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NOT YET RECRUITING
NCT07578428
NA

Comparative Outcomes of Rezūm Versus EchoLaser for Treatment of Benign Prostatic Hyperplasia With Enlarged Median Lobe.

Sponsor: Benha University

View on ClinicalTrials.gov

Summary

This study evaluates and compares two minimally invasive surgical therapies for treating men with benign prostatic hyperplasia (BPH) who specifically have an enlarged median lobe. The two treatments being compared are Rezūm (water vapor thermal therapy) and EchoLaser (transperineal laser ablation). Participants will be randomized into two equal groups to receive either the Rezūm treatment or the EchoLaser treatment. The primary goal of the study is to evaluate the change in urinary symptoms over a 6-month period using the International Prostate Symptom Score (IPSS). The study will also assess how well each treatment improves urine flow, reduces the size of the prostate, preserves sexual function, and minimizes complications.

Official title: Comparative Outcomes of Rezūm (Water Vapor Therapy) Versus EchoLaser (Transperineal Laser Ablation) for Treatment of Benign Prostatic Hyperplasia With Enlarged Median Lobe. A Prospective Randomized Comparative Study.

Key Details

Gender

MALE

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-05-01

Completion Date

2027-05-01

Last Updated

2026-05-11

Healthy Volunteers

No

Interventions

DEVICE

Rezūm Water Vapor Thermal Therapy

Conducted via a transurethral approach. Standard 9-second thermal water vapor injections will be delivered into the transition zone, alongside mandatory, specifically angled injections directed explicitly into the intravesical protruding median lobe to induce targeted coagulative necrosis.

DEVICE

EchoLaser Transperineal Laser Ablation (TPLA)

Conducted via a transperineal approach. Under real-time transrectal ultrasound (TRUS) guidance, 21G introducer needles are placed, and optical fibers (300 µm) deliver continuous-wave diode laser energy (1064 nm) directly to the adenoma and the obstructing median lobe.