The Feasibility and Safety of the Glean Urodynamics System: The Modern Urodynamics System Efficacy Study.

Abstract

Purpose: Urodynamics is used to diagnose lower urinary tract dysfunction; however, conventional urodynamics results often poorly correlate to patient symptoms because of the nonphysiological nature of the test. The Glean^TM Urodynamics System is a novel, wireless, catheter-free ambulatory urodynamics system that allows clinicians to study lower urinary tract dysfunction in a more physiological manner. The objective of this study was to evaluate the feasibility, efficacy, and safety of the Glean Urodynamics System for use in clinic. Materials and Methods: This prospective, single-arm, multicenter interventional trial 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. After the removal of the Glean sensor, participants completed comfort and preference questionnaires. Participants were followed up within 7-14 days to assess the incidence of adverse events. Results: Thirty-eight participants were enrolled. Glean sensor insertion was attempted in 33 participants and successful in 32 (97.0%). The median sensor insertion time was 33.62 seconds (range: 12.32-256). The Glean Urodynamics System recorded vesical pressure, and all 32 participants were able to void with the sensor indwelling. Median sensor removal time was 5.71 seconds (range: 0.79-22.15). There were 14 adverse events in 12 participants, of which 7 events (in 7 participants) were attributed to the Glean Urodynamics System. There were no serious adverse events. Overall participant feedback on the Glean Urodynamics System was positive, and clinicians reported it was easy to use. Conclusions: The Glean Urodynamics System is a feasible, efficacious, safe, and well-tolerated device that enables ambulatory urodynamics with physiological bladder filling and without catheters impeding lower urinary tract function.