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.
Who can participate
Age range
40 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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
Timeframe: Up to 24 weeks
2
The impact of different energy sources and morcellation devices on bladder injury