Validation of Bladder Health Instrument for Evaluation in Women

Completed

Conditions studied: Lower Urinary Tract Symptoms

In brief

The Prevention of Lower Urinary Symptoms (PLUS) Research Consortium is working to optimize prevention of lower urinary tract symptoms (LUTS) in women and adolescent females across their life spans. The ability to measure bladder health and key risk and protective factors is crucial to the PLUS mission. To describe and measure the spectrum of bladder health in diverse populations, researchers need a valid and reliable instrument. To date, the Consortium's work on design of a bladder health instrument has been a culmination of expert opinion, information from focus groups, and incorporation of previously validated items and language where appropriate, along with cognitive interviews of participants from the general public. The next step in the consortium's work is to prospectively collect data to test and validate bladder health instrument (BHI) items for inclusion in a final bladder health scale (BHS) that can assess the full range of bladder health of women. This will be through a combination of general population recruitment for completing mailed surveys, clinical population recruitment for completing surveys and an in-person evaluation, and postpartum women.

Key facts

Study ID

NCT04016298

Run by

University of Minnesota

People needed

1222

Starts

2019-07-31

Expected to finish

2022-05-25

Last updated by the study team

2022-05-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Community dwelling
• Age ≥18 years old
• Female sex assigned at birth
• Fluent in written and spoken English
• Able to read and provide informed consent

You may not qualify if…

• Institutional living arrangement, e.g., skilled nursing, long term care or rehabilitation center
• Physical or mental condition that would prohibit self-administration of questionnaire either electronically or using paper and pencil (e.g., dementia/cognitive impairment/blindness/severe arthritis).

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California, San Diego — San Diego, California, United States
• Yale University — New Haven, Connecticut, United States
• Loyola University Chicago — Chicago, Illinois, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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