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A Prospective Comparative Study Evaluating the Safety and Efficacy of Transurethral Thulium Fiber Laser, Holmium Laser and Bipolar Enucleation of Large Sized Prostate

RecruitingNAAges any - anyMaleTanta University
NCT07627178 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
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What it tests

  • Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP)
  • Holmium Laser Enucleation of the Prostate (HoLEP)
  • Bipolar Transurethral Enucleation of the Prostate (B-TUEP)
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Where

1 site
Tanta University Hospital
Tanta, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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