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

点击翻译按钮获取中文摘要

PROJECT SUMMARY/ABSTRACT The primary objectives of this Phase II SBIR Proposal are to develop the UroMonitor (UM) with an ISO-13485 certified manufacturer and evaluate the safety and feasibility of the UM in a Clinical Feasibility Study. Urodynamics evaluations are conducted to aid in diagnosis and treatment of patients with Lower Urinary Tract Symptoms (LUTS). This evaluation measures the pressure and volume in the bladder to characterize bladder performance and inform decisions regarding the appropriate course of treatment. In many cases, Urodynamics evaluations fail to reproduce patient symptoms, which limit effectiveness. One major reason this occurs is because the test requires patients to remain static and artificially fill their bladders using catheters. Bright Uro has developed a method to conduct Ambulatory Urodynamic Monitoring that is wireless and catheter-free. We are confident this will result in more accurate, more comprehensive evaluations that improve outcomes for patients, clinicians and payers. Bright Uro has developed the UM as a wireless sensing platform for extended urological monitoring in the home environment. The UM can remain in the bladder for up to 7 days and record pressure and volume. When synthesized with a Voiding Diary, Uroflowmetry, and other physiological data, the UM will provide the most comprehensive Urodynamic report available to clinicians. The UM system leverages promising clinical results from a First in Woman clinical study recently completed at the Cleveland Clinic. This lays the foundation for our proposed Clinical Feasibility Study where we will evaluate the safety and feasibility of the UM for an extended period in the home setting. Data collected from this study will provide valuable insight and inform future clinical studies. If successful, the UM will be postured for follow-on studies including a potential Phase IIB application and a larger pivotal study with greater statistical power. Our goal is to bring the UM to market where it could revolutionize the way Urodynamics evaluations are conducted and significantly improve outcomes for patients, clinicians, and payers.