Remote Access to Urinary Incontinence Treatment for Women Veterans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-06

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pilot: Mind Over Matter: Healthy Bowels, Healthy Bladder

NCT02671747

Urinary Incontinence Fecal Incontinence Accidental Bowel Leakage

COMPLETED NA

Enhancing Conservative Treatment for Urge Incontinence

NCT00223821

Urinary Incontinence

COMPLETED NA

Improving Primary Care Access to Urinary Incontinence Treatment for Women Veterans

NCT05438849

Urinary Incontinence

ACTIVE_NOT_RECRUITING

Chronic Electrical Stimulation to Reduce Bladder Hyperreflexia

NCT03472599

Neurogenic Bladder Dysfunction

COMPLETED NA

Mind Over Matter: Electronic Bladder and Bowel Continence Self-management Program

NCT03976414

Incontinence, Urinary Incontinence Bowel

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

MyHealtheBladder

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

VA Video Connect

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Telehealth visit with Continence Provider Mobile health bladder education

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No