Glean Urodynamics System for Bladder Dysfunction

(ALLURE Trial)

This trial tests a new system called the Glean Urodynamics System, which includes sensors and software to monitor the bladder and lower urinary tract. The goal is to assess the safety and effectiveness of this system for evaluating bladder function in a clinical setting. As a single-arm trial, all participants receive the same treatment. Suitable candidates for this trial are those who require bladder function testing but have no history of urinary tract infections or specific medical conditions affecting the bladder or lower urinary tract. As an unphased trial, this study provides a unique opportunity to contribute to innovative research and potentially enhance future bladder function testing.

The trial information does not specify whether you need to stop taking your current medications. However, if you have used antibiotics in the past 7 days, you may not be eligible to participate.

Research has shown that the Glean Urodynamics System is generally safe for people. One study found that this system, which assesses bladder function, is comfortable for patients. It employs a wireless method, eliminating the need for tube insertion, which reduces discomfort and risks compared to traditional methods.

Researchers are excited about the Glean Urodynamics System because it offers a fresh approach to diagnosing bladder dysfunction. Unlike traditional methods that often rely on separate devices and manual data interpretation, this system integrates a bladder pressure sensor, an abdominal pressure sensor, and a uroflowmeter, all managed by sophisticated software apps. This all-in-one solution aims to provide more accurate and comprehensive data, potentially leading to better personalized treatment plans for patients. By enhancing the precision and ease of diagnosing bladder issues, the Glean Urodynamics System could revolutionize the way clinicians understand and manage bladder dysfunction.

Studies have shown that the Glean Urodynamics System, used by participants in this trial, outperforms traditional catheter-based methods for assessing bladder function. This wireless, catheter-free system offers greater comfort for patients. Research indicates it provides a more accurate assessment of lower urinary tract function. It also minimizes common testing issues, such as discomfort and errors from rapid bladder filling. Overall, the Glean Urodynamics System appears promising for effective and patient-friendly bladder monitoring.⁶⁷⁸⁹¹⁰