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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorTanta University

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

Qualifiers

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

Treatments tested in this trial

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

Treatment groups

90 Participants
are divided into 3 treatment groups

Sponsors and collaborators