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OpenTrials
Completed

NCT Number: NCT04016298

Validation of Bladder Health Instrument for Evaluation in Women

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Bladder Health Instrument

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Loyola University Chicago
  • University of Alabama at Birmingham
  • University of California, San Diego
  • University of Illinois at Chicago
  • University of Michigan
  • University of Pennsylvania
  • Washington University School of Medicine
  • Yale University

Registry information

Acronym: VIEW

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 11, 2019
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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