Bladder Injury, Prostate Hyperplasia
Conditions
Keywords
BICEP classification, Anatomic Endoscopic Enucleation of Prostate, Bladder Injury, HoLEP, BiLEP, ThuFLEP
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.
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.
Interventions
PROCEDUREEndoscopic Prostate Interventions for Anatomic Enucleation
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.
Sponsors
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
Necmettin Erbakan University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Qmax Increase Following Morcellation in AEEP Operations | 1 month post surgery | Assessed by maximum flow rate (Q-max) measured using uroflowmetry by ml/sec, better outcome above 15ml/sec |
| Postoperative Improvement in International Prostate Symptom Score (IPSS) | 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. |
| Duration of catheterization | Up to 10 weeks | The duration of catheterization post-operation will be calculated in days. |
| Length of hospital stay | Up to 6 weeks | The duration of hospital stay post-operation will be calculated in days. |
Countries
Turkey (Türkiye)
Outcome results
None listed