Efficacy and Safety of Vibegron for Persistent Symptoms of Overactive Bladder in Men Being Pharmacologically Treated for Benign Prostatic Hyperplasia: Results From the Phase 3 Randomized Controlled COURAGE Trial.

PURPOSE: Efficacy and safety of vibegron, a β3 -adrenergic receptor agonist, was assessed among men with symptoms of overactive bladder (OAB) receiving pharmacologic treatment for benign prostatic hyperplasia (BPH) in a phase 3 randomized controlled trial.

MATERIALS AND METHODS: Men ≥ 45 years with OAB symptoms and BPH, treated with α-blocker with/without 5α-reductase inhibitors, were randomized 1:1 to vibegron or placebo for 24 weeks. Coprimary endpoints were change from baseline (CFB) at week 12 in mean daily micturitions and urgency episodes. Secondary endpoints were CFB at week 12 in mean nightly nocturia and daily urge urinary incontinence (UUI) episodes, International Prostate Symptom Score (IPSS)‒storage score, and volume voided per micturition. Safety was evaluated via adverse events (AEs).

RESULTS: Of 1105 participants randomized, 965 (87.3%) completed the trial. At week 12, vibegron was associated with significant reductions vs placebo in daily micturitions (least squares mean difference [LSMD; 95% CI], -0.74 [-1.02, -0.46]; P < .0001) and urgency episodes (-0.95 [-1.37, -0.54]; P < .0001). Vibegron was also associated with significant improvements vs placebo at week 12 in nocturia episodes (LSMD, -0.22 [-0.36, -0.09]; P = .002), UUI episodes (-0.80 [-1.33, -0.27]; P = .003), IPSS‒storage scores (-0.9 [-1.2, -0.6]; P < .0001), and volume voided (15.07 mL [9.13-21.02]; P < .0001). AE rates were similar in vibegron (45.0%) and placebo (39.0%) arms; AEs occurring in ≥ 2% of participants were hypertension (9.0% vs 8.3%, respectively), COVID-19 (4.0% vs 3.1%), urinary tract infection (2.5% vs 2.2%), and hematuria (2.0% vs 2.5%).

CONCLUSIONS: In this trial, vibegron met all primary and secondary endpoints and was safe and well tolerated in men with OAB symptoms and pharmacologically treated BPH.