To evaluate the preclinical and clinical performance of a pivoting lens rigid endoscope Endocameleon®, (ECAM) in white light cystoscopy (WLC).
Preclinical evaluation was performed ex vivo in CT-based, anatomically correct and validated bladder phantoms. Six defined tasks with objective endpoints were compared between ECAM-WLC and rigid WLC (30° view angle, rWLC) in 30 interventions. Subsequently, the comparison was transferred in vivo in n=21 interventions. A validated usability score (SUS) as well as physician and patient-related outcomes were assessed using Likert-scale based questionnaires. Intra- and postinterventional complications were recorded according to the Clavien-Dindo classification.
The ex vivo evaluation showed a significant superiority of ECAM-WLC in 4/6 endoscopic tasks. Noteworthy is the lower pressure on the bladder neck due to the alteration of the endoscope (4/60 vs. 17/60, p<0.0001) and a more precise imaging of all bladder regions (22/30 vs. 30/30, p=0.046), including the anterior wall (0/30 vs. 28/30, p< 0.0001). In vivo, surgeons rated the ECAM-WLC with an "excellent" SUS of 86.79%, also expressing that ECAM-WLC would enhance bladder surface visualization (4.52/5.0 ± 0.51), with a preferred use for ECAM-WLC during their next cystoscopy (4.62 ± 0.50). Patients reported ECAM-WLC to be less painful (4.5/5.0 ± 0.84) compared to rWLC. No intervention-related complications were observed.
ECAM-WLC is a safe and accessible procedure that could improve conventional diagnostic WLC by combination of the advantages of fWLC and rWLC.
Urology. 2020 May 07 [Epub ahead of print]
Frank Waldbillig, Lennard von Rohr, Malin Nientiedt, Britta Witte, Simon Hein, Rodrigo Suarez-Ibarrola, Arkadiusz Miernik, Christian Gratzke, Manuel Ritter, Maximilian C Kriegmair
Department of Urology, University Medical Center Mannheim, University of Heidelberg, Mannheim, Germany; RaVeNNA 4pi - Consortium of the German Federal Ministry of Education and Research (BMBF). Electronic address: ., Department of Urology, University Medical Center Mannheim, University of Heidelberg, Mannheim, Germany., Department of Urology, University Medical Center Mannheim, University of Heidelberg, Mannheim, Germany; RaVeNNA 4pi - Consortium of the German Federal Ministry of Education and Research (BMBF)., RaVeNNA 4pi - Consortium of the German Federal Ministry of Education and Research (BMBF); Department of Urology, Faculty of Medicine, University of Freiburg - Medical Centre, Freiburg, Germany., Department of Urology, Faculty of Medicine, University of Freiburg - Medical Centre, Freiburg, Germany., RaVeNNA 4pi - Consortium of the German Federal Ministry of Education and Research (BMBF); Department of Urology and Pediatric Urology, University Medical Center Bonn, University of Bonn, Bonn, Germany.