Background: Urinary bladder stones affect millions worldwide, yet current management relies on episodic imaging that fails to provide real-time disease monitoring. Wearable infrared extracorporeal non-invasive monitors (WIENMs) represent a potential paradigm shift toward continuous, patient-centered care, but evidence regarding their clinical effectiveness remains fragmented and underexplored. Objective: This study aims to evaluate the clinical effectiveness and health outcomes of the Extracorporeal Bladder Stone Monitor (E.B.S.M.), a novel wearable device employing mid-infrared spectroscopy (750-2500 nm) for continuous, non-invasive bladder stone monitoring, compared to standard care. Methods: A mixed-methods design comprising a scoping review and a 12-month randomized controlled trial across five countries (Nigeria, Bangladesh, China, Kenya, United Kingdom). The scoping review will systematically map existing evidence using Arksey and O'Malley's framework, searching PubMed, Scopus, Web of Science, and grey literature. The RCT will randomize 250 adults with confirmed bladder stones 1:1 to receive WIENM plus standard care or standard care alone. Primary outcomes include spontaneous stone passage rate, diagnostic accuracy (sensitivity/specificity), quality of life (I-QOL, UDI-6), and healthcare utilization. Secondary outcomes include adherence, usability, and barriers to clinical integration, analyzed using the Technology Acceptance Model (TAM). Results: The scoping review confirms a critical evidence gap, with few direct studies on infrared-based stone monitoring but promising evidence for optical sensing principles. The RCT hypothesizes significantly higher stone passage rates (15-25% absolute increase), improved quality of life scores, 40-60% reduction in follow-up imaging, and 30-50% reduction in unplanned emergency visits in the intervention group. Barriers will include device adherence, EHR integration, and workflow alignment. Conclusion: This comprehensive evaluation will provide foundational evidence for WIENM technology, potentially transforming bladder stone management from reactive, episodic interventions to proactive, continuous, data-driven care. The findings will inform regulatory approval, clinical adoption, cost-effectiveness analysis, and future research in digital urological health.
Peters et al. (Fri,) studied this question.