RISE FOR HEALTH Study

NCT ID: NCT05365971

Last Updated: 2025-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-14

Study Completion Date

2025-06-30

Brief Summary

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The RISE FOR HEALTH study (RISE) is an initiative of the Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium, which was formed by the NIDDK in 2015 to develop the science to improve bladder health in women and girls. RISE is designed to identify risk and protective factors for bladder health and lower urinary tract symptoms (LUTS) and to estimate the distributions of bladder health and bladder health knowledge, attitudes, and beliefs in women of all ages across the life course.

This will be accomplished by conducting a population-based prospective cohort study. A sample of individuals who live within the study base, i.e., the county containing each PLUS clinical research center and each adjacent county, will be invited to complete two baseline surveys and then two follow-up surveys one year later. A subset of participants will be invited to attend an in-person evaluation to collect additional clinical information and biologic specimens.

Detailed Description

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Conditions

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Lower Urinary Tract Symptoms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Community dwelling
* Age ≥18 years
* Identify or born as female (includes cis- and trans-women, and trans-men)
* Able to read and understand English or Spanish
* Able to read and provide informed consent

Exclusion Criteria

* Physical or mental health conditions that would prohibit self-administration of questionnaires either electronically or using paper and pencil (e.g., dementia/cognitive impairment/blindness/severe arthritis).
* Residence in a nursing home or other institutionalized living facility.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Diego

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role collaborator

Loyola University Chicago

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Siobhan Sutcliffe, PhD

Role: STUDY_CHAIR

Washington University School of Medicine

Ariana Smith, MD

Role: STUDY_CHAIR

University of Pennsylvania

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of California, San Diego

San Diego, California, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Loyola University Chicago

Chicago, Illinois, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00012315

Identifier Type: -

Identifier Source: org_study_id

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