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

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

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.

Study Overview

Status

Completed

Intervention / 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).

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • San Antonio, Texas, United States, 78229
        • South Texas Veterans Health Care System, Audie L. Murphy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Neurogenic Bladder
Spinal Cord Injury patients with known neurogenic bladder on treatment with Anticholinergic Agents at baseline switched to mirabegron as the study intervention
Beta-3 adenoreceptor agonist
Other Names:
  • MYRBETRIQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cognitive measure - Logical Memory I (Immediate) - baseline and post treatment with mirabegron
Time Frame: Change from Week 0 to Week 26
Wechsler Memory Scale, 4th edition (WMS-IV) subtest
Change from Week 0 to Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cognitive measure of memory (SLUMS) - baseline and post treatment with mirabegron
Time Frame: Change from Week 0 to Week 26
Saint Louis University Mental Status Exam (SLUMS) - a series of shapes and recall measures
Change from Week 0 to Week 26
Change in cognitive measure of executive function (Stroop test) - baseline and post treatment with mirabegron
Time Frame: Change from Week 0 to Week 26
Stroop Color and Word Test - a series of color-word and picture-word tests of executive function
Change from Week 0 to Week 26
Change in cognitive measure of executive function (SDMT) - baseline and post treatment with mirabegron
Time Frame: Change from Week 0 to Week 26
Symbol Digit Modalities Test - a series of symbols to assess executive function
Change from Week 0 to Week 26
Change in memory and executive function (TEXAS) - baseline and post treatment with mirabegron
Time Frame: Change from Week 0 to Week 26
Texas Executive Assessment (TEXAS) - A series of short term recall measures
Change from Week 0 to Week 26
Change in Neurogenic Bladder Symptom Score (NBSS) - baseline and post treatment with mirabegron
Time Frame: Change from Week 0 to Week 26
Neurogenic bladder symptom questionnaire
Change from Week 0 to Week 26
Change in Neurogenic Bowel Dysfunction Score (NBD) - baseline and post treatment with mirabegron
Time Frame: Change from Week 0 to Week 26
Neurogenic bowel questionnaire
Change from Week 0 to Week 26
Change in cognitive measure - Logical Memory II (Delayed) - baseline and post treatment with mirabegron
Time Frame: Change from Week 0 to Week 26
Wechsler Memory Scale, 4th edition (WMS-IV) subtest
Change from Week 0 to Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michelle Trbovich, MD, UT Health San Antonio and VA Spinal Cord Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 5, 2018

Primary Completion (ACTUAL)

March 23, 2020

Study Completion (ACTUAL)

March 31, 2021

Study Registration Dates

First Submitted

July 9, 2018

First Submitted That Met QC Criteria

July 26, 2018

First Posted (ACTUAL)

August 2, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 22, 2021

Last Update Submitted That Met QC Criteria

June 15, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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