Rezum versus prostatic artery embolization for relieving urinary symptoms from BPH
Comparison Between Water Vapor Thermal Therapy and Prostatic Artery Embolization in Treatment of Benign Prostatic Hyperplasia
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 50 Years and up |
| Sex | Male |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo, Abbassia) |
| Trial ID | NCT07416227 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cairo, Abbassia
- Ain Shams University — Cairo, Abbassia, Egypt (Recruiting)
Study contacts
- Study coordinator: Seif AbdElmomen Yosef, MBBCh, MSc Faculty of Medicine
- Email: siefabdelmomen@gmail.com
- Phone: 01093390291
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.