Validation of Bladder Health Instrument for Evaluation in Women

Lower Urinary Tract Symptoms Clinical Trial

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Official title:

Validation of Bladder Health Instrument for Evaluation in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04016298
• Other study ID #: Pro00032238
• Status: Completed
• Start date: July 31, 2019
• Est. completion date: May 25, 2022

Study information

• Verified date: May 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1222
• Est. completion date: May 25, 2022
• Est. primary completion date: May 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Loyola University Chicago	Chicago	Illinois
United States	University of Minnesota	Minneapolis	Minnesota
United States	Yale University	New Haven	Connecticut
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of California, San Diego	San Diego	California

Sponsors (9)

Lead Sponsor	Collaborator
University of Minnesota	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

Country where clinical trial is conducted

United States, 

References & Publications (24)

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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. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.