Bladder InjuryBICEPNCT06469125
Anatomic Endoscopic Prostate Enucleation and BICEP Classification
An observational study of Bladder Injury and Prostate Hyperplasia, run by Necmettin Erbakan University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bladder Injury, Prostate Hyperplasia
- What is being tested?
- Endoscopic Prostate Interventions for Anatomic Enucleation
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 8 Oct 2025to 14 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul Medipol University Hospital
Istanbul
Necmettin Erbakan University
Konya, Konya, 42250
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Bladder Injury, Prostate Hyperplasia
- Being tested
- Endoscopic Prostate Interventions for Anatomic Enucleation
- Keywords
- BICEP classification, Anatomic Endoscopic Enucleation of Prostate, Bladder Injury, HoLEP, BiLEP, ThuFLEP
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Prostate Interventions for Anatomic EnucleationProcedure or surgery
Also called Morcellation
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 24 weeks
Secondary outcomes (4)
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
Measured: 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.
Measured: 1 month post surgery
Duration of catheterization
The duration of catheterization post-operation will be calculated in days.
Measured: Up to 10 weeks
Length of hospital stay
The duration of hospital stay post-operation will be calculated in days.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start8 Oct 2025
- Primary completion14 Nov 2025
- Study completion14 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bladder InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Collaborators
- Danube University Krems, University General Hospital of Heraklion, Paracelsus Medical University, University of Turin, Italy, Menoufia University, Acibadem Ankara Hospital, Universitätsmedizin Mannheim, Martini-Klinik am UKE GmbH, Asklepios Kliniken Hamburg GmbH, Istanbul Medipol University Hospital, Saint Petersburg State University, Russia, HM Sanchinarro University Hospital, Alexandria University, Spital Thurgau AG, Medical University of Graz, King's College Hospital NHS Trust, Sheikh Khalifa Medical City
- Responsible party
- Principal investigator, Selim Soyturk, Necmettin Erbakan University
- Investigators
- Selçuk Güven, Prof. Dr., Study director, Necmettin Erbakan UniversityBülent Erkurt, Prof. Dr., Study chair, Istanbul Medipol University HospitalSelim Soytürk, RA, Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469125
- Sponsor's protocol ID
- ResCORE-2024-12
- Acronym
- BICEP
- Status last verified
- May 2025
- First submitted
- 4 Jun 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19638912Breda 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.
PubMed 35665840Gilling 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.
PubMed 9847070Soyturk S, Mateos FL, Sonmez G, Ortner G, Torres D, Tozsin A, Barlas IS, Turan A, Rechner R, Ferretti S, Erkurt B, Karabulut I, Sonmez MG, Kactan MC, Akdere H, Balasar M, Gadzhiev N, Somani B, Tunc L, Otero JR, Herrmann T, Guven S. Bladder injury in anatomical endoscopic enucleation of the prostate and morcellation using the Bladder Injury Classification for Endoscopic Procedures: a European Association of Urology endourology prospective study. BJU Int. 2026 May;137(5):797-804. doi: 10.1111/bju.70170. Epub 2026 Feb 13.
PubMed 41685659
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Prospective Evaluation of Bladder Injuries During Morcellation Using BICEP (Bladder Injury Classification During Endoscopic Procedures)
- ClinicalTrials.gov ID
- NCT06469125
- Acronym / sponsor ID
- BICEP / ResCORE-2024-12
- Conditions
- Bladder Injury, Prostate Hyperplasia
- Keywords
- BICEP classification, Anatomic Endoscopic Enucleation of Prostate, Bladder Injury, HoLEP, BiLEP, ThuFLEP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Collaborators
- Danube University Krems, University General Hospital of Heraklion, Paracelsus Medical University, University of Turin, Italy, Menoufia University, Acibadem Ankara Hospital, Universitätsmedizin Mannheim, Martini-Klinik am UKE GmbH, Asklepios Kliniken Hamburg GmbH, Istanbul Medipol University Hospital, Saint Petersburg State University, Russia, HM Sanchinarro University Hospital, Alexandria University, Spital Thurgau AG, Medical University of Graz, King's College Hospital NHS Trust, Sheikh Khalifa Medical City
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- 14 Nov 2025 (actual)
- Study completion
- 14 Nov 2025 (actual)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Prostate Interventions for Anatomic EnucleationAlso: MorcellationThe 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. | Procedure or surgery | – |
Primary outcome
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.
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.
4 secondary outcomes
Postoperative Qmax Increase Following Morcellation in AEEP Operations
Time frame: 1 month post surgery
Postoperative Improvement in International Prostate Symptom Score (IPSS)
Time frame: 1 month post surgery
Duration of catheterization
Time frame: Up to 10 weeks
Length of hospital stay
Time frame: Up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Results publication: PubMed 19638912Clavien 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.
- Results publication: PubMed 35665840Breda 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.
- Results publication: PubMed 9847070Gilling 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.
- Derived from this study: PubMed 41685659Soyturk S, Mateos FL, Sonmez G, Ortner G, Torres D, Tozsin A, Barlas IS, Turan A, Rechner R, Ferretti S, Erkurt B, Karabulut I, Sonmez MG, Kactan MC, Akdere H, Balasar M, Gadzhiev N, Somani B, Tunc L, Otero JR, Herrmann T, Guven S. Bladder injury in anatomical endoscopic enucleation of the prostate and morcellation using the Bladder Injury Classification for Endoscopic Procedures: a European Association of Urology endourology prospective study. BJU Int. 2026 May;137(5):797-804. doi: 10.1111/bju.70170. Epub 2026 Feb 13.
- A case of blunt abdominal trauma resulting in significant bladder injury (AAST grade IV)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selçuk Güven, Prof. Dr. study director
Necmettin Erbakan University
Bülent Erkurt, Prof. Dr. study chair
Istanbul Medipol University Hospital
Selim Soytürk, RA principal investigator
Necmettin Erbakan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Injury and Prostate Hyperplasia, run by Necmettin Erbakan University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06469125, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.