Mirabegron as a treatment for overactive bladder symptoms in men (MIRACLE study): Efficacy and safety results from a multicenter, randomized, double-blind, placebo-controlled, parallel comparison phase IV study

To evaluate the efficacy and safety of mirabegron in males with overactive bladder (OAB) symptoms.

In total, 464 males with OAB symptoms were enrolled from 14 institutes and were sorted into either the mirabegron 50 mg (n = 310) or placebo (n = 154) groups. The change in (i) the mean number of 24-h micturition episodes; (ii) OAB Symptom Scale (OABSS); and (iii) International Prostate Symptom Score (IPSS) from baseline to 12 weeks of treatment were compared between the two groups. Safety assessments included treatment-emergent adverse events, blood pressure, pulse rate, postvoid residual volume, and maximum urinary flow rate. After 12 weeks, the study was extended for 14 additional weeks by administering mirabegron 50 mg to both groups.

The reduction in the mean number of 24-h micturition episodes from baseline to 12 weeks of treatment was similar between the two groups. However, significantly greater changes from baseline to 12 weeks were observed in total OABSS, OABSS urgency incontinence score (Q4), IPSS storage subscore (Q2 + Q4 + Q7), and IPSS urgency score (Q4) in the mirabegron group (P = 0.01 for all). According to the extended study, the changes of all efficacy variables from baseline to 26 weeks were similar between both groups. The safety assessment results were also similar between the two groups at 12 and 26 weeks.

A daily 50 mg dose of mirabegron for 12 weeks reduced OAB symptoms in men, and no significant adverse events compared to the placebo group were noted.

Neurourology and urodynamics. 2018 Oct 12 [Epub ahead of print]

Dong Gil Shin, Hyeon Woo Kim, Sang Jin Yoon, Sang Hoon Song, Young Ho Kim, Young Goo Lee, Kwan Joong Joo, Jae Hyun Bae, Taek Won Kang, Seong Jin Jeong, Seung Hyo Woo, Eun Sang Yoo, Hwancheol Son, Kyo Chul Koo, Soo Woong Kim

Pusan National University Hospital, Busan, Korea., Gacheon University Gil Medical Center, Incheon, Korea., Asan Medical Center, Seoul, Korea., Soon Chun Hyang University Bucheon Hospital, Bucheon, Korea., Hallym University Kangnam Sacred Heart Hospital, Seoul, Korea., Kangbuk Samsung Hospital, Seoul, Korea., Korea University Ansan Hospital, Ansan, Korea., Chonnam National University Hospital, Gwangju, Korea., Seoul National University Bundang Hospital, Seongnam, Korea., Eulji University Hospital, Daejeon, Korea., Kyungpook National University Hospital, Daegu, Korea., Seoul National University Boramae Medical Center, Seoul, Korea., Gangnam Severance Hospital, Seoul, Korea., Seoul National University Hospital, Seoul, Korea.