Feasibility and Safety of Primary Ureteroscopy with Single-Use Flexible Ureteroscope HU30M (6.3 Fr, HugeMed): An Initial Experience.

Abstract

Background: The miniaturization of ureterorenoscopes increasingly enables atraumatic primary ureteroscopy, without ureteral dilation or presenting. This study aims to evaluate the feasibility and safety of primary ureteroscopy using the HU30M (6.3 Fr, HugeMed, Shenzhen HugeMed Medical Technical Development Co., Ltd., Shenzhen, China), the smallest currently available ureteroscope. Methods: We analyzed consecutive patients in whom primary ureteroscopy using the HU30M was performed or attempted, using prospectively collected in-hospital and 30-day follow-up data for retrospective evaluation. The primary outcome was the success rate of primary ostial intubation. Secondary outcomes included the stone-free rate (SFR) in patients with urolithiasis, incidence of in-hospital complications (Clavien-Dindo classification) and 30-day emergency readmission. Additionally, we conducted a propensity score-matched comparative analysis of the HU30M versus a contemporary 7.5 Fr digital single-use ureteroscope (PUSEN PU3033AH, Zhuhai Pusen Medical Technology Co., Ltd., Jinhua, China). Results: Between January and April 2025, primary ureteroscopy using the HU30M was performed or attempted in 34 patients, including four bilateral procedures. Primary ureteroscopy was defined as ureteroscopic access without prior stenting or dilation. Indications were diagnostic evaluation in 15 patients (44%), uretreroscopic stone treatment in 10 patients (29%) and endoscopic combined intrarenal surgery (ECIRS) in 9 patients (27%). Successful primary ostial intubation was achieved in 36 of 38 renal units (95%). Among urolithiasis cases, SFR was 17/19 (90%) in-hospital complications were limited to postoperative fever in two patients (6%) and no procedure-related 30-day emergency readmission occurred. In matched analyses, HU30M demonstrated significantly shorter operative times compared with the 7.5 Fr ureteroscope, while postoperative hemoglobin drop, inflammatory parameters and renal function were comparable. Conclusions: Primary ureteroscopy with HU30M is feasible and safe across diverse indications, achieving high success of atraumatic ostial access. Comparative analyses suggest procedural efficiency advantages and overall safety comparable to the current digital single-use ureteroscope standard.