title: First clinical evaluation of a new single-use flexible cystoscope dedicated to double-J stent removal (Isiris™): a European prospective multicenter study.
abstract: OBJECTIVE
  We evaluated a new single-use digital flexible cystoscope with an integrated grasper designed for double-J stent removal, Isiris™, addressing success rate, image quality, deflection, maneuverability and grasper functionality.
  
  
  METHODS
  In September 2015, a prospective cohort study was conducted in six tertiary European reference centers. All consecutive patients included underwent double-J stent removal and were 18 years or older. Success rate was defined by complete stent removal. Image quality, deflection, maneuverability and grasper functionality were rated with a Likert scale.
  
  
  RESULTS
  A total of 83 procedures were performed. 82% of procedures were performed in the endoscopy room, while the others were in the operating room since a consecutive endourological intervention was planned. The median duration of stent implantation was 28 days [14; 60]. In five patients, stent removal was not possible. Four patients had an incrusted double-J stent, and in one patient, the stent migrated into the ureter. After unsuccessful attempts of stent removal with conventional flexible cystoscope and grasper, the five patients had to be scheduled for an ureterorenoscopy procedure to remove the stent. In the other 78 patients, all double-J stents were removed successfully. Image quality, deflection, maneuverability and grasper functionality were rated as "very good" in 72.3, 78.3, 72.3 and 73.5%, respectively.
  
  
  CONCLUSIONS
  This multicenter clinical evaluation of Isiris™ displayed good image quality, active deflection, maneuverability and grasper functionality. Further evaluation of stent removal outcomes, cost analysis and microbiology will help to delineate the possible place of Isiris™ in the current practice.
authors.affiliation: Department of Urology, Tenon Hospital, Assistance-Publique Hôpitaux de Paris, 4 rue de la Chine, 75020, Paris, France.|Pierre et Marie Curie University, Paris, France.|Sorbonne Universités, UPMC Univ Paris 06, AP-HP, GRC n°20, Groupe de Recherche Clinique sur la Lithiase Urinaire, Hôpital Tenon, 4 rue de la Chine, 75020, Paris, France.
authors.forename: Steeve
authors.initials: S
authors.lastname: Doizi
authors.affiliation: Department of Urology, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Guido
authors.initials: G
authors.lastname: Kamphuis
authors.affiliation: Department of Urology, IRCCS San Raffaele Scientific Institute, Ville Turro Division, Milan, Italy.
authors.forename: Guido
authors.initials: G
authors.lastname: Giusti
authors.affiliation: Department of Urology, Hospital Universitario La Ribera, Alzira, Valencia, Spain.
authors.forename: J L
authors.initials: JL
authors.lastname: Palmero
authors.affiliation: Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
authors.forename: J M
authors.initials: JM
authors.lastname: Patterson
authors.affiliation: Department of Urology, IRCCS San Raffaele Scientific Institute, Ville Turro Division, Milan, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Proietti
authors.affiliation: Department of Urology, Technische Universität München, Munich, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Straub
authors.affiliation: Department of Urology, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Jean
authors.initials: J
authors.lastname: de la Rosette
authors.affiliation: Department of Urology, Tenon Hospital, Assistance-Publique Hôpitaux de Paris, 4 rue de la Chine, 75020, Paris, France. olivier.traxer@aphp.fr.|Pierre et Marie Curie University, Paris, France. olivier.traxer@aphp.fr.|Sorbonne Universités, UPMC Univ Paris 06, AP-HP, GRC n°20, Groupe de Recherche Clinique sur la Lithiase Urinaire, Hôpital Tenon, 4 rue de la Chine, 75020, Paris, France. olivier.traxer@aphp.fr.
authors.forename: Olivier
authors.initials: O
authors.lastname: Traxer
mesh_terms: D015331:Cohort Studies; D020684:Cystoscopes; D020878:Device Removal / Q000295:instrumentation*; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D015607:Stents; D014513:Ureter
keywords: Cystoscopy; Device removal; Double-J stent; Stents; Ureteral stent