Wireless, Catheter-Free Device Accurately Monitors Bladder Dysfunction

An estimated 80 million Americans suffer from voiding dysfunction, including overactive bladder, urinary incontinence, enlarged prostate, and neurogenic bladder. Conventional urodynamic assessments (tests that demonstrate how well the bladder, sphincters, and urethra hold and release urine to determine the source of leaks or blockages) have several limitations. Catheter-based testing can be painful and embarrassing because patients must force urination in an office setting to replicate the symptoms they experience in their daily lives. Because of the artificial conditions and a catheter obstructing the urethra, the simulation is not always a physiologic reflection of patients’ experiences and often generates inaccurate data. Now, a novel solution that eliminates the need for a catheter offers streamlined testing that is easier for clinicians to use, delivers more accurate data, and offers a more comfortable experience for the patient.

Bright Uro’s (Irvine, CA, USA) Glean Urodynamics System is a wireless, catheter-free method of urodynamic monitoring based on foundational technology created at the Cleveland Clinic (Cleveland, OH, USA). The Glean bladder sensor consists of a silicone tube that houses the pressure-sensing technology and curls into a coil shape upon insertion to remain within the bladder. The device may utilize natural physiology to fill the bladder while gathering diagnostic data. By enabling monitoring of the bladder without a catheter in place, this technology can offer a more accurate and patient-centered approach to diagnosing lower urinary tract dysfunction, which can also increase treatment rates.

Glean can be performed in any clinic, any exam room. Patients do not need to wait weeks or drive long distances to get tested, enabling them to move to treatment more efficiently. Studies have shown a failure to reproduce symptoms in up to 46% of patients during conventional UDS. Glean's minimally invasive design enhances detection and enables more reliable assessments. Published data in The Journal of Urology in July 2023 confirmed the device's safety while demonstrating that it did not impede lower urinary tract function and could reliably identify bladder events when compared to conventional urodynamics. Cleveland Clinic is the first to use the Glean Urodynamics System, following 510(k) clearance from the U.S. Food and Drug Administration in March.

“We are so excited to bring this important innovation into clinical practice where it will help clinicians and patients across the US,” said Derek Herrera, CEO of Bright Uro. “The level of enthusiasm is truly remarkable, as we hear from so many clinicians who believe Glean will transform how we diagnose bladder dysfunction. It’s especially meaningful that the first commercial case is taking place at the Cleveland Clinic, where this concept originated. We’re deeply grateful to all the researchers and clinical teams who worked tirelessly to lay the foundation for us to transform the field.”

Related Links:
Bright Uro 
Cleveland Clinic