RISE FOR HEALTH Study

Lower Urinary Tract Symptoms Clinical Trial

Official title:

RISE FOR HEALTH Study by the PLUS Consortium

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05365971
• Other study ID #: STUDY00012315
• Status: Enrolling by invitation
• Start date: May 14, 2022
• Est. completion date: June 2025

Study information

• Verified date: October 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 4000
• Est. completion date: June 2025
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Loyola University Chicago	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois
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 (10)

Lead Sponsor	Collaborator
University of Minnesota	Emory University, Loyola University Chicago, Northwestern University, University of Alabama at Birmingham, University of California, San Diego, University of Michigan, University of Pennsylvania, Washington University School of Medicine, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bladder Health Scales and Function Indices	Multi-item measurement to assess bladder health comprised of subscales and indices ranging from zero to 100	Baseline assessment
Secondary	Knowledge, Attitudes and Beliefs (KAB)	Several questions on knowledge, attitudes, and beliefs regarding bladder health and influences on bladder health	Baseline assessment
Secondary	Change in Bladder Health Scales and Function Indices	Change in multi-item measurement to assess bladder health comprised of subscales and indices ranging from zero to 100	1 year follow-up from baseline assessment