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

NCT03612401 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: HSC20180376H
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Neurogenic Bladder; Cognitive Change

Keywords

Spinal cord injury; SCI; Neurogenic bladder; Overactive bladder; anticholinergic; mirabegron; cognitive; cognition; NGB; OAB

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in cognitive measure of memory (SLUMS) - baseline and post treatment with mirabegron

  Change from Week 0 to Week 26

• Change in cognitive measure of executive function (Stroop test) - baseline and post treatment with mirabegron

  Change from Week 0 to Week 26

• Change in cognitive measure of executive function (SDMT) - baseline and post treatment with mirabegron

  Change from Week 0 to Week 26

• Change in memory and executive function (TEXAS) - baseline and post treatment with mirabegron

  Change from Week 0 to Week 26

• Change in Neurogenic Bladder Symptom Score (NBSS) - baseline and post treatment with mirabegron

  Change from Week 0 to Week 26

Study Arms (1)

Neurogenic Bladder

OTHER

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

Drug: Mirabegron

Interventions

Mirabegron DRUG

Beta-3 adenoreceptor agonist

Also known as: MYRBETRIQ

Neurogenic Bladder

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

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

San Antonio, Texas, 78229, United States

Location

Related Links

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

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Bladder, Neurogenic; Urinary Bladder, Overactive

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lower Urinary Tract Symptoms; Urological Manifestations

Study Officials

• Michelle Trbovich, MD

  UT Health San Antonio and VA Spinal Cord Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label, pilot study comparing baseline measurement anticholinergic agent vs. study intervention mirabegron (MYRBETRIC ®) to evaluate cognitive impact and efficacy (SCIMYR)

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: August 2, 2018
• Study Start: December 5, 2018
• Primary Completion: March 23, 2020
• Study Completion: March 31, 2021
• Last Updated: June 22, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)