Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- Drug: Embozene Microspheres
- Registration Number
- NCT02206243
- Lead Sponsor
- Jena University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 300
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Embozene Embozene Microspheres Patients receiving Embozene microspheres
- Primary Outcome Measures
Name Time Method 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 Baseline, follow-up after 1 months, 6 months, 12 months, 24 months Improvement of feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia
- Secondary Outcome Measures
Name Time Method 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 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.
Trial Locations
- Locations (1)
Department of Radiology, University Hospital Jena
🇩🇪Jena, Thuringia, Germany