Remote Access Treatment for Urinary Incontinence

(PRACTICAL Trial)

No longer recruiting at 2 trial locations

Overseen By T. R Lane, CRNP

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Unstable medical, psychiatric, housing, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two remote methods to help women veterans manage bladder leakage, also known as urinary incontinence. Participants will either use an online program called MyHealtheBladder, which provides daily health education and exercises, or have video consultations with a healthcare provider through VA Video Connect. The trial aims to determine which method more effectively reduces symptoms. Women veterans who have experienced bladder leakage at least once a month for three months and have internet access might be suitable candidates for this study. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance future care for women veterans.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have started new treatments for incontinence in the last 3 months or plan to start during the study, you may not be eligible to participate.

What prior data suggests that these treatment delivery methods are safe for urinary incontinence?

Research has shown that both MyHealtheBladder and VA Video Connect are safe and effective for managing urinary incontinence, which involves accidentally leaking urine. MyHealtheBladder is a daily mobile health program that educates users about their bladder and includes exercises to strengthen pelvic muscles. These exercises can help control urine leakage, and no safety issues have been reported.

VA Video Connect enables remote appointments with a continence care provider. This platform has been used for other health issues without major safety concerns. A VA data and safety monitoring board oversees its use to ensure patient safety, and no serious problems have been reported. Both methods emphasize education and exercises, which are generally safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for urinary incontinence because they bring care directly to patients through remote and digital platforms. MyHealtheBladder offers daily mobile health education that empowers individuals to learn about bladder anatomy and function, engage in pelvic floor exercises, and use self-monitoring tools—all from their smartphones. Meanwhile, VA Video Connect provides remote telehealth visits with a continence care provider, combining personalized guidance with the convenience of at-home access. These approaches stand out because they make it easier for patients to manage their condition without frequent clinic visits, potentially increasing adherence and improving outcomes.

What evidence suggests that this trial's treatments could be effective for urinary incontinence?

Research has shown that the MyHealtheBladder app, one of the treatments in this trial, can help reduce symptoms of urinary incontinence. In a study, women veterans using the app experienced improvements exceeding the minimum required for significance on urinary incontinence scales. These women also reported noticeable relief from bladder control problems.

Similarly, the VA Video Connect telehealth service, another treatment option in this trial, effectively educates and supports women veterans with urinary incontinence. The study found that women who had video visits with a continence care provider received helpful advice on managing their urinary issues. Both the app and the video service focus on teaching bladder health and pelvic floor exercises, which are known to improve bladder control. ^{6 7 8 9 10}

Who Is on the Research Team?

Susan N. Hastings, MD MHSc

Principal Investigator

Durham VA Medical Center, Durham, NC

Elizabeth Camille Vaughan, MD MS

Principal Investigator

Atlanta VA Medical and Rehab Center, Decatur, GA

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 experience bladder leakage at least once a month for three months, can access the internet daily, and have their own email. It's not suitable for those with neurological conditions like MS or Parkinson's, recent major surgeries, unstable medical conditions affecting urine volume, new incontinence treatments within the last 3 months, post-partum within 3 months, severe psychiatric issues, active genitourinary cancer treatment or unstable housing.

Inclusion Criteria

Able to access daily internet via computer or mobile device

Access to personal email for MyHealtheBladder and VA Video Connect visit initiation and reminder

I have experienced urinary incontinence at least once a month for the last 3 months.

Exclusion Criteria

I am currently receiving chemotherapy or radiation for genitourinary cancer.

You have unstable mental health conditions, such as psychosis, suicidal thoughts, or active alcohol or drug abuse.

I don't have any health issues that could worsen incontinence.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either MyHealtheBladder or VA Video Connect for 8-12 weeks

8-12 weeks

Daily mobile health education or single video session

Mid-study Assessment

Participants' bladder symptoms are assessed, and treatment may be adjusted

1 week

Assessment via phone or survey

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at 8-weeks, 12-weeks, and 6-months

What Are the Treatments Tested in This Trial?

Interventions

• MyHealtheBladder
• VA Video Connect

Trial Overview The study compares two remote treatment methods for urinary incontinence: an online educational program called MyHealtheBladder and video visits with providers via VA Video Connect. Participants are randomly assigned to one of these methods and may switch halfway if symptoms don't improve. The goal is to determine which method better helps manage bladder leakage over six months.

How Is the Trial Designed?

Group I: MyHealthebladder Active Control 1 Intervention

Daily mobile health education with information on bladder anatomy and function, pelvic floor muscle exercises with behavioral strategies, and self-monitoring tools for urine leakage

Group II: VA Video Connect Active Control 1 Intervention

Remote telehealth visits with continence care provider who will provide education on bladder anatomy and function, pelvic floor muscle exercises with behavioral strategies, and self-monitoring tools for urine leakage

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A new intravesical device was successfully tested in 35 patients with stress urinary incontinence, providing a novel treatment option that allows for voluntary bladder opening while blocking leaks.

This device addresses the limitations of existing treatments, as it does not create a communication between the bladder and vulva, thereby reducing the risk of urinary infections commonly associated with other surgical methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New approach to the management of stress urinary incontinence in patients with treatment failure. Yachia, D.[2016]

Citations

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

Remote Access to Urinary Incontinence Treatments for ... This randomized clinical trial compares the effectiveness of urinary incontinence behavioral treatments delivered via a mobile health app vs ...

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

Remote Access to Urinary Incontinence Treatments for ... This randomized clinical trial compares the effectiveness of urinary incontinence behavioral treatments delivered via a mobile health app vs ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07219433

Implementing a Mobile Health Application for Women ... The overall goal is to implement, evaluate, and sustain MyHealtheBladder in 20 VA facilities using a type III effectiveness-implementation ...

4. drugs.com drugs.com/news/bladder-control-problems-there-may-app-126733.html

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31774200/

Development and pilot evaluation of MyHealtheBladder Women veterans using an 8-week behavioral mHealth program for the treatment of UI had symptom improvements that exceeded the MCID for the ICIQ-SF.

6. myhealth.alberta.ca myhealth.alberta.ca/Health/pages/conditions.aspx?Hwid=acn7841

Urinary Incontinence - MyHealth Alberta Urinary incontinence is the accidental release of urine. It can happen when you cough, laugh, sneeze, or jog. Or you may have a sudden need to go to the toilet ...

7. womenshealth.gov womenshealth.gov/a-z-topics/urinary-incontinence

Urinary incontinence Drinks with caffeine can cause the bladder to fill quickly, which can cause you to leak urine. Studies suggest that women who drink more than two cups of drinks ...

8. my.clevelandclinic.org my.clevelandclinic.org/health/diseases/17596-urinary-incontinence

Urinary Incontinence: Causes, Leakage, Types & Treatment Incontinence is loss of bladder control, often leading to uncontrollable pee leakage. It's more common in females and people over 50.

9. myhealth.umassmemorial.org myhealth.umassmemorial.org/RelatedItems/85,P01528

Urinary Incontinence - Health Library Safety and Injury Prevention ... Regular, daily exercise of pelvic muscles may make the bladder muscles stronger and improve, and even prevent, urinary ...

10. mayoclinic.org mayoclinic.org/diseases-conditions/urinary-incontinence/symptoms-causes/syc-20352808

Urinary incontinence - Symptoms and causes Learn about possible causes of the loss of bladder control and what treatments are available for this problem.