Study Design: Observational
Conditions: Urinary Bladder Diseases
Division: KUH
Duration: July 31, 2019 - May 25, 2022
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Clinical Trials URL:
https://clinicaltrials.gov/ct2/show/NCT04016298
Study Website: https://plusconsortium.umn.edu/
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. Prior to the VIEW study, the Consortium's work on the design of a bladder health instrument was 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 was 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 was 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.
The primary objective of the VIEW study is to validate a novel bladder health instrument to measure the spectrum of bladder health from very healthy to very unhealthy in population based and clinical research. 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. The items cover the range of bladder health dimensions specified by our model.
Construct validity of the bladder health scales and function indices was guided by a multitrait-multimethod approach using health and condition-specific questionnaires, bladder diaries, expert ratings of bladder health, and noninvasive bladder function testing.
The following were inclusion and exclusion criteria for the general population sample:
Inclusion criteria:
The following were the inclusion and exclusion criteria for the participants recruited from the clinical research centers:
Inclusion criteria:
Exclusion criteria
The paper and electronic forms of the bladder health scales and function indices are reliable and valid measures of bladder health for use in non-postpartum women's health research.