D, et al. J Urol. 2024;212(2):256-266] across a cohort of men with OAB symptoms receiving pharmacologic treatment for benign prostatic hyperplasia (BPH). A subsequent analysis, presented at AUA 2025, showed that vibegron was safe and well tolerated during the extension phase of the COURAGE trial, and continued to control urinary symptoms in men with BPH up to 52 weeks.

The COMPOSUR study was designed to evaluate vibegron in real-world clinical settings by assessing patient satisfaction with treatment and adherence to therapy. The 12-month, prospective phase 4 study enrolled 403 U.S. patients with OAB who were aged 18 years or older, with or without urge urinary incontinence. All participants started a new course of vibegron after previous treatment with anticholinergics or mirabegron with or without anticholinergics. Patients’ attitudes toward therapy were assessed monthly using the OAB Satisfaction With Treatment questionnaire (OAB-SAT-q) with scores between 0 and 100 (higher scores denoting greater satisfaction). The primary endpoint was the OAB-SAT-q satisfaction domain score at 12 months. The researchers also assessed persistence and incidence of adverse events in the nearly 60% of the participants who completed the trial.

Assessments at month 12 showed that 69% of the participants were consistently satisfied with treatment, with a mean OAB-SAT-q satisfaction domain score of 65.6. Approximately three-quarters of the cohort had positive responses to key questions about symptom relief, the time it takes for treatment to start working, and efficacy compared to patient expectations. Persistence with vibegron was nearly 60% at 12 months. Treatment-related adverse events affected 36% of the participants, but only 2% of the cohort experienced a serious event. The most common adverse events, documented in 2% to 4% of the participants, were urinary tract infection, headache, dizziness, and diarrhea.

After 12 months, most patients receiving vibegron were satisfied with their treatment and had a relatively high adherence to therapy, suggesting that vibegron may be a viable long-term option for the management of urinary symptoms associated with OAB.