Fall Prevention in Older Adults With OAB

Overactive Bladder Clinical Trial

Official title:

Prevention of Fall in Older Adults With Overactive Bladdar

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03946124
• Other study ID #: 822377
• Status: Completed
• Phase: Phase 4
• Start date: July 25, 2015
• Est. completion date: July 19, 2017

Study information

• Verified date: May 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 19, 2017
• Est. primary completion date: July 19, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

adults aged 65 or older, urinary urgency of quite a bit severity or more on the Overactive Bladder Questionnaire-Short Form (OABq-SF), eligible for pharmacologic therapy for overactive bladder

Exclusion Criteria:

predominant stress incontinence (on UDI-6), current/recent use (6 m) or contraindication to anti-cholinergic medication, severe voiding difficulties, men on 5-alpha reductase inhibitors, severe neurologic disease, recent anti-incontinence or prolapse surgery, other urinary tract conditions such as calculus or recurrent UTI.

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Fesoterodine
Fesoterodine, the drug used in this study, is an appropriate medication for routine and standard care of overactive bladder.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of Physical Activity	Physical activity was measured by using accelerometer worn over the course of a week at follow up. Average daily step counts were derived from this weeklong measurement.	1 week