RISE FOR HEALTH Study

RISE FOR HEALTH Study by the PLUS Consortium

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Lower Urinary Tract Symptoms

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • California
    • San Diego, California, United States, 92121
      • University of California, San Diego
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60153
      • Loyola University Chicago
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Missouri
    • Saint Louis, Missouri, United States, 63100
      • Washington University School of Medicine
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge, Attitudes and Beliefs (KAB)	Several questions on knowledge, attitudes, and beliefs regarding bladder health and influences on bladder health	Baseline assessment
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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: University of Pennsylvania; Washington University School of Medicine; University of California, San Diego; Northwestern University; Yale University; University of Alabama at Birmingham; University of Michigan; Emory University; Loyola University Chicago
• Investigators: Study Chair: Siobhan Sutcliffe, PhD, Washington University School of Medicine; Study Chair: Ariana Smith, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2022
• Primary Completion (Actual): August 31, 2023
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: LUTS; Bladder Health; PLUS; RISE
• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms
• Other Study ID Numbers: STUDY00012315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Submission to NIDDK central repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No