NCT06469125

Anatomic Endoscopic Prostate Enucleation and BICEP Classification

Multicentric Prospective Evaluation of Bladder Injuries During Morcellation Using BICEP (Bladder Injury Classification During Endoscopic Procedures)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 250 (actual)
• Sponsor: Necmettin Erbakan University · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

The Bladder Injury Classification System for Endoscopic Procedure (BICEP) is designed to provide a systematic framework for categorizing bladder injuries that occur during endoscopic procedures. By standardizing the classification of these injuries, BICEP promotes a more consistent approach to diagnosis, management, and prevention across different urologic interventions. This study aims to validate and implement the BICEP system during morcellation. This study will: Validate BICEP by using real-life clinical scenarios to ensure its applicability and effectiveness. Assess the incidence and types of bladder injuries during morcellation, using the BICEP categorization to standardize injury reporting and enhance treatment protocols.

Detailed description

Insufficient knowledge exists about bladder injuries during morcellation, as the existing literature primarily consists of isolated case reports. The Bladder Injury Classification System for Endoscopic Procedures (BICEP) aims to standardize the reporting and management of bladder injuries during endoscopic surgeries. This study proposes an external validation of the BICEP system through an international, multicenter, prospective observational study. The objectives of this study are fourfold: Validate the newly developed BICEP classification system with real-life clinical scenarios to ensure its applicability and effectiveness. Evaluate the incidence and types of bladder injuries during morcellation using the BICEP framework to standardize injury reporting and enhance treatment protocols. Assess the robustness of BICEP across different departments. Facilitate the adoption of BICEP as a global standard for classifying bladder injuries in endoscopic surgery. Through this study, the validity of BICEP will be confirmed and the bladder injuries occurring during morcellation after AEEP will be examined.

Conditions

• Bladder Injury
• Prostate Hyperplasia

Interventions

Type	Name	Description
PROCEDURE	Endoscopic Prostate Interventions for Anatomic Enucleation	The intervention in this study involves performing anatomic endoscopic enucleation of the prostate (AEEP) using different energy sources. Following the enucleation, the resected prostate tissue will be morcellated within the bladder using various morcellators to remove the enlarged prostate tissue minimally invasively. The process will also involve evaluating and categorizing any resulting bladder injuries using the BICEP classification system.

Timeline

• Start date: 2025-10-08
• Primary completion: 2025-11-14
• Completion: 2025-11-14
• First posted: 2024-06-21
• Last updated: 2025-11-18

Locations

2 sites across 1 country: Turkey (Türkiye)