Comparison Between Water Vapor Thermal Therapy and Prostatic Artery Embolization in Treatment of … (NCT07416227) | Clinical Trial Compass
RecruitingNot Applicable
Comparison Between Water Vapor Thermal Therapy and Prostatic Artery Embolization in Treatment of Benign Prostatic Hyperplasia
Egypt30 participantsStarted 2025-10-01
Plain-language summary
The aim of this study is to compare the effectiveness of Rezum therapy versus Prostatic Artery Embolization in managing moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), with the primary endpoint being the improvement in the International Prostate Symptom Score (IPSS) over a 6-month follow-up period. Secondary endpoints include changes in post-void residual urine (PVR), maximum urinary flow rate (Qmax), patient-reported quality of life (QoL), and the preservation of ejaculatory and overall sexual function as assessed by validated questionnaires. This study aims to provide evidence-based guidance for optimizing treatment strategies for men with BPH, particularly those seeking alternatives to pharmacological therapy.
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:
* 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.
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
1
Improvement in the International Prostate Symptom Score (IPSS) over a 6-month follow-up period.
Timeframe: 6 months follow up for each patient following the procedure
Trial details
NCT IDNCT07416227
SponsorAin Shams University
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-10-01
Contact for this trial
Seif AbdElmomen Yosef, MBBCh, MSc Faculty of Medicine