We assessed the clinical performance of a new digital single-use flexible ureteroscope (UscopePU3022).
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.
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%.
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.
Central European journal of urology. 2018 Oct 02 [Epub]
Thomas James Johnston, Joyce Baard, Jean de la Rosette, Steeve Doizi, Guido Giusti, Thomas Knoll, Silvia Proietti, Marianne Brehmer, Esteban Emiliani, Daniel Pérez-Fentes, Palle Jorn Sloth Osther, Christian Seitz, Naomi Neal, Ben Turney, Mudhar Hasan, Olivier Traxer, Oliver Wiseman
Cambridge University Hospitals, Department of Urology, Cambridge, United Kingdom., AMC University Hospital, Department of Urology, Amsterdam, The Netherlands., Istanbul Medipol University, Department of Urology, Istanbul, Turkey., Orbonne Université, Groupe de Recherche Clinique sur la Lithiase Urinaire, Hôpital Tenon Paris, France., San Raffaele-Turro Hospital, Department of Urology, Milan, Italy., Sindelfingen-Boeblingen Medical Center, Department of Urology, University of Tuebingen, Germany., Danderyd University Hospital, Department of Surgery and Urology, Stockholm, Sweden., Fundació Puigvert, Endourology and Urolithiasis Unit, Department of Urology, Barcelona, Spain., Santiago de Compostela Hospital, Department of Urology, Santiago de Compostela, Spain., Lillebaelt Hospital, Department of Urology, Vejle, Denmark., Medical University of Vienna, Department Urology, Vienna, Austria., Oxford University Hospitals, Department of Urology, Oxford, United Kingdom.