Urinary Incontinence
Conditions
Keywords
women's health, Veterans, telemedicine, urinary incontinence, overactive urinary bladder, urinary bladder diseases, stress urinary incontinence, urge urinary incontinence, health education
Brief 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.
Detailed 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.
Interventions
BEHAVIORALVA Video Connect
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
BEHAVIORALMyHealtheBladder
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
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized clinical trial with adaptive trial design. Randomization will first involve treatment with one of two delivery methods: (1) a web-based mobile health application or (2) a single video session. For women who do not improve (SMART design), they will receive a first or second video session.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) | baseline to 12 weeks | Urinary incontinence severity questionnaire, range 0-21, higher scores represent greater symptom severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change International Consultation on Incontinence Modular Questionnaire (ICIQ)-Overactive Bladder (OAB) | baseline to 12-weeks | Overactive bladder symptom severity questionnaire, range 0-12, higher scores represent greater symptoms severity |
| Global Rating of Patient Satisfaction | 12-weeks | Patient satisfaction question (PSQ) - 3 categories of response (highly satisfied, satisfied, not satisfied) |
| Self-reported Pelvic floor muscle exercise adherence | 12-weeks | Adherence to pelvic floor muscle exercises reported as exercises per day completed over each week. Adherence defined as 80% of days with exercises completed over 12-week intervention period. |
| Change in International Consultation on Incontinence Modular Questionnaire (ICIQ)- Urinary Incontinence Short Form (ICIQ-UI SF) | baseline to 24-weeks | Urinary incontinence severity questionnaire, range 0-21, higher scores represent greater symptom severity, longer term outcome |
Other
| Measure | Time frame | Description |
|---|---|---|
| Miles saved | 12-weeks | Mean miles saved from home location to specialty care clinic location over 12-week intervention |
Countries
United States
Outcome results
None listed