Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Conditions
Keywords
Benign prostatic hyperplasia (BPH), Prostatic artery embolization (PAE), Lower urinary tract symptoms (LUTS), Prostate artery embolization
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.
Interventions
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.
Sponsors
Andrew Picel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed