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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fesoterodine | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fesoterodine | Drug | Fesoterodine, the drug used in this study, is an appropriate medication for routine and standard care of overactive bladder. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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.
Female
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34807883 | Derived | Chu CM, Harvie H, Arya LA, Andy UU. Short-Term Effect of Fesoterodine on Physical Function Relevant to Fall Risk in Older Women With Overactive Bladder. Female Pelvic Med Reconstr Surg. 2021 Dec 1;27(12):759-765. doi: 10.1097/SPV.0000000000001046. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Patients who were present at follow up and completed accelerometer wear were included in analysis. | Posted | Median | Inter-Quartile Range | steps per day | 1 week |
|
18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Side effects | Gastrointestinal disorders | Non-systematic Assessment | Patients who experienced expected side effects of medication, including constipation, dry eyes, and dry mouth |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lily Arya | University of Pennsylvania | 215-662-3230 | larya@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 29, 2018 | Sep 19, 2019 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 9, 2017 | Sep 19, 2019 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C526675 | fesoterodine |
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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.
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Physical Activity - Daily Steps | Median | Inter-Quartile Range | Steps per day |
|
| Physical Activity - CHAMPS questionnaire caloric expenditure/week, all activities | Mean | Standard Deviation | Kcal/week |
|
| Physical Activity - IPAQ questionnaire total physical activity | Mean | Standard Deviation | MET-min/wk |
|
| Short Physical Performance Battery total score | The short physical performance battery (SPPB) is a combination measure that examines gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability and measures physical function in older people. Score 0-12. Higher scores mean better lower extremity function. | Mean | Standard Deviation | units on a scale |
|
| Mini Cog screening test | The Mini Cog screening test consists of a 3-item recall test for memory and a clock drawing test. A score of <3 is considered a positive screen for cognitive impairment. | Not all patients completed baseline Mini Cog testing | Count of Participants | Participants |
|
| OABq-SF Symptoms Severity score | The OABq-SF 19 item validated questionnaire that measures the impact of OAB symptoms on health-related quality of life and bother. Total scores range 0 to 100, with higher scores reflecting greater symptoms. | Mean | Standard Deviation | units on a scale |
|
| UDI-6 total score | The UDI-6 is a validated questionnaire that measures the impact of urinary incontinence on quality of life. Scores range from 0-100, with higher scores indicating higher bother from urinary incontinence. | Mean | Standard Deviation | units on a scale |
|
|
|
| 0 |
| 74 |
| 0 |
| 74 |
| 7 |
| 74 |
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| Dizziness, edema | Vascular disorders | Non-systematic Assessment | Patients who reported side effects not typically associated with fesoterodine, such as dizziness and edema. One subject experienced both AEs concurrently. |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |