Anatomic Endoscopic Prostate Enucleation and BICEP Classification
NCT Number: NCT06469125
Acronym: BICEP
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Bladder Injury|Prostate Hyperplasia
Interventions: PROCEDURE: Endoscopic Prostate Interventions for Anatomic Enucleation
Sponsor: Necmettin Erbakan University
Collaborators: Danube University Krems|University General Hospital of Heraklion|Paracelsus Medical University|University of Turin, Italy|Menoufia University|Acibadem Ankara Hospital|Universitätsmedizin Mannheim|Martini-Klinik am UKE GmbH|Asklepios Kliniken Hamburg GmbH|Istanbul Medipol University Hospital|Saint Petersburg State University, Russia|HM Sanchinarro University Hospital|Alexandria University|Spital Thurgau AG|Medical University of Graz|King's College Hospital NHS Trust|Sheikh Khalifa Medical City
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-08
Completion Date: 2024-12-30
Locations: Istanbul Medipol University Hospital, Istanbul, Turkey|Necmettin Erbakan University, Konya, 42250, Turkey

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.

Primary Outcome Measures: 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, 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., Up to 24 weeks|The impact of different energy sources and morcellation devices on bladder injury, 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., Up to 24 weeks
Secondary Outcome Measures: Postoperative Qmax Increase Following Morcellation in AEEP Operations, Assessed by maximum flow rate (Q-max) measured using uroflowmetry by ml/sec, better outcome above 15ml/sec, 1 month post surgery|Postoperative Improvement in International Prostate Symptom Score (IPSS), 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., 1 month post surgery|Duration of catheterization, The duration of catheterization post-operation will be calculated in days., Up to 10 weeks|Length of hospital stay, The duration of hospital stay post-operation will be calculated in days., Up to 6 weeks