S485 Qualitative Comparison of Air-Charged and Solid-State HRAM Catheter Normative Values in Healthy Subjects

Introduction: While high-resolution anorectal manometry (HRAM) is essential for evaluating anorectal function, absolute pressure values can vary substantially depending on the catheter type. Air-charged and solid-state catheters differ in construction, transduction mechanism, and calibration method—each influencing recorded values. This variability necessitates catheter-specific interpretation. As a secondary objective of the ILLUMINATE study, we compared normative data from a novel 10-Channel Air-Charged Disposable HRAM Catheter (Solar catheter) to published values from solid-state systems to assess qualitative agreement and highlight device-specific considerations. Methods: The ILLUMINATE study was a prospective, multi-center, open-label trial wherein all subjects underwent standardized HRAM using a novel 10-channel air-charged disposable HRAM catheter per International Anorectal Physiology Working Group protocol and London Classification, and a subset also underwent testing with the solid-state (UniTip) catheter (n = 30). Parameters collected included: anal resting pressure, squeeze pressure, cough pressure, and functional anal canal length. Values were descriptively compared to published normative datasets from solid-state catheter systems. Results: There were 30 subjects (3 men, 37 women; mean age = 39 ± 9 years) who underwent both novel 10-channel air-charged disposable catheter and solid-state catheter ARM studies. Anal resting pressures recorded with the air-charged catheter were approximately equivalent to solid-state reference values. Functional anal canal length measurements were consistent across technologies as well. Conclusion: Minor differences were observed between air-charged and solid-state HRAM catheters, but in general physiologic trends were preserved across systems. These findings underscore the importance of using catheter-specific normative values when interpreting HRAM results and reinforce that direct numeric comparison between devices may not be valid. The novel 10-Channel Air-Charged Disposable HRAM catheter demonstrated consistent performance and clinical utility within its calibrated reference range.