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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MyHealthebladder | Active Comparator | 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 |
|
| VA Video Connect | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VA Video Connect | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) | Urinary incontinence severity questionnaire, range 0-21, higher scores represent greater symptom severity | baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change International Consultation on Incontinence Modular Questionnaire (ICIQ)-Overactive Bladder (OAB) | Overactive bladder symptom severity questionnaire, range 0-12, higher scores represent greater symptoms severity | baseline to 12-weeks |
| Global Rating of Patient Satisfaction |
| Measure | Description | Time Frame |
|---|---|---|
| Miles saved | Mean miles saved from home location to specialty care clinic location over 12-week intervention | 12-weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alayne D Markland, DO MSc | Birmingham VA Medical Center, Birmingham, AL | Principal Investigator |
| Elizabeth Camille Vaughan, MD MS | Atlanta VA Medical and Rehab Center, Decatur, GA | Principal Investigator |
| Susan N. Hastings, MD MHSc | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham VA Medical Center, Birmingham, AL | Birmingham | Alabama | 35233-1927 | United States | ||
| Atlanta VA Medical and Rehab Center, Decatur, GA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40956581 | Derived | Markland AD, Goldstein KM, Beasley TM, Boyd EM, Zubkoff L, Kelly UA, Burgio KL, Vaughan CP. Remote Access to Urinary Incontinence Treatments for Women Veterans: The PRACTICAL Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2532111. doi: 10.1001/jamanetworkopen.2025.32111. | |
| 39704322 | Derived | Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2. |
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For purposes of this study, all data will be stripped of all patient identifiers and each participant will be given a unique identifier for the study. Participant records will be stored in a locked cabinet in a locked office and will be accessible only to the Principal Investigator, Nurse Practitioner delivering the intervention, Research Coordinator, and Site PI's (Markland, Vaughan, and Goldstein) and co-investigators per site-PI's guidance. Computer-based records will be maintained through the Veteran's Administration Computerized Patient Record System (CPRS), a secure network with password protection. A separate tracking database with participant identifiers that provide a link to the unique study IDs will be stored on a secure VA research server at each study site. Only deidentified data will be entered into the Redcap database by study personnel who are credentialed at the Birmingham VAMC through the research office.
Data will become available 1-year following the reporting of the primary and secondary outcome analyses.
By study team permission
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 24, 2022 | Apr 28, 2023 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 29, 2026 |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D053201 | Urinary Bladder, Overactive |
| D001745 | Urinary Bladder Diseases |
| D014550 | Urinary Incontinence, Stress |
| D053202 | Urinary Incontinence, Urge |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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.
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|
| MyHealtheBladder | Behavioral | 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 |
|
|
Patient satisfaction question (PSQ) - 3 categories of response (highly satisfied, satisfied, not satisfied) |
| 12-weeks |
| Self-reported Pelvic floor muscle exercise adherence | 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. | 12-weeks |
| Change in International Consultation on Incontinence Modular Questionnaire (ICIQ)- Urinary Incontinence Short Form (ICIQ-UI SF) | Urinary incontinence severity questionnaire, range 0-21, higher scores represent greater symptom severity, longer term outcome | baseline to 24-weeks |
| Decatur |
| Georgia |
| 30033 |
| United States |
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705 | United States |
| 37811598 | Derived | Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2. |
| 37659594 | Derived | Markland AD, Vaughan CP, Goldstein KM, Hastings SN, Kelly U, Beasley TM, Boyd EM, Zubkoff L, Burgio KL. Optimizing remote access to urinary incontinence treatments for women veterans (PRACTICAL): Study protocol for a pragmatic clinical trial comparing two virtual care options. Contemp Clin Trials. 2023 Oct;133:107328. doi: 10.1016/j.cct.2023.107328. Epub 2023 Sep 1. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |