Remote Access to Urinary Incontinence Treatment for Women Veterans (PRACTICAL)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    260
  • sponsor
    VA Office of Research and Development
Updated on 29 May 2022
leakage of urine

Summary

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.

Description

This study represents a unique opportunity to improve access to treatments for urine leakage for women Veterans. 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 includes 260 women Veterans recruited from 3 sites: the Birmingham VAMC, the Atlanta VAHCS, and the Durham VAMC (86 per site). Women will receive first-line treatments for urine leakage through randomization to one of two delivery methods for direct treatment: (1) a web-based mobile health application that delivers content daily for 8 weeks compared to (2) a single video session delivered by VA Video Connect. At 8-weeks, women who do not have improved symptoms will have the ability to continue the treatment or receive an initial or booster video session. The investigators will measure bladder symptoms (3 questions by self-report over the phone or via survey) at baseline, 8-weeks, 12-weeks, and 6-months. Additionally, the investigators will interview 54 women Veterans and 12 providers to learn about their experiences with the technologies using 1:1 telephone interviews at 12-weeks. The findings from this study will inform the best technology to improve access for bladder leakage among women Veterans across a wider array of VHA facilities.

Details
Condition Urinary Incontinence
Treatment VA Video Connect, MyHealtheBladder
Clinical Study IdentifierNCT04237753
SponsorVA Office of Research and Development
Last Modified on29 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Women Veterans
Urinary incontinence occurring at least monthly for 3 months
Able to access daily internet via computer or mobile device
Access to personal email for MyHealtheBladder and VA Video Connect visit initiation and reminder

Exclusion Criteria

Unstable medical conditions that could contribute to incontinence (e.g., recent major hospitalization, planned major surgery, conditions that affect urine volume - hemoglobin A1c of 9.0, chronic kidney disease with planned dialysis within 3 months, as assessed by PI or Site PI)
Unstable psychiatric conditions (e.g., psychosis, suicidal, active alcohol/substance abuse based on history and medical records)
Unstable housing situation
Genitourinary cancer undergoing active treatment with chemotherapy or radiation
Neurologic conditions known to contribute to incontinence (Multiple Sclerosis, Parkinson's Disease, TBI, Dementia, and Stroke Survivors with limited mobility)
New treatments for incontinence started in the prior 3 months or planned during the 6-month study duration, includes medications and/or surgery
Three months post-partum
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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