Plain language summary of safety and symptom improvement with vibegron in people with overactive bladder: results from the EMPOWUR study

J Comp Eff Res. 2023 Sep;12(9):CER. doi: 10.57264/cer-2023-0043. Epub 2023 Aug 10.

Abstract

What is this summary about? This is a plain language summary of an article originally published in the Journal of Urology. Overactive bladder (also called OAB) has been treated with the same type of medicine for more than 40 years. Vibegron is in a newer class of medicine for treating overactive bladder called beta-3 adrenergic receptor agonists. The EMPOWUR study was a phase 3 clinical trial that looked at whether vibegron was safe and improved symptoms in people with overactive bladder. Vibegron was approved by the US Food and Drug Administration (also called the FDA) based in part on the results of this study. What were the results? Participants of the EMPOWUR study who took vibegron showed an improvement in their overactive bladder symptoms. These symptoms include the number of urinations (peeing), the urgent need to urinate, and accidental urination (bladder leaks). After 12 weeks, participants who took vibegron had significantly greater improvements than participants who took placebo. What do the results mean? This study suggests that vibegron could safely improve symptoms in people with overactive bladder. Clinical Trial Registration: NCT03492281 (ClinicalTrials.gov).

Keywords: anticholinergic; beta-3 adrenergic receptor agonist; bladder leaks; clinical trial; incontinence; lay summary; overactive bladder; plain language summary; randomized controlled trial; urge; urinary frequency; urinary incontinence.

Publication types

  • Review
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adrenergic beta-3 Receptor Agonists / therapeutic use
  • Double-Blind Method
  • Humans
  • Treatment Outcome
  • Urinary Bladder, Overactive* / drug therapy

Substances

  • N-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamide
  • Adrenergic beta-3 Receptor Agonists

Associated data

  • ClinicalTrials.gov/NCT03492281