Clinical trial NCT02206243: Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign prostatic hyperplasia
BPH
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2014-08-01
Enrollment: 300
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic (within clinical routine)

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline, follow-up after 1 months, 6 months, 12 months, 24 months
Secondary outcomes:
measure: Evaluate the safety of prostate artery embolization (PAE) for the treatment of lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH)
timeFrame: Within 1st week after PAE and follow-up after 1 months, 6 months, 12 months, 24 months
Other outcomes:
measure: Change in Qmax (reduction of postvoid residual volume)
timeFrame: Follow-up after 6 months
measure: Reduction of prostate volume determined by volumetric measurement (MRI / transrectal Ultrasound)
timeFrame: Follow up MRI examinations: within the first week after PAE, 1, 3 and 6 months after PAE
Locations:
city: Jena
country: Germany
facility: Department of Radiology, University Hospital Jena
state: Thuringia
Study officials:
affiliation: Institute of Diagnostic and Interventional Radiology
name: Ulf Teichgräber, Prof.
role: STUDY_DIRECTOR
affiliation: Department of Urology
name: Marc-Oliver Grimm, Prof.
role: STUDY_CHAIR
affiliation: Institute of Diagnostic and Interventional Radiology
name: Tobias Franiel, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: