About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male patients diagnosed with BPH
Clinical diagnosis of BPH with lower urinary tract symptoms.
IPSS ≥ 20 (severe symptoms)
Maximum urinary flow rate (Qmax) ≤ 10 mL/s
Disqualifiers
Prostate cancer (current or history).
Previous prostate surgery
Previous urethral surgery.
Neurogenic bladder dysfunction.
Trial design
Parallel
Treatments tested in this trial
Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP)
Procedure/SurgeryAnatomical 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.
Holmium Laser Enucleation of the Prostate (HoLEP)
Procedure/SurgeryAnatomical 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/SurgeryAnatomical endoscopic enucleation of the prostate performed transurethrally using standard bipolar electrical energy. Enucleated tissue was removed using a morcellator.
Treatment groups
Trial outcomes
Primary outcomes
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.
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).
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.
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.
Secondary outcomes
Total Operative Time in Minutes
Total surgical time from start of procedure to completion, including enucleation and morcellation phases.
Enucleation Efficiency in Grams per Minute
Weight of enucleated prostatic tissue (grams) divided by enucleation time (minutes), reflecting surgical speed and effectiveness.
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.
Catheterization Duration in Days
Number of days from end of surgery until urethral catheter removal, based on resolution of hematuria and clinical assessment.
Sponsors and contacts
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