Overview

Treatment of Spinal Cord Injury Patients for Neurogenic Bladder: Anticholinergic Agent vs. Mirabegron

Status:
Completed
Trial end date:
2021-03-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Treatments:
Cholinergic Antagonists
Mirabegron
Criteria
Inclusion Criteria:

1. Both genders with spinal cord injury being treated for neurogenic bladder and age >60
years

2. All ethnic groups

3. Veterans will be enrolled to allow mailing of study medication by VA pharmacies.

4. 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)

5. Taking a minimum regimen for 3 months of anticholinergic agent.

Exclusion Criteria:

1. Diagnosis of dementia or cognitive impairment from another condition such as TBI
(traumatic brain injury), ALZ (alzheimers), Lewy body dementia or vascular dementia

2. End stage renal disease (GFR <30) or bladder obstruction

3. Poorly controlled blood pressure (BP), systolic BP>180, diastolic BP>110 mmHg)

4. Renal function - exclude if serum creatinine >2x normal range

5. Liver function - exclude if >2x normal liver enzyme levels

6. 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)

7. Current treatment with desipramine, digoxin

8. 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).

9. Subject is considered unsuitable for the study in the opinion of the investigator for
any other reason