Objective: To report enrollment and tolerability data of mirabegron treatment in PD patients with OAB.

Background: Lower urinary tract symptoms in PD have an estimated prevalence of 27% to 88%. Although anticholinergics may be recommended in the pharmacological management of urinary dysfunction, they may worsen cognitive function and constipation. Mirabegron, a Beta-3 adrenergic agonist, is approved for Overactive Bladder (OAB). We are examining the efficacy and tolerability of mirabegron for treatment of OAB in Parkinson`s Disease PD patients. This report reviews preliminary tolerability data; efficacy will be evaluated at the conclusion of the trial.

Methods: This is a randomized, double-blind, placebo-controlled trial of mirabegron vs placebo as add-on therapy to an educational intervention of behavioral modification including pelvic floor exercise in a cohort of 40 PD subjects over the age of 30 with OAB. The subjects were divided into two groups, receiving either mirabegron or placebo. The study is conducted over 12 weeks, using mirabegron 25 mg daily with optional titration at the study’s midpoint to 50 mg daily. Subjects are enrolled based on entries in a micturition diary. The primary outcome measure is mean daily OAB symptom composite score (summation of all urgency scores recorded at all voids in a 72-hr diary,averaged over 3 days). This measure accounts for both frequency and urgency components of OAB.

Results: This study is still enrolling. To date, 43 patients have been screened with 12 screen failures (28%). Of  31 enrolled, 5 patients (16%) withdrew before randomization, 22 (71%) patients completed the study and one is still in active follow up. There were 3 early terminations (10%), 1 due to a change in other medications and 2 due to adverse events: diarrhea and hallucinations. Relationship to the active drug is unclear, however, because study blinding remains in effect.

Conclusions: Mirabegron appears to be well tolerated in PD patients with OAB symptoms. Efficacy will be evaluated at the conclusion of this double blind trial and will be used to decide on future, larger-scale trials.

References: 1.Chapple CR, Kaplan SA, et al. (2013). Randomized Double-blind, Active-controlled Phase 3 Study to Assess 12-Month Safety and Efficacy of Mirabegron, a β(3)-adrenoceptor agonist, in Overactive Bladder. Eur Urol 63:296-305.

2.Iacovelli E, Gilio F, Meco G et al. (2010). Bladder symptoms assessed with overactive bladder questionnaire in Parkinson’s disease. Mov Disord 25(9):1203-9.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/preliminary-report-on-the-maestro-study-a-pilot-study-of-mirabegron-and-behavioral-modification-including-pelvic-floor-exercise-for-overactive-bladder-in-parkinson-disease/