Clinical trial NCT05365971: RISE FOR HEALTH Study
Official title: RISE FOR HEALTH Study by the PLUS Consortium
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Lower Urinary Tract Symptoms
Keywords: Bladder Health
LUTS
PLUS
RISE
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
name: University of Pennsylvania
name: Yale University
name: University of Michigan
name: Loyola University Chicago
name: University of Alabama at Birmingham
name: Washington University School of Medicine
name: Northwestern University
name: Emory University
First posted: 2022-05-09
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The source population for RISE will be adult (18 years of age or older) cis-gendered women, trans-men, and trans-women from the resident, civilian, non-institutionalized US population capable of completing a survey in English or Spanish (see eligibility criteria for exact criteria).

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Bladder Health Scales and Function Indices
timeFrame: Baseline assessment
Secondary outcomes:
measure: Knowledge, Attitudes and Beliefs (KAB)
timeFrame: Baseline assessment
measure: Change in Bladder Health Scales and Function Indices
timeFrame: 1 year follow-up from baseline assessment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Loyola University Chicago
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Washington University School of Medicine
name: Siobhan Sutcliffe, PhD
role: STUDY_CHAIR
affiliation: University of Pennsylvania
name: Ariana Smith, MD
role: STUDY_CHAIR
References: