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We propose to test the hypothesis that cognition will improve with substitution of mirabegron for the anticholinergic agent (AC) in elderly persons with spinal cord injury (SCI) who require neurogenic bladder (NGB) treatment.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurogenic Bladder | Other | Spinal Cord Injury patients with known neurogenic bladder on treatment with Anticholinergic Agents at baseline switched to mirabegron as the study intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirabegron | Drug | Beta-3 adenoreceptor agonist |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive measure - Logical Memory I (Immediate) - baseline and post treatment with mirabegron | Wechsler Memory Scale, 4th edition (WMS-IV) subtest | Change from Week 0 to Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive measure of memory (SLUMS) - baseline and post treatment with mirabegron | 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Trbovich, MD | UT Health San Antonio and VA Spinal Cord Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Texas Veterans Health Care System, Audie L. Murphy Hospital | San Antonio | Texas | 78229 | United States |
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| Label | URL |
|---|---|
| Publication of study results in Spinal cord series and cases. | View source |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D001750 | Urinary Bladder, Neurogenic |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| C520025 | mirabegron |
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Open label, pilot study comparing baseline measurement anticholinergic agent vs. study intervention mirabegron (MYRBETRIC ®) to evaluate cognitive impact and efficacy (SCIMYR)
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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 | 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 | Texas Executive Assessment (TEXAS) - A series of short term recall measures | Change from Week 0 to Week 26 |
| Change in Neurogenic Bladder Symptom Score (NBSS) - baseline and post treatment with mirabegron | Neurogenic bladder symptom questionnaire | Change from Week 0 to Week 26 |
| Change in Neurogenic Bowel Dysfunction Score (NBD) - baseline and post treatment with mirabegron | Neurogenic bowel questionnaire | Change from Week 0 to Week 26 |
| Change in cognitive measure - Logical Memory II (Delayed) - baseline and post treatment with mirabegron | Wechsler Memory Scale, 4th edition (WMS-IV) subtest | Change from Week 0 to Week 26 |
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |