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| Name | Class |
|---|---|
| Theodor Bilharz Research Institute | OTHER |
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To compare bipolar plasmakinetic enucleation versus holmium laser enucleation for management of large BPH.
To compare safety and efficacy of bipolar plasmakinetic enucleation (BPEP) versus holmium laser enucleation (HoLEP) for management of large BPH (>80gm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HoLEP holmium laser enucleation of the prostate | Active Comparator | holmium laser enucleation of the prostate |
|
| BPEP bipolar plasmakinetic enucleation of the prostate | Active Comparator | bipolar plasmakinetic enucleation of the prostate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Holmium laser enucleation of the prostate | Procedure | cystoscopic transurethral enucleation of the prostate using Holmium laser (Asclepion MultiPulse HoPlus 110W and Lumenis pulse 100W and 120W) |
| Measure | Description | Time Frame |
|---|---|---|
| hemoglobin drop postoperatively (gm/dL) | difference in hemoglobin concentration postoperatively vs preoperatively | Immediate postoperatively |
| operative time | operative time in minutes | during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| complications (%) | intraoperative and postoperative complications including blood transfusion, capsular perforation, irritative symptoms, SUI, urethral stricture, bladder neck contracture, urinary retention. | one year |
| urine flow |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| enmar I Habib, Prof. | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University Hospitals | Cairo | 12222 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31813283 | Derived | Habib E, Ayman LM, ElSheemy MS, El-Feel AS, Elkhouly A, Nour HH, Badawy MH, Elbaz AG, Roshdy MA. Holmium Laser Enucleation vs Bipolar Plasmakinetic Enucleation of a Large Volume Benign Prostatic Hyperplasia: A Randomized Controlled Trial. J Endourol. 2020 Mar;34(3):330-338. doi: 10.1089/end.2019.0707. Epub 2020 Feb 28. |
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|
| Bipolar plasma kinetic enucleation of the prostate | Procedure | cystoscopic transurethral enucleation of the prostate using bipolar plasma kinetic energy (KLS Martin Maxium or Covidien Force Triad) |
|
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Qmax (ml/s),
| one year |
| post-voiding residual urine | postvoiding residual urine (ml) | one year |
| International prostate symptom score (IPSS) | an international commonly used score ranging from 0 - 35 (the worst is 35) evaluating voiding and storage urinary symptoms using 7 questions each one is scored from 0 to 5 according to severity of symptom | one year |
| Quality of life (QoL) section of International prostate symptom score (IPSS) | one question scored from 0 up to 6 (6 is worst) | one year |