Evaluation of a new disposable flexible ureterorenoscope and comparison to an established disposable flexible ureterorenoscope: a prospective, observational study

Purpose To objectively and subjectively assess the performance and surgical outcomes of the new Innovex EU-scope™ single-use digital flexible ureteroscope (fURS). Methods A prospective cohort study was carried out (August 2019 to May 2020). The new single-use fURS (Innovex Medical Devices Co. Shanghai, China) was analysed with regard to visibility, manoeuvrability, laser interference and overall performance using a validated Likert scale. Outcomes are compared to the LithoVue™ (Boston Scientific, Marlborough, MA). Results One hundred patients were included in this study. 50 cases underwent retrograde fURS using the Innovex EU-scope™ and 50 with the LithoVue™. There were no differences in the patient demographics data, or operative data between the two groups. The Innovex EU-scope™ scored higher visibility scores compared to the LithoVue™, median 4, interquartile range (IQR) (4–4), vs. 3.5, IQR (3–5), p = 0.5086. Both scopes had similar manoeuvrability scores. The Innovex EU-scope™ scored significantly lower with regard to comfort compared to the LithoVue, median 4 IQR (3–4) vs. 4.5 IQR (4–5), p = 0.0445. Whereas, laser interference, affected the Innovex much less than the LithoVue™. Both scopes scored well for overall performance. The median overall performance score for the Innovex was 4 IQR (4–4) vs. 4 IQR (4–5). Conclusions This Innovex EU-scope™ has good objective and subjective visibility and manoeuvrability profiles. This single-use flexible ureteroscope may achieve similar clinical outcomes to an established single use instrument.