This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder

Summary

The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.

Timeline

Start

2013-11-05

Primary completion

2015-10-22

Completion

2015-10-22

Outcome

Mixed primary results

registry Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 25 mg; p = 0.072 NCT01972841 ↗

registry Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 50 mg; p = 0.033; Least squares mean difference -0.20 NCT01972841 ↗

registry Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 25 mg; p = 0.040; Least squares mean difference -0.29 NCT01972841 ↗

registry Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 50 mg; p = 0.006; Least squares mean difference -0.39 NCT01972841 ↗

Publications

• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mirabegron	Other / unclassified	25 mg	Oral
Subject	Mirabegron	Other / unclassified	50 mg	Oral
Subject	Solifenacin	Small molecule	5 mg	Oral

Indications