Mobile Health App for Urinary Incontinence

(MHB Trial)

Overseen By Caitlin B Kappler, MSW

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: No device, No email, Institutionalized

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile health app, MyHealtheBladder, designed to help women veterans manage urinary incontinence (uncontrolled bladder leaks). The trial compares two approaches to determine which better implements the app and supports users while assessing the app's impact on users' health. Participants will receive either foundational support, including training resources and peer networks, or an enhanced support package focusing on equity (fair treatment) and reach. Women veterans who have experienced urinary incontinence for three months or more and have access to a mobile device may be a good fit for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve health management tools for women veterans.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mobile health app is safe for women veterans with urinary incontinence?

Research has shown that MyHealtheBladder, a mobile app for urinary incontinence (urine leakage), is safe to use. In earlier studies, the app helped women control their bladder through exercises and strategies. These studies found that users generally had a positive experience with the app.

No serious side effects were reported from using the app. It teaches users muscle exercises and how to manage fluid intake, making it a low-risk option for those seeking to improve bladder control. Additionally, real-world evidence supports its safety and effectiveness in managing urinary incontinence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile Health App for Urinary Incontinence because it offers a fresh, tech-savvy approach to managing this condition. Unlike standard treatments like pelvic floor exercises or medications, this app-based solution aims to provide continuous support and education through a mobile platform. The Reach+Equity Bundle is especially innovative, as it includes external facilitation and an equity-focused toolkit to ensure that the app is accessible and effective for a diverse range of users. This emphasis on equity and personalized support could revolutionize how urinary incontinence is managed, making it more inclusive and tailored to individual needs.

What evidence suggests that the MyHealtheBladder app is effective for urinary incontinence?

Research has shown that the MyHealtheBladder app effectively helps women manage urinary incontinence. In this trial, participants will join different treatment arms to evaluate the app's effectiveness. One arm, Foundational Support, uses the Replicating Effective Program (REP) implementation strategy. Another arm, the Reach+Equity Bundle, includes additional activities focused on equitable reach and implementation. In one study, women using the app noticed significant improvement in their symptoms after 12 weeks. Another study confirmed that digital health treatments like this app are both effective and safe for women with bladder control issues. The app has also helped female veterans manage these problems. Overall, the MyHealtheBladder app appears to be a promising tool for managing urinary incontinence through self-care strategies. ^{1 6 7 8 9}

Who Is on the Research Team?

Karen Goldstein, MD MSPH

Principal Investigator

Durham VA Medical Center, Durham, NC

Alayne D Markland, DO MSc

Principal Investigator

Birmingham VA Medical Center, Birmingham, AL

Are You a Good Fit for This Trial?

This trial is for women veterans who are experiencing urinary incontinence. Specific eligibility criteria have not been provided, but typically participants would need to meet certain health conditions and agree to use the mobile health application as directed.

Inclusion Criteria

I am a woman who has served in the military.

I have had urinary incontinence for at least 3 months.

Exclusion Criteria

No access to computer or mobile device

No email account

Institutionalized

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of MyHealtheBladder using foundational support or Reach+Equity bundle

18 months

Evaluation

Evaluation of implementation outcomes such as reach, adoption, and fidelity

18 months

Follow-up

Participants are monitored for effectiveness outcomes such as UI severity, quality of life, and satisfaction

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MyHealtheBladder

Trial Overview The study is testing two implementation strategies for a mobile health app called MyHealtheBladder. It aims to see which approach works best for helping women veterans manage urinary incontinence and focuses on reaching all intended users fairly.

How Is the Trial Designed?

Group I: Reach+Equity Bundle Experimental Treatment 1 Intervention

The Reach+Equity bundle will include the same activities as foundational support plus the Reach+Equity bundle activities which include: 1) external facilitation (provide an outside perspective to help sites identify barriers, develop effective strategies, and navigate complex change processes particularly through the lens of achieving equitable reach); 2) equity in implementation toolkit (guide that supports awareness and consideration of health equity during the implementation process); and 3) equity-focused data-driven monitoring (inform progress regarding equitable reach-related goals).

Group II: Foundational Support Active Control 1 Intervention

Foundational Support uses the Replicating Effective Program (REP) implementation strategy and includes 5 elements that were developed and tested in our prior Function QUERI work: shareholder engagement, MHB toolkit, Online shared resources (SharePoint) access for clinical program training materials, data reports to assist sites with tracking their data, and Diffusion Networks to promote peer-to-peer sharing and implementation support.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2839007

Remote Access to Urinary Incontinence Treatments for ... In the ITT analysis (Table 4), women in the UI app group reported greater improvements in OAB symptom severity scores at 12 weeks (−2.5 [95% CI, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38935967/

Real-World Evidence From a Digital Health Treatment ... This study provides real-world evidence to support the effectiveness and safety of a prescribed digital health treatment program for female UI.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772973723000127

Care provider views on app-based treatment for female ... Mobile eHealth (mHealth) apps hold the promise of improving healthcare delivery and outcomes. App-based treatment for urinary incontinence (UI), for example ...

4. usnews.com usnews.com/news/health-news/articles/2025-09-18/bladder-control-problems-there-may-be-an-app-for-that

Bladder Control Problems? There May Be An App For That Female veterans suffering from urinary incontinence received effective relief using a smartphone app called MyHealtheBladder, researchers ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8056293/

A Mobile App for Self-management of Urgency and Mixed ... The treatment app was effective for improving urgency and mixed incontinence in women. When self-management is appropriate, this app may be a good alternative ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12208298/

A mobile telehealth program for behavioral treatment of ... MyHealtheBladder uses mobile telehealth technology to teach pelvic floor muscle exercises, bladder control strategies, fluid management, risk factor reduction, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04237753

NCT04237753 | Remote Access to Urinary Incontinence ... This research study will examine the effects of two mobile health technologies on improving bladder symptoms, as part of a randomized clinical trial. The study ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12441875/

Remote Access to Urinary Incontinence Treatments for ... Remote interventions included (1) a mobile health UI app (MyHealtheBladder) with daily sessions delivered for 8 weeks or (2) a single video ...

9. formative.jmir.org formative.jmir.org/2024/1/e58551/

Real-World Evidence From a Digital Health Treatment ... This study provides real-world evidence to support the effectiveness and safety of a prescribed digital health treatment program for female UI.