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

Optimizing Remote Access to Urinary Incontinence Treatment for Women Veterans

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Urinary Incontinence
• Intervention / Treatment: Behavioral: MyHealtheBladder; Behavioral: VA Video Connect

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.

• Study Type: Interventional
• Enrollment (Actual): 286
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alayne D Markland, DO MSc; Phone Number: (205) 933-8101; Email: alayne.markland@va.gov
• Study Contact Backup: Name: T. R Lane, CRNP; Phone Number: (205) 558-7067; Email: terri.lane@va.gov

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233-1927
      • Birmingham VA Medical Center, Birmingham, AL
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Atlanta VA Medical and Rehab Center, Decatur, GA
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Durham VA Medical Center, Durham, NC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MyHealthebladder; 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; 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; Other Names: Mobile health bladder education
Active Comparator: VA 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	Behavioral: VA 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; Other Names: Telehealth visit with Continence Provider

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Miles saved	Mean miles saved from home location to specialty care clinic location over 12-week intervention	12-weeks

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Susan N. Hastings, MD MHSc, Durham VA Medical Center, Durham, NC; Principal Investigator: Elizabeth Camille Vaughan, MD MS, Atlanta VA Medical and Rehab Center, Decatur, GA; Principal Investigator: Alayne D Markland, DO MSc, Birmingham VA Medical Center, Birmingham, AL

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2020
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 31, 2019
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Veterans; telemedicine; stress urinary incontinence; women's health; health education; urinary incontinence; urge urinary incontinence; overactive urinary bladder; urinary bladder diseases
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis
• Other Study ID Numbers: IIR 18-266

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will become available 1-year following the reporting of the primary and secondary outcome analyses.
• IPD Sharing Access Criteria: By study team permission
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No