Phase 4
N=59
The Effect of Anticholinergics on Cognitive Function in the Elderly
Mental Competency · Urinary Bladder, Overactive · Cognitive Function
Bottom Line
View on ClinicalTrials.gov: NCT01922115 ↗Enrolled (actual)
59
Serious AEs
3.4%
Results posted
Jul 2016
Primary outcome: Primary: Hopkins Verbal Learning Test - Revised — 22.00; 24.38; 6.71; 7.83 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Trospium Chloride (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Female
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hopkins Verbal Learning Test - Revised |
81.68; 83.49 | — |
| PRIMARY Hopkins Verbal Learning Test - Revised |
81.68; 83.49 | — |
| SECONDARY Mini-Mental State Examination |
28.14; 28.38 | — |
| SECONDARY Overactive Bladder Questionnaire |
41.45; 56.04 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Female 50 or older
- Diagnosis of OAB (ICS definition)
- English literacy
- Ability to swallow oral medication
- Cognitive ability to give consent
Exclusion Criteria
- Dementia/Depression/Delirium
- Current anticholinergic use (requires 2 week washout period)
- Current cholinesterase
- Urinary or gastric retention
- Severe decreased gastrointestinal motility
- Uncontrolled narrow-angle glaucoma
- Myasthenia gravis
- Diagnosis fo renal impairment (creatinine clearance <30 mL/min)
Data sourced from ClinicalTrials.gov (NCT01922115). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.