An interventional study of VA Video Connect and MyHealtheBladder in Urinary Incontinence, sponsored by VA Office of Research and Development. Completed at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-30.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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.
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.
983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.
This study's enrollment of 286 is above the median of 66 across 739 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Behavioral: MyHealtheBladder
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
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
Also known as: Telehealth visit with Continence Provider
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
Also known as: Mobile health bladder education
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
Time frame: baseline to 12 weeks
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
Time frame: baseline to 12-weeks
Global Rating of Patient Satisfaction
Patient satisfaction question (PSQ) - 3 categories of response (highly satisfied, satisfied, not satisfied)
Time frame: 12-weeks
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.
Time frame: 12-weeks
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
Time frame: baseline to 24-weeks
Miles saved
Mean miles saved from home location to specialty care clinic location over 12-week intervention
Time frame: 12-weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — For purposes of this study, all data will be stripped of all patient identifiers and each participant will be given a unique identifier for the study. Participant records will be stored in a locked cabinet in a locked office and will be accessible only to the Principal Investigator, Nurse Practitioner delivering the intervention, Research Coordinator, and Site PI's (Markland, Vaughan, and Goldstein) and co-investigators per site-PI's guidance. Computer-based records will be maintained through the Veteran's Administration Computerized Patient Record System (CPRS), a secure network with password protection. A separate tracking database with participant identifiers that provide a link to the unique study IDs will be stored on a secure VA research server at each study site. Only deidentified data will be entered into the Redcap database by study personnel who are credentialed at the Birmingham VAMC through the research office.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Data will become available 1-year following the reporting of the primary and secondary outcome analyses.
Access criteria: By study team permission
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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