Fall Prevention in Older Adults With OAB

NCT03946124 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 822377
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Drug: Fesoterodine

Interventions

Fesoterodine DRUG

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

Fesoterodine

Eligibility Criteria

• Age: 65 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Pfizer: collaborator

Related Publications (1)

• 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.

  PMID: 34807883 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

fesoterodine

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Lily Arya
• Organization: University of Pennsylvania

larya@pennmedicine.upenn.edu

215-662-3230

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: May 10, 2019
• Study Start: July 25, 2015
• Primary Completion: July 19, 2017
• Study Completion: July 19, 2017
• Last Updated: May 6, 2023
• Results First Posted: December 11, 2019

Record last verified: 2023-05