Validation of Bladder Health Instrument for Evaluation in Women

NCT ID: NCT04016298

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1222 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-31
• Study Completion Date: 2022-05-25

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.

Conditions

Lower Urinary Tract Symptoms

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Diego

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: collaborator

Loyola University Chicago

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily Lukacz, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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

Countries

United States

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Other Identifiers

Pro00032238

Identifier Type: -

Identifier Source: org_study_id