Prostatic Artery Embolization for Obstructive Uropathy Due to Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Ability to void spontaneously
研究概览
简要总结
The aim of this study is to investigate the safety and efficacy of prostatic artery embolization of patients with recurrent symptoms secondary to locally advanced prostatic cancer including pelvic pain, bleeding or need for permanent urinary catheter who are unfit for or refuse surgical treatment.
详细描述
This is a prospective study investigating the safety and efficacy of PAE for patients with prostate cancer who suffers from acute urinary retention, severe LUTS and/or recurrent complications such as haematuria.
Our hypothesis is that PAE will eliminate the need for indwelling catheter and improve IPSS and QoL 12 months post-procedure.
1, and 6 months follow-up.
Main outcome Ability to void after removal of indwelling catheter
Secondary outcomes International Prostate Symptom Score (IPSS) Quality of Life (QoL) International Index of Erectile Function (IIEF) Prostate volume Peak void flow (Qmax) Post-void residual (PVR) Classify complications according to Society of Interventional Radiology (SIR) guidelines for reporting Prostate-specific antigen (PSA)
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
- •Indwelling catheter secondary to locally advanced prostate cancer (PCa) or
- •Moderate-severe Obstructive LUTS secondary to PCa
- •Unsuitable for or refuse surgery
排除标准
- •Bladder dysfunction(and known neurological conditions affecting bladder function)
- •Urethral strictures
- •Bladder neck contracture
- •Known sphincter anomalies
- •Big bladder diverticulum or stones
- •Kidney insufficiency (eGFR < 45)
- •Coagulation disturbances
- •Severe atheromatous or tortuosity of arteries
- •Allergy to contrast medium
- •Unable to undergo MR imaging
- •Bladder malignancy
研究组 & 干预措施
Prostatic Artery Embolization
Embolization of the prostatic arteries to induce necrosis and a reduction of the prostate volume.
干预措施: Prostatic Artery Embolization (Procedure)
结局指标
主要结局
Ability to void spontaneously
时间窗: 1 months
The ability to void after removal of the indwelling catheter
次要结局
- IPSS(1, 6 months)
- IIEF(1, 6 months)
- PV(1, 6 months)
- PVR(1, 6 months)
- Qmax(1, 6 months)
- PSA(1, 24-hours, 6 months)
- QoL(1, 6 months)
研究者
Brian Malling
MD
Rigshospitalet, Denmark