NCT03612401

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 60 Years – 99 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Spinal Cord Injuries
• Neurogenic Bladder
• Cognitive Change

Interventions

Type	Name	Description
DRUG	Mirabegron	Beta-3 adenoreceptor agonist

Timeline

• Start date: 2018-12-05
• Primary completion: 2020-03-23
• Completion: 2021-03-31
• First posted: 2018-08-02
• Last updated: 2021-06-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study