Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia

• Status: Completed
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this observational study is to evaluate the prostatic arterial embolization (PAE) with Embozene® Microspheres (Boston Scientific) in sphere sizes of 250 µm for the treatment of symptomatic benign prostatic hyperplasia (BPH).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jena University Hospital
• Collaborator: Boston Scientific Corporation

Criteria

Inclusion Criteria:

• male

• adults > 40 years old

• severe symptomatic BPH with IPSS > 18 and/or QoL > 3 or maximum urinary flow rate (Qmax) ≤ 15 ml/sec or transurethral catheter for retention

• no improvement after or intolerance of medical treatment for at least six months

• prostatic volume > 30 cm³

Exclusion Criteria:

• female

• less than 40 years old

• eGFR < 45 ml/min * m²

• suspicion of prostatic malignancy

• prostatic malignancy

• acute prostatitis or cystitis

• hydronephrosis

• bladder stone or bladder diverticulum

• urethral stenosis

• major surgery within 4 weeks prior to the screening visit

• active clinically serious infection

• progressive arteriosclerosis

• contraindications against angiography