Importance Incorporating community engagement (CE) strategies can inform and enhance study design, recruitment, retention, dissemination, and access for diverse populations; however, these approaches are underutilized in pelvic floor disorders trials. Objectives The objectives of this study are to describe the CE methods used in a multisite randomized trial comparing beta-3 adrenergic agonists and intradetrusor onabotulinumtoxinA for the treatment of urgency urinary incontinence (UUI). Specific objectives of engagement methods included identifying barriers to recruitment and retention and improving study access for underrepresented populations. This study enrollment and community engagement are ongoing. Study Design We describe the formation of strategic CE partnerships with patients, clinicians, CE specialists, community organization leaders locally, and at the national level to guide the development of a randomized trial at 5 U.S. academic medical centers. Insight from these various partners have shaped the implementation of CE studios (listening sessions) with patients, caregivers, and clinicians in English, Spanish, and Amharic, focused on participation barriers and culturally appropriate recruitment materials. Engagement Approach Completed CE studios identified potential participation barriers, including mistrust, UUI stigma, limited health literacy, cultural and linguistic accessibility, financial and logistical challenges, and clinician constraints. Potential solutions identified in the CE studios included partnering with trusted community organizations, tailored study materials, simplified visit scheduling, appropriate compensation, and clinician resources. We have encouraged variation of recruitment strategies across study sites unified by common engagement principles, including tailored recruitment materials, culturally responsive imagery, outreach efforts by local community liaisons, and bidirectional communication with community partners. Throughout study enrollment, we continue our engagement efforts, and ongoing insight from partners continues to shape this trial, including recruitment, retention, and dissemination efforts. Conclusions Including different voices through CE can help identify varied and culturally tailored opportunities for recruitment and retention in randomized trials for UUI, which will help ensure study feasibility and relevance to diverse patients and community partners.
Jeppson et al. (Wed,) studied this question.