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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Mirabegron 25mg PO daily for 2 weeks, with dose increase to Mirabegron 50mg PO daily for the remaining 8 weeks.
Matched placebo capsules to the intervention arm
Rehabiliation Center, Health Sciences Center
Winnipeg, Manitoba, Canada
Kingston General Hospital and Hotel Dieu Hospital (Queens University)
Kingston, Ontario, Canada
Western University
London, Ontario, Canada
University of Ottawa
Ottawa, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Bladder Capacity
Urodynamic bladder capacity
Time frame: 10 weeks
3 Day Voiding Diary
The 3 day voiding diary is a simple patient maintained record of fluid intake, voided volume and incontinence episodes. This will be used to assess number of episodes of urgency incontinence, urinary frequency, longest time between voids, functional capacity, and mean voided volume
Time frame: 10 weeks
24hr Urinary Pad Weights
This will determine the amount of urinary incontinence that occurs over a 24hr period.
Time frame: 10 weeks
Quality of Life (Bladder Specific)
The Short Form-Qualiveen is a urinary specific quality of life measure developed and studied specifically for neurogenic bladder patients; validity, reliability and responsiveness have been established.
Time frame: 10 weeks
Quality of Life (Incontinence)
The I-QOL is an incontinence specific quality of life tool that has been shown to be a valid, reliable and responsive measurement among patients with neurogenic bladder dysfunction
Time frame: 10 weeks
Patient Reported Outcome Measure-NBSS
The Neurogenic bladder symptom score (NBSS) is a symptom specific measure of urinary symptoms developed for patients with neurogenic bladder dysfunction with demonstrated validity and reliability. Minimum score is 0, maximum score is 74. Higher score is worse neurogenic bladder symptoms.
Time frame: 10 weeks
Patient Perception of Bladder Condition
The patient perception of bladder condition is a commonly used measure in the assessment of oral medications for the treatment of overactive bladder symptoms
Time frame: 10 weeks
Adverse Events
Adverse events will be monitored passively. They will be actively monitored for hypertension, tachycardia, and urinary retention.
Time frame: 10 weeks
Secondary Urodynamic Characteristics: Maximum Detrusor Pressure
Time frame: 10 weeks
Secondary Urodynamic Characteristics: Volume at Maximum Detrusor Pressure
Time frame: 10 weeks
Secondary Urodynamic Characteristics: Bladder Sensation
Time frame: 10 weeks
Secondary Urodynamic Characteristics: Bladder Compliance
Time frame: 10 weeks
Secondary Urodynamic Characteristics: Volume at First Detrusor Overactivity
Time frame: 10 weeks
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