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

Area of Science:

• Urology
• Endoscopic Surgery
• Medical Device Classification

Background:

• Rapid advancements in endoscopic and laser bladder interventions necessitate standardized classification of iatrogenic bladder injuries.
• Existing methods lack uniformity in grading injury severity and guiding management during procedures.

Purpose of the Study:

• To develop and validate the Bladder Injury Classification System for Endoscopic Procedures (BICEP).
• To establish a standardized system for classifying bladder injuries and intervention requirements during endoscopic procedures.

Main Methods:

• A mixed-methods approach involving European Association of Urology experts.
• Iterative refinement through focus groups, expert surveys, and revisions.
• Face and content validity assessed via two-round expert surveys using a 5-point Likert scale.

Main Results:

• The BICEP system categorizes injuries into ten subcategories (scores 0-4) based on severity and management needs.
• Achieved 95% consensus for face validity (clarity, relevance, comprehensiveness).
• Demonstrated strong content validity with high expert acceptance (average scores 4.53 and 4.58).

Conclusions:

• The BICEP system is a robust, comprehensive classification with strong expert-validated face and content validity.
• It provides a standardized basis for classifying and treating bladder injuries in endoscopic urology.
• Further external validation is recommended for widespread adoption and efficacy.