Urodynamic and Clinical Efficacy of Mirabegron for Neurogenic Bladder Patients
- Registration Number
- NCT02044510
- Lead Sponsor
- Lawson Health Research Institute
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Inert placebo pill, matching active treatment pill. Mirabegron Mirabegron Patients randomised to this arm start with mirabegron 25mg PO daily for two weeks, and then at 2 weeks titrate to 50mg PO daily, and maintain that dose for the duration of the study (8 additional weeks).
- Primary Outcome Measures
Name Time Method Bladder Capacity 10 weeks Urodynamic bladder capacity
- Secondary Outcome Measures
Name Time Method 3 Day Voiding Diary 10 weeks 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
24hr Urinary Pad Weights 10 weeks This will determine the amount of urinary incontinence that occurs over a 24hr period.
Quality of Life (Bladder Specific) 10 weeks 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.
Quality of Life (Incontinence) 10 weeks 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
Patient Reported Outcome Measure-NBSS 10 weeks 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.
Patient Perception of Bladder Condition 10 weeks The patient perception of bladder condition is a commonly used measure in the assessment of oral medications for the treatment of overactive bladder symptoms
Adverse Events 10 weeks Adverse events will be monitored passively. They will be actively monitored for hypertension, tachycardia, and urinary retention.
Secondary Urodynamic Characteristics: Maximum Detrusor Pressure 10 weeks Secondary Urodynamic Characteristics: Volume at Maximum Detrusor Pressure 10 weeks Secondary Urodynamic Characteristics: Bladder Sensation 10 weeks Secondary Urodynamic Characteristics: Bladder Compliance 10 weeks Secondary Urodynamic Characteristics: Volume at First Detrusor Overactivity 10 weeks
Trial Locations
- Locations (5)
Rehabiliation Center, Health Sciences Center
🇨🇦Winnipeg, Manitoba, Canada
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Kingston General Hospital and Hotel Dieu Hospital (Queens University)
🇨🇦Kingston, Ontario, Canada
Western University
🇨🇦London, Ontario, Canada
University of Ottawa
🇨🇦Ottawa, Ontario, Canada