Use of a Novel Radiopaque Embolic Agent in Prostatic Artery Embolisation for Symptomatic Benign Prostatic Enlargement
试验速览
- 阶段
- 2 期
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Adverse event rate
研究概览
简要总结
This is a study protocol for the use of a novel radiopaque embolic agent in the treatment of lower urinary tract Symptoms (LUTS) with prostatic artery embolisation (PAE). This study will allow us to evaluate the safety and efficacy of this embolic in PAE along with giving us a better understanding of embolic distribution.
详细描述
This is a study protocol for the use of a novel radiopaque embolic agent in the treatment of lower urinary tract Symptoms (LUTS) with prostatic artery embolisation (PAE). This study will allow us to evaluate the safety and efficacy of this embolic in PAE along with giving us a better understanding of embolic distribution. It would also give us answers to:
- How does embolic efficacy compare to current available embolic agents?
- Does enhancement on rotational CT correlate with embolic distribution?
- How does embolic distribution compare with tissue infarction?
- Does the density of embolic packing correlate with degree of infarction and volume loss?
- How predictable is superselective target embolisation?
- Does embolic distribution vary with anatomy and gland size?
- Does embolic distribution tally with glandular enhancement/ transitional zone vascularity?
- If visible, what is the effect and significance of non target embolisation? This is a cohort study aiming to recruit 22 patients to power a non-inferiority assessment comparing the novel embolic agent against current available embolics.
Data will be added to our on going local registry of patients who have undergone this procedure . This will provide information about how safe and effective it is for patients and how it compares to the other established embolic agents such as polyvinyl alcohol (PVA) and other spherical agents such as Embospheres and Embozenes.
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
盲法说明
No masking
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 50-80 Moderate to severe lower urinary tract symptoms secondary to benign prostatic enlargement (BPE) IPSS>14, QOL≥4 Prostate volume ≥ 40 cc Maximum urinary flow rate < 12ml/s Medically refractory BPE > 6 months (or unable/ unwilling to tolerate medical treatment due to side effects)
排除标准
- •Atherosclerosis of the prostatic arteries Surgical indications (Chronic retention, bladder diverticulae, urethral stenosis), detrusor instability, neurogenic bladder Malignancy (TRUS/ MRI/ Biopsy proven). PSA > 4 or high SWOP risk need prostate biopsy Urodynamics - non-obstructed eGFR ≤ 45ml min-1m-2
结局指标
主要结局
Adverse event rate
时间窗: 12 months
Rate of adverse events compared with currently available other embolic agents
次要结局
- Scale of symptomatic improvement(12 months)