Anatomic Endoscopic Prostate Enucleation and BICEP Classification
NCT06469125 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 250
Last updated 2025-11-18
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.
Conditions
- Bladder Injury
- Prostate Hyperplasia
Interventions
- 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.
Sponsors & Collaborators
-
Danube University Krems
collaborator OTHER -
University General Hospital of Heraklion
collaborator OTHER -
Paracelsus Medical University
collaborator OTHER -
University of Turin, Italy
collaborator OTHER -
Menoufia University
collaborator OTHER -
Acibadem Ankara Hospital
collaborator OTHER -
Universitätsmedizin Mannheim
collaborator OTHER -
Martini-Klinik am UKE GmbH
collaborator OTHER -
Asklepios Kliniken Hamburg GmbH
collaborator OTHER -
Istanbul Medipol University Hospital
collaborator OTHER -
Saint Petersburg State University, Russia
collaborator OTHER -
HM Sanchinarro University Hospital
collaborator OTHER -
Alexandria University
collaborator OTHER -
Spital Thurgau AG
collaborator OTHER -
Medical University of Graz
collaborator OTHER -
King's College Hospital NHS Trust
collaborator OTHER -
Sheikh Khalifa Medical City
collaborator OTHER -
Necmettin Erbakan University
lead OTHER
Principal Investigators
-
Selçuk Güven, Prof. Dr. · Necmettin Erbakan University
-
Bülent Erkurt, Prof. Dr. · Istanbul Medipol University Hospital
-
Selim Soytürk, RA · Necmettin Erbakan University
Eligibility
- Min Age
- 40 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-10-08
- Primary Completion
- 2025-11-14
- Completion
- 2025-11-14
Countries
- Turkey (Türkiye)
Study Locations
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