Abstract
What is this summary about?
This is a plain language summary of an article published in the journal Advances in Therapy. In 2020, the US Food and Drug Administration (also called the FDA) approved a medicine called vibegron to treat overactive bladder, also called OAB. The key results used to approve vibegron were from the EMPOWUR study. In the EMPOWUR study, participants who took vibegron had fewer urination episodes, urgency episodes, and bladder leaks each day than those who took a pill containing no medicine, called a placebo. At the end of the study, participants also rated how much their overactive bladder symptoms changed overall during EMPOWUR by responding to a survey. Many participants rated their overactive bladder symptoms as improved overall.
This study asked if improvements in the number of urination episodes, urgency episodes, and bladder leaks caused by urgency were associated with feeling better overall. This study also looked at how many participants in the EMPOWUR study had improvements in the number of urination episodes, urgency episodes, and bladder leaks that were big enough to matter. A separate group of people with overactive bladder were asked about the magnitude of improvements that would be important to them. This group had not participated in the EMPOWUR study.
What were the results?
EMPOWUR participants who reported that taking medicine resulted in their overactive bladder symptoms getting better overall also generally reported fewer daily urinations, urgency episodes, and bladder leaks after treatment. Many had changes in their symptoms that were meaningful. Meaningful was defined for each symptom as: at least 15% fewer urinations, 50% fewer urgency episodes, and 75% fewer bladder leaks. Participants who received vibegron had meaningful reductions in the daily number of episodes of urination, urgency, and bladder leaks more often than those who received the placebo (pill with no active medicine). People with overactive bladder who did not participate in the study were interviewed and said that improvements to those symptoms, similar to those seen in the EMPOWUR study, would be important to them.
What do the results mean?
This study suggests that the results we measured in the EMPOWUR study may also reflect changes in overactive bladder symptoms that are big enough to be important to people with overactive bladder. Many participants who took vibegron in the EMPOWUR study felt that it helped to improve their individual overactive bladder symptoms. This may also help improve quality of life of participants.
Clinical Trial Registration: NCT03492281 (ClinicalTrials.gov)
Keywords: beta-3 adrenergic receptor agonist, bladder leaks, clinical meaningfulness, lay summary, overactive bladder, patient-reported outcomes, plain language summary, quality of life, trial, urinary frequency, urinary urgency, vibegron
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
Jeffrey Frankel, MD, is an advisor for Sumitomo Pharma America (formerly Urovant Sciences); is a meeting participant/lecturer for Myovant, Pfizer, and Sumitomo Pharma America (formerly Urovant Sciences); and is an investigator for Astellas, Exact Sciences, Johnson & Johnson, and Pfizer. 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. Susann Varano, MD, is a consultant and speaker for Sumitomo Pharma America (formerly Urovant Sciences), a principal investigator for Clinical Research Consulting, and holds academic positions at Sacred Heart University and University of Bridgeport. Diane K Newman, DNP, ANP-BC, is an editor for Digital Science Press, an advisor to COSM and Sumitomo Pharma America (formerly Urovant Sciences), and has received research funding from the Society of Urologic Nurses and Associates and National Institutes of Health. Steven G Gregg, PhD, is Executive Director at the National Association for Continence, Charleston, SC. Janet Owens-Grillo, PhD, MS, is an employee of Sumitomo Pharma America (formerly Urovant Sciences).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.
Medical writing and editorial support were provided by Joseph Kruempel, PhD, CMPP, and Tania R. Iqbal, PhD, CMPP, of The Curry Rockefeller Group, LLC (Tarrytown, NY), and were funded by Sumitomo Pharma America (formerly Urovant Sciences).
Open access
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