Objective: To assess safety, tolerability, and efficacy of mirabegron and Pelvic floor Exercise (PFE)-based behavioral therapy for the treatment of overactive bladder (OAB) in patients with Parkinson’s disease (PD).

Background: Overactive bladder (OAB), has a prevalence of 24%–96% in Parkinson’s disease (PD) and is associated with negative impact on quality of life. Anticholinergic medications commonly used for OAB may worsen cognition and constipation.
Treatment guidelines for OAB recommend behavioral interventions including pelvic floor exercises as first-line treatment.
Mirabegron has a novel mechanism of action and an FDA approved treatment for OAB.
However, there are no published prospective studies of Mirabegron in PD.

Method: Thirty-one patients with PD and OAB were randomized 1:1 into placebo and treatment arms in prospective, double-blind, placebo-controlled study.
All patients received pelvic floor exercise (PFE) training for the study duration of 10 weeks. Patients in the control arm received placebo while treatment arm received mirabegron 25 mg with optional up-titration to 50 mg.
The primary endpoint was  an  improvement in OAB Symptom Composite Score (OAB-SCS), which assesses voiding frequency and urgency. Secondary measures included number and volume of micturition, incontinence episodes, and patient assessments of OAB severity.

Results: At 10 weeks of treatment no statistically significant difference was noted in OAB-SCS score between the placebo and treatment arms.
Patients on Mirabegron had statistically significant improvement in micturition volume between baseline and study midpoint but not sustained till  study end. Trends suggesting treatment-related improvement in other secondary outcomes were seen, but the results did not meet statistical significance.

Conclusion: Mirabegron had an excellent safety profile and was well tolerated in this PD population. The primary outcome measure in this study did not achieve statistical significance. However, trends in secondary variables suggest clinically meaningful improvement in overactive bladder symptoms and that the combination of mirabegron along with pelvic floor exercises may be  effective in PD patients. Further prospective randomized trials with larger study population may elucidate the extent of the treatment effect on PD patients with bladder dysfunction.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/effectiveness-and-tolerability-of-mirabegron-and-behavioral-therapy-in-patients-with-parkinsons-disease-and-overactive-bladder-a-prospective-randomized-placebo-controlled-pilot-study/