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This study compares the safety and efficacy of three endoscopic enucleation techniques for large prostates (>100 mL) in patients with benign prostatic hyperplasia (BPH): Thulium Fiber Laser Enucleation (ThuFLEP), Holmium Laser Enucleation (HoLEP), and Bipolar Enucleation (B-TUEP). Ninety male patients with severe lower urinary tract symptoms (IPSS ≥20, Qmax ≤10 mL/s) who failed medical therapy will be randomized 1:1:1 into three groups of 30. Primary outcomes include IPSS, quality of life score, maximum flow rate (Qmax), and post-void residual at 1, 3, and 6 months postoperatively. Secondary outcomes include operative time, enucleation efficiency, blood loss, catheterization duration, hospital stay, and complication rates assessed by the Clavien-Dindo classification.
Benign prostatic hyperplasia (BPH) is a progressive condition causing lower urinary tract symptoms (LUTS) that significantly impairs quality of life in aging men. While medical therapy with alpha-blockers and 5-alpha reductase inhibitors represents first-line management, surgical intervention becomes necessary when symptoms are severe or complications arise.
Anatomical endoscopic enucleation of the prostate has emerged as the size-independent gold standard surgical approach. This prospective randomized controlled trial will be conducted at the Urology Department, Tanta University Hospital (October 2025 - October 2027) following IRB approval (Code: 36265MD479/10/25).
Patients will undergo preoperative evaluation including IPSS, QoL index, IIEF-5, uroflowmetry, transrectal ultrasound, PSA, CBC, coagulation profile, and renal/liver function tests. Intraoperative data will include total operative time, enucleation time, morcellation time, enucleation efficiency (g/min), and estimated blood loss. Postoperative follow-up at 1, 3, and 6 months will assess IPSS, QoL, IIEF-5, Qmax, and post-void residual. Complications will be graded using the Clavien-Dindo classification. Randomization will use the sealed opaque envelope method with 1:1:1 allocation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ThuFLEP Group | Active Comparator | 30 patients undergoing Thulium Fiber Laser Enucleation of the Prostate using Quanta 60W with 550nm Thulium fiber |
|
| HoLEP Group | Active Comparator | 30 patients undergoing Holmium Laser Enucleation of the Prostate using Quanta 150W with 550nm Holmium YAG fiber |
|
| Bipolar Enucleation Group | Active Comparator | 30 patients undergoing Bipolar Transurethral Enucleation of the Prostate using standard bipolar energy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) | Procedure | Anatomical endoscopic enucleation of the prostate performed transurethrally using a Quanta thulium fiber laser at 60 watts with a 550 μm thulium fiber. Enucleated tissue was removed using a morcellator. |
| Measure | Description | Time Frame |
|---|---|---|
| International Prostate Symptom Score (IPSS) | Change from baseline in IPSS total score (0-35 scale; higher scores indicate worse urinary symptoms). Scores compared across ThuFLEP, HoLEP, and bipolar enucleation groups. | at 1, 3 and 6 months post-surgery |
| Quality of Life Score (QoL) | Change from baseline in the IPSS-linked Quality of Life index (0-6 scale; higher scores indicate worse quality of life due to urinary symptoms). | Baseline and at 1, 3, and 6 months post-surgery |
| Maximum Urinary Flow Rate (Qmax) | Change from baseline in maximum urinary flow rate in mL/s as measured by uroflowmetry. Higher values indicate better voiding function. | Baseline and at 1, 3, and 6 months post-surgery |
| Post-Void Residual Urine Volume (PVR) | Change from baseline in post-void residual urine volume in mL as measured by transabdominal ultrasound. Lower values indicate better bladder emptying. | Baseline and at 1, 3, and 6 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total Operative Time in Minutes | Total surgical time from start of procedure to completion, including enucleation and morcellation phases. | Intraoperative |
| Enucleation Efficiency in Grams per Minute |
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Inclusion Criteria:
Exclusion Criteria:
Prostate disease - all participants are male by definition.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdullah Salah Al Debeiky, MD | Contact | +201221430915 | abdullah.aldebeiky@med.tanta.edu.eg | |
| Omar Khaled Gad, MSc | Contact | +201117837272 | omar_khaled@med.tanta.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Hassan Hussein El-Tatawy, MD | Tanta University Faculty of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University Hospital | Recruiting | Tanta | Gharbia Governorate | 31111 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30816063 | Background | Giulianelli R, Gentile BC, Mirabile G, Tema G, Nacchia A, Albanesi L, Tariciotti P, Mavilla L, Bellangino M, Lopes Mendes L, Rizzo G, Aloisi P, Vincenti G, Lombardo R. Bipolar Plasma Enucleation of the Prostate: 5 Years Outcomes. J Endourol. 2019 May;33(5):396-399. doi: 10.1089/end.2019.0050. | |
| 38886739 | Background |
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Individual participant data underlying published results will be shared after de-identification, including data for primary and secondary outcome measures. Data will be available upon reasonable request to the corresponding author following publication.
Beginning 6 months after publication of primary results
Researchers who provide a methodologically sound proposal approved by the study team. Requests should be directed to the corresponding author. Data will be shared for individual participant meta-analyses or systematic reviews.
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| Holmium Laser Enucleation of the Prostate (HoLEP) | Procedure | Anatomical endoscopic enucleation of the prostate performed transurethrally using a Quanta holmium YAG laser at 150 watts with a 550 μm holmium fiber. Enucleated tissue was removed using a morcellator. |
|
| Bipolar Transurethral Enucleation of the Prostate (B-TUEP) | Procedure | Anatomical endoscopic enucleation of the prostate performed transurethrally using standard bipolar electrical energy. Enucleated tissue was removed using a morcellator. |
|
Weight of enucleated prostatic tissue (grams) divided by enucleation time (minutes), reflecting surgical speed and effectiveness.
| Intraoperative |
| Estimated Blood Loss as Change in Hemoglobin Level | Difference between preoperative and 24-hour postoperative serum hemoglobin levels (g/dL). Greater decrease indicates more blood loss. | Baseline and 24 hours postoperatively |
| Catheterization Duration in Days | Number of days from end of surgery until urethral catheter removal, based on resolution of hematuria and clinical assessment. | Up to 7 days postoperatively |
| Length of Hospital Stay in Days | Total number of days from surgery to hospital discharge. | Up to 7 days postoperatively |
| Number of Participants with Postoperative Complications as Assessed by Clavien-Dindo Classification | Rate and severity of complications including urinary incontinence, urinary tract infection, urethral stricture, and need for reoperation, graded using the Clavien-Dindo classification system (Grade I-V; higher grade indicates more severe complication). | Up to 6 months postoperatively |
| Erectile Function Score (IIEF-5) | Change from baseline in International Index of Erectile Function-5 (IIEF-5) questionnaire score (range 5-25; higher scores indicate better erectile function). | Baseline and at 1, 3, and 6 months postoperatively |
| Chen YY, Hua WX, Huang YH, Shen XY, You JN, Ding X. The safety and efficacy of five surgical treatments in prostate enucleation: a network meta-analysis. BMC Urol. 2024 Jun 17;24(1):128. doi: 10.1186/s12894-024-01517-5. |
| 38244076 | Background | Kosiba M, Filzmayer M, Welte MN, Hugenell L, Keller AC, Traumann MI, Muller MJ, Kluth LA, Mandel PC, Chun FK, Becker A. Thulium fiber laser vs. holmium laser enucleation of the prostate: results of a prospective randomized non-inferiority trial. World J Urol. 2024 Jan 20;42(1):49. doi: 10.1007/s00345-023-04748-7. |
| 32397634 | Background | Herrmann TRW, Gravas S, de la Rosette JJ, Wolters M, Anastasiadis AG, Giannakis I. Lasers in Transurethral Enucleation of the Prostate-Do We Really Need Them. J Clin Med. 2020 May 10;9(5):1412. doi: 10.3390/jcm9051412. |
| 37667842 | Background | Shoma AM, Ghobrial FK, El-Tabey N, El-Hefnawy AS, El-Kappany HA. A randomized trial of holmium laser vs thulium laser vs bipolar enucleation of large prostate glands. BJU Int. 2023 Dec;132(6):686-695. doi: 10.1111/bju.16174. Epub 2023 Sep 28. |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D059411 | Lower Urinary Tract Symptoms |
| D001748 | Urinary Bladder Neck Obstruction |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014524 | Urethral Obstruction |
| D014522 | Urethral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D001745 | Urinary Bladder Diseases |
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