Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Comparing the peri-operative outcomes in patients with benign prostatic hyperplasia (BPH) who will undergo bipolar enucleation of the prostate versus thulium laser enucleation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thulium Laser Enucleation | Experimental | Patients in this arm will undergo thulium laser enucleation of the prostate. |
|
| Bipolar Enucleation | Experimental | Patients in this arm will undergo bipolar enucleation of the prostate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thulium laser enucleation of the prostate | Procedure | Using the thulium laser to achieve complete endoscopic enucleation of the prostate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect on the operative time and other intra-operative and post-operative parameters | Effect of the chosen technique on the operative time including both enucleation and morcellation times. The occurrence of any inta-operative complications including significant blood loss necessitating blood transfusion, capsular perforation, sub-trigonal dissection and complications related to morcellation for example bladder perforation. The occurrence of any post-operative complications which is divided into either immediate post-operative and long term complications. Immediate post-operative complications occurring in the first 48 hours after enucleation include affection of the hemodynamics and vital signs of the patient, drop in hemoglobin level, high grade fever or uro-sepsis, retention with re-catheterization, hematuria with clot retention. long term complications occurring include persistent urge or stress urinary incontinence, secondary hemorrhage with hematuria and clot retention, recurrent urinary tract infections, urethral stricture or bladder neck contracture. | 3 to 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the urine flow of the patients. | Improvement of the uroflowmetry parameters after catheter removal especially the Qmax (maximum flow rate), Qavg (Average flow rate) in addition to a bell shaped curve in the flowmetry plotted curve. | 3 to 6 month |
| Change of the IPSS (International Prostatic Symptom Score) of the patients |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Omar AbdelRazzak, MD Urology | Kasr AlAiny | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr AlAiny School of Medicine | Cairo | Cairo Governorate | 11562 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6206240 | Background | Berry SJ, Coffey DS, Walsh PC, Ewing LL. The development of human benign prostatic hyperplasia with age. J Urol. 1984 Sep;132(3):474-9. doi: 10.1016/s0022-5347(17)49698-4. | |
| 21438974 | Background | Gravas S, Bachmann A, Reich O, Roehrborn CG, Gilling PJ, De La Rosette J. Critical review of lasers in benign prostatic hyperplasia (BPH). BJU Int. 2011 Apr;107(7):1030-43. doi: 10.1111/j.1464-410X.2010.09954.x. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Prospective randomized study comparing two techniques of endoscopic enucleation of the prostate.
Not provided
Not provided
Prospective randomized study comparing the two techniques with patient allocation using computer generated randomization.
| Bipolar enucleation of the prostate | Procedure | Using the bipolar plasma energy to achieve complete endoscopic enucleation of the prostate. |
|
Improvement of the IPSS score of the patients after catheter removal compared to the value of the IPSS before enucleation. Values of the IPSS: Mild Symptoms from 1 to 7 Moderate Symptoms from 8 to 19 Severe Symptoms from 20 to 35 |
| 3 to 6 month |
| Change of residual urine volume after surgery | Reduction in the amount of residual urine by US after catheter removal below 150 cc. | 3 to 6 month |
| 29430969 | Background | Enikeev D, Glybochko P, Okhunov Z, Alyaev Y, Rapoport L, Tsarichenko D, Enikeev M, Sorokin N, Dymov A, Taratkin M. Retrospective Analysis of Short-Term Outcomes After Monopolar Versus Laser Endoscopic Enucleation of the Prostate: A Single Center Experience. J Endourol. 2018 May;32(5):417-423. doi: 10.1089/end.2017.0898. Epub 2018 Mar 13. |
| 26658753 | Background | Scoffone CM, Cracco CM. The en-bloc no-touch holmium laser enucleation of the prostate (HoLEP) technique. World J Urol. 2016 Aug;34(8):1175-81. doi: 10.1007/s00345-015-1741-y. Epub 2015 Dec 11. |
| 15735378 | Background | Fried NM, Murray KE. High-power thulium fiber laser ablation of urinary tissues at 1.94 microm. J Endourol. 2005 Jan-Feb;19(1):25-31. doi: 10.1089/end.2005.19.25. |
| 25518001 | Background | Hardy LA, Wilson CR, Irby PB, Fried NM. Thulium fiber laser lithotripsy in an in vitro ureter model. J Biomed Opt. 2014 Dec;19(12):128001. doi: 10.1117/1.JBO.19.12.128001. |
| 32441397 | Background | Ryang SH, Ly TH, Tran AV, Oh SJ, Cho SY. Bipolar enucleation of the prostate-step by step. Andrologia. 2020 Sep;52(8):e13631. doi: 10.1111/and.13631. Epub 2020 May 22. |
| D052801 |
| Male Urogenital Diseases |