RISE FOR HEALTH Study

NCT05365971 | Completed

• 1 other identifier: STUDY00012315
• Study Type: observational
• Target: 3,400
• Locations: 1 country
• Sites: 9

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.

Conditions

Lower Urinary Tract Symptoms

Keywords

Bladder Health; LUTS; PLUS; RISE

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Knowledge, Attitudes and Beliefs (KAB)

  Baseline assessment

• Change in Bladder Health Scales and Function Indices

  1 year follow-up from baseline assessment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Identify as female or have female listed on their birth certificate (including cisgender women, trans men, trans women, and non-binary persons)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead
• University of California, San Diego: collaborator
• University of Pennsylvania: collaborator
• Yale University: collaborator
• University of Michigan: collaborator
• Loyola University Chicago: collaborator
• University of Alabama at Birmingham: collaborator
• Washington University School of Medicine: collaborator
• Northwestern University: collaborator
• Emory University: collaborator

Study Sites (9)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of California, San Diego

San Diego, California, 92121, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Loyola University Chicago

Chicago, Illinois, 60153, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63100, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Smith AL, Sutcliffe S; Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium. Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium-Update for Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU). Neurourol Urodyn. 2026 Feb 4. doi: 10.1002/nau.70230. Online ahead of print.

  PMID: 41640096 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and vaginal swab; additionally stool for subset

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Siobhan Sutcliffe, PhD

  Washington University School of Medicine

  STUDY CHAIR

• Ariana Smith, MD

  University of Pennsylvania

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 9, 2022
• Study Start: May 14, 2022
• Primary Completion: August 31, 2023
• Study Completion: June 30, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (9)