Clinically Meaningful Improvements With Vibegron in Men With Overactive Bladder and Benign Prostatic Hyperplasia: A Responder Analysis of the Phase 3 COURAGE Trial.

Objective: To demonstrate the impact of vibegron treatment in the phase 3 COURAGE trial (NCT03902080) on clinically meaningful response parameters in men with overactive bladder (OAB) receiving pharmacological therapy for benign prostatic hyperplasia (BPH) as measured by standard, validated patient-reported outcomes.

Methods: Men age ≥45 years with OAB receiving pharmacotherapy for BPH were randomly assigned 1:1 to vibegron 75 mg or placebo for 24 weeks. Participants completed bladder diaries assessing changes in micturition frequency, nocturia, and urge urinary incontinence (UUI); International Prostate Symptom Score (IPSS); and OAB questionnaire (OAB-q). Post hoc analyses assessed the percentage of responders (ie, ≤8 daily micturitions, ≤1 nightly nocturia episodes, ≤1 daily UUI episodes, ≥3-point decrease in IPSS scores, ≥10-point improvement in OAB-q subscale scores). Responder endpoints were analyzed using a Cochran-Mantel-Haenszel common risk difference estimation.

Results: Of 1105 participants, 1080 were included in the analysis (vibegron, n=538; placebo, n=542). At week 12, greater percentages of participants receiving vibegron vs placebo achieved responder endpoints for micturitions (33.3% vs 20.5%, respectively; P<.0001), nocturia episodes (34.6% vs 26.8%; P=.0036), and UUI episodes (65.8% vs 53.0%; P=.0267). At week 12, greater percentages of participants receiving vibegron versus placebo achieved a ≥3-point decrease in IPSS storage, voiding, and total scores and 10-point increase in OAB-q subscale scores. Results were generally sustained through week 24.

Conclusion: In this post hoc responder analysis from the phase 3 COURAGE trial, participants receiving vibegron vs placebo achieved clinically relevant reductions in bothersome OAB symptoms, as well as improvements in IPSS and OAB-q scores.