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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Beta-3 adenoreceptor agonist
South Texas Veterans Health Care System, Audie L. Murphy Hospital
San Antonio, Texas, United States
Change in cognitive measure - Logical Memory I (Immediate) - baseline and post treatment with mirabegron
Wechsler Memory Scale, 4th edition (WMS-IV) subtest
Time frame: Change from Week 0 to Week 26
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
Time frame: Change from Week 0 to Week 26
Change in cognitive measure of executive function (Stroop test) - baseline and post treatment with mirabegron
Stroop Color and Word Test - a series of color-word and picture-word tests of executive function
Time frame: 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
Time frame: 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
Time frame: Change from Week 0 to Week 26
Change in Neurogenic Bladder Symptom Score (NBSS) - baseline and post treatment with mirabegron
Neurogenic bladder symptom questionnaire
Time frame: Change from Week 0 to Week 26
Change in Neurogenic Bowel Dysfunction Score (NBD) - baseline and post treatment with mirabegron
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Neurogenic bowel questionnaire
Time frame: 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
Time frame: Change from Week 0 to Week 26