Urology 2021 Jan 10;147:235-242. Epub 2020 Oct 10.
Department of Surgery/Urology, University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Department of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, IL; Department of Urology, Infanta Leonor Hospital, Madrid, Spain; Department of Urology, Royal Berkshire Hospital, Reading, United Kingdom; Astellas Pharma Global Development Inc., Northbrook, IL; Astellas Pharma Europe Ltd., Chertsey, United Kingdom; Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY.
Objective: To analyze the safety of mirabegron add-on therapy in men with overactive bladder symptoms concurrently receiving tamsulosin for lower urinary tract symptoms associated with benign prostatic hyperplasia.
Methods: The Phase 4 PLUS study comprised a 4-week run-in period (tamsulosin [0.4 mg]) and a 12-week randomized treatment period (add-on treatment: mirabegron [25 mg] or placebo). Read More