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Lower Urinary Tract SymptomsVIEWNCT04016298

Validation of Bladder Health Instrument for Evaluation in Women

An observational study of Lower Urinary Tract Symptoms, run by University of Minnesota at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Lower Urinary Tract Symptoms
How many people
1,222 participants
Where
8 sitesUnited States
Study dates
31 Jul 2019to 25 May 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The BHI is intended for use in the general US population and it is critical that the BHI validation include individuals who meet these criteria. The goal is to include women over the age of 18 that meet the inclusion criteria. It is our hope to get a broad spectrum of women with varying degrees of bladder health, age, race, and community.

Who may be able to join

  • Community dwelling
  • Age ≥18 years old
  • Female sex assigned at birth
  • Fluent in written and spoken English
  • Able to read and provide informed consent

Who cannot join

  • 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).

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35223

  • Loyola University Chicago

    Chicago, Illinois, 60153

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Yale University

    New Haven, Connecticut, 06510

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of California, San Diego

    San Diego, California, 92121

  • Washington University School of Medicine

    St Louis, Missouri, 63100

Other trials in United States

About this study

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.

Keywords
Bladder Health, LUTS, PLUS, VIEW
Medical subject headings
Lower Urinary Tract Symptoms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bladder Health Instrument

    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.

    Measured: Will be assessed throughout the duration of study, an average of one year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2019
  2. Study start31 Jul 2019
  3. Primary completion25 May 2022
  4. Study completion25 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
1,222 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04016298
Sponsor's protocol ID
Pro00032238
Acronym
VIEW
Status last verified
May 2022
First submitted
5 Jul 2019
Last updated
27 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lukacz ES, Bavendam TG, Berry A, Fok CS, Gahagan S, Goode PS, Hardacker CT, Hebert-Beirne J, Lewis CE, Lewis J, Low LK, Lowder JL, Palmer MH, Smith AL, Brady SS. A Novel Research Definition of Bladder Health in Women and Girls: Implications for Research and Public Health Promotion. J Womens Health (Larchmt). 2018 Aug;27(8):974-981. doi: 10.1089/jwh.2017.6786. Epub 2018 May 24.

    PubMed 29792542

  • Brady SS, Bavendam TG, Berry A, Fok CS, Gahagan S, Goode PS, Hardacker CT, Hebert-Beirne J, Lewis CE, Lewis JB, Kane Low L, Lowder JL, Palmer MH, Wyman JF, Lukacz ES; Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium. The Prevention of Lower Urinary Tract Symptoms (PLUS) in girls and women: Developing a conceptual framework for a prevention research agenda. Neurourol Urodyn. 2018 Nov;37(8):2951-2964. doi: 10.1002/nau.23787. Epub 2018 Aug 22.

    PubMed 30136299

  • Bandilla W, Bosnjak M, Altdorfer P. Survey Administration Effects?: A Comparison of Web-Based and Traditional Written Self-Administered Surveys Using the ISSP Environment Module. Soc Sci Comput Rev. 2003;21(2):235-243. doi:10.1177/0894439303021002009.

  • Dillman DA, Sangster RL, Tarnai J, Rockwood TH. Understanding differences in people's answers to telephone and mail surveys. New Dir Eval. 1996;1996(70):45-61. doi:10.1002/ev.1034.

  • Vernon SW, Tiro JA, Vojvodic RW, Coan S, Diamond PM, Greisinger A, Fernandez ME. Reliability and validity of a questionnaire to measure colorectal cancer screening behaviors: does mode of survey administration matter? Cancer Epidemiol Biomarkers Prev. 2008 Apr;17(4):758-67. doi: 10.1158/1055-9965.EPI-07-2855. Epub 2008 Apr 1.

    PubMed 18381467

  • Schwarz N, Strack F, Hippler H, Bishop G. The impact of administration mode on response effects in survey measurement. Jobe JB, Loftus EF, eds. Appl Cogn Psychol. 1991;5(3):193-212. doi:10.1002/acp.2350050304.

  • Cronbach L. Coefficient alpha and the internal structure of tests. Psychometrika. 1951;16(3):297-334. doi:10.1007/BF02310555.

  • Swartz RJ, de Moor C, Cook KF, Fouladi RT, Basen-Engquist K, Eng C, Carmack Taylor CL. Mode effects in the center for epidemiologic studies depression (CES-D) scale: personal digital assistant vs. paper and pencil administration. Qual Life Res. 2007 Jun;16(5):803-13. doi: 10.1007/s11136-006-9158-0. Epub 2007 Feb 13.

    PubMed 17295102

  • Messick S. The interplay of evidence and consequences in the validation of performance assessments. ETS Res Rep Ser. 1992;1992(1):i-42. doi:10.1002/j.2333-8504.1992.tb01470.x.

  • Kane MT. Validating the Interpretations and Uses of Test Scores. J Educ Meas. 2013;50(1):1-73. doi:10.1111/jedm.12000.

  • Hawkins M, Elsworth GR, Osborne RH. Application of validity theory and methodology to patient-reported outcome measures (PROMs): building an argument for validity. Qual Life Res. 2018 Jul;27(7):1695-1710. doi: 10.1007/s11136-018-1815-6. Epub 2018 Feb 20.

    PubMed 29464456

  • American Educational Research Association. Standards for Educational and Psychological Testing. (Association AP, Education NC on M in, (U.S.) JC on S for E and PT, eds.). Washington, DC: Washington, DC : American Educational Research Association; 2014.

  • Streiner D. Health Measurement Scales : A Practical Guide to Their Development and Use. Fifth edit. (Norman GR, Cairney J, ebrary I, eds.). New York, New York: New York, New York : Oxford University Press; 2015.

  • Messick S. VALIDITY. Educ Test Serv Res Rep Ser. 1987;1987(2):i-208. doi:10.1002/j.2330-8516.1987.tb00244.x.

  • CAMPBELL DT, FISKE DW. Convergent and discriminant validation by the multitrait-multimethod matrix. Psychol Bull. 1959 Mar;56(2):81-105. No abstract available.

    PubMed 13634291

Questions about this trial

What is this clinical trial studying?

An observational study of Lower Urinary Tract Symptoms, run by University of Minnesota at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bladder Health Instrument (time frame: Will be assessed throughout the duration of study, an average of one year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04016298, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.

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