Urodynamic and Clinical Efficacy of Mirabegron for Neurogenic Bladder Patients
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|ClinicalTrials.gov Identifier: NCT02044510|
Recruitment Status : Terminated (Slow recruitment and small observed effect size)
First Posted : January 24, 2014
Results First Posted : January 7, 2019
Last Update Posted : February 5, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Urinary Bladder, Neurogenic||Drug: Mirabegron Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double Blind, Randomized Placebo Controlled Trial Evaluating the Urodynamic and Clinical Efficacy of Mirabegron Among Neurogenic Bladder Patients|
|Actual Study Start Date :||July 2014|
|Actual Primary Completion Date :||January 2018|
|Actual Study Completion Date :||February 2018|
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
- Bladder Capacity [ Time Frame: 10 weeks ]Urodynamic bladder capacity
- 3 Day Voiding Diary [ Time Frame: 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 [ Time Frame: 10 weeks ]This will determine the amount of urinary incontinence that occurs over a 24hr period.
- Quality of Life (Bladder Specific) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|University of Ottawa|
|Ottawa, Ontario, Canada, K1Y 4E9|
|Toronto Western Hospital|
|Toronto, Ontario, Canada, M5T 2S8|
|Principal Investigator:||Blayne Welk, MD MSc||Western University|