EUCTR2020-000915-53-DK进行中（未招募）1 期
Randomized double-blind placebo-controlled trial on the efficiency of a single dose dexamethasone in reducing the postembolization syndrome in men undergoing prostatic artery embolization for benign prostatic hyperplasia - DEXAPAE
Department of Radiology, Rigshospitalet, Denmark0 个研究点目标入组 60 人开始时间: 2020年3月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •INCLUSION CRITERIA:
- •- Diagnosis of LUTS secondary to BPH refractory to/contraindicated for medical treatment or not patient preference.
- •- Moderate to severe urinary symptoms on IPSS (IPSS score equal or over 8)
- •- Qmax <=15ml/sec, based on flowmetry
- •- Unsuitable for TURP or refuses surgery
- •- Ability to understand and the willingness to sign an informed consent
- •- Prostate volume > 80 milliliters
- •- Men with low-risk prostate cancer (T1c, Gleason score <=6 on a maximum of 3 biopsies) who have LUTS due to a large BPH component is allowed.
- •- Indwelling catheter or intermittent catheter is allowed
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
排除标准
- •EXCLUSION CRITERIA:
- •- History of bladder cancer
- •- Previous pelvic radiation for cancer treatment
- •- Bladder stones, significant bladder diverticula
- •- Current urethral strictures or bladder neck contracture
- •- Neurologic conditions such as multiple sclerosis, Parkinson’s disease and other neurological diseases known to affect bladder function
- •- Neurogenic bladder
- •- Active urinary tract infection at the time of intervention unless in case of regular catheter dependence and thought to represent colonization
- •- Documented bacterial prostatitis in the last year
- •- Severe atheromatous disease or other pathology preventing catheter-based intervention (as rated on CT angiography by an interventional radiologist)
- •- Allergy to iodinated contrast media
- •- Renal failure (eGFR < 30ml/min)
- •- High bleeding risk (spontaneous INR > 1.6)
- •- Contraindication to conscious sedation
- •- Allergy to dexamethasone
- •- Positive HIV, hepatitis B or C
- •- Immunoinflammatory disease (except topically treated skin or respiratory diseases)
- •- Glaucoma
- •- Active peptic or duodenal ulcer
- •- Systemic fungal infections
- •- Immunosuppressive treatment
- •- Current treatment of cancer
研究者
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