About this trial
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.
Eligibility criteria
Qualifiers
Age ≥50 years.
IPSS ≥13.
Prostate volume between 30-80 mL.
Maximum urinary flow rate (Qmax) ≤15 mL/sec in patients with voiding LUTs.
Disqualifiers
History or suspicion of prostate cancer.
Previous prostate surgery or minimally invasive BPH intervention.
Neurological bladder dysfunction.
Active urinary tract infection.
Trial design
Treatments tested in this trial
- Rezum
- Prostatic Artery Embolization