Impact of vibegron on quality of life in men with overactive bladder receiving treatment for benign prostatic hyperplasia: patient-reported outcomes from the randomized placebo-controlled COURAGE trial

Abstract Background Men receiving pharmacologic treatment for benign prostatic hyperplasia (BPH) may experience reduced quality of life (QoL) owing to persistent overactive bladder (OAB) symptoms. Vibegron, a β 3 -adrenergic receptor agonist, was approved for OAB symptoms based on the COURAGE trial. We present exploratory patient-reported outcomes from COURAGE. Methods Eligible men were ≥ 45 years old with OAB symptoms receiving BPH treatment (α-blocker ± 5α-reductase inhibitor). Patients were randomly assigned 1:1 to receive vibegron 75 mg or placebo for 24 weeks. Patients completed the OAB questionnaire (OAB-q) and Patient Global Impression (PGI) scales at baseline and weeks 12 and 24. Changes from baseline in OAB-q subscores and PGI scales were assessed. An anchor-based approach was used to determine the distribution of change from baseline in COURAGE trial endpoints (micturitions, urgency, nocturia, and urge urinary incontinence [UUI] episodes) by category of change on the PGI change (PGI-C) scale. Results Of 1105 patients (vibegron, n = 551; placebo, n = 554); 1080 (vibegron, n = 538; placebo, n = 542) had evaluable data and were included in the analysis. Baseline mean OAB-q and PGI scores were similar between treatment groups. Patients receiving vibegron had statistically significantly greater improvements vs. placebo from baseline to week 12 ( P < 0.05) for all OAB-q subscale scores and improvements remained statistically significant at week 24 ( P < 0.05), except for social interaction. Patients receiving vibegron had improvements from baseline on all PGI endpoints at weeks 12 and 24. A higher percentage of patients receiving vibegron (81.9%) reported improvement on the PGI-C vs. placebo (69.3%). Patients receiving vibegron who reported moderately or much better on the PGI-C scale demonstrated improvement in mean change from baseline to week 12 in micturitions, urgency, nocturia, and UUI. Conclusions Men with OAB symptoms receiving pharmacologic BPH treatment demonstrated statistically significant and clinically meaningful improvement in QoL with vibegron vs. placebo, consistent with improvements in OAB symptoms. Trial registration Clinicaltrials.gov NCT03902080 Registered 04-01-2019 .