Opinion
Video
Howard B. Goldman, MD, who was the first to use the device in a clinical setting, shares his initial thoughts on the technology and its role in real-world practice.
The Glean Urodynamics System received FDA 510(k) clearance in March 2025 for use in diagnosing lower urinary tract dysfunction (LUTD) in adult patients.1
In a recent interview with Urology Times®, Howard B. Goldman, MD, who was the first to use the device in a clinical setting,2 shares his initial thoughts on the technology and its role in real-world practice. Goldman is a professor of urology, the vice chairman of the department of urology, and the fellowship director in urogynecology and urogenital reconstruction at the Cleveland Clinic in Cleveland, Ohio.
According to Goldman, the device was easy to use and well-tolerated. He also noted that the data/workflows that were collected appeared similar to those seen with conventional urodynamics.
Goldman also shared the clinical situations where the Glean System may be preferred over the traditional approach.
“[This may be helpful for] places that have multiple offices and may only have 1 or 2 urodynamics machines, and you don't want to send patients across town. I think it's ideal in those situations,” Goldman explained. “I think it's also ideal in patients who may have some trouble emptying. These are the patients who, when you try to do conventional urodynamics and they're in a laboratory setting, they have a lot worse trouble urinating, and you may not get the information that you want.”
REFERENCES
1. Bright Uro receives FDA clearance for Glean Urodynamics System. News release. Bright Uro. April 2, 2025. Accessed July 18, 2025. https://www.businesswire.com/news/home/20250402777960/en/Bright-Uro-Receives-FDA-Clearance-for-Glean-Urodynamics-System
2. Cleveland Clinic is first to use wireless, catheter-free device to monitor bladder dysfunction in patients. News release. Cleveland Clinic. June 10, 2025. Accessed July 18, 2025. https://newsroom.clevelandclinic.org/2025/06/10/cleveland-clinic-is-first-to-use-wireless-catheter-free-device-to-monitor-bladder-dysfunction-in-patients
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