Clinical trial NCT04237753: Remote Access to Urinary Incontinence Treatment for Women Veterans
Official title: Optimizing Remote Access to Urinary Incontinence Treatment for Women Veterans
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Urinary Incontinence
Keywords: women's health
Veterans
telemedicine
urinary incontinence
overactive urinary bladder
urinary bladder diseases
stress urinary incontinence
urge urinary incontinence
health education
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-01-23
Enrollment: 286
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
timeFrame: baseline to 12 weeks
Secondary outcomes:
measure: Change International Consultation on Incontinence Modular Questionnaire (ICIQ)-Overactive Bladder (OAB)
timeFrame: baseline to 12-weeks
measure: Global Rating of Patient Satisfaction
timeFrame: 12-weeks
measure: Self-reported Pelvic floor muscle exercise adherence
timeFrame: 12-weeks
measure: Change in International Consultation on Incontinence Modular Questionnaire (ICIQ)- Urinary Incontinence Short Form (ICIQ-UI SF)
timeFrame: baseline to 24-weeks
Other outcomes:
measure: Miles saved
timeFrame: 12-weeks
Locations:
city: Birmingham
country: United States
facility: Birmingham VA Medical Center, Birmingham, AL
state: Alabama
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur, GA
state: Georgia
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Birmingham VA Medical Center, Birmingham, AL
name: Alayne D Markland, DO MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Atlanta VA Medical and Rehab Center, Decatur, GA
name: Elizabeth Camille Vaughan, MD MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Durham VA Medical Center, Durham, NC
name: Susan N. Hastings, MD MHSc
role: PRINCIPAL_INVESTIGATOR
References: