First clinical evaluation of a flexible digital ureteroscope with direct in scope suctioning system (Pusen DISS 7.5Ch): prospective multicentric feasibility study.

ABSTRACT

PURPOSE: A new digital single-use flexible ureteroscope, Pusen direct in scope suction (DISS) 7.5Fr (PU3033AH), was evaluated with respect to manoeuvrability, suction quality, visibility and clinical efficiency. METHODS: A prospective cohort study was conducted in six tertiary reference centers in Europe and Asia between February-April 2024. Adult patients who underwent flexible ureteroscopy and laser lithotripsy (fURSL) for urolithiasis were included. Demographic, intraoperative and follow-up characteristics were recorded. Quality parameters were rated by each surgeon using a Likert scale. RESULTS: a total of 57 fURSL were performed. Preoperative characteristics revealed a mean stone volume of 480.00mm3 (mean Hounsfield Unit- 998). 57.9%(n = 33) of the patients were pre-stented, and a ureteric access sheath was used in 64.9%(n = 37). Integrated-suction was deemed helpful in 94.7%(n = 54) fURSL as reported by the operators. An initial stone free rate (SFR) confirmed by postoperative imaging was achieved in 84.21%(n = 48). Quality parameters of the scope reached a mean Likert score of 4.5, with a "very good" mean evaluation for "scope placement", "visual quality", "irrigation", "deflection", "manoeuvrability", and "weight". "Suction quality" and "overall performance satisfaction" were rated "good". Comparing the Pusen DISS scope with other previously used scopes, overall satisfaction was rated 4.1. When asked if the surgeons would be willing to use the Pusen DISS 7.5Fr scope in the future, all the six surgeons answered positively. CONCLUSION: The DISS 7.5 Pusen ureteroscope displayed good visibility, manoeuvrability and suction quality, with excellent operative results. Further evaluation with larger comparative cohorts will help understand the potential of in-vivo use of integrated suctioning systems for fURSL.