Anatomic Endoscopic Prostate Enucleation and BICEP Classification

• Conditions: Bladder Injury; Prostate Hyperplasia

• Registration Number: NCT06469125
• Lead Sponsor: Necmettin Erbakan University

Brief 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.

Study Timeline

• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-14
• Study First Posted: 2024-06-21
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Study Start: 2025-05-08
• Last Update Posted: 2025-05-09
• Primary Completion: 2025-08-15
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Male
• Target Recruitment: 250

Inclusion Criteria

• Patients aged ≥40
• ASA (American Society of Anesthesiologists) score ≤3
• Estimated weight on ultrasound (USG) ≥40 grams for prostate weight
• Patients undergoing Holmium Laser Enucleation of the Prostate (HoLEP) or Transurethral Resection of the Prostate (TURP) surgery.

Exclusion Criteria

• Patients with neurological disorders that may affect bladder function, such as cerebrovascular stroke or Parkinson's disease.
• Patients with active urinary tract infection.
• Patients diagnosed with bladder cancer within the last 2 years.
• Patients with prostate cancer.
• Patients who have undergone previous prostate surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The impact of different energy sources and morcellation devices on bladder injury	Up to 24 weeks	The severity of the injury will be assessed using a scoring system ranging from 0 to 4. A score of 0 indicates no injury, while a score of 4 indicates the highest degree of avulsion of part of the bladder. In this system, the severity of the injury increases as the score increases.
Number of Participants with Successful Validation of the Bladder Injury Classification System for Endoscopic Procedure Classification System for Bladder Injuries Occurring During Morcellation in AEEP Operations	Up to 24 weeks	Approximately 250 participants will be evaluated using a scoring system ranging from 0 to 4 to assess the severity of the injury. A score of 0 indicates no injury, while a score of 4 indicates extensive avulsion of part of the bladder. In this system, the severity of the injury increases as the score increases.

Secondary Outcome Measures

Name	Time	Method
Postoperative Improvement in International Prostate Symptom Score (IPSS)	1 month post surgery	The IPSS form will be filled out for calculation. Scores of 0-7 indicate mild symptoms, 8-19 indicate moderate symptoms, and 20-35 indicate severe symptoms.
Postoperative Qmax Increase Following Morcellation in AEEP Operations	1 month post surgery	Assessed by maximum flow rate (Q-max) measured using uroflowmetry by ml/sec, better outcome above 15ml/sec
Length of hospital stay	Up to 6 weeks	The duration of hospital stay post-operation will be calculated in days.
Duration of catheterization	Up to 10 weeks	The duration of catheterization post-operation will be calculated in days.

Trial Locations

Locations (2)

Istanbul Medipol University Hospital; 🇹🇷 Istanbul, Turkey

Necmettin Erbakan University; 🇹🇷 Konya, Turkey