Clinical Feasibility of Wireless Catheter-Free Urodynamics for Extended, Comprehensive Urological Evaluation in the Home Setting

ABSTRACT Urodynamics (UDS) evaluations are conducted to aid in diagnosis and treatment of patients with Lower Urinary Tract Dysfunction (LUTD). Although conventional UDS (cUDS) is the current objective standard, up to 46% of UDS evaluations fail to replicate the patient’s symptoms. This failure is primarily due to the lack of physiological relevance of the study itself. The placement of a urinary catheter, a rectal catheter, retrograde filling of the bladder during pressure-flow studies, and the patient discomfort and anxiety involved in the study have all been identified as sources of error and have confounded the diagnostic accuracy of cUDS. Thus, the study is fundamentally flawed due to limitations of technology, and only provides a snapshot of bladder performance in an artificially controlled setting. Therefore, there is a clinical need for a diagnostic study that can accurately reproduce patient symptoms to identify patients with detrusor underactivity and enable Urologists to plan their treatment path accordingly. While ambulatory UDS (aUDS) has shown promise, the presence of both a urinary and rectal catheter continue to confound the diagnostic capabilities of the system. In addition, allowing for natural filling removes the clinician’s ability to precisely monitor the amount of fluid in the bladder, which can impact the specificity of this approach. While aUDS is an improvement over cUDS, it has not been widely adopted due to the complexity of the study, the time demand, and the technical failure rate of these systems. Therefore, there is a clear clinical need for a wireless, catheter-free UDS that provides a more physiologically relevant and natural assessment of bladder function. To address this need, Bright Uro has developed the UroMonitor to provide high- resolution information about bladder function under more physiologically relevant conditions to better replicate patient symptoms and improve diagnostic accuracy. The UroMonitor has been tested in both preclinical models and human subjects and has shown a concordance with cUDS during simultaneous assessment of 0.874, with high accuracy and precision. The overall goal of the parent Phase II award is to demonstrate the safety and clinical feasibility of the UroMonitor in a rigorous, pivotal study. In the parent award, we are optimizing the UroMonitor to include pressure sensing and improve device performance for clinical use (Specific Aim 1). Subsequently, we will evaluate the safety and feasibility of the UroMonitor for extended urological monitoring in the home environment (Specific Aim 2). In the present supplement, we have assigned Dr. Brittany Carter, Director of Clinical Affairs, a clinical research management role in the project and will support her entrepreneurship skills to ultimately allow her to advance her career in clinical leadership within the Medical Device startup space. She will manage the clinical study led by PD/PI and mentor Mr. Derek Herrera and develop and execute clinical strategies and health and economics outcomes research to support future commercialization of the UroMonitor. The proposed work for Brittany will be performed within the overall scope of the parent award.