Remote Access Treatment for Urinary Incontinence

(PRACTICAL Trial)

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

286 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is about assessing the helpfulness of two treatment delivery methods for bladder leakage or urinary incontinence. It is being funded by the Department of Veterans Affairs. By doing this study, the investigators hope to learn which treatment method is the most helpful remote delivery method for treating bladder leakage. The total participation time in this research is 6 months. During the first 8 -12 weeks of the study, you will receive standard of care from an online educational program (MyHealtheBladder) or a video visit with a provider through VA Video Connect. You will be selected by chance to receive MyHealtheBladder or VA Video Connect. About half-way through the study, the investigators will ask you about your bladder symptoms. If your bladder symptoms are not better, you will be selected by chance to continue the previous treatment or receive an initial or booster video session with a provider. Throughout the study, you will be asked to answer questions related to your health, bladder leakage, costs due to bladder leakage, and track your behavioral training.

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 data supports the effectiveness of the treatment MyHealtheBladder, VA Video Connect for urinary incontinence?

Research shows that a mobile telehealth program like MyHealtheBladder can help women veterans manage urinary incontinence effectively. Additionally, virtual clinics and telehealth interventions have been shown to improve patient experience and reduce costs in managing urinary incontinence. ^{1 2 3 4 5}

Is remote access treatment for urinary incontinence safe for humans?

The research articles reviewed do not provide specific safety data for remote access treatment for urinary incontinence, but they do indicate that telehealth technologies like VA Video Connect have been used safely for other conditions, such as mental health and chronic disease management, suggesting a general safety in humans. ^{6 7 8 9 10}

How is the treatment MyHealtheBladder for urinary incontinence unique?

MyHealtheBladder is unique because it uses a mobile telehealth program to provide behavioral treatment for urinary incontinence, allowing patients to access care remotely through VA Video Connect, which is different from traditional in-person treatments. ^{1 2 3 11 12}

Research Team

Elizabeth Camille Vaughan, MD MS

Principal Investigator

Atlanta VA Medical and Rehab Center, Decatur, GA

Susan N. Hastings, MD MHSc

Principal Investigator

Durham VA Medical Center, Durham, NC

Alayne D Markland, DO MSc

Principal Investigator

Birmingham VA Medical Center, Birmingham, AL

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluating the impact of a 'virtual clinic' on patient experience, personal and provider costs of care in urinary incontinence: A randomised controlled trial. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

A mobile telehealth program for behavioral treatment of urinary incontinence in women veterans: Development and pilot evaluation of MyHealtheBladder. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Evidence for the Appropriate Use of Telemedicine in Female Pelvic Medicine and Reconstructive Surgery. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Randomized trial comparing efficacy of pelvic floor muscle training with a digital therapeutic motion-based device to standard pelvic floor exercises for treatment of stress urinary incontinence (SUV trial): An all-virtual trial design. [2021]

5. Spain pubmed.ncbi.nlm.nih.gov

[Telerehabilitation to treat stress urinary incontinence. Pilot study]. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Patterns of Telehealth Use for Mental Health Treatment Among Hispanic Veterans. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Home Telehealth in the Veterans Health Administration: Trends and Correlates of Length of Enrollment from 2010 to 2017. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Home Talk/Healthy Talk: improving patient's health status with telephone technology. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Implementation and outcomes of a pharmacist-managed clinical video telehealth anticoagulation clinic. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Vet Connect: A Quality Improvement Program to Provide Telehealth Subspecialty Care for Veterans Residing in VA-Contracted Community Nursing Homes. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

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

12. United States pubmed.ncbi.nlm.nih.gov

Biofeedback therapy for female incontinence due to low urethral resistance. [2019]