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Clinical trialNCT04016298CompletedObservational

Validation of Bladder Health Instrument for Evaluation in Women

SponsorUniversity of MinnesotaEnrollment1,222Lower Urinary Tract Symptoms
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • 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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Jul 2019
Primary completion
25 May 2022
Completion
25 May 2022
Last update posted
27 May 2022
Registered enrollment
1,222
Registry id
NCT04016298

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.