Validation of Bladder Health Instrument for Evaluation in Women

NCT04016298 | Completed

• 1 other identifier: Pro00032238
• Study Type: observational
• Target: 1,222
• Locations: 1 country
• Sites: 8

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.

Conditions

Lower Urinary Tract Symptoms

Keywords

Bladder Health; LUTS; PLUS; VIEW

Outcome Measures

Primary Outcomes (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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (8)

University of Alabama at Birmingham

Birmingham, Alabama, 35223, United States

Location

University of California, San Diego

San Diego, California, 92121, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Loyola University Chicago

Chicago, Illinois, 60153, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63100, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (27)

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• Rickey LM, Mueller ER, Newman DK, Markland AD, Falke C, Rudser K, Smith AL, Mueller MG, Lowder JL, Lukacz ES; Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium. Reliability of Uroflowmetry Pattern Interpretation in Adult Women. Neurourol Urodyn. 2024 Nov;43(8):2084-2092. doi: 10.1002/nau.25584. Epub 2024 Sep 12.

  PMID: 39264028 DERIVED

• Constantine ML, Rockwood TH, Rickey LM, Bavendam T, Low LK, Lowder JL, Markland AD, McGwin G, Mueller ER, Newman DK, Putnam S, Rudser K, Smith AL, Stapleton AE, Miller JM, Lukacz ES; of the Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium. Validation of bladder health scales and function indices for women's research. Am J Obstet Gynecol. 2023 May;228(5):566.e1-566.e14. doi: 10.1016/j.ajog.2022.12.319. Epub 2022 Dec 31.

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• Lukacz ES, Constantine ML, Kane Low L, Lowder JL, Markland AD, Mueller ER, Newman DK, Rickey LM, Rockwood T, Rudser K; Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium. Rationale and design of the validation of bladder health instrument for evaluation in women (VIEW) protocol. BMC Womens Health. 2021 Jan 7;21(1):18. doi: 10.1186/s12905-020-01136-w.

  PMID: 33413284 DERIVED

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emily Lukacz, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2019
• First Posted: July 11, 2019
• Study Start: July 31, 2019
• Primary Completion: May 25, 2022
• Study Completion: May 25, 2022
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

US (8)