Prostatic Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)

Study Overview
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Brief Summary
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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.

Official Title
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Prostatic Artery Embolization (PAE) Using LC Bead LUMI for the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)

Conditions
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Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

Intervention / Treatment
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* Device: Prostatic artery embolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 45 years and ≤ 85 years old Prostate volume ≥ 40 mL and ≤ 300 mL Diagnosis of BPH with moderate to severe lower urinary tract symptoms (LUTS) Refractory or intolerant to medical management Ineligibility for or refusal of surgical management No evidence of prostate cancer Exclusion Criteria: History of pelvic cancer Neurogenic bladder disorder Bladder diverticula greater than 5 cm or bladder stones Acute urinary retention with Foley catheter dependence Active urinary tract infection, interstitial cystitis, or prostatitis within the last 3 months Prior surgical prostate intervention Active participation in another clinical trial

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Balloon occlusion microcatheter<br>Participants will undergo the PAE procedure using LC Bead LUMI delivered through a balloon occlusion microcatheter. | Device: Prostatic artery embolization<br>* 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.<br>|
| Experimental: Standard microcatheter<br>Participants will undergo the PAE procedure using LC Bead LUMI delivered through a standard microcatheter. | Device: Prostatic artery embolization<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with treatment related adverse events assessed by CTCAE v4.0. |  | 12 months post PAE | 
| Mean change from baseline in symptom score using the IPSS scale at 6 months |  | Baseline and 6 months post PAE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in Qmax (maximum urinary flow) |  | Baseline, 6 months and 12 months post PAE | 
| Mean change from baseline in PVR (post void residual) |  | Baseline, 6 months and 12 months post PAE | 
| Mean change from baseline in prostate volume |  | Baseline, 6 months and 12 months post PAE | 
| Mean change from baseline in IPSS to measure long-terms subjective outcome |  | Baseline, 12 and 24 months post PAE | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign prostatic hyperplasia (BPH), Prostatic artery embolization (PAE), Lower urinary tract symptoms (LUTS), Prostate artery embolization