#United States #Irvine #Bright Uro #Glean Urodynamics #Lower Urinary Tract

Transforming Urodynamics with Glean™

Bright Uro, a pioneering medical device company, recently unveiled remarkable findings from its latest feasibility study concerning the Glean™ Urodynamics System. Published in the esteemed Journal of Endourology, the research demonstrates that the Glean system is both safe and highly effective for diagnosing lower urinary tract dysfunction (LUTD). This innovative, catheter-free technology enables an ambulatory approach to urodynamics, overcoming limitations associated with traditional methods.

A Breakthrough in Urodynamics

The purpose of urodynamics is to evaluate the function of the lower urinary tract. However, conventional methods often yield results that poorly correlate with patient symptoms, primarily due to their non-physiological nature. This limitation has propelled the need for a more patient-centered approach, which is precisely what the Glean Urodynamics System offers.

The system is unique as the first FDA-cleared wireless device designed to function without catheters, facilitating a more natural and effective assessment of LUTD. The prospective multicenter trial known as the Modern Urodynamics System Efficacy (MUSE) study aimed to evaluate the Glean system's feasibility and safety in clinical practice, involving adults diagnosed with LUTD.

Study Insights

A total of 32 participants underwent conventional urodynamic tests followed by assessments using the Glean bladder sensor. The insertion of the Glean device into the bladder took a median of just 34 seconds, with subsequent removal occurring in a swift 6 seconds. Impressively, every participant was able to void while the sensor remained in place—a groundbreaking achievement in urodynamics. Participants reflected positively on their experiences with Glean, and clinicians reported high usability, with 81% rating the insertions as easy or very easy and 97% giving similar feedback for removals.

The study recorded no serious adverse events, with all self-reported issues resolving swiftly within days.

Dr. Keith Xavier from Urology Partners of North Texas emphasized the significance of these results, stating, "Achieving a 100% success rate in voiding with Glean in place is revolutionary. Traditional methods often see a quarter of patients unable to void due to catheter constraints, so this advancement promises quality uroflow data."

Expanding Access

Dr. Jason Kim of Stony Brook Medicine echoed these sentiments, explaining how Glean is transforming urodynamic testing. He pointed out that traditional systems incurred high costs, limiting their availability to only two out of ten practice locations. With Glean, however, the opportunity to deploy this critical diagnostic tool across all sites presents an exciting prospect for improving patient access and care efficiency.

Optimism for Future Research

Derek Herrera, Founder and CEO of Bright Uro, expressed his excitement regarding the enthusiasm surrounding Glean technology: "The MUSE study results surpassed our expectations. Being accepted into a renowned journal highlights the potential for Glean to fundamentally change urodynamic monitoring. We are committed to establishing a robust foundation of evidence from ongoing clinical trials."

About the Glean™ Urodynamics System

The Glean Urodynamics System is designed to assess the pressure and flow characteristics of the lower urinary tract, making it suitable for various diagnostic studies, including uroflowmetry and cystometry. Its primary use involves diagnosing conditions such as incontinence and urinary retention, making it a crucial tool in the realm of urology.

About Bright Uro

Operating out of Irvine, California, Bright Uro is on a mission to revolutionize the management of LUTD through innovative technology. The Glean Urodynamics System is central to this vision, seeking to enhance patient comfort while improving clinical outcomes via wireless and catheter-free monitoring. For further details on Glean and its applications, visit www.GleanUDS.com.