Anatomic Endoscopic Prostate Enucleation and BICEP Classification (BICEP)

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

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.

Study Overview

• Status: Completed
• Conditions: Bladder Injury; Prostate Hyperplasia
• Intervention / Treatment: Procedure: Endoscopic Prostate Interventions for Anatomic Enucleation

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Istanbul Medipol University Hospital
  • Konya
    • Konya, Konya, Turkey (Türkiye), 42250
      • Necmettin Erbakan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Necmettin Erbakan University
• Collaborators: King's College Hospital NHS Trust; Medical University of Graz; Alexandria University; Menoufia University; University of Turin, Italy; Istanbul Medipol University Hospital; Asklepios Kliniken Hamburg GmbH; Universitätsmedizin Mannheim; Martini-Klinik am UKE GmbH; Paracelsus Medical University; Saint Petersburg State University, Russia; Sheikh Khalifa Medical City; University General Hospital of Heraklion; Danube University Krems; Acibadem Ankara Hospital; HM Sanchinarro University Hospital; Spital Thurgau AG
• Investigators: Study Director: Selçuk Güven, Prof. Dr., Necmettin Erbakan University; Study Chair: Bülent Erkurt, Prof. Dr., Istanbul Medipol University Hospital; Principal Investigator: Selim Soytürk, RA, Necmettin Erbakan University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2025
• Primary Completion (Actual): November 14, 2025
• Study Completion (Actual): November 14, 2025

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 14, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Bladder Injury; HoLEP; ThuFLEP; BICEP classification; Anatomic Endoscopic Enucleation of Prostate; BiLEP
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Morcellation
• Other Study ID Numbers: ResCORE-2024-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No