Fall Prevention in Older Adults With OAB

NCT03946124

Last updated date
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Bladder
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Overactive BladderFesoterodine and Oxybutynin XL for Overactive Bladder Syndrome in Children
NCT02327936
ALL GENDERS
5 Years+
years
MULTIPLE SITES
Overactive BladderExtension Study of Fesoterodine for Overactive Bladder Syndrome in Children.
NCT02614482
  1. Québec City, Quebec
ALL GENDERS
5 Years+
years
MULTIPLE SITES
Overactive BladderInterventions to Enhance Medication Persistence and Compliance in Patients With Overactive Bladder
NCT01515722
  1. Seoul,
  2. Daegu,
  3. Changwon,
  4. Seoul,
  5. Bucheon,
  6. Seoul,
  7. Bucheon,
  8. Seoul,
  9. Seoul,
  10. Pusan,
  11. Gwangju,
  12. Deajeon,
  13. Seoul,
Female
18 Years+
years
MULTIPLE SITES
Overactive BladderFall Prevention in Older Adults With OAB
NCT03946124
Female
65 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Fall Prevention in Older Adults With OAB
Official Title  ICMJE Prevention of Fall in Older Adults With Overactive Bladdar
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Overactive Bladder
Intervention  ICMJE Drug: Fesoterodine
Fesoterodine, the drug used in this study, is an appropriate medication for routine and standard care of overactive bladder.
Study Arms  ICMJE 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.
Intervention: Drug: Fesoterodine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 21, 2019)
74
Original Actual Enrollment  ICMJE
 (submitted: May 9, 2019)
80
Actual Study Completion Date  ICMJE July 19, 2017
Actual Primary Completion Date July 19, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
Gender Eligibility Description:Female
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03946124
Other Study ID Numbers  ICMJE 822377
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD:Undecided
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account University of Pennsylvania
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP