An interventional study of Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) and Holmium Laser Enucleation of the Prostate (HoLEP) in Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptom and Bladder Outlet Obstruction, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to male participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
30 patients undergoing Thulium Fiber Laser Enucleation of the Prostate using Quanta 60W with 550nm Thulium fiber
Procedure: Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP)
30 patients undergoing Holmium Laser Enucleation of the Prostate using Quanta 150W with 550nm Holmium YAG fiber
Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)
30 patients undergoing Bipolar Transurethral Enucleation of the Prostate using standard bipolar energy
Procedure: Bipolar Transurethral Enucleation of the Prostate (B-TUEP)
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.
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.
Anatomical endoscopic enucleation of the prostate performed transurethrally using standard bipolar electrical energy. Enucleated tissue was removed using a morcellator.
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline and at 1, 3, and 6 months post-surgery
Total Operative Time in Minutes
Total surgical time from start of procedure to completion, including enucleation and morcellation phases.
Time frame: Intraoperative
Enucleation Efficiency in Grams per Minute
Weight of enucleated prostatic tissue (grams) divided by enucleation time (minutes), reflecting surgical speed and effectiveness.
Time frame: 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.
Time frame: 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.
Time frame: Up to 7 days postoperatively
Length of Hospital Stay in Days
Total number of days from surgery to hospital discharge.
Time frame: 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).
Time frame: 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).
Time frame: Baseline and at 1, 3, and 6 months postoperatively
Plan to share: Yes — 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.
Supporting information: Study protocol, Icf
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