Bladder Function and Safety of Vibegron in Men With Overactive Bladder Receiving Treatment for Benign Prostatic Hyperplasia: Outcomes From the Phase 3 Randomized Controlled COURAGE Trial

Abstract

ABSTRACT Purpose Vibegron was associated with improvements in efficacy versus placebo and was well tolerated in men with overactive bladder (OAB) on pharmacotherapy for benign prostatic hyperplasia (BPH) in the COURAGE trial (NCT03902080). Additional safety, bladder function, and urodynamics data are provided. Methods This 24‐week, phase 3, double‐blind, placebo‐controlled trial randomized men ≥ 45 years with OAB and BPH receiving α‐blocker ± 5α‐reductase inhibitors to once‐daily vibegron or placebo (1:1). From the safety analysis set (SAF), postvoid residual urine volume (PVR), maximum urinary flow rate (Uroflow‐Q max ), International Prostate Symptom Score (IPSS) total score, and urologic‐related adverse events (AEs) were collected throughout the trial. Q max and detrusor pressure at Q max (P det Q max ) were collected at baseline and week 12 in a urodynamics substudy (urodynamics evaluable set [UES]). Results In the SAF, differences between vibegron ( n = 553) and placebo ( n = 551) in PVR and Uroflow‐Q max were minimal at baseline, week 12, and week 24. Mean (SD) change from baseline (CFB) at week 24 in IPSS total score was −7.3 (6.96) with vibegron and −5.7 (7.14) with placebo. Urinary retention was reported as an AE for 5 (0.9%) and 4 (0.7%) participants receiving vibegron and placebo, respectively. In the UES (vibegron, n = 21; placebo, n = 22), least squares mean difference (95% CI) between vibegron and placebo in CFB at week 12 was 2.75 (0.16, 5.34) mL/s in Q max and 2.86 (–13.52, 19.25) cmH 2 O in P det Q max . Conclusions There were no safety signals related to bladder function identified by urodynamics; risk of protocol‐defined AEs of urinary retention or residual urine volume increase was not increased with vibegron compared with placebo in this population. Clinical Trial Registration This study is registered at www.clinicaltrials.gov . The registration identification number is NCT03902080.

Affiliated Institutions

• Tufts University US
• University of Toronto CA
• Beaumont Hospital, Troy US
• Sunnybrook Health Science Centre CA
• Health Sciences Centre CA
• Oakland University US
• Medical University of South Carolina US

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