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

ConditionBenign Prostatic Hyperplasia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50+
SponsorBenha University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Rezūm GroupActive comparator 1 intervention
Group B: EchoLaser TPLA GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in International Prostate Symptom Score (IPSS)

The absolute and percentage difference in total IPSS, reflecting the primary subjective alleviation of lower urinary tract symptoms (LUTS).

Time frame
Baseline to 6 months

Secondary outcomes

1

Change in Peak Urinary Flow Rate (Qmax)

Objective change in peak urinary flow rate, measured in mL/s using uroflowmetry.

Time frame
Baseline, 1 month, 3 months, and 6 months
2

Change in Post-Void Residual Volume (PVR)

Objective change in post-void residual volume, measured in mL via abdominal ultrasound.

Time frame
Baseline, 1 month, 3 months, and 6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Benha University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: