Preclinical and Clinical Evaluation of a Novel, Variable-View, Rigid Endoscope for Female Cystoscopy.

OBJECTIVE

To evaluate the preclinical and clinical performance of the pivoting lens rigid Endocameleon (ECAM) endoscope in white light cystoscopy (WLC).

MATERIALS AND

METHODS

Preclinical evaluation was performed ex vivo in CT-based, anatomically accurate 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 to in vivo n = 21 interventions. A validated usability score (System Usability Scale, 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.

RESULTS

The ex vivo evaluation showed a significant superiority of ECAM-WLC in 4 of 6 endoscopic tasks. Noteworthy is the lower pressure on the bladder neck due to the endoscopesalteration of the endoscope (4/60 vs 17/60, P <.0001) and a more precise imaging of all bladder regions (22/30 vs 30/30, P = .046), including the anterior wall (0/30 vs 28/30, P <.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.

CONCLUSION

ECAM-WLC is a safe and accessible procedure that could improve conventional diagnostic WLC by combination of the advantages of fWLC and rWLC.