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

Benign Prostatic Hyperplasia Clinical Trial

— EmboProstate  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02206243
• Other study ID #: 3952-12/13
• Status: Completed
• Start date: September 2014
• Est. completion date: February 2019

Study information

• Verified date: November 2017
• Source: Jena University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Embozene Microspheres
Intraarterial application

Locations

Country	Name	City	State
Germany	Department of Radiology, University Hospital Jena	Jena	Thuringia

Sponsors (2)

Lead Sponsor	Collaborator
Jena University Hospital	Boston Scientific Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Qmax (reduction of postvoid residual volume)	Measure of urine flow rate. Q max = max flow rate	Follow-up after 6 months
Other	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
Primary	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	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