Embosphere® PROstate Post Market Study

Merit Medical Systems

Status: Completed

Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia

Treatments: Device: Prostate artery embolization

Study type: Observational

Funder types: Industry

Identifiers

NCT03527589

PAE-P4-17-01

Details and patient eligibility

About

Prostatic artery embolization with Embosphere Microspheres is a relatively new procedure. The goal of this post market study is to evaluate long-term safety and effectiveness in a 'real world' setting.

Full description

This is a prospective, open label post market study to evaluate the long-term safety and effectiveness of prostatic artery embolization (PAE) using Embosphere Microspheres. Up to 500 patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be enrolled in this single arm post market study. All patients at sites who meet eligibility criteria will be offered participation. Long term effectiveness of PAE on LUTS will be evaluated by International Prostate Symptom Score (IPSS) at baseline, 3 months, 12 months and 24 months. Safety will be assessed by evaluating device or procedure-related adverse events at the same time points, plus at 4 weeks following embolization. Erectile function will be assessed at baseline and 12 months by Sexual Health Inventory for Men (SHIM) score. Additional treatments for refractory or recurrent LUTS due to BPH post prostatic artery embolization will also be recorded.

Enrollment: 499 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has signed informed consent
• Patient age is 18 years or older at time of informed consent
• Patient will undergo prostatic artery embolization with Embosphere Microspheres for the treatment of symptomatic benign prostatic hyperplasia with lower urinary tract symptoms

Exclusion criteria

• Patient is unable or unwilling to provide follow-up information
• Patient is undergoing prostatic artery embolization for reasons that do not include symptomatic benign prostatic hyperplasia with lower urinary tract symptoms
• Any other reason the investigator deems cause for exclusion

Trial design

499 participants in 1 patient group

Treated with Embosphere Microspheres

Description:

Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres (size of embolic determined at Investigator discretion).

Treatment:

Device: Prostate artery embolization