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JU INSIGHT First in Human Testing of UroMonitor: Catheter-free Wireless Ambulatory Bladder Pressure Monitor

By: Brendan T. Frainey, MD, Cleveland Clinic, Ohio; Steve J. A. Majerus, PhD, Louis Stokes VA Medical Center, Cleveland, Ohio; Cleveland Clinic, Ohio; Samir Derisavifard, MD, Cleveland Clinic, Ohio; Kevin C. Lewis, MD, Cleveland Clinic, Ohio; Anna R. Williams, RN, Cleveland Clinic, Ohio; Brian M. Balog, PhD, Cleveland Clinic, Ohio; Robert S. Butler, MS, Cleveland Clinic, Ohio; Howard B. Goldman, MD, Cleveland Clinic, Ohio; Margot S. Damaser, PhD, Cleveland Clinic, Ohio, Louis Stokes VA Medical Center, Cleveland, Ohio | Posted on: 20 Jul 2023

Frainey BT, Majerus SJA, Derisavifard S, et al. First in human subjects testing of the UroMonitor: a catheter-free wireless ambulatory bladder pressure monitor. J Urol. 2023;210(1):186-195.

Study Need and Importance

Urodynamics is the standard method of diagnosing bladder dysfunction, but involves catheters and retrograde bladder filling. With these artificial conditions, urodynamics cannot always reproduce patient complaints. We have developed a wireless, catheter-free intravesical pressure sensor, the UroMonitor, which enables catheter-free telemetric ambulatory bladder monitoring (see Figure). The purpose of this study was to evaluate accuracy of UroMonitor pressure data and assess safety and feasibility of use in humans.

Figure. A, UroMonitor schematic with key components identified. B, Insertable UroMonitor device.

What We Found

With short-term use in 11 women undergoing urodynamics for suspected overactive bladder, we found that the UroMonitor did not significantly alter capacity, sensation, or flow during urodynamics. The UroMonitor was also easily inserted and removed in all subjects. The UroMonitor successfully captured 98% (85/87) of voiding and nonvoiding urodynamic events. All subjects voided with low post-void residual volume with the UroMonitor in place. Median ambulatory pain score with the UroMonitor was rated 0 (0-2). There were no post-procedural infections or changes to voiding behavior.

Limitations

This was a feasibility study designed to assess safety and accuracy while minimizing risk to human subjects. The study was not designed or powered to demonstrate superiority of the UroMonitor over urodynamics in terms of diagnostic capability. The UroMonitor in this current early prototype stage measures pressure only and does not include bladder volume or other diagnostic measures. Future versions will be designed to expand the scope of measured and transmitted parameters.

Interpretation for Patient Care

Current urodynamics methodologies have limitations including catheters and nonphysiological filling. This is the first report of measurement of catheter-free wireless bladder pressure data during ambulation and voiding in human subjects. Longer monitoring times in a patient’s home have the potential to revolutionize our understanding of lower urinary tract function and could provide a more accurate, less distressing method of diagnosing lower urinary tract dysfunction.

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