An Observational Study to Evaluate the Safety and Efficacy of Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Embozene
Patients receiving Embozene microspheres
干预措施: Embozene Microspheres (Drug)
结局指标
主要结局
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
时间窗: 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
次要结局
- 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)