LBA01-10 MIRABEGRON FOR TREATMENT OF OVERACTIVE BLADDER SYMPTOMS IN PATIENTS WITH PARKINSON'S DISEASE: A DOUBLE-BLIND, RANDOMIZED PLACEBO-CONTROLLED TRIAL

Abstract

INTRODUCTION: This study is to investigate the efficacy and safety of mirabegron for parkinsonism patients with overactive bladder (OAB) symptoms in a randomized, placebo‐controlled, multicenter study. METHODS: Inclusion criteria consisted of parkinsonism with OAB symptoms for > 4 weeks, OAB symptom score (OABSS) questionnaire scores > 2 with urgency question > 1, and activity of daily living < 8 according to the Expanded Disability Status Scale. After two weeks of wash‐out period, patients were randomized into groups of placebo and mirabegron at visit 2. Call visit was performed after four weeks of medication. Mirabegron was prescribed to the two groups for the rest of study period. International Prostate Symptom Score (IPSS), OABSS score, Overactive Bladder questionnaire short form (OAB‐q SF), 3‐day frequency‐volume chart, uroflowmetry, and treatment satisfaction questionnaires were evaluated. RESULTS: 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 were dropped out. OABSS scores were significantly different between the two groups at weeks 4 (call visit, 8.2 ± 2.9 vs. 6.6 ± 3.6, p = 0.015) and 8 (visit 3, 7.7 ± 2.8 vs. 6.5 ± 3.1, p=0.035). The OABSS scores became the same in the two groups at week 12 (visit 4). PVR showed mild increase to 64 ml in the mirabegron group compared to the placebo group at visit 3 (64.29 ± 64.17 vs. 36.71 ± 39.07, p = 0.022). Adverse events occurred in 27 patients (23.1%). The level of degree was mild in 26 cases (78.8%), moderate in 5 (15.2%) and severe in 2 (6.1%). Only 13 cases (39.4%) showed medication‐related adverse events. Acute urinary retention occurred in four cases. Treatment satisfaction questionnaires showed no significant differences between the two groups. CONCLUSIONS: Mirabegron was effective for treating OAB symptoms in patients with parkinsonism with acceptable adverse events.