Not Yet RecruitingNot Applicable

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

80 participantsStarted 2026-05-01

Plain-language 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.

Who can participate

Age range

50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Inclusion Criteria: 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. Exclusion Criteria: 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in International Prostate Symptom Score (IPSS)

Timeframe: Baseline to 6 months

Trial details

NCT IDNCT07578428

SponsorBenha University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-01

View on ClinicalTrials.gov More Benign Prostatic Hyperplasia trials