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
This is an abstract of the Plain Language Summary of Publication article.
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Link to original article here
Acknowledgments
The authors thank all those who participated in this trial, along with their families and caregivers.
Footnotes
Financial & competing interests disclosure
David Staskin, MD, is a consultant for Astellas, AzuraBio, UroCure, and Sumitomo Pharma America (formerly Urovant Sciences); is an investigator and meeting participant/lecturer for Astellas and Sumitomo Pharma America (formerly Urovant Sciences); and holds other interests in AzuraBio and UroCure. Jeffrey Frankel, MD, is an advisor for Sumitomo Pharma America (formerly Urovant Sciences); a meeting participant/lecturer for Myovant, Pfizer, and Sumitomo Pharma America (formerly Urovant Sciences); and is an investigator for Exact Sciences, Johnson & Johnson, and Pfizer. Steven G Gregg, PhD, is Executive Director at the National Association for Continence, Charleston, SC. Susann Varano, MD, is a consultant and speaker for Sumitomo Pharma America (formerly Urovant Sciences), is a principal investigator for Clinical Research Consulting, and holds academic positions at Sacred Heart University and University of Bridgeport. Janet Owens-Grillo, PhD, MS, is an employee of Sumitomo Pharma America (formerly Urovant Sciences).
Medical writing and editorial support were provided by Jory Fleischauer, PharmD, and Tania R. Iqbal, PhD, CMPP, of The Curry Rockefeller Group, LLC (Tarrytown, NY), and were funded by Sumitomo Pharma America (formerly Urovant Sciences; Marlborough, MA).The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed
Open access
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