Benign Prostatic Hyperplasia
Conditions
Keywords
Benign prostatic hyperplasia, BPH
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.
Interventions
Intraarterial application
Sponsors
Boston Scientific Corporation
Jena University Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Qmax (reduction of postvoid residual volume) | Follow-up after 6 months | Measure of urine flow rate. Q max = max flow rate |
| 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 | 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. |
Countries
Germany
Outcome results
None listed