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

The University of Texas System (UT)

Status and phase: Completed; Early Phase 1

Conditions: Cognitive Change; Spinal Cord Injuries; Neurogenic Bladder

Treatments: Drug: Mirabegron

Study type: Interventional

Funder types: Other

Identifiers

NCT03612401

HSC20180376H

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 patients

Sex: All

Ages: 60 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Neurogenic Bladder

Other group

Description:

Spinal Cord Injury patients with known neurogenic bladder on treatment with Anticholinergic Agents at baseline switched to mirabegron as the study intervention

Treatment:

Drug: Mirabegron