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

NCT ID: NCT03612401

Last Updated: 2021-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-05
• Study Completion Date: 2021-03-31

Brief 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.

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).

Conditions

Spinal Cord Injuries; Neurogenic Bladder; Cognitive Change

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neurogenic Bladder

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

Group Type: OTHER

Mirabegron

Intervention Type: DRUG

Beta-3 adenoreceptor agonist

Interventions

Mirabegron

Beta-3 adenoreceptor agonist

Intervention Type: DRUG

Other Intervention Names

MYRBETRIQ

Eligibility 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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Trbovich, MD

Role: PRINCIPAL_INVESTIGATOR

UT Health San Antonio and VA Spinal Cord Clinic

Locations

South Texas Veterans Health Care System, Audie L. Murphy Hospital

San Antonio, Texas, United States

Countries

United States

Related Links

https://pubmed.ncbi.nlm.nih.gov/34112758/

Publication of study results in Spinal cord series and cases.

Other Identifiers

HSC20180376H

Identifier Type: -

Identifier Source: org_study_id