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

An Observational Study to Evaluate the Safety and Efficacy of Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia

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).

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Drug: Embozene Microspheres

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Germany
  • Thuringia
    • Jena, Thuringia, Germany, 07740
      • Department of Radiology, University Hospital Jena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic (within clinical routine)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Embozene; Patients receiving Embozene microspheres	Drug: Embozene Microspheres; Intraarterial application; Other Names: Vascular embolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptomatic improvement of BPH symptoms (= International Prostate Symptom Score (IPSS) < 18 and reduction > 25% QoL (Quality of Life) < 4 & reduction ≥ & / or Qmax > 15 ml/s & increase of Qmax ≥ 3,0ml/s) at 6 and 12 months post intervention	Improvement of feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia	Baseline, follow-up after 1 months, 6 months, 12 months, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the safety of prostate artery embolization (PAE) for the treatment of lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH)	The number and the severity of adverse events will be recorded to evaluate the safety of prostate artery embolization. Events will be reported by subjects within the 1st week after PAE and at follow-up after 6 months.	Within 1st week after PAE and follow-up after 1 months, 6 months, 12 months, 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Qmax (reduction of postvoid residual volume)	Measure of urine flow rate. Q max = max flow rate	Follow-up after 6 months
Reduction of prostate volume determined by volumetric measurement (MRI / transrectal Ultrasound)	Measuring the percentage of prostate tissue devascularized, based on contrast-enhanced MRI by estimating the prostate volume and the estimated portion that is non-perfused on MRI.	Follow up MRI examinations: within the first week after PAE, 1, 3 and 6 months after PAE

Collaborators and Investigators

• Sponsor: Jena University Hospital
• Collaborators: Boston Scientific Corporation
• Investigators: Study Director: Ulf Teichgräber, Prof., Institute of Diagnostic and Interventional Radiology; Study Chair: Marc-Oliver Grimm, Prof., Department of Urology; Principal Investigator: Tobias Franiel, Dr. med., Institute of Diagnostic and Interventional Radiology

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2014
• Primary Completion (ACTUAL): November 1, 2018
• Study Completion (ACTUAL): February 1, 2019

Study Registration Dates

• First Submitted: July 29, 2014
• First Submitted That Met QC Criteria: July 31, 2014
• First Posted (ESTIMATE): August 1, 2014

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2019
• Last Update Submitted That Met QC Criteria: June 12, 2019
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: BPH; Benign prostatic hyperplasia
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: 3952-12/13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No