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

Andrew Picel

Status

Withdrawn

Conditions

Lower Urinary Tract Symptoms

Benign Prostatic Hyperplasia

Treatments

Device: Prostatic artery embolization

Study type

Interventional

Funder types

Other

Identifiers

NCT04563221

51982

Details and patient eligibility

About

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.

Sex

Male

Ages

45 to 85 years old

Volunteers

No Healthy Volunteers

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