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NCT Number: NCT06469125

Anatomic Endoscopic Prostate Enucleation and BICEP Classification

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.

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Key information

Conditions

Bladder Injury Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostate Hyperplasia Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

40 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Necmettin Erbakan University, Konya, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged ≥40
  • ASA (American Society of Anesthesiologists) score ≤4
  • 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.

Treatment and study plan

Endoscopic Prostate Interventions for Anatomic Enucleation

Procedure

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.

Other names: Morcellation

Primary outcomes

  1. 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

    Time frame: 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.

  2. The impact of different energy sources and morcellation devices on bladder injury

    Time frame: 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.

Secondary outcomes

  1. Postoperative Qmax Increase Following Morcellation in AEEP Operations

    Time frame: 1 month post surgery

    Assessed by maximum flow rate (Q-max) measured using uroflowmetry by ml/sec, better outcome above 15ml/sec

  2. Postoperative Improvement in International Prostate Symptom Score (IPSS)

    Time frame: 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.

  3. Duration of catheterization

    Time frame: Up to 10 weeks

    The duration of catheterization post-operation will be calculated in days.

  4. Length of hospital stay

    Time frame: Up to 6 weeks

    The duration of hospital stay post-operation will be calculated in days.

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Collaborators

  • Acibadem Ankara Hospital
  • Alexandria University
  • Asklepios Kliniken Hamburg GmbH
  • Danube University Krems
  • HM Sanchinarro University Hospital
  • Istanbul Medipol University Hospital
  • King's College Hospital NHS Trust
  • Martini-Klinik am UKE GmbH
  • Medical University of Graz
  • Menoufia University
  • Paracelsus Medical University
  • Saint Petersburg State University, Russia
  • Sheikh Khalifa Medical City
  • Spital Thurgau AG
  • University General Hospital of Heraklion
  • University of Turin, Italy
  • Universitätsmedizin Mannheim

Registry information

Official study title

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

Acronym: BICEP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 21, 2024
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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