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Remote Access Treatment for Urinary Incontinence (PRACTICAL Trial)

N/A
Waitlist Available
Led By Alayne D Markland, DO MSc
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
Women Veterans
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24-weeks
Awards & highlights

PRACTICAL Trial 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.Check my eligibility
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.See study design
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.

PRACTICAL Trial 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.
Select...
I am a woman who has served in the military.

PRACTICAL Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
Secondary outcome measures
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 outcome measures
Change in Adaptive Behavior Index scores
Change in Incontinence Resource Utilization Questionnaire: IRUQ
Health Information Technology Usability Evaluation Scale (Health-ITUES)
+1 more

PRACTICAL 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

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,605 Previous Clinical Trials
3,305,310 Total Patients Enrolled
4 Trials studying Urinary Incontinence
497 Patients Enrolled for Urinary Incontinence
Alayne D Markland, DO MScPrincipal InvestigatorBirmingham VA Medical Center, Birmingham, AL
1 Previous Clinical Trials
80 Total Patients Enrolled
Elizabeth Camille Vaughan, MD MSPrincipal InvestigatorAtlanta VA Medical and Rehab Center, Decatur, GA
2 Previous Clinical Trials
150 Total Patients Enrolled

Media Library

MyHealtheBladder Clinical Trial Eligibility Overview. Trial Name: NCT04237753 — N/A
Urinary Incontinence Research Study Groups: MyHealthebladder, VA Video Connect
Urinary Incontinence Clinical Trial 2023: MyHealtheBladder Highlights & Side Effects. Trial Name: NCT04237753 — N/A
MyHealtheBladder 2023 Treatment Timeline for Medical Study. Trial Name: NCT04237753 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are investigators currently seeking participants for this research?

"According to the records on clinicaltrials.gov, this medical research is actively recruiting participants since its inception back in April 6th 2020 and was recently modified on May 12th 2022."

Answered by AI

How many participants are engaged in this research project?

"This trial necessitates the enrolment of 260 qualifying participants. Those interested in taking part can do so at either Birmingham VA Medical Center, situated in Alabama's Birmingham, or Durham VA Medical Center located in North carolina's city of Durham."

Answered by AI
~17 spots leftby Jun 2024