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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2019-02-28

Brief Summary

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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).

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Detailed Description

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EmboProstate is an observational study that collects data of patients with benign prostatic hyperplasia that are treated with 250 µm Embozene ® Microspheres (Boston Scientific). The study evaluates the efficacy and safety of the microspheres for prostatic arterial embolization for benign prostata hyperplasia treatment. 10 adult male subjects will be enrolled in this study. If eligible patients are recruited, they will undergo the prostate artery embolization procedure in our radiology department. Once the catheter is placed in the prostate artery, a fluid containing thousands of tiny particles (microspheres) is injected through the catheter into these small arteries which nourish the prostate. The injected embospheres will slow the blood flow to the prostate reducing urinary tract symptoms caused by BPH. Within one week after PAE as well as after one, three and six months post-procedure an MRI examination ill occur. A follow-up visit using a questionnaire is due after 6 months.

Conditions

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Benign Prostatic Hyperplasia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Embozene

Patients receiving Embozene microspheres

Embozene Microspheres

Intervention Type DRUG

Intraarterial application

Interventions

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Embozene Microspheres

Intraarterial application

Intervention Type DRUG

Other Intervention Names

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Vascular embolization

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No