Wagg A, et al. - Experts designed A phase IV study to compare flexibly dosed mirabegron vs placebo in elderly individuals with overactive bladder (OAB) and urgency incontinence. Community-dwelling individuals aged ≥ 65 yr with OAB for ≥ 3 mo were included in this study. Following a 2-wk placebo run-in, individuals with one or more incontinence episodes, three or more urgency episodes, and an average of eight or more micturitions/24 h were assigned randomly in a 1:1 ratio to double-blind 25 mg/d mirabegron or matched placebo, for 12 wk. Examination of covariance (ANCOVA) was applied for the mean number of micturitions/24 h, mean volume voided/micturition, and mean number of urgency episodes/24 h. This study found statistically significant improvements for mirabegron vs placebo in change from baseline to EOT in the mean number of micturitions/24 h, the mean number of incontinence episodes/24 h, mean volume voided/micturition, the mean number of urgency episodes/24 h, and mean number of urgency incontinence episodes/24 h. In individuals aged ≥ 65 yr, mirabegron efficacy, safety, and tolerability over 12 wk were confirmed with OAB and incontinence.