Comparative Pressure Measurement Performance of the Glean Urodynamics System-a Novel Wireless and Catheter-Free...

The Glean^® Urodynamics System was developed to enable catheter-free, wireless assessment of lower urinary tract function for use in ambulatory urodynamic testing. This study assesses the performance of the Glean Urodynamics System relative to the Laborie Goby™ conventional urodynamics (UDS) system using a human bladder model.

Thirty Glean intravesical pressure sensors and 30 air-charged catheters were compared relative to a reference sensor. Three pressure simulations were conducted in the bench-top human bladder model (stepped, sinusoidal, and ramping) on each test device to evaluate rise and fall times, bandwidth, maximum error (accuracy), and linearity. Data are presented as means and standard deviations and compared using independent sample t-tests.

The Glean intravesical pressure sensors showed significantly faster rise time (0.104 seconds) and fall time (0.111 seconds) than the comparator (0.172 and 0.264 seconds, respectively; both, p < 0.001 between groups). The bandwidth of the Glean sensors more closely matched the tested maximum frequency of 5 Hertz (Hz) compared with the comparator (4.978 Hz vs 2.250 Hz; p < 0.001). The maximum error was significantly lower with the Glean sensors than the comparator (6.882 vs 21.549; p < 0.001). Linearity showed that both behaved linearly; however, the Glean sensors performed significantly better (p < 0.001 between groups).

Comparative testing demonstrated equivalent or better performance of the Glean Urodynamics System's intravesical pressure sensors relative to a conventional UDS system's air-charged catheters, including greater bandwidth, increased dynamic response, and reduced maximum error. These results support the superior performance of the Glean Urodynamics System for urodynamic monitoring over a conventional catheter-based UDS system.