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Validation of Bladder Health Instrument for Evaluation in Women

Validation of Bladder Health Instrument for Evaluation in Women

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04016298
Acronym
VIEW
Enrollment
1222
Registered
2019-07-11
Start date
2019-07-31
Completion date
2022-05-25
Last updated
2022-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Urinary Tract Symptoms

Keywords

Bladder Health, LUTS, PLUS, VIEW

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.

Interventions

None listed

Sponsors

University of California, San Diego
CollaboratorOTHER
University of Pennsylvania
CollaboratorOTHER
Yale University
CollaboratorOTHER
University of Michigan
CollaboratorOTHER
University of Illinois at Chicago
CollaboratorOTHER
Loyola University Chicago
CollaboratorOTHER
University of Alabama at Birmingham
CollaboratorOTHER
Washington University School of Medicine
CollaboratorOTHER
University of Minnesota
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Bladder Health InstrumentWill 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026