Study 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.
Eligible Conditions
- Urinary Incontinence
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: baseline to 24-weeks
12-weeks
Global Rating of Patient Satisfaction
Health Information Technology Usability Evaluation Scale (Health-ITUES)
Miles saved
Self-reported Pelvic floor muscle exercise adherence
baseline and 12-weeks
Change in Incontinence Resource Utilization Questionnaire: IRUQ
baseline to 12 weeks
Change in International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
baseline to 12-weeks
Change International Consultation on Incontinence Modular Questionnaire (ICIQ)-Overactive Bladder (OAB)
Change in Adaptive Behavior Index scores
baseline to 24-weeks
Change in International Consultation on Incontinence Modular Questionnaire (ICIQ)- Urinary Incontinence Short Form (ICIQ-UI SF)
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
MyHealthebladder
1 of 2
VA Video Connect
1 of 2
Active Control
260 Total Participants · 2 Treatment Groups
Primary Treatment: MyHealthebladder · No Placebo Group · N/A
MyHealthebladder
Behavioral
ActiveComparator Group · 1 Intervention: MyHealtheBladder · Intervention Types: BehavioralVA Video Connect
Behavioral
ActiveComparator Group · 1 Intervention: VA Video Connect · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 24-weeks
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,483 Previous Clinical Trials
2,741,807 Total Patients Enrolled
3 Trials studying Urinary Incontinence
463 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
163 Total Patients Enrolled
Susan N. Hastings, MD MHScPrincipal InvestigatorDurham VA Medical Center, Durham, NC
5 Previous Clinical Trials
14,598 Total Patients Enrolled
Eligibility Criteria
Age 18+ · Female Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have access to personal email for MyHealtheBladder and VA Video Connect visit initiation and reminder.
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Conditions
Cancer Related
Treatments