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

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ClinicalTrials.gov Identifier: NCT03612401
Recruitment Status : Enrolling by invitation
First Posted : August 2, 2018
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Neurogenic Bladder Cognitive Change Drug: Mirabegron Early Phase 1

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Mirabegron

Arm Intervention/treatment
Neurogenic Bladder
Spinal Cord Injury patients with known neurogenic bladder on treatment with Anticholinergic Agents at baseline switched to mirabegron as the study intervention
Drug: Mirabegron
Beta-3 adenoreceptor agonist
Other Name: MYRBETRIQ




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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



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Ages Eligible for Study:   60 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. Anemia (HCT <34%)
  3. End stage renal disease (GFR <30) or bladder obstruction
  4. Poorly controlled blood pressure (BP), systolic BP>180, diastolic BP>110 mmHg)
  5. Renal function - exclude if serum creatinine >2x normal range
  6. Liver function - exclude if >2x normal liver enzyme levels
  7. History of, or currently active treatment for cardiac dysrhythmias, including atrial fibrillation (eg, metoprolol and apixaban)
  8. Current treatment with metoprolol, desipramine, digoxin, warfarin or NOAC/DOAC (novel oral anticoagulants/direct oral anticoagulants)
  9. 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).
  10. Subject is considered unsuitable for the study in the opinion of the investigator for any other reason

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03612401


Locations
United States, Texas
South Texas Veterans Health Care System, Audie L. Murphy Hospital
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Michelle Trbovich, MD UT Health San Antonio and VA Spinal Cord Clinic

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT03612401     History of Changes
Other Study ID Numbers: HSC20180376H
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by The University of Texas Health Science Center at San Antonio:
Spinal cord injury
SCI
Neurogenic bladder
Overactive bladder
anticholinergic
mirabegron
cognitive
cognition
NGB
OAB

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Urinary Bladder, Neurogenic
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Neurologic Manifestations
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms
Mirabegron
Cholinergic Antagonists
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Cholinergic Agents