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NCT Number: NCT05438849

Improving Primary Care Access to Urinary Incontinence Treatment for Women Veterans

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Birmingham VA Healthcare System, Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile Health Application focused on behavioral treatments to treat urinary incontinence

Behavioral

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

Other names: MyHealtheBladder

Practice Facilitation

Combination Product

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.

Other names: Practice facilitation toolkit

Primary outcomes

  1. Urinary incontinence (UI) screening rates

    Time frame: Baseline and 6 months post-Baseline

    This 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.

  2. Change, over time, in usage of the provider clinical data dashboard

    Time frame: Baseline and 6 months post-Baseline

    This 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 outcomes

  1. Enrollment rates of women Veterans for MyHealtheBladder

    Time frame: 2-, 4-, and 6-months post-Baseline

    Women receiving behavioral urinary incontinence treatment on MyHealtheBladder

  2. International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)

    Time frame: Baseline and 2-months post-Baseline

    4-item tool to measure UI symptoms, scored on scale from 0-21 with a higher score indicating worse symptoms

  3. Pelvic Floor Muscle Exercise (PFME) Adherence

    Time frame: 2-months post-Baseline

    2-item questionnaire to explore adherence to completing PFMEs

  4. System Usability Scale

    Time frame: 2-months post-Baseline

    10-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,

  5. Satisfaction and Perception of Improvement

    Time frame: 2-months post-Baseline

    3-item tool for feedback on participant satisfaction and perceived symptom improvement

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • US Department of Veterans Affairs

Registry information

Official study title

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

Acronym: PURSUIT

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jun 30, 2022
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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