Clinical trial NCT01922115: The Effect of Anticholinergics on Cognitive Function in the Elderly
Official title: The Effect of Anticholinergics on Cognitive Function in the Elderly: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mental Competency
Urinary Bladder, Overactive
Cognitive Function
Keywords: COGNITIVE FUNCTION
OVERACTIVE BLADDER
[C23.888.942.343.780]
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: American Urogynecologic Society
First posted: 2013-08-14
Enrollment: 59
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: 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.

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)

Primary outcomes:
measure: Hopkins Verbal Learning Test - Revised
timeFrame: Week 4
measure: Hopkins Verbal Learning Test - Revised
timeFrame: Week 4
Secondary outcomes:
measure: Mini-Mental State Examination
timeFrame: Week 4
measure: Overactive Bladder Questionnaire
timeFrame: Week 4
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Unc Chapel Hill Urogynecology A2 Clinic
state: North Carolina
Study officials:
affiliation: UNC CHAPEL HILL
name: Elizabeth Geller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Geller EJ, Dumond JB, Bowling JM, Khandelwal CM, Wu JM, Busby-Whitehead J, Kaufer DI. Effect of Trospium Chloride on Cognitive Function in Women Aged 50 and Older: A Randomized Trial. Female Pelvic Med Reconstr Surg. 2017 Mar/Apr;23(2):118-123. doi: 10.1097/SPV.0000000000000374.