A Prospective Comparative Study Evaluating the Safety and Efficacy of Transurethral Thulium Fiber Laser, Holmium Laser and Bipolar Enucleation of Large Sized Prostate
Recruiting now · Not applicable
Conditions studied: Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptom, Bladder Outlet Obstruction
In brief
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.
Key facts
- Study ID
- NCT07627178
- Run by
- Tanta University
- People needed
- 90
- Starts
- 2025-10-21
- Expected to finish
- 2027-05-30
- Last updated by the study team
- 2026-06-05
Who can join
Age: any. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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
- Prostate volume >100 mL (measured by transrectal ultrasound)
- Failed medical therapy and fit for operation
You may not qualify if…
- Prostate cancer (current or history).
- Previous prostate surgery
- Previous urethral surgery.
- Neurogenic bladder dysfunction.
- Active urinary tract infection.
- Severe cardiovascular disease (ASA Class IV).
- Previous pelvic radiation.
- Urethral stricture
- Urinary bladder stones.
Where it is running
- Tanta University Hospital — Tanta, Gharbia Governorate, Egypt (enrolling)
Full record on ClinicalTrials.gov
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