Mirabegron for treatment of overactive bladder symptoms in patients with Parkinson's disease: A double-blind, randomized placebo-controlled trial (Parkinson's Disease Overactive bladder Mirabegron, PaDoMi Study).

This study aimed to investigate the efficacy and safety of mirabegron for Parkinsonism patients with overactive bladder (OAB) symptoms in a randomized, placebo-controlled, multicenter study.

Inclusion criteria are Parkinsonism with OAB symptoms for 4 weeks or more, OAB symptom score (OABSS) questionnaire scores greater than 2, and OABSS urgency question scores greater than 1. After a 2-week wash-out period, the patients were randomized into placebo and mirabegron groups at visit 2. Visit 3 was performed after 4 weeks of medication. Mirabegron was prescribed to the two groups for the rest of the study period at visit 4.

The mean age was 68.1 ± 8.1 years and 72 males and 64 females were included. A total of 136 patients were screened, 117 patients were randomized, and 25 patients dropped out. The OABSS scores were significantly different between the two groups at Weeks 4 and 8. The OABSS scores became the same in the two groups at Week 12 (visit 5). The postvoid residual urine volume showed a mild increase to 64 ml in the mirabegron group compared to the placebo group at visit 4. Adverse events occurred in 27 patients (23.1%). The degree was mild in 26 cases (78.8%), moderate in five (15.2%), and severe in two (6.1%). Only 13 cases (39.4%) showed medication-related adverse events. Acute urinary retention occurred in a single case. The treatment satisfaction questionnaires showed no significant differences between the two groups.

Mirabegron was effective in treating OAB symptoms in patients with Parkinsonism with acceptable adverse events.

Neurourology and urodynamics. 2021 Jan 03 [Epub ahead of print]

Sung Yong Cho, Seong Jin Jeong, Sangchul Lee, Janghwan Kim, Seong Ho Lee, Min Soo Choo, Seung-June Oh

Department of Urology, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea., Department of Urology, Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea., Department of Urology and Urological Science Institute, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea., Department of Urology, College of Medicine, Dongtan Sacred Heart Hospital, Hallym University, Hwaseong, South Korea., Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, South Korea.