Abstract
PURPOSE: Current guidelines recommend clean intermittent catheterization (CIC) at regular time intervals for patients with spinal cord injuries; however, many patients experience difficulties. Performing time-based CIC outside the home is a significant burden for patients. In this study, we aimed to overcome the limitations of the current guidelines by developing a digital device to monitor bladder urine volume in real-time. METHODS: The optode sensor is a near-infrared spectroscopy (NIRS)-based wearable device intended to be attached to the skin of the lower abdomen where the bladder is located. The sensor's primary function is to detect changes in urine volume within the bladder. An in vitro study was conducted using a bladder phantom that mimicked the optical properties of the lower abdomen. To validate the data in the human body at the proof-of-concept level, one volunteer attached the device to the lower abdomen to measure the light intensity between the first voiding and immediately before the second voiding. RESULTS: The degree of attenuation at the maximum test volume was equivalent across experiments, and the optode sensor with multiplex measurements demonstrated robust performance for patient diversity. Moreover, the symmetric feature of the matrix was deemed a potential parameter for identifying the accuracy of sensor localization in a deep-learning model. The validated feasibility of the sensor showed almost the same results as an ultrasound scanner, which is routinely used in the clinical field. CONCLUSION: The optode sensor of the NIRS-based wearable device can measure the urine volume in the bladder in real-time.