Improving Primary Care Access to Urinary Incontinence Treatment for Women Veterans

NCT ID: NCT05438849

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 2500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2026-06-30

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.

Conditions

Urinary Incontinence

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Mobile Health Application focused on behavioral treatments to treat urinary incontinence

Intervention Type: BEHAVIORAL

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

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.

Practice Facilitation

Intervention Type: 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.

Interventions

Mobile 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

Intervention Type: BEHAVIORAL

Practice 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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

MyHealtheBladder; Practice facilitation toolkit

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Alayne D. Markland

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alayne D Markland, DO, MSc

Role: PRINCIPAL_INVESTIGATOR

UNIVERSITY OF ALABAMA AT BIRMINGHAM, BIRMINGHAM , AL

Locations

Birmingham VA Healthcare System

Birmingham, Alabama, United States

Atlanta VA Health Care System

Decatur, Georgia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 31774200 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

U18HS028736

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

1658917-2

Identifier Type: -

Identifier Source: org_study_id