← Back to Search

Remote Access Treatment for Urinary Incontinence (PRACTICAL Trial)

N/A

Waitlist Available

Led By Elizabeth Camille Vaughan, MD MS

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Urinary incontinence occurring at least monthly for 3 months

Be older than 18 years old

Must not have

Genitourinary cancer undergoing active treatment with chemotherapy or radiation

Three months post-partum

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 24-weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether two methods of treatment delivery (online education or video visits with a provider) are helpful for treating bladder leakage. Participants will be randomly assigned to one of the two groups, and will be asked about their symptoms halfway through the study. If their symptoms are not improved, they will be randomly assigned to either continue their current treatment or receive an initial or booster video session with a provider.

Who is the study for?

This trial is for women veterans who experience bladder leakage at least once a month for three months, can access the internet daily, and have their own email. It's not suitable for those with neurological conditions like MS or Parkinson's, recent major surgeries, unstable medical conditions affecting urine volume, new incontinence treatments within the last 3 months, post-partum within 3 months, severe psychiatric issues, active genitourinary cancer treatment or unstable housing.

What is being tested?

The study compares two remote treatment methods for urinary incontinence: an online educational program called MyHealtheBladder and video visits with providers via VA Video Connect. Participants are randomly assigned to one of these methods and may switch halfway if symptoms don't improve. The goal is to determine which method better helps manage bladder leakage over six months.

What are the potential side effects?

Since this trial involves non-invasive educational programs and virtual consultations rather than medications or surgical interventions, there are no direct side effects associated with the treatments being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have experienced urinary incontinence at least once a month for the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently receiving chemotherapy or radiation for genitourinary cancer.

Select...

I gave birth three months ago.

Select...

I have a neurological condition like MS, Parkinson's, had a stroke, or similar, contributing to my incontinence.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 24-weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 24-weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24-weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

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

Global Rating of Patient Satisfaction

+1 more

Other study objectives

Miles saved

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: MyHealthebladderActive Control1 Intervention

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 II: VA Video ConnectActive Control1 Intervention

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

0 / 4Eligibility criteria met