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

Primary Purpose

Spinal Cord Injuries, Neurogenic Bladder, Cognitive Change

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mirabegron
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal cord injury, SCI, Neurogenic bladder, Overactive bladder, anticholinergic, mirabegron, cognitive, cognition, NGB, OAB

Eligibility Criteria

60 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Neurogenic Bladder

Arm Description

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

Outcomes

Primary Outcome Measures

Change in cognitive measure - Logical Memory I (Immediate) - baseline and post treatment with mirabegron
Wechsler Memory Scale, 4th edition (WMS-IV) subtest

Secondary Outcome Measures

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 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 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 in memory and executive function (TEXAS) - baseline and post treatment with mirabegron
Texas Executive Assessment (TEXAS) - A series of short term recall measures
Change in Neurogenic Bladder Symptom Score (NBSS) - baseline and post treatment with mirabegron
Neurogenic bladder symptom questionnaire
Change in Neurogenic Bowel Dysfunction Score (NBD) - baseline and post treatment with mirabegron
Neurogenic bowel questionnaire
Change in cognitive measure - Logical Memory II (Delayed) - baseline and post treatment with mirabegron
Wechsler Memory Scale, 4th edition (WMS-IV) subtest

Full Information

First Posted
July 9, 2018
Last Updated
June 15, 2021
Sponsor
The University of Texas Health Science Center at San Antonio
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1. Study Identification

Unique Protocol Identification Number
NCT03612401
Brief Title
Treatment of Spinal Cord Injury Patients for Neurogenic Bladder: Anticholinergic Agent vs. Mirabegron
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 5, 2018 (Actual)
Primary Completion Date
March 23, 2020 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Neurogenic Bladder, Cognitive Change
Keywords
Spinal cord injury, SCI, Neurogenic bladder, Overactive bladder, anticholinergic, mirabegron, cognitive, cognition, NGB, OAB

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Open label, pilot study comparing baseline measurement anticholinergic agent vs. study intervention mirabegron (MYRBETRIC ®) to evaluate cognitive impact and efficacy (SCIMYR)
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurogenic Bladder
Arm Type
Other
Arm Description
Spinal Cord Injury patients with known neurogenic bladder on treatment with Anticholinergic Agents at baseline switched to mirabegron as the study intervention
Intervention Type
Drug
Intervention Name(s)
Mirabegron
Other Intervention Name(s)
MYRBETRIQ
Intervention Description
Beta-3 adenoreceptor agonist
Primary Outcome Measure Information:
Title
Change in cognitive measure - Logical Memory I (Immediate) - baseline and post treatment with mirabegron
Description
Wechsler Memory Scale, 4th edition (WMS-IV) subtest
Time Frame
Change from Week 0 to Week 26
Secondary Outcome Measure Information:
Title
Change in cognitive measure of memory (SLUMS) - baseline and post treatment with mirabegron
Description
Saint Louis University Mental Status Exam (SLUMS) - a series of shapes and recall measures
Time Frame
Change from Week 0 to Week 26
Title
Change in cognitive measure of executive function (Stroop test) - baseline and post treatment with mirabegron
Description
Stroop Color and Word Test - a series of color-word and picture-word tests of executive function
Time Frame
Change from Week 0 to Week 26
Title
Change in cognitive measure of executive function (SDMT) - baseline and post treatment with mirabegron
Description
Symbol Digit Modalities Test - a series of symbols to assess executive function
Time Frame
Change from Week 0 to Week 26
Title
Change in memory and executive function (TEXAS) - baseline and post treatment with mirabegron
Description
Texas Executive Assessment (TEXAS) - A series of short term recall measures
Time Frame
Change from Week 0 to Week 26
Title
Change in Neurogenic Bladder Symptom Score (NBSS) - baseline and post treatment with mirabegron
Description
Neurogenic bladder symptom questionnaire
Time Frame
Change from Week 0 to Week 26
Title
Change in Neurogenic Bowel Dysfunction Score (NBD) - baseline and post treatment with mirabegron
Description
Neurogenic bowel questionnaire
Time Frame
Change from Week 0 to Week 26
Title
Change in cognitive measure - Logical Memory II (Delayed) - baseline and post treatment with mirabegron
Description
Wechsler Memory Scale, 4th edition (WMS-IV) subtest
Time Frame
Change from Week 0 to Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both genders with spinal cord injury being treated for neurogenic bladder and age >60 years All ethnic groups Veterans will be enrolled to allow mailing of study medication by VA pharmacies. 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) Taking a minimum regimen for 3 months of anticholinergic agent. Exclusion Criteria: Diagnosis of dementia or cognitive impairment from another condition such as TBI (traumatic brain injury), ALZ (alzheimers), Lewy body dementia or vascular dementia End stage renal disease (GFR <30) or bladder obstruction Poorly controlled blood pressure (BP), systolic BP>180, diastolic BP>110 mmHg) Renal function - exclude if serum creatinine >2x normal range Liver function - exclude if >2x normal liver enzyme levels 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) Current treatment with desipramine, digoxin 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). Subject is considered unsuitable for the study in the opinion of the investigator for any other reason
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Trbovich, MD
Organizational Affiliation
UT Health San Antonio and VA Spinal Cord Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Texas Veterans Health Care System, Audie L. Murphy Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/34112758/
Description
Publication of study results in Spinal cord series and cases.

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

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