Status:
COMPLETED
Self-Care to Prevent Birth-Related Urinary Incontinence in Diverse Women
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The primary goal of this project is to determine the efficacy of an antenatal Bladder Health class to prevent UI in a diverse sample of African American, Caucasian, and Hispanic childbearing women. Th...
Detailed Description
This study is significant because UI prevalence is 34% overall among US women, nearly half of whom consider their incontinence to be moderately to extremely bothersome. UI is 2.0 to 2.6 fold greater i...
Eligibility Criteria
Inclusion
- Women who are pregnant and expecting their first, second, or third baby are eligible if they:
- are age eighteen years or older
- are able to understand and read English or Spanish
- are low risk antepartum (first, second or third pregnancy)
- are 16-25 weeks pregnant
- expect a vaginal birth
- have lost no more than a few drops of urine as often as every other day
- have no previous or current urinary incontinence treatment with medication, formal behavioral programs or surgery
- have no history of bladder cancer, diabetes, stroke, multiple sclerosis, muscular dystrophy, cerebral palsy, Parkinson's, epilepsy, or trauma of the spinal cord
- Do not have (or have not had within the last 3 years) \*chronic urinary tract infection. \*Chronic is defined as having more than 3 urinary tract infections in one year.
Exclusion
- If participant does not meet all of the above criterion for inclusion
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
432 Patients enrolled
Trial Details
Trial ID
NCT00763984
Start Date
October 1 2007
End Date
December 1 2013
Last Update
January 15 2015
Active Locations (3)
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1
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
2
Jackson Center for Family Health
Jackson, Michigan, United States, 49202
3
La Clinica de la Santa Teresa
Pontiac, Michigan, United States, 48341