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

NCT02206243 | Completed

• 1 other identifier: 3952-12/13
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign prostatic hyperplasia; BPH

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluate the safety of prostate artery embolization (PAE) for the treatment of lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH)

  Within 1st week after PAE and follow-up after 1 months, 6 months, 12 months, 24 months

Other Outcomes (2)

• Change in Qmax (reduction of postvoid residual volume)

  Follow-up after 6 months

• Reduction of prostate volume determined by volumetric measurement (MRI / transrectal Ultrasound)

  Follow up MRI examinations: within the first week after PAE, 1, 3 and 6 months after PAE

Study Arms (1)

Embozene

Patients receiving Embozene microspheres

Drug: Embozene Microspheres

Interventions

Embozene Microspheres DRUG

Intraarterial application

Also known as: Vascular embolization

Embozene

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic (within clinical routine)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jena University Hospital: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Department of Radiology, University Hospital Jena

Jena, Thuringia, 07740, Germany

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Ulf Teichgräber, Prof.

  Institute of Diagnostic and Interventional Radiology

  STUDY DIRECTOR

• Marc-Oliver Grimm, Prof.

  Department of Urology

  STUDY CHAIR

• Tobias Franiel, Dr. med.

  Institute of Diagnostic and Interventional Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: August 1, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2018
• Study Completion: February 1, 2019
• Last Updated: June 14, 2019

Record last verified: 2017-11

Locations

DE (1)