Primary objective was for safety, frequency of adverse events. Secondary objectives involved efficacy as in the change from baseline to end of treatment in the mean number of UI episodes/24 hr and micturition/ 24 hr. Mean voided volume per micturition, OAB-q Symptom Bother Score and TS-VAS were additional variables. 1,819 patients were enrolled and were randomized in a 12-week double-blind treatment course to 3 arms: 1) combination Soli + Mira or 2) Soli alone, or 3) Mira alone. All treatments were generally well-tolerated. Slight increase frequency of overall AEs in the combination group (Combination + Soli alone=dry mouth; Mira=Nasopharyngitis). Efficacy indicated that clear and clinically relevant improvements with combination compared with each monotherapy. Also, combination treatment did not reveal any new safety concerns.
Presented by: Christian Gratzke, MD, University of Munich
Written by: Diane K. Newman, DNP, FAAN, BCB-PMD, Perelman School of Medicine, University of Pennsylvania
at the 2017 AUA Annual Meeting - May 12 - 16, 2017 – Boston, Massachusetts, USA