Urodynamics with MEMS-Based pressure sensors, a clinical validation

Cystometry is a urodynamic investigation used to examine the pressure-volume relationship during bladder filling. In clinical practice, cystometry is typically performed with water or air-filled catheters connected to an external transducer. These catheters, which are primarily suited for short-duration measurements, can compromise pressure transmission due to air bubbles, clogging, bending, and movements, and they are not sensitive enough to rapid pressure fluctuations. Moreover, ensuring proper leveling of the transducer is crucial for accurate measurement. To overcome these limitations, a MEMS pressure sensor prototype was previously developed. This study now evaluates the concurrent validity and reliability of this prototype against a conventional cystometry system during a series of clinical cases involving 33 patients undergoing routine cystometry. Excluding three sensors for which a correct placement during cystometry could not be verified, 83.3% of sensors produced useful data. Among these, 88% demonstrated a strong correlation with the reference system in the time-amplitude domain and 72% exhibited a high correlation in the time-frequency domain. Although these sensors were manually assembled and did not go through a standardized manufacturing process to enhance stability and detect potential failures, over 78.8% of the 33 sensors tested remained functional after the trial. Therefore, these results support the adoption of this technology in clinical practice, as it may improve diagnostic efficiency, reduce patient discomfort, and potentially be used for long-term and ambulatory urodynamics.