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

Sponsor
Benha University
Study ID
NCT07578428
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rezūm Water Vapor Thermal Therapy — DEVICE
    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.
  • EchoLaser Transperineal Laser Ablation (TPLA) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
May 2026
Primary completion
Dec 1, 2026
Completion
May 1, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Rezūm Group
    40 patients receiving transurethral water vapor thermal therapy (Rezūm). The procedure involves targeted 9-second steam injections into the transition zone and the median lobe.
  • Active Comparator: EchoLaser TPLA Group
    40 patients receiving Transperineal Laser Ablation utilizing the EchoLaser system. Optical fibers will deliver localized diode laser energy to the adenoma and the intravesical median lobe.

Primary Outcome Measure

Change in International Prostate Symptom Score (IPSS) [ Time Frame: Baseline to 6 months ]

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