Clinical trial Recruiting at 1 site Interventional Ages 50 and up Men only

Rezum versus prostatic artery embolization for relieving urinary symptoms from BPH

Official title: Comparison Between Water Vapor Thermal Therapy and Prostatic Artery Embolization in Treatment of Benign Prostatic Hyperplasia

Run by Ain Shams University · NCT07416227 · Data updated 2026-11-12

This study will test whether Rezum (water vapor therapy) or prostatic artery embolization works better at reducing bothersome urinary symptoms in men with moderate-to-severe BPH.

Quick facts

Study typeInterventional
Ages50 Years and up
SexMen only
Enrollment30 (estimated)
SponsorAin Shams University
Academic / other
Locations1 site (Cairo, Abbassia)
StatusRecruiting
StartedOctober 1, 2025
Main results expectedOctober 1, 2027
Study endsOctober 1, 2027
Registry record updatedFebruary 18, 2026
Trial IDNCT07416227 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men aged 50 or older with IPSS ≥13, prostate volume 30–80 mL, Qmax ≤15 mL/sec when relevant, and symptoms not controlled by medication.

Probably not a fit

Patients with suspected or prior prostate cancer, previous prostate surgery or minimally invasive BPH procedures, neurological bladder dysfunction, active urinary tract infection, or prostate sizes outside the 30–80 mL range are unlikely to be eligible or to benefit from the study interventions.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial will enroll at least 30 men with moderate-to-severe LUTS from BPH and randomize them 1:1 to receive Rezum or prostatic artery embolization using a closed-envelope system. The primary outcome is change in International Prostate Symptom Score (IPSS) at six months, with secondary outcomes including post-void residual, maximum urinary flow rate (Qmax), quality of life measures, and validated sexual function questionnaires. Participants will undergo baseline history, physical examination, pelvic ultrasound and scheduled follow-up visits to measure symptoms and urinary function. The trial is single-center at Ain Shams University in Cairo and will recruit over a two-year period.

Why it matters

Potential benefit: If successful, the comparison could identify a minimally invasive option that improves urinary symptoms while preserving ejaculatory and overall sexual function.

How similar studies have gone: Separate studies have shown that Rezum improves symptoms and preserves sexual function, and that prostatic artery embolization can reduce prostate size and LUTS, but randomized head-to-head comparisons between these two approaches are limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age ≥50 years.
* IPSS ≥13.
* Prostate volume between 30-80 mL.
* Maximum urinary flow rate (Qmax) ≤15 mL/sec in patients with voiding LUTs.
* Patients not responding to medical treatment.

Exclusion Criteria:

* History or suspicion of prostate cancer.
* Previous prostate surgery or minimally invasive BPH intervention.
* Neurological bladder dysfunction.
* Active urinary tract infection.

Where it's running

  • Ain Shams University
    Cairo, Abbassia, Egypt
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.