RecruitingNot ApplicableNCT07627178

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


Sponsor

Tanta University

Enrollment

90 participants

Start Date

Oct 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: MALE

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Bipolar Transurethral Enucleation of the Prostate (B-TUEP), a procedure called Holmium Laser Enucleation of the Prostate (HoLEP), and others for people with benign prostatic hyperplasia (bph), bladder outlet obstruction, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include men.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREThulium Fiber Laser Enucleation of the Prostate (ThuFLEP)

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.

PROCEDUREHolmium Laser Enucleation of the Prostate (HoLEP)

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.

PROCEDUREBipolar Transurethral Enucleation of the Prostate (B-TUEP)

Anatomical endoscopic enucleation of the prostate performed transurethrally using standard bipolar electrical energy. Enucleated tissue was removed using a morcellator.


Locations(1)

Tanta University Hospital

Tanta, Gharbia Governorate, Egypt

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NCT07627178


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