Glean Urodynamics System for Urinary Function

This trial aims to gather information on normal urinary function using the Glean Urodynamics System, which includes sensors and software to monitor bladder and abdominal pressures. The goal is to establish reference ranges for these measurements in healthy adults. Participants should be healthy men or women without a history of pregnancy, urinary, or neurological issues. The study seeks individuals who can use a smartphone to record data. As an unphased trial, this study offers participants the opportunity to contribute to foundational research that could enhance future diagnostic tools.

Yes, if you are currently taking medications that may affect urological functions, such as diuretics, anticholinergics, or alpha-blockers, you would not be eligible to participate in this trial.

Research has shown that the Glean Urodynamics System is safe for people. In earlier studies, participants tolerated the system well, meaning it effectively studied urine flow without causing major problems. Of the 14 reported side effects, only 7 were directly related to the system, indicating general safety. Additionally, the FDA has approved the system for use in adults with urinary tract issues, further supporting its safety.¹²³⁴⁵

The Glean Urodynamics System is unique because it offers a comprehensive approach to assessing urinary function with cutting-edge technology. Unlike traditional methods, which typically rely on separate devices and manual interpretations, this system integrates a bladder pressure sensor, an abdominal pressure sensor, and an in-clinic uroflowmeter, all supported by advanced software apps. This integration allows for more accurate and real-time monitoring, potentially leading to better diagnosis and management of urinary issues. Researchers are excited because this system could provide more precise data and improve patient outcomes by streamlining the process and enhancing the accuracy of urodynamic assessments.

Research has shown that the Glean Urodynamics System, used by participants in this trial, effectively assesses bladder function. Studies have found it outperforms traditional systems, such as the Laborie Goby™. The system boasts a positive satisfaction score of 22.6, surpassing the negative scores of older methods. Patients report greater comfort with the Glean system due to its wireless design and catheter-free operation. Additionally, it has proven safe and does not impact normal bladder function. These findings suggest the system reliably examines bladder health.¹⁶⁷⁸⁹