Preclinical Evaluation of the Safety of Robotic-Assisted Ureteroscopy and Guided Percutaneous Nephrolithotomy

Purpose: Robotic-assisted urologic stone removal and any potential histopathological effects of this approach have not been well studied. Here we assess safety and user experience of the novel MONARCH™ Platform, Urology, in performing both robotic-assisted ureteroscopy (URS) and percutaneous nephrolithotomy (PCNL) within a preclinical setting, alongside conventional devices. Materials and Methods: Two endourologists conducted six simulated robotic-assisted URS and six robotic-assisted PCNL in a porcine model, comparing these with conventional approaches. The primary objectives were (1) perceived ease of completion as rated by the endourologists using a numerical 1–4 rating scale; (2) occurrence of adverse safety events as determined by the operating endourologists; (3) assessment of contrast extravasation seen on post-operative retrograde pyelogram; and (4) histopathological evaluation of the porcine models’ urinary tracts. Mantel-Haenszel chi-square test was used, with p < 0.05 considered significant. Results: Tasks within URS and PCNL exhibited comparable ease of completion score means (median of all scores 4 in conventional URS and 4 in robot-assisted URS, p = 0.131; 3.17 in conventional PCNL and 4 in robot-assisted PCNL, p = 0.258). No safety events were observed by the endourologist during URS or PCNL procedures for either the robotic-assisted or conventional devices. In post-procedure pyelograms, none of the robotic-assisted cohort had more than minimal contrast extravasation, statistically similar to conventional devices (URS: median [range]; conventional, 0 [0–2] vs. robotic-assisted, 0 [0–1], p = 0.337; and PCNL: conventional, 0 [0–2] vs. robotic-assisted, 0 [0–1], p = 0.379). Blinded pathology assessment demonstrated no biologically significant nor clinically relevant differences between robotic-assisted and conventional devices in any category. Conclusions: This study demonstrates that the MONARCH™ Platform in Urology has a safety profile comparable with conventional devices and a trend of easier completion of some tasks. This foundational study establishes the feasibility of a single platform to complete both robotic-assisted URS and PCNL, as a new treatment paradigm for urologic stone management.