In this pragmatic clinical trial, the primary objective is to increase access to behavioral treatment of urinary incontinence (UI) for women Veterans by comparing the effectiveness of two virtual care delivery modalities.
Veterans Affairs (VA) clinical sites in AL, GA, NC will virtually randomize 286 women Veterans with UI (ie, stress, urge, or mixed). We will compare the effectiveness of our mHealth UI application (MyHealtheBladder) to a single VA Video Connect (VVC) session delivered by trained UI providers. Women without improvement after 8 weeks will receive an optimization VVC visit using a sequential, multiple assignment, randomized trial (SMART) design. The primary outcome is UI symptom improvement at 12-weeks with or without optimization; secondary outcomes include improvements in lower urinary tract symptoms, adherence, retention rates, perceptions of improvement, and visit-related miles saved. Sample size needed to identify a 2.5-point change (range 0-21) in the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) from baseline to 12-weeks post-randomization is 200 participants. Allowing for an attrition rate of 25%, 286 participants are required.
Study team initiated remote recruitment on April 2020. Recruitment is on target with a 75% retention rate. We expect completion in fall of 2023 (clinicaltrials.govNCT04237753).
Engaging women Veterans with virtual modalities for initial UI treatment may increase access to UI care while also improving symptoms. After assessing efficacy, adherence, and retention, the next step is to implement the most effective option for remote delivery of evidence-based behavioral UI treatment for women Veterans.
ClinicalTrials.gov number NCT04237753.
Contemporary clinical trials. 2023 Aug 31 [Epub ahead of print]
Alayne D Markland, Camille P Vaughan, Karen M Goldstein, Susan N Hastings, Ursula Kelly, T Mark Beasley, Emily Malone Boyd, Lisa Zubkoff, Kathryn L Burgio
Birmingham/Atlanta Geriatric Research, Education, and Clinical Center (GRECC), Department of Veterans Affairs, Birmingham, AL, United kingdom; Birmingham/Atlanta Geriatric Research, Education, and Clinical Center (GRECC), Department of Veterans Affairs, Atlanta, GA, Georgia; University of Alabama at Birmingham, Department of Medicine, Birmingham, AL, United kingdom. Electronic address: ., Birmingham/Atlanta Geriatric Research, Education, and Clinical Center (GRECC), Department of Veterans Affairs, Birmingham, AL, United kingdom; Birmingham/Atlanta Geriatric Research, Education, and Clinical Center (GRECC), Department of Veterans Affairs, Atlanta, GA, Georgia; Emory University Department of Medicine, Atlanta, GA, Georgia; The Atlanta VA Medical Center, Georgia., Durham VA Health Care System, Durham, NC, United States of America; Duke University School of Medicine, Durham, NC, United States of America., Emory University Department of Medicine, Atlanta, GA, Georgia; The Atlanta VA Medical Center, Georgia., Birmingham/Atlanta Geriatric Research, Education, and Clinical Center (GRECC), Department of Veterans Affairs, Birmingham, AL, United kingdom; Birmingham/Atlanta Geriatric Research, Education, and Clinical Center (GRECC), Department of Veterans Affairs, Atlanta, GA, Georgia; University of Alabama at Birmingham, Department of Medicine, Birmingham, AL, United kingdom., University of Alabama at Birmingham, Department of Medicine, Birmingham, AL, United kingdom.