Trial Outcomes & Findings for Fall Prevention in Older Adults With OAB (NCT NCT03946124)

NCT ID: NCT03946124

Last Updated: 2023-05-06

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 74 participants
• Primary outcome timeframe: 1 week
• Results posted on: 2023-05-06

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	74
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Measure

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.

Overall Study Withdrawal by Subject

19

Baseline Characteristics

Not all patients completed baseline Mini Cog testing

Baseline characteristics by cohort

Measure	Fesoterodine n=74 Participants 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.
Age, Continuous	76.5 years STANDARD_DEVIATION 7.2 • n=74 Participants
Sex: Female, Male Female	74 Participants n=74 Participants
Sex: Female, Male Male	0 Participants n=74 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=74 Participants
Race (NIH/OMB) Asian	1 Participants n=74 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=74 Participants
Race (NIH/OMB) Black or African American	26 Participants n=74 Participants
Race (NIH/OMB) White	47 Participants n=74 Participants
Race (NIH/OMB) More than one race	0 Participants n=74 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=74 Participants
Region of Enrollment United States	74 participants n=74 Participants
Physical Activity - Daily Steps	2117.7 Steps per day n=74 Participants
Physical Activity - CHAMPS questionnaire caloric expenditure/week, all activities	2552.4 Kcal/week STANDARD_DEVIATION 2560.12 • n=74 Participants
Physical Activity - IPAQ questionnaire total physical activity	785.62 MET-min/wk STANDARD_DEVIATION 1609.84 • n=74 Participants
Short Physical Performance Battery total score	7.82 units on a scale STANDARD_DEVIATION 2.21 • n=74 Participants
Mini Cog screening test Normal cognition	60 Participants n=68 Participants • Not all patients completed baseline Mini Cog testing
Mini Cog screening test Abnormal cognition	8 Participants n=68 Participants • Not all patients completed baseline Mini Cog testing
OABq-SF Symptoms Severity score	61.9 units on a scale STANDARD_DEVIATION 23.8 • n=74 Participants
UDI-6 total score	44.2 units on a scale STANDARD_DEVIATION 20.5 • n=74 Participants

PRIMARY outcome

Timeframe: 1 week

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

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.

Outcome measures

Measure

Fesoterodine n=56 Participants 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 of Physical Activity

1634.19 steps per day Interval 980.1 to 2367.3

Adverse Events

Fesoterodine

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Fesoterodine n=74 participants at risk 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.
Gastrointestinal disorders Side effects	8.1% 6/74 • Number of events 6 • 18 months
Vascular disorders Dizziness, edema	1.4% 1/74 • Number of events 1 • 18 months

Additional Information

Dr. Lily Arya

University of Pennsylvania

Phone: 215-662-3230

Email: larya@pennmedicine.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place