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NCT Number: NCT07219433

Implementing a Mobile Health Application for Women Veterans With Urinary Incontinence (MyHealtheBladder): Function QUERI 3.0

Implementing a Mobile Health Application for Women Veterans with Urinary Incontinence (MyHealtheBladder): Function QUERI 3.0 aims to compare implementation approaches while also gathering information on clinical effects of the Evidence-Based Program (EBP) in its new context and focusing on equitable reach (extent to which the program serves all members of its intended audience). The overall goal is to implement, evaluate, and sustain MyHealtheBladder in 20 VA facilities using a type III effectiveness-implementation hybrid study framework and parallel cluster randomized trial (CRT) design.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location status: Recruiting

Location contact

Heidi D Bassani

CONTACT

[email protected]

(919) 286-0411

Karen Goldstein, MD MSPH

PRINCIPAL_INVESTIGATOR

About this study

Background/Purpose. Urinary incontinence (UI) is a highly prevalent condition among women, especially as they age, and can directly impair quality of life, daily function, and long-term independence. Evidence-based behavioral management approaches are first-line treatment for UI; these include treatments such as pelvic floor muscle training, fluid management, and bladder control and voiding strategies. Despite being prevalent and burdensome, UI is often unrecognized and undertreated.

MyHealtheBladder (MHB) is an interactive mobile health application designed to deliver evidence-based behavioral self-management instruction specifically for Women Veterans (WV). In a multi-site RCT (VA IIR HX002827) conducted in VA (n=286) comparing MHB to video visits via VA Video Connect (VVC) delivered by a trained Continence Care provider, MHB resulted in equivalent or greater improvements in UI symptoms and satisfaction compared with VVC. Engagement in MHB was high, with 70% retention and an average of 58 miles saved per Veteran. MHB does not require a clinical visit and has the potential to scale across other VA facilities and generate healthcare savings while maintaining comparable patient-level outcomes to individual clinical encounters.

Objectives. The investigators aim to develop scalable approaches for implementing and sustaining use of MyHealtheBladder in clinical settings. Additionally, they will assess the reach of MyHealtheBladder when delivered through the Foundational arm compared to an enhanced-implementation strategy, the REACH (Reach Equity And Collective Health) arm.

Key questions. How can the REACH arm be optimized to implement MHB across all patients who would benefit? What are shareholder perspectives on refinements needed for MHB foundational activities, as well as strategies to enhance equitable reach? To address the question "Are there differences in implementation outcomes (reach [primary], patient engagement, time to adoption) between arms?", the investigators will use generalized linear models to examine the effect of foundational vs. REACH on implementation outcomes of reach and patient engagement at 12 and 18 months (primary). Average time to adoption will be compared between study arms.

Methodology. To evaluate implementation, the investigators will randomize sites (n=20) 1:1 to either the foundational arm or REACH arm. The investigators will use generalized linear models to examine the effect of foundational vs. REACH on implementation outcomes of reach and patient engagement at 18 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Site Inclusion Criteria:

  • Facility is part of the U.S. Department of Veterans Affairs (VA) health system.
  • Clinic serves at least 100 Women Veterans annually.
  • Identified site champion (e.g., clinician or staff member) who is willing to assume required program responsibilities for implementation.

Patient Inclusion Criteria:

  • Women Veterans
  • Have any type of Urinary Incontinence existing for at least 3 months

Exclusion criteria

Site Exclusion Criteria:

  • Clinic has already implemented the MyHealtheBladder program.

Patient Exclusion Criteria:

  • No access to computer or mobile device
  • No email account
  • Institutionalized

Treatment and study plan

Implementation Strategy: Foundational Arm

Other

The Foundational Arm includes the following activities: Program sign up, toolkit, kickoff call, SharePoint, TEAMS channel, office hours calls, and site specific data reports.

Implementation Strategy: REACH Arm

Other

The REACH Arm includes everything in the Foundational Arm, plus additional components: targeted data reports, a data dashboard, and external facilitation.

Primary outcomes

  1. Reach

    Time frame: 18 months

    Reach will be defined as the percentage of Women Veterans that accessed (logged into) the MHB app.

Secondary outcomes

  1. Reach

    Time frame: 12 months

    Reach will be defined as the percentage of Women Veterans that accessed (logged into) the MHB app.

  2. Patient Engagement

    Time frame: 12 months

    Patient engagement will be defined as the proportion of MyHealtheBladder sessions completed by Women Veterans at each clinic, among those who completed at least one session.

  3. Patient Engagement

    Time frame: 18 months

    Patient engagement will be defined as the proportion of MyHealtheBladder sessions completed by Women Veterans at each clinic, among those who completed at least one session.

  4. Time to Adoption

    Time frame: 18 months

    Time to Adoption will be defined as the time from baseline to the time at which a site crosses the adoption threshold (5 or more Women Veterans who have accessed the app). This will be computed for each site meeting the adoption criteria.

Study contacts

Contact information is provided by the study sponsor or research team.

Caitlin B Kappler, MSW

CONTACT

[email protected]

(919) 286-6936

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Implementing a Mobile Health Application for Women Veterans With Urinary Incontinence: MyHealtheBladder in Function QUERI 3.0 (QUE 25-008)

Acronym: MHB

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Oct 21, 2025
Registry last updated
May 22, 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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