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

Spinal Cord Injuries Clinical Trial

— SCIMYR  

Official title:

Treatment of Spinal Cord Injury Patients for Neurogenic Bladder: an Open Label Pilot Study of Anticholinergic Agent vs. Mirabegron (MYRBETRIQ ®) to Evaluate Cognitive Impact and Efficacy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03612401
• Other study ID #: HSC20180376H
• Status: Completed
• Phase: Early Phase 1
• Start date: December 5, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: June 2021
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 31, 2021
• Est. primary completion date: March 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Change
• Neurogenic Bladder
• Spinal Cord Injuries
• Urinary Bladder, Neurogenic
• Wounds and Injuries

Intervention

Drug:
• Mirabegron
Beta-3 adenoreceptor agonist

Locations

Country	Name	City	State
United States	South Texas Veterans Health Care System, Audie L. Murphy Hospital	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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	Change from Week 0 to Week 26
Secondary	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
Secondary	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
Secondary	Change in Neurogenic Bladder Symptom Score (NBSS) - baseline and post treatment with mirabegron	Neurogenic bladder symptom questionnaire	Change from Week 0 to Week 26
Secondary	Change in Neurogenic Bowel Dysfunction Score (NBD) - baseline and post treatment with mirabegron	Neurogenic bowel questionnaire	Change from Week 0 to Week 26
Secondary	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

External Links

•   Publication of study results in Spinal cord series and cases.