This is a single center, prospective, investigational study to evaluate the safety and efficacy of prostatic artery embolization (PAE) for the treatment of moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Embolization will be performed with LC Bead LUMI particles using a balloon occlusion microcatheter or standard microcatheter.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Prostatic artery embolization is performed using LC Bead LUMI, which is the investigational device. The particles are administered to the prostatic arteries using either a balloon occlusion or standard microcatheter. Follow-up is performed at 1 month, 6 months, 12 months, and 24 months after intervention.
Stanford University
Palo Alto, California, United States
Number of patients with treatment related adverse events assessed by CTCAE v4.0.
Time frame: 12 months post PAE
Mean change from baseline in symptom score using the IPSS scale at 6 months
Time frame: Baseline and 6 months post PAE
Mean change from baseline in Qmax (maximum urinary flow)
Time frame: Baseline, 6 months and 12 months post PAE
Mean change from baseline in PVR (post void residual)
Time frame: Baseline, 6 months and 12 months post PAE
Mean change from baseline in prostate volume
Time frame: Baseline, 6 months and 12 months post PAE
Mean change from baseline in IPSS to measure long-terms subjective outcome
Time frame: Baseline, 12 and 24 months post PAE
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