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Improving Primary Care Access to Urinary Incontinence Treatment for Women Veterans

Improving Primary Care Understanding of Resources and Screening for Urinary Incontinence to Enhance Treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05438849
Acronym
PURSUIT
Enrollment
2500
Registered
2022-06-30
Start date
2022-11-01
Completion date
2026-06-30
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

Keywords

women, Veterans, behavioral treatment, primary care

Brief summary

The PURSUIT project aims to improve access to evidence-based nonsurgical UI treatment for women Veterans in the Southeast region of the United States using the most effective remote delivery modality. Using cluster randomization, the study will compare two models at the practice level: (1) the use of a practice facilitation toolkit with a mHealth UI modality alone and (2) the practice facilitation toolkit with a mHealth UI model combined with education on clinical pathways for consultation. Patient level outcomes related to UI symptom improvement will be compared. Patient and provider perceptions of factors that could influence future remote UI treatment scalability will also be assessed. All primary care practices will receive practice facilitation with a PURSUIT toolkit that includes (1) 1-2 visits with a practice facilitator; (2) mobile-health or mHealth application training (MAT); 3) online resource hub; and (4) health information technology (HIT) assistance. PURSUIT's future goal is to disseminate the most effective modality for delivering nonsurgical UI treatment for women Veterans nationally within the VHA.

Detailed description

PURSUIT aims to recruit 62 practices to participate in the trial implementation at 50 practices. Specifically, Community-Based Outpatient Clinics (CBOCs) from VA Integrated Service Network (VISN) 7 will be targeted, spanning the states of Alabama, Georgia, and South Carolina. The project will focus on VISN 7 CBOCs, serving at least 50 women Veterans with primary care services, will be recruited through connections with local women's health providers. The team estimates outreach to approximately 50,000 women Veterans and estimates that 30 percent (n=15,000) of these women will have UI symptoms, and, among those, 15 percent (n=2,500) will participate.

Interventions

BEHAVIORALMobile Health Application focused on behavioral treatments to treat urinary incontinence

Mobile health application for cell phones and computers that delivers evidence-based behavioral treatment for urinary incontinence, specifically tailored to women Veterans

COMBINATION_PRODUCTPractice Facilitation

The toolkit has 4 components: (1) Practice Facilitation Visits, (2) Mobile-health or mHealth Application Training (MAT) training, (3) Access and education on the Data Dashboard, and (4) Health information technology (HIT) assistance.

Sponsors

US Department of Veterans Affairs
CollaboratorFED
Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Veteran * English-speaking, community-dwelling women Veterans * Diagnosis of UI (all types) * Access to the internet via a mobile device or computer

Exclusion criteria

* Women Veterans who are currently pregnant or less than 12 weeks postpartum

Design outcomes

Primary

MeasureTime frameDescription
Urinary incontinence (UI) screening ratesBaseline and 6 months post-BaselineThis will include measuring changes, over time, in UI diagnoses for women Veterans. These changes will be measured by pulling data on UI ICD-9 and ICD-10 codes collected via the program's clinical data dashboard.
Change, over time, in usage of the provider clinical data dashboardBaseline and 6 months post-BaselineThis will include capturing the unique number of clinic site champions (i.e. designated women's health provider) who engage with this program's clinical data dashboard. Dashboard engagement will be measured as the number of unique site champions who use the dashboard divided by the total number of site champions involved in this program.

Secondary

MeasureTime frameDescription
Pelvic Floor Muscle Exercise (PFME) Adherence2-months post-Baseline2-item questionnaire to explore adherence to completing PFMEs
Enrollment rates of women Veterans for MyHealtheBladder2-, 4-, and 6-months post-BaselineWomen receiving behavioral urinary incontinence treatment on MyHealtheBladder
Satisfaction and Perception of Improvement2-months post-Baseline3-item tool for feedback on participant satisfaction and perceived symptom improvement
System Usability Scale2-months post-Baseline10-item questionnaire, using 5-point Likert scale, to gauge the usability of MHB. Scoring range is 0-100 with a higher score indicating the system is more usable,
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)Baseline and 2-months post-Baseline4-item tool to measure UI symptoms, scored on scale from 0-21 with a higher score indicating worse symptoms

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026