- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03612401
Treatment of Spinal Cord Injury Patients for Neurogenic Bladder: Anticholinergic Agent vs. Mirabegron (SCIMYR)
Treatment of Spinal Cord Injury Patients for Neurogenic Bladder: an Open Label Pilot Study of Anticholinergic Agent vs. Mirabegron (MYRBETRIQ ®) to Evaluate Cognitive Impact and Efficacy
Study Overview
Status
Intervention / Treatment
Detailed Description
The strong evidence for detrimental effects of AC agents on cognition, led the American Urological Association to update its guidelines in 2015 to include mirabegron as an alternative first-line agent for treatment of overactive bladder (OAB). NGB symptoms are very similar to OAB so the conditions are often treated similarly; however, data is lacking on the use of this promising agent for NGB. We thus propose to test the hypothesis that cognition will improve with substitution of mirabegron for the AC agent in elderly persons with SCI who require NGB treatment.
Subjects eligible for enrollment will have been treated with an anticholinergic agent for at least 3 months prior to enrollment. Baseline measurements will be recorded for subjects currently treated with an AC agent, after enrollment, the subject will start treatment with the study drug. Measurements from baseline (AC agent) will be compared to measurements taken after study intervention (mirabegron).
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Texas
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San Antonio, Texas, United States, 78229
- South Texas Veterans Health Care System, Audie L. Murphy Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Both genders with spinal cord injury being treated for neurogenic bladder and age >60 years
- All ethnic groups
- Veterans will be enrolled to allow mailing of study medication by VA pharmacies.
Laboratory results:
Normal clinical labs for CBC (complete blood count), CMP (comprehensive metabolic panel), and UA (urinalysis) within past 6 months or repeat at screening if none. For example: HCT (hematocrit) ≥34%, GFR (glomerular filtration rate) ≥ 30 mL/min, liver enzymes (AST (aspartate aminotransferase test) < 2 x upper limit of normal, ALT (alanine aminotransferase test) < 2 x upper limit of normal, alkaline phosphatase < 2 X upper limit of normal), normal electrolytes, urinalysis and asymptomatic for UTI (urinary tract infection)
- Taking a minimum regimen for 3 months of anticholinergic agent.
Exclusion Criteria:
- Diagnosis of dementia or cognitive impairment from another condition such as TBI (traumatic brain injury), ALZ (alzheimers), Lewy body dementia or vascular dementia
- End stage renal disease (GFR <30) or bladder obstruction
- Poorly controlled blood pressure (BP), systolic BP>180, diastolic BP>110 mmHg)
- Renal function - exclude if serum creatinine >2x normal range
- Liver function - exclude if >2x normal liver enzyme levels
- History of, or currently active treatment for cardiac dysrhythmias, including atrial fibrillation (eg. apixaban. If subject is currently taking metoprolol they will be monitored and dose may need to be adjusted on mirabegron)
- Current treatment with desipramine, digoxin
- Active/unstable conditions: inflammatory, thyroid, autoimmune, gastrointestinal (GI), hematologic, or neoplastic disorders. Exclude subjects with clinical lab values outside the normal range (other than as specified above).
- Subject is considered unsuitable for the study in the opinion of the investigator for any other reason
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Neurogenic Bladder
Spinal Cord Injury patients with known neurogenic bladder on treatment with Anticholinergic Agents at baseline switched to mirabegron as the study intervention
|
Beta-3 adenoreceptor agonist
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cognitive measure - Logical Memory I (Immediate) - baseline and post treatment with mirabegron
Time Frame: Change from Week 0 to Week 26
|
Wechsler Memory Scale, 4th edition (WMS-IV) subtest
|
Change from Week 0 to Week 26
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cognitive measure of memory (SLUMS) - baseline and post treatment with mirabegron
Time Frame: Change from Week 0 to Week 26
|
Saint Louis University Mental Status Exam (SLUMS) - a series of shapes and recall measures
|
Change from Week 0 to Week 26
|
Change in cognitive measure of executive function (Stroop test) - baseline and post treatment with mirabegron
Time Frame: Change from Week 0 to Week 26
|
Stroop Color and Word Test - a series of color-word and picture-word tests of executive function
|
Change from Week 0 to Week 26
|
Change in cognitive measure of executive function (SDMT) - baseline and post treatment with mirabegron
Time Frame: Change from Week 0 to Week 26
|
Symbol Digit Modalities Test - a series of symbols to assess executive function
|
Change from Week 0 to Week 26
|
Change in memory and executive function (TEXAS) - baseline and post treatment with mirabegron
Time Frame: Change from Week 0 to Week 26
|
Texas Executive Assessment (TEXAS) - A series of short term recall measures
|
Change from Week 0 to Week 26
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Change in Neurogenic Bladder Symptom Score (NBSS) - baseline and post treatment with mirabegron
Time Frame: Change from Week 0 to Week 26
|
Neurogenic bladder symptom questionnaire
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Change from Week 0 to Week 26
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Change in Neurogenic Bowel Dysfunction Score (NBD) - baseline and post treatment with mirabegron
Time Frame: Change from Week 0 to Week 26
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Neurogenic bowel questionnaire
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Change from Week 0 to Week 26
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Change in cognitive measure - Logical Memory II (Delayed) - baseline and post treatment with mirabegron
Time Frame: Change from Week 0 to Week 26
|
Wechsler Memory Scale, 4th edition (WMS-IV) subtest
|
Change from Week 0 to Week 26
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michelle Trbovich, MD, UT Health San Antonio and VA Spinal Cord Clinic
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Urologic Diseases
- Urinary Bladder Diseases
- Neurologic Manifestations
- Trauma, Nervous System
- Spinal Cord Diseases
- Wounds and Injuries
- Spinal Cord Injuries
- Urinary Bladder, Neurogenic
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Urological Agents
- Adrenergic Agonists
- Adrenergic beta-Agonists
- Adrenergic beta-3 Receptor Agonists
- Mirabegron
Other Study ID Numbers
- HSC20180376H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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