Remote Access to Urinary Incontinence Treatment for Women Veterans

Urinary Incontinence Clinical Trial

— PRACTICAL  

Official title:

Optimizing Remote Access to Urinary Incontinence Treatment for Women Veterans

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04237753
• Other study ID #: IIR 18-266
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 6, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 286
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Birmingham VA Medical Center, Birmingham, AL	Birmingham	Alabama
United States	Atlanta VA Medical and Rehab Center, Decatur, GA	Decatur	Georgia
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Miles saved	Mean miles saved from home location to specialty care clinic location over 12-week intervention	12-weeks
Primary	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	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
Secondary	Global Rating of Patient Satisfaction	Patient satisfaction question (PSQ) - 3 categories of response (highly satisfied, satisfied, not satisfied)	12-weeks
Secondary	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
Secondary	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