Development of a Bladder Injury Classification System for Endoscopic Procedures: A Mixed-methods Study Involving Expert Consensus and Validation.

Background and objective: The widespread adoption and rapid integration of new technologies and techniques in endoscopic and laser bladder interventions, particularly endoscopic enucleation, have led to new types of bladder injuries. This underscores the need for an intraoperative injury classification system. This study aims to develop and validate the Bladder Injury Classification System for Endoscopic Procedures (BICEP), which standardizes the classification of complications and intervention requirements.

Methods: This mixed-methods study involved experts from the European Association of Urology Section of Urotechnology to standardize and validate the BICEP classification system. An iterative process involving focus groups, expert surveys, and revisions assessed clarity, relevance, comprehensiveness, and practicality. Validity was confirmed through expert surveys conducted in two rounds for face and content validity, using a 5-point Likert scale to correlate ratings with expected outcomes.

Key findings and limitations: The novel BICEP classification system categorizes bladder injuries into ten subcategories with scores ranging from 0 to 4, reflecting injury severity and management requirements. Face validity was demonstrated by a 95% consensus on the system's clarity, relevance, and comprehensiveness. Content validity was supported by high acceptance rates in expert surveys, with average scores of 4.53 and 4.58 in the first and second rounds, respectively. This demonstrates strong support for its applicability in clinical practice. However, the primary limitation is the lack of external validation.

Conclusions and clinical implications: Our study demonstrates that the BICEP system is a robust and comprehensive classification system, with strong support for its face and content validity. The BICEP system is a proposal based on expert opinion, and additional studies are necessary to ensure its widespread adoption and efficacy.

Patient summary: Our study addressed the critical need for standardized classification in the increasingly widespread context of urology endoscopic technologies by focusing on intraoperative evaluation, reporting, and standardization of bladder injuries. This study provides a globally standardized basis for the classification and treatment of bladder injuries in urology endoscopic procedures.