Published Feasibility Study Shows Glean™ Urodynamics System is Safe and Efficacious

100% of patients with Glean were able to void with the sensor indwelling.

IRVINE, Calif., May 15, 2025 /PRNewswire/ -- Bright Uro, a medical device company with a mission to transform care for lower urinary tract dysfunction (LUTD) through innovations in urodynamics, today announced that its recent feasibility study was published in the Journal of Endourology. Results showed that the Glean™ Urodynamics System is a safe, and well-tolerated device that enables ambulatory urodynamics without catheters impeding lower urinary tract function.

Urodynamics is used to diagnose lower urinary tract dysfunction; however, conventional urodynamics results often poorly correlate to patient symptoms because of the non-physiological nature of the test. The Glean Urodynamics System is the first and only FDA-cleared, wireless, catheter-free ambulatory urodynamics system that allows clinicians to study lower urinary tract dysfunction in a more physiological manner.

The objective of the Modern Urodynamics System Efficacy (MUSE) study was to evaluate the feasibility, safety and efficacy of the Glean Urodynamics System for use in the clinic setting.

MUSE was a prospective, single-arm, multicenter interventional trial that enrolled adults with lower urinary tract dysfunction. Participants underwent conventional urodynamics per standard of care followed by ambulatory urodynamics using the intravesical Glean bladder sensor.

The Glean sensor was successfully inserted in 32 patients. The median sensor insertion time was 34 seconds and median sensor removal time was 6 seconds. The Glean Urodynamics System, placed in the bladder, recorded vesical pressure, and all 32 participants were able to void with the sensor indwelling. Overall participant feedback on the Glean Urodynamics System was positive, and clinicians reported it was easy to use. Eighty-one percent of insertions were rated by clinicians as easy or very easy while 97% removals were rated as easy or very easy.

There were no serious adverse events in the study. All adverse events were commonly associated with urodynamics and self-resolved within days after the procedure.

"The fact that all 32 patients were able to void with Glean in place was groundbreaking. With conventional urodynamics, at least a quarter of the patients in my practice are unable to void due to the catheter in place. I'm confident I will get quality uroflow data with Glean," said Dr. Keith Xavier of Urology Partners of North Texas.

"Glean has been a game-changer in our approach to urodynamic testing," said Dr. Jason Kim of Stony Brook Medicine. "It's remarkably easy to place and remove, and I felt fully confident with the system after just a few cases. Traditional urodynamics has been limited to only two of our ten practice locations due to the high capital costs and resource-intensive setup. As a result, wait times are long and many patients simply give up before getting tested. With Glean, we have an opportunity to dramatically expand access to this essential diagnostic tool by offering it across all ten of our sites—bringing testing closer to patients and streamlining care."

"The level of enthusiasm surrounding the Glean technology has been truly remarkable! Results from the MUSE study exceeded expectations and we are excited that the results have been accepted in such a renowned peer-reviewed journal. We look forward to sharing more results from ongoing clinical trials as we continue to build a strong foundation of evidence while creating the future of urodynamic monitoring," added Derek Herrera, Founder and CEO of Bright Uro.

About Glean

The Glean™ Urodynamics System is a urodynamic analyzer system that is intended to quantify the pressure and flow characteristics of the lower urinary tract. The system can be used in adult patients to perform standard urodynamic tests such as uroflow, cystometrogram, urethral pressure profile, and micturition studies. The major application of urodynamics is the diagnosis of uncontrolled loss of urine (incontinence), abnormal urinary retention, or neurological cases of micturition disorder. The device is intended to be used as medical diagnostic equipment.

About Bright Uro

Based in Irvine, Calif., Bright Uro's mission is to transform care of lower urinary tract dysfunction (LUTD) with its innovative technology that is poised to disrupt outdated urodynamics approaches. The Company's FDA-cleared Glean™ Urodynamics System is designed to enable wireless, catheter-free ambulatory urodynamics monitoring, with the goal of improving patient comfort and clinical outcomes. For more information, visit www.GleanUDS.com.

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SOURCE Bright Uro