Clinical Trials Directory

Trials / Completed

CompletedNCT03946124

Fall Prevention in Older Adults With OAB

Prevention of Fall in Older Adults With Overactive Bladdar

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
74 (actual)
Sponsor
University of Pennsylvania · Academic / Other
Sex
Female
Age
65 Years
Healthy volunteers
Not accepted

Summary

Though OAB treatment may improve physical activity, there is a lack of easily administered instruments for measuring physical activity in older adults. Aim is to validate instruments to measure physical activity and preference for medication, and to determine the effect of preference for anti-cholinergic medication on adherence, physical activity, and falls risk. It's plan a prospective cohort study of adults aged 65 or older with OAB undergoing treatment with anti-cholinergic medication.

Detailed description

Older adults with overactive bladder (OAB) have reduced physical activity and are at increased risk for falls. Though recent studies suggest that treatment of OAB may improve physical activity, there is a lack of easily administered instruments for measuring physical activity in older adults. Furthermore, physical activity outcomes in older adults with OAB are affected by treatment preference and potential neurocognitive dysfunction caused by anti-cholinergic medication. The aims of the present proposal are 1) to validate an instrument to measure physical activity 2) to validate an instrument to measure preference for medication and 3) to determine the effect of preference for anti-cholinergic medication on adherence, physical activity, and falls risk. Plan: a prospective cohort study of adults aged 65 or older with OAB undergoing treatment with anti-cholinergic medication. The primary outcome will be physical activity measured using a self-reported instrument and accelerometer at baseline and 8 weeks after treatment. Secondary outcomes will be fall risk defined by changes in neurocognitive testing, urinary symptoms, and medication adherence at 8 weeks after treatment. The findings of this study could provide a paradigm shift in the management of older adults with OAB and at increased risk for falls.

Conditions

Interventions

TypeNameDescription
DRUGFesoterodineFesoterodine, the drug used in this study, is an appropriate medication for routine and standard care of overactive bladder.

Timeline

Start date
2015-07-25
Primary completion
2017-07-19
Completion
2017-07-19
First posted
2019-05-10
Last updated
2023-05-06
Results posted
2019-12-11

Regulatory

Source: ClinicalTrials.gov record NCT03946124. Inclusion in this directory is not an endorsement.