Urinary IncontinenceMHBNCT07219433
Implementing a Mobile Health Application for Women Veterans With Urinary Incontinence (MyHealtheBladder): Function QUERI 3.0
A study testing Implementation Strategy: Foundational Arm and Implementation Strategy: REACH Arm in people with Urinary Incontinence, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Implementation Strategy: Foundational Arm and Implementation Strategy: REACH Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2026to 30 Sep 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Site Exclusion Criteria:
- Clinic has already implemented the MyHealtheBladder program through the PURSUIT trial
- Patient Exclusion Criteria:
- No access to computer or mobile device
- No email account
- Institutionalized
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
Heidi D Bassani, (919) 286-0411, Heidi.Bassani@va.gov
Karen Goldstein, MD MSPH
About this study
Official title: Implementing a Mobile Health Application for Women Veterans With Urinary Incontinence: MyHealtheBladder in Function QUERI 3.0 (QUE 25-008)
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.
Read the detailed description
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.
- Conditions
- Urinary Incontinence
- Being tested
- Implementation Strategy: Foundational Arm, Implementation Strategy: REACH Arm
- Keywords
- Veterans, Implementation Science, Functional Status, Quality of Life, Mobile Applications
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation Strategy: Foundational ArmOther
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 ArmOther
The REACH Arm includes everything in the Foundational Arm, plus additional components: targeted data reports, a data dashboard, and external facilitation.
| Study group | Role | What they receive |
|---|---|---|
| Foundational Arm | Active comparator | The Foundational Arm uses the Replicating Effective Program (REP) implementation strategy and includes 3 elements that were developed and tested in the investigators' prior Function QUERI work: program initiation, self-guided resources, and technical assistance. Receives: Other: Implementation Strategy: Foundational Arm |
| REACH (Reach Equity And Collective Health) Arm | Experimental | The REACH Arm will include the same activities as the foundational arm plus REACH activities: 1) external facilitation and 2) equity-focused data-driven monitoring. Receives: Other: Implementation Strategy: REACH Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach
Reach will be defined as the percentage of Women Veterans that accessed (logged into) the MyHealtheBladder (MHB) app.
Measured: 18 months
Secondary outcomes (4)
Reach
Reach will be defined as the percentage of Women Veterans that accessed (logged into) the MyHealtheBladder (MHB) app.
Measured: 12 months
Patient Engagement
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.
Measured: 12 months
Patient Engagement
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.
Measured: 18 months
Time to Adoption
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start30 Apr 2026
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel cluster-randomized trial (parallel-CRT): used in pragmatic evaluations of health program or policy interventions, where half the clusters (in this case, VA sites) are randomly assigned to two interventions: Foundational arm (active comparator) vs. REACH (Reach Equity And Collective Health) arm (experimental).
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Karen Goldstein, MD MSPH, Principal investigator, Durham VA Medical Center, Durham, NCAlayne D Markland, DO MSc, Principal investigator, Birmingham VA Medical Center, Birmingham, AL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219433
- Sponsor's protocol ID
- QUX 25-003
- Acronym
- MHB
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified, anonymized dataset will be available upon request. Prior to distribution, a local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI). Data will be provided to requestor in electronic format. Sufficient data and descriptors will be made available to duplicate statistical analysis and confirm conclusions in publication. No data or statistical code that could lead to re-identification of individuals will be released. Data will be stored \& maintained in an approved, secured location as described in the VA Research Data Inventory Form. The statistician will create de-identified, publication-specific datasets that includes variables from statistical models presented in publication. Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re-identify any individual whose data are included in the dataset.