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Clinical Trial Summary

Anticholinergic medication is used to treat overactive bladder (OAB). A known side effect of this medication is cognitive dysfunction. OAB is more prevalent in the elderly population - a group that also has a higher baseline risk of cognitive dysfunction. Our objective is to evaluate the effect of an anticholinergic medication on cognitive function in elderly women. Subjects will be randomized to:1) trospium chloride or 2) placebo. There are three aims: 1) To evaluate changes in cognitive function in elderly women taking trospium versus placebo, using validated cognitive assessment tests. 2) To develop a useful battery of cognitive screening tests for monitoring the cognitive safety of OAB management. 3) To understand how the timing of cognitive changes relates to the timing of improvement in OAB symptoms. The investigators will recruit 60 women aged ≥ 50 with the diagnosis of OAB. Cognitive assessments will be performed at baseline and Week 1 and 4 after drug initiation using paper-based validated questionnaires. OAB improvement will be assessed with validated questionnaires.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


NCT number NCT01922115
Study type Interventional
Source University of North Carolina, Chapel Hill
Contact
Status Completed
Phase Phase 4
Start date June 2013
Completion date June 2015

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