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

NCT07578428 | Not Yet Recruiting

• 1 other identifier: MS5/1/2025
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Benign Prostatic Hyperplasia

Keywords

Rezūm; EchoLaser

Outcome Measures

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).

  Baseline to 6 months

Secondary Outcomes (2)

• Change in Peak Urinary Flow Rate (Qmax)

  Baseline, 1 month, 3 months, and 6 months

• Change in Post-Void Residual Volume (PVR)

  Baseline, 1 month, 3 months, and 6 months

Study Arms (2)

Rezūm Group

ACTIVE COMPARATOR

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.

Device: Rezūm Water Vapor Thermal Therapy

EchoLaser TPLA Group

ACTIVE COMPARATOR

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.

Device: EchoLaser Transperineal Laser Ablation (TPLA)

Interventions

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.

EchoLaser TPLA Group

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.

Rezūm Group

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients aged 50 years or older.
• Diagnosis of symptomatic BPH with moderate-to-severe lower urinary tract symptoms, defined as an IPSS ≥ 12.
• Total prostate volume between 30 mL and 80 mL, confirmed via Transrectal Ultrasound (TRUS) or mpMRI.
• Presence of an enlarged, obstructing intravesical median lobe visualized via imaging or baseline cystoscopy.
• Peak urinary flow rate (Qmax) between 5 and 15 mL/s with a minimum voided volume of ≥ 125 mL.

You may not qualify if:

• Confirmed or suspected prostate cancer (e.g., PSA \> 4.0 ng/mL without a subsequent negative prostate biopsy or MRI).
• History of prior surgical interventions for BPH (e.g., TURP, HOLEP, or other MISTs).
• Presence of urethral strictures, bladder neck contracture, or established neurogenic bladder dysfunction.
• Active urinary tract infection (UTI) or an episode of acute urinary retention requiring an indwelling catheter at the time of screening.
• Previous pelvic radiation therapy or severe pelvic trauma.
• Inability to safely pause anticoagulant/antiplatelet therapy per standard hospital perioperative protocols, if applicable.

Sponsors & Collaborators

• Benha University: lead

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Candidate

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05