Lower Urinary Tract SymptomsNCT05365971
RISE FOR HEALTH Study
An observational study of Lower Urinary Tract Symptoms, run by University of Minnesota at 9 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lower Urinary Tract Symptoms
- How many people
- 3,400 participants
- Where
- 9 sitesUnited States
- Study dates
- 14 May 2022to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30329
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Loyola University Chicago
Chicago, Illinois, 60153
Northwestern University
Chicago, Illinois, 60611
Yale University
New Haven, Connecticut, 06510
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of California, San Diego
San Diego, California, 92121
Washington University School of Medicine
St Louis, Missouri, 63100
About this study
Official title: 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.
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Bladder Health, LUTS, PLUS, RISE
- Medical subject headings
- Lower Urinary Tract Symptoms
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder Health Scales and Function Indices
Multi-item measurement to assess bladder health comprised of subscales and indices ranging from zero to 100
Measured: Baseline assessment
Secondary outcomes (2)
Knowledge, Attitudes and Beliefs (KAB)
Several questions on knowledge, attitudes, and beliefs regarding bladder health and influences on bladder health
Measured: 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
Measured: 1 year follow-up from baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start14 May 2022
- Primary completion31 Aug 2023
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego, University of Pennsylvania, Yale University, University of Michigan, Loyola University Chicago, University of Alabama at Birmingham, Washington University School of Medicine, Northwestern University, Emory University
- Responsible party
- Sponsor
- Investigators
- Siobhan Sutcliffe, PhD, Study chair, Washington University School of MedicineAriana Smith, MD, Study chair, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365971
- Sponsor's protocol ID
- STUDY00012315
- Status last verified
- Jul 2025
- First submitted
- 28 Apr 2022
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Submission to NIDDK central repository.
Publications
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 Apr;45(4):662-667. doi: 10.1002/nau.70230. Epub 2026 Feb 4.
PubMed 41640096
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RISE FOR HEALTH Study by the PLUS Consortium
- ClinicalTrials.gov ID
- NCT05365971
- Acronym / sponsor ID
- STUDY00012315
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Bladder Health, LUTS, PLUS, RISE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,400 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- University of California, San Diego, University of Pennsylvania, Yale University, University of Michigan, Loyola University Chicago, University of Alabama at Birmingham, Washington University School of Medicine, Northwestern University, Emory University
- Study start
- 14 May 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bladder Health Scales and Function Indices
Time frame: Baseline assessment
Multi-item measurement to assess bladder health comprised of subscales and indices ranging from zero to 100
2 secondary outcomes
Knowledge, Attitudes and Beliefs (KAB)
Time frame: Baseline assessment
Change in Bladder Health Scales and Function Indices
Time frame: 1 year follow-up from baseline assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Derived from this study: PubMed 41640096Smith 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 Apr;45(4):662-667. doi: 10.1002/nau.70230. Epub 2026 Feb 4.
- Individual participant dataSharing planned: Yes. Submission to NIDDK central repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siobhan Sutcliffe, PhD study chair
Washington University School of Medicine
Ariana Smith, MD study chair
University of Pennsylvania
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Tract Symptoms, run by University of Minnesota at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder Health Scales and Function Indices (time frame: Baseline assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05365971, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.