NCT01835860已完成2 期
Prostatic Artery Embolization for Benign Prostatic Hyperplasia
Saskatchewan Health Authority - Regina Area2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2013年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Change from baseline in symptom severity at 1, 3, 6 and 12 months follow-up, as measured by International prostate symptoms score (IPSS).
研究概览
简要总结
To evaluate whether Prostatic Artery Embolization (PAE) might be an effective alternative treatment option for benign prostatic hyperplasia (BPH), in comparison to current gold standard surgical treatment- Transurethral Resection of Prostate (TURP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe lower urinary tract symptoms (i.e. International prostate symptom score IPSS>8) who are bothered by their symptoms (i.e., interfere with the daily activities of living)
- •Urinary retention (related to BPH) leading to catheterization.
- •Refractory to medical treatment or patient is not willing to consider medical treatment
- •Pre trans-urethral resection of prostate (TURP) to reduce the size of prostate gland if prostate is too big for TURP surgery.
排除标准
- •Mild symptoms (IPSS <8)
- •Moderate to severe lower urinary tract symptoms (i.e. IPSS>8) who are not bothered by their symptoms (i.e., symptoms do not interfere with the daily activities of living).
- •Suspected malignancy.
- •Any of the following clearly related to BPH- bladder stones, recurrent UTIs, and renal insufficiency.
- •Advanced atherosclerosis and unsuitable vascular access.
- •Allergy to intravenous contra
结局指标
主要结局
Change from baseline in symptom severity at 1, 3, 6 and 12 months follow-up, as measured by International prostate symptoms score (IPSS).
时间窗: 1, 3, 6 and 12 months
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
尚未招募
不适用
Comparison of Glue with Microparticles in Prostatic Artery EmbolizationBenign Prostatic HyperplasiaNCT06678308Almaviva Sante96
终止
不适用
Prostatic Artery Embolization vs Medication for Benign Prostatic HyperplasiaBPHEnlarged Prostate (BPH)Prostatic HyperplasiaNCT04398966University of North Carolina, Chapel Hill12
已完成
不适用
Prostatic Artery Embolization for Benign Prostatic ObstructionHyperplasia ProstaticLower Urinary Tract SymptomsProstatic DiseasesUrological ManifestationsNCT03099421Rigshospitalet, Denmark11
已完成
不适用
Prostate Artery Embolization for Symptomatic Benign Prostatic HyperplasiaBenign Prostate HyperplasiaNCT02822924Chinese University of Hong Kong82
已完成
不适用
Prostate Embolization in Chronically Surveyed Patients: Effectiveness of Unilateral vs. Bilateral EmbolizationUnilateral vs Bilateral Embolization of the Prostate ArteriesNCT04006431Centre Hospitalier Universitaire de Nīmes50