Objectives: 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.
Methods: 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.
Key results: 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).
Discussion/conclusion: 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.
Trial registration: ClinicalTrials.gov number NCT04237753.
Keywords: Behavioral medicine; Mobile health; Pragmatic clinical trial; Self-management; Telehealth; Urinary incontinence; Veterans; Women.
Published by Elsevier Inc.