Overactive Bladder
Conditions
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.
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.
Interventions
DRUGFesoterodine
Fesoterodine, the drug used in this study, is an appropriate medication for routine and standard care of overactive bladder.
Sponsors
Pfizer
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Fesoterodine: Fesoterodine, the drug used in this study, is an appropriate medication for routine and standard care of overactive bladder. | 74 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 19 |
Baseline characteristics
| Characteristic | Fesoterodine |
|---|---|
| Age, Continuous | 76.5 years STANDARD_DEVIATION 7.2 |
| Mini Cog screening test Abnormal cognition | 8 Participants |
| Mini Cog screening test Normal cognition | 60 Participants |
| OABq-SF Symptoms Severity score | 61.9 units on a scale STANDARD_DEVIATION 23.8 |
| Physical Activity - CHAMPS questionnaire caloric expenditure/week, all activities | 2552.4 Kcal/week STANDARD_DEVIATION 2560.12 |
| Physical Activity - Daily Steps | 2117.7 Steps per day |
| Physical Activity - IPAQ questionnaire total physical activity | 785.62 MET-min/wk STANDARD_DEVIATION 1609.84 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 47 Participants |
| Region of Enrollment United States | 74 participants |
| Sex: Female, Male Female | 74 Participants |
| Sex: Female, Male Male | 0 Participants |
| Short Physical Performance Battery total score | 7.82 units on a scale STANDARD_DEVIATION 2.21 |
| UDI-6 total score | 44.2 units on a scale STANDARD_DEVIATION 20.5 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 74 |
| other Total, other adverse events | 7 / 74 |
| serious Total, serious adverse events | 0 / 74 |
Outcome results
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.
Time frame: 1 week
Population: Patients who were present at follow up and completed accelerometer wear were included in analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fesoterodine | Measure of Physical Activity | 1634.19 steps per day |