Improving Primary Care Access to Urinary Incontinence Treatment for Women Veterans

NCT05438849 | Active Not Recruiting

• 2 other identifiers: 1658917-2U18HS028736
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 2

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.

Conditions

Urinary Incontinence

Keywords

women; Veterans; behavioral treatment; primary care

Outcome Measures

Primary Outcomes (2)

• Urinary incontinence (UI) screening rates

  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.

  Baseline and 6 months post-Baseline

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

  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.

  Baseline and 6 months post-Baseline

Secondary Outcomes (5)

• Enrollment rates of women Veterans for MyHealtheBladder

  2-, 4-, and 6-months post-Baseline

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

  Baseline and 2-months post-Baseline

• Pelvic Floor Muscle Exercise (PFME) Adherence

  2-months post-Baseline

• System Usability Scale

  2-months post-Baseline

• Satisfaction and Perception of Improvement

  2-months post-Baseline

Study Arms (2)

Women Veterans receiving primary care in VISN-7 of the VA Healthcare Administration (VHA)

This project will include English-speaking, community-dwelling women Veterans 20 years or older with a diagnosis of UI (all types) and access to the internet via a mobile device or computer. Women Veterans who are currently pregnant or less than 12 weeks postpartum will be excluded. PURSUIT utilizes a mobile health application, called MyHealtheBladder, to connect patients with nonsurgical treatment options.

Behavioral: Mobile Health Application focused on behavioral treatments to treat urinary incontinence

Health care providers in community-based outpatient clinics in VISN-7 of the the VHA

Community-Based Outpatient Clinics (CBOCs) from VA Integrated Service Network (VISN) 7 will be targeted, spanning the states of Alabama, Georgia, and South Carolina. VISN 7 CBOCs, serving at least 50 women Veterans with primary care services, will be recruited.

Combination Product: Practice Facilitation

Interventions

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

Also known as: MyHealtheBladder

Women Veterans receiving primary care in VISN-7 of the VA Healthcare Administration (VHA)

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.

Also known as: Practice facilitation toolkit

Health care providers in community-based outpatient clinics in VISN-7 of the the VHA

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• US Department of Veterans Affairs: collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (2)

Birmingham VA Healthcare System

Birmingham, Alabama, 35233, United States

Location

Atlanta VA Health Care System

Decatur, Georgia, 30033, United States

Location

Related Publications (1)

• Goode PS, Markland AD, Echt KV, Slay L, Barnacastle S, Hale G, Wright MK, Lane TR, Burgio KL. A mobile telehealth program for behavioral treatment of urinary incontinence in women veterans: Development and pilot evaluation of MyHealtheBladder. Neurourol Urodyn. 2020 Jan;39(1):432-439. doi: 10.1002/nau.24226. Epub 2019 Nov 27.

  PMID: 31774200 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

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

Study Officials

• Alayne D Markland, DO, MSc

  UNIVERSITY OF ALABAMA AT BIRMINGHAM, BIRMINGHAM , AL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 30, 2022
• Study Start: November 1, 2022
• Primary Completion: November 21, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

US (2)