Prostatic Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)
Not Applicable
Withdrawn
- Conditions
- Benign Prostatic HyperplasiaLower Urinary Tract Symptoms
- Interventions
- Device: Prostatic artery embolization
- Registration Number
- NCT04563221
- Lead Sponsor
- Andrew Picel
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Balloon occlusion microcatheter Prostatic artery embolization Participants will undergo the PAE procedure using LC Bead LUMI delivered through a balloon occlusion microcatheter. Standard microcatheter Prostatic artery embolization Participants will undergo the PAE procedure using LC Bead LUMI delivered through a standard microcatheter.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Stanford University
🇺🇸Palo Alto, California, United States