Urodynamic and Clinical Efficacy of Mirabegron for Neurogenic Bladder Patients
Status:
Terminated
Trial end date:
2018-02-01
Target enrollment:
Participant gender:
Summary
The proposed study is a randomized, double blind placebo controlled multicenter study to
determine the effectiveness of mirabegron in the treatment of neurogenic bladder dysfunction.
Patients will be randomized into one of two trial arms: mirabegron 25mg for two weeks, with
escalation to 50mg for the remaining 8 weeks, or matched placebo capsule for two weeks, with
placebo escalation for the remaining 8 weeks. Each of these trial arms will be stratified
based on whether the patient is already taking an anticholinergic medication or not. The
study will treat a total of 144 patients (72 with placebo, 72 with mirabegron). The study
hypothesis is that mirabegron will result in a statistically superior (increased) urodynamic
bladder capacity.
The study duration is 12 weeks, with a 1-4 week run in period where no active or placebo
treatment will be administered. The primary outcome measure will be based on an increase in
urodynamic bladder capacity. Secondary outcome measures will be additional urodynamic
parameters, urinary symptom scales, urinary quality of life indices, and voiding diary
results.
Patients who are over 18 years of age with a diagnosis of multiple sclerosis (MS) or spinal
cord injury (SCI) will be eligible to participate. All eligible patients will have urodynamic
studies performed within 4 weeks of trial enrollment, and at the end of study (week 9-10).
Adverse events and study outcomes will be assessed at predefined study time points.