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). Issue 1 (3rd January 2021)

• Record Type: Journal Article
• Authors: Cho, Sung Yong; Jeong, Seong Jin; Lee, Sangchul; Kim, Janghwan; Lee, Seong Ho; Choo, Min Soo; Oh, Seung‐June
• Is Part Of: Neurourology and urodynamics. Volume 40:Issue 1(2021)
• Page Start: 286
• Page End: 294
• Publication Date: 2021-01-03
• Subjects: mirabegron -- overactive -- Parkinson disease -- Parkinsonian disorders -- patient satisfaction -- urinary bladder; Urinary organs -- Periodicals; Urodynamics -- Periodicals; Urology -- Periodicals; 616.6
• DOI: 10.1002/nau.24552
• Languages: English
• ISSNs: 0733-2467

Abstract

Abstract: Aims: 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. Materials and Methods: 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. Result: 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. Conclusion: Mirabegron was effective in treating OAB symptoms in patients with Parkinsonism with acceptable adverse events.