A Study to Examine the Safety and Efficacy of a New Drug in Patients With Symptoms of Overactive Bladder (OAB)

Summary

This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in patients with OAB.

Timeline

Start

2018-03-26

Primary completion

2019-01-10

Completion

2019-02-04

Outcome

Met primary endpoint

registry Placebo vs Vibegron 75 mg; p <0.001; Least Squares Mean Difference -0.5 (95% CI -0.8 to -0.2) NCT03492281 ↗

registry Placebo: OAB Wet vs Vibegron 75 mg: OAB Wet; p <0.0001; Least Squares Mean Difference -0.6 (95% CI -0.9 to -0.3) NCT03492281 ↗

Publications

• Staskin D, Frankel J, Gregg SG, Varano S, Owens-Grillo J. 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.
• Frankel J, Staskin D, Varano S, Newman DK, Gregg SG, Owens-Grillo J. Plain language summary: does treatment with vibegron result in improvements in overactive bladder (OAB) symptoms that are meaningful to people with OAB? J Comp Eff Res. 2023 Sep;12(9):CER. doi: 10.57264/cer-2023-0049. Epub 2023 Aug 10.
• Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
• Newman DK, Thomas E, Greene H, Haag-Molkenteller C, Varano S. Efficacy and Safety of Vibegron for the Treatment of Overactive Bladder in Women: A Subgroup Analysis From the Double-Blind, Randomized, Controlled EMPOWUR Trial. Urogynecology (Phila). 2023 Jan 1;29(1):48-57. doi: 10.1097/SPV.0000000000001258. Epub 2022 Oct 21.
• Staskin D, Frankel J, Varano S, Kennelly M, Newman DK, Rosenberg MT, Shortino DD, Jankowich RA, Mudd PN Jr. Vibegron for the Treatment of Patients with Dry and Wet Overactive Bladder: A Subgroup Analysis from the EMPOWUR Trial. Int J Clin Pract. 2022 Apr 13;2022:6475014. doi: 10.1155/2022/6475014. eCollection 2022.
• Frankel J, Staskin D, Varano S, Kennelly M, Newman DK, Rosenberg MT, Jankowich RA, Shortino D, Mudd PN Jr, Girman CJ. Interpretation of the Meaningfulness of Symptom Reduction with Vibegron in Patients with Overactive Bladder: Analyses from EMPOWUR. Adv Ther. 2022 Feb;39(2):959-970. doi: 10.1007/s12325-021-01972-8. Epub 2021 Dec 18.
• Varano S, Staskin D, Frankel J, Shortino D, Jankowich R, Mudd PN Jr. Efficacy and Safety of Once-Daily Vibegron for Treatment of Overactive Bladder in Patients Aged >/=65 and >/=75 Years: Subpopulation Analysis from the EMPOWUR Randomized, International, Phase III Study. Drugs Aging. 2021 Feb;38(2):137-146. doi: 10.1007/s40266-020-00829-z. Epub 2021 Jan 20.
• Frankel J, Varano S, Staskin D, Shortino D, Jankowich R, Mudd PN Jr. Vibegron improves quality-of-life measures in patients with overactive bladder: Patient-reported outcomes from the EMPOWUR study. Int J Clin Pract. 2021 May;75(5):e13937. doi: 10.1111/ijcp.13937. Epub 2021 Jan 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Tolterodine	Unknown	4 mg	Oral
Subject	Vibegron	Unknown	75 mg	Oral

Indications