Anatomic Endoscopic Prostate Enucleation and BICEP Classification

NCT06469125 | Completed

• 1 other identifier: ResCORE-2024-12
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

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.

Conditions

Bladder Injury; Prostate Hyperplasia

Keywords

BICEP classification; Anatomic Endoscopic Enucleation of Prostate; Bladder Injury; HoLEP; BiLEP; ThuFLEP

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Postoperative Qmax Increase Following Morcellation in AEEP Operations

  1 month post surgery

• Postoperative Improvement in International Prostate Symptom Score (IPSS)

  1 month post surgery

• Duration of catheterization

  Up to 10 weeks

• Length of hospital stay

  Up to 6 weeks

Interventions

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.

Also known as: Morcellation

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will include adult patients undergoing AEEP surgery. The presence of bladder injuries during the operation will be assessed according to the BICEP classification, and any potential injuries will be recorded.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

Necmettin Erbakan University

Konya, Konya, 42250, Turkey (Türkiye)

Location

Istanbul Medipol University Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

  PMID: 19638912 RESULT

• Breda A, Gallioli A, Diana P, Fontana M, Territo A, Gaya JM, Rodriguez-Faba O, Huguet J, Piana A, Verri P, Baboudjian M, Aumatell J, Algaba F, Palou J. The DEpth of Endoscopic Perforation scale to assess intraoperative perforations during transurethral resection of bladder tumor: subgroup analysis of a randomized controlled trial. World J Urol. 2023 Oct;41(10):2583-2589. doi: 10.1007/s00345-022-04052-w. Epub 2022 Jun 4.

  PMID: 35665840 RESULT

• Gilling PJ, Kennett K, Das AK, Thompson D, Fraundorfer MR. Holmium laser enucleation of the prostate (HoLEP) combined with transurethral tissue morcellation: an update on the early clinical experience. J Endourol. 1998 Oct;12(5):457-9. doi: 10.1089/end.1998.12.457.

  PMID: 9847070 RESULT

Related Links

• A case of blunt abdominal trauma resulting in significant bladder injury (AAST grade IV)

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Morcellation

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Selçuk Güven, Prof. Dr.

  Necmettin Erbakan University

  STUDY DIRECTOR

• Bülent Erkurt, Prof. Dr.

  Istanbul Medipol University Hospital

  STUDY CHAIR

• Selim Soytürk, RA

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 21, 2024
• Study Start: October 8, 2025
• Primary Completion: November 14, 2025
• Study Completion: November 14, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)