NCT04237753

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
286

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

April 6, 2020

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

5.2 years

First QC Date

December 31, 2019

Last Update Submit

July 25, 2025

Conditions

Urinary Incontinence

Keywords

women's healthVeteranstelemedicineurinary incontinenceoveractive urinary bladderurinary bladder diseasesstress urinary incontinenceurge urinary incontinencehealth education

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Change International Consultation on Incontinence Modular Questionnaire (ICIQ)-Overactive Bladder (OAB)

    baseline to 12-weeks

  • Global Rating of Patient Satisfaction

    12-weeks

  • Self-reported Pelvic floor muscle exercise adherence

    12-weeks

  • Change in International Consultation on Incontinence Modular Questionnaire (ICIQ)- Urinary Incontinence Short Form (ICIQ-UI SF)

    baseline to 24-weeks

Other Outcomes (1)

  • Miles saved

    12-weeks

Study Arms (2)

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

Behavioral: MyHealtheBladder

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

Behavioral: VA Video Connect

Interventions

VA Video ConnectBEHAVIORAL

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

Also known as: Telehealth visit with Continence Provider
VA Video Connect
MyHealtheBladderBEHAVIORAL

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

Also known as: Mobile health bladder education
MyHealthebladder

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, 35233-1927, United States

Location

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Related Publications (4)

  • 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.

    PMID: 40956581DERIVED

  • 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.

    PMID: 39704322DERIVED

  • 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.

    PMID: 37811598DERIVED

  • 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.

    PMID: 37659594DERIVED

MeSH Terms

Conditions

Urinary IncontinenceUrinary Bladder, OveractiveUrinary Bladder DiseasesUrinary Incontinence, StressUrinary Incontinence, UrgeHealth Education

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2019

First Posted

January 23, 2020

Study Start

April 6, 2020

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data will become available 1-year following the reporting of the primary and secondary outcome analyses.
Access Criteria
By study team permission

Locations

US(3)