Urodynamic and Clinical Efficacy of Mirabegron for Neurogenic Bladder Patients
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 or spinal cord injury 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.
Urinary Bladder, Neurogenic
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double Blind, Randomized Placebo Controlled Trial Evaluating the Urodynamic and Clinical Efficacy of Mirabegron Among Neurogenic Bladder Patients|
- Bladder capacity [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]Urodynamic bladder capacity
- 3 day Voiding diary [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]This will determine the amount of urinary incontinence that occurs over a 24hr period.
- Quality of life (bladder specific) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]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) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]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
- Patient perception of bladder condition [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]Adverse events will be monitored passively. They will be actively monitored for hypertension, tachycardia, and urinary retention.
- Secondary urodynamic characteristics: maximum detrusor pressure [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
- Secondary urodynamic characteristics: Volume at maximum detrusor pressure [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
- Secondary urodynamic characteristics: Bladder sensation [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
- Secondary urodynamic characteristics: bladder compliance [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
- Secondary urodynamic characteristics: Volume at first detrusor overactivity [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||July 2014|
|Estimated Study Completion Date:||February 2016|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
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).
Mirabegron 25mg PO daily for 2 weeks, with dose increase to Mirabegron 50mg PO daily for the remaining 8 weeks.
Other Name: MYRBETRIQ
Placebo Comparator: Placebo
Inert placebo pill, matching active treatment pill.
Matched placebo capsules to the intervention arm
Please refer to this study by its ClinicalTrials.gov identifier: NCT02044510
|Rehabiliation Center, Health Sciences Center|
|Winnipeg, Manitoba, Canada, R3A 1M4|
|Kingston General Hospital and Hotel Dieu Hospital (Queens University)|
|Kingston, Ontario, Canada, K7L 5G2|
|London, Ontario, Canada, N6A 4V2|
|Principal Investigator:||Blayne Welk, MD MSc||Western University|