Evaluation of Performance Parameters of the Disposable Flexible Ureterorenoscope (LITHOVUE) in Patients with Renal Stones: A Prospective, Observational, Single-arm, Multicenter Study

Abstract

We investigated performance parameters of disposable flexible ureterorenoscopy (LITHOVUE) in patients with renal stones in a prospective, multicenter, observational study. Sixty two patients who underwent ureterorenoscopic surgery by LITHOVUE were included. Surgeons using a numerical scale, evaluated the maneuverability of the scopes and general perceptions of visibility related to the monitor and irrigation systems. General pain and fatigue scores were evaluated and compared to existing scopes. Mean patient age was 57.3 years and stone size was 15.4 mm. Clinical success of overall stone removal was 82.3%. Complications occurred in 4 cases of the Clavien classification grade I in a single case and II in 3 cases. Comparative parameters of maneuverability, perception of the monitor system and perception of the irrigation channel were 2.5, 2.5, and 3.0, respectively. The most favorable evaluation of physical strain was about 'shoulder fatigue' and 'hand fatigue'. Unfavorable evaluations were recorded for 'wrist stiffness' and 'thumb fatigue'. Maximal deflection angles of 270° were preserved in 53 cases (85.5%). No pre-stenting procedure and the longer operative time were significant predictors of poorly-preserved deflection angles <270°. LITHOVUE showed good maneuverability and perception scores for the monitor and irrigation systems. LITHOVUE received favorable evaluations on pain and fatigue scores.