The LURN Urinary Urgency and Lifestyle Wearable Tracker (ULTra) study: Design and feasibility

Introduction The ULTra study was designed to better understand the relationship of lifestyle factors with urinary urgency, specifically by assessing physical activity and sleep quality using a wearable tracker. Our objectives here are to describe study design and enrollment, adherence, and data evaluability results. Methods The Urinary U rgency and L ifestyle Wearable Tra cker (ULTra) study of the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) is a 3-month, prospective study performed within the larger 1-year Urinary Urgency Phenotyping (UUP) study. The UUP and ULTra studies enrolled adults with bothersome urinary urgency without (URG) or with urgency urinary incontinence (UUI) and a sex- and age-matched control group (no urinary symptoms). Data collection using the wearable tracker, including steps, heart rate, logged physical activities, and sleep episode information, occurred over two weeks at baseline and again 3-months after enrollment. Adherence and data validity criteria were developed for physical activity and sleep data obtained via the wearable tracker. Results We enrolled 270 participants (64 URG, 143 UUI, 63 controls), and 205 (76%) had evaluable data (at least 5 valid days) for either physical activity or sleep. In cases, data evaluability differed by sex, but not by age or case-control status. Female participants (versus male) and those with higher comorbidity and incontinence scores were less likely to contribute evaluable data. Conclusion This manuscript describes the design of the LURN ULTra study and discusses feasibility and challenges encountered in conducting a multicenter study employing wearable technology in an adult population seeking care for urinary symptoms.