Validation of Bladder Health Instrument for Evaluation in Women

Completed

• Conditions: Lower Urinary Tract Symptoms

• Registration Number: NCT04016298
• Lead Sponsor: University of Minnesota

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-07-05
• Study First Submitted QC: 2019-07-10
• Study First Posted: 2019-07-11
• Study Start: 2019-07-31
• Status Verified: 2022-05
• Primary Completion: 2022-05-25
• Study Completion: 2022-05-25
• Last Update Submitted: 2022-05-26
• Last Update Posted: 2022-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1222

Inclusion Criteria

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

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Exclusion Criteria

• 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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bladder Health Instrument	Will be assessed throughout the duration of study, an average of one year.	Multi-item measurement is used to assess the range of bladder health dimensions as defined by the model of bladder health adopted by the PLUS consortium. It is anticipated that the self-administeredBHI instrument (PAPI or CASI) will consist of approximately 85 items: 53-67 are items all respondents will be asked to answer, and 48 are asked only of women who self-identify as experiencing a specific LUTS. The items cover the range of bladder health dimensions specified by our model.

Trial Locations

Locations (8)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Loyola University Chicago; 🇺🇸 Chicago, Illinois, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

University of California, San Diego; 🇺🇸 San Diego, California, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States