Fall Prevention in Older Adults With OAB

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT03946124
• Collaborator: Pfizer (Industry)
• Enrollment: 74
• Arm: 1
• Actual Duration (Months): 23.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder	Drug: Fesoterodine	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: prospective cohort design examining effects in adults aged 65 and older with OAB undergoing treatment with medication in a clinical setting. A follow up period of 8 weeks has been selected because this is the period of maximal drop in adherence.prospective cohort design examining effects in adults aged 65 and older with OAB undergoing treatment with medication in a clinical setting. A follow up period of 8 weeks has been selected because this is the period of maximal drop in adherence.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prevention of Fall in Older Adults With Overactive Bladdar
• Actual Study Start Date: Jul 25, 2015
• Actual Primary Completion Date: Jul 19, 2017
• Actual Study Completion Date: Jul 19, 2017

Arms and Interventions

Arm

Intervention/Treatment

Other: Fesoterodine Subjects (irrespective of preference) will receive a 90-day supply of open label fesoterodine 4 mg per day. Medication will start 1 week after the baseline visit. After 2 weeks of treatment, dose may be increased to 8 mg over the telephone based on symptom report. This dosing regimen is direct alignment with clinical care. Change of prescription to another anti-cholinergic may occur during the study period, if determined necessary by the physician.

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

Outcome Measures

Primary Outcome Measures

1. Measure of Physical Activity [1 week]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Pennsylvania
• Pfizer

Investigators

None specified.

Study Documents (Full-Text)

• Informed Consent Form - May 9, 2017
• Study Protocol and Statistical Analysis Plan - Mar 29, 2018

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03946124
• Other Study ID Numbers: 822377
• First Posted: May 10, 2019
• Last Update Posted: Dec 11, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Urinary Bladder, Overactive; Fesoterodine

Study Results

Participant Flow

Arm/Group Title	Fesoterodine
Arm/Group Description	Subjects (irrespective of preference) will receive a 90-day supply of open label fesoterodine 4 mg per day. Medication will start 1 week after the baseline visit. After 2 weeks of treatment, dose may be increased to 8 mg over the telephone based on symptom report. This dosing regimen is direct alignment with clinical care. Change of prescription to another anti-cholinergic may occur during the study period, if determined necessary by the physician. Fesoterodine: Fesoterodine, the drug used in this study, is an appropriate medication for routine and standard care of overactive bladder.
Period Title: Overall Study
STARTED	74
COMPLETED	55
NOT COMPLETED	19

Baseline Characteristics

Arm/Group Title	Fesoterodine
Arm/Group Description	Subjects (irrespective of preference) will receive a 90-day supply of open label fesoterodine 4 mg per day. Medication will start 1 week after the baseline visit. After 2 weeks of treatment, dose may be increased to 8 mg over the telephone based on symptom report. This dosing regimen is direct alignment with clinical care. Change of prescription to another anti-cholinergic may occur during the study period, if determined necessary by the physician. Fesoterodine: Fesoterodine, the drug used in this study, is an appropriate medication for routine and standard care of overactive bladder.
Overall Participants	74
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	76.5 (7.2)
Sex: Female, Male (Count of Participants)
Female	74 100%
Male	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 1.4%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	26 35.1%
White	47 63.5%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	74 100%
Physical Activity - Daily Steps (Steps per day) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Steps per day]	2117.7
Physical Activity - CHAMPS questionnaire caloric expenditure/week, all activities (Kcal/week) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kcal/week]	2552.4 (2560.12)
Physical Activity - IPAQ questionnaire total physical activity (MET-min/wk) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [MET-min/wk]	785.62 (1609.84)
Short Physical Performance Battery total score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	7.82 (2.21)
Mini Cog screening test (Count of Participants)
Normal cognition	60 81.1%
Abnormal cognition	8 10.8%
OABq-SF Symptoms Severity score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	61.9 (23.8)
UDI-6 total score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	44.2 (20.5)

Outcome Measures

1. Primary Outcome

Title	Measure of Physical Activity
Description	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.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Patients who were present at follow up and completed accelerometer wear were included in analysis.

Arm/Group Title	Fesoterodine
Arm/Group Description	Subjects (irrespective of preference) will receive a 90-day supply of open label fesoterodine 4 mg per day. Medication will start 1 week after the baseline visit. After 2 weeks of treatment, dose may be increased to 8 mg over the telephone based on symptom report. This dosing regimen is direct alignment with clinical care. Change of prescription to another anti-cholinergic may occur during the study period, if determined necessary by the physician. Fesoterodine: Fesoterodine, the drug used in this study, is an appropriate medication for routine and standard care of overactive bladder.
Measure Participants	56
Median (Inter-Quartile Range) [steps per day]	1634.19

Adverse Events

Time Frame	18 months
Arm/Group Title	Fesoterodine
Arm/Group Description	Subjects (irrespective of preference) will receive a 90-day supply of open label fesoterodine 4 mg per day. Medication will start 1 week after the baseline visit. After 2 weeks of treatment, dose may be increased to 8 mg over the telephone based on symptom report. This dosing regimen is direct alignment with clinical care. Change of prescription to another anti-cholinergic may occur during the study period, if determined necessary by the physician. Fesoterodine: Fesoterodine, the drug used in this study, is an appropriate medication for routine and standard care of overactive bladder.
All Cause Mortality
	Fesoterodine
	Affected / at Risk (%)	# Events
Total	0/74 (0%)
Serious Adverse Events
	Fesoterodine
	Affected / at Risk (%)	# Events
Total	0/74 (0%)
Other (Not Including Serious) Adverse Events
	Fesoterodine
	Affected / at Risk (%)	# Events
Total	7/74 (9.5%)
Gastrointestinal disorders
Side effects	6/74 (8.1%)	6
Vascular disorders
Dizziness, edema	1/74 (1.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.