Introduction: We assessed the clinical performance of a new digital single-use flexible ureteroscope (UscopePU3022).
Material and methods: A prospective cohort study was carried out across 11 centers (July-Oct. 2017). The UscopePU3022 was assessed regarding ease of insertion; deflection, image quality, maneuverability and overall performance using either a visual analog* or Likert scale.
Results: A total of 56 procedures were performed in 11 centers (16 surgeons) with the indication being renal stones in 83%. The median score for ease of scope insertion was 10 (3-10). Intraoperative maneuverability was rated as 'good' in 38% and 'very good' in 52%. Visual quality was rated as 'poor or bad' in 18%, 'fair' in 37% and 'good or very good' in 43%. Two scopes failed intraoperatively (4%). Preoperative and postoperative median upward and downward deflection was 270 degrees. Compared to standard flexible ureteroscopy (f-URS) maneuverability was rated as 'equivalent' in 30% and 'better' in 60%; visual quality was 'worse' in 38% and 'equivalent or better' in 62%; limb fatigue scores were 'better' in 86%; and overall performance was 'worse' in 55% and 'equivalent or better' in 45%.
Conclusions: UscopeTM3022 performed well with regards to maneuverability, deflection and limb fatigue and appears to be at least non-inferior to standard f-URS with regards to these parameters. Poor image quality is a concern for UscopePU3022 with it receiving a low overall performance rating when compared to standard f-URS. Despite this it scored highly when investigators were asked if they would use it in their practice if it was cost-effective to do so.
Keywords: digital; disposable; flexible ureteroscope; single-use.