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
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.
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.
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,105 participants or records.
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