Ignite Creation Date:
2024-05-06 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03612401
Status:
COMPLETED
Last Update Posted:
2021-06-22
First Post:
2018-07-09
Brief Title:
Treatment of Spinal Cord Injury Patients for Neurogenic Bladder Anticholinergic Agent vs Mirabegron
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCIMYR
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None