Anatomic Endoscopic Prostate Enucleation and BICEP Classification

NCT06469125 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2025-11-18

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06469125 on ClinicalTrials.gov