Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE): Open Multicentric Randomized Study for Evaluation of Outcomes, Complications, and Health Economics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 8
- 主要终点
- Improvement of lower urinary tract symptoms
研究概览
简要总结
This study focuses on the treatment of benign prostatic hyperplasia which causes lower urinary tract symptoms.
The purpose of the research project is to evaluate PAE in terms of both medical and health economic outcomes. To evaluate whether there are any differences in effect (IPSS), complications, costs and perceived quality of life compared with TUR-P.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Benign prostatic hyperplasia where medical treatment has not helped or for other reasons has not been deemed applicable
- •Prostate volume [40-80] ml measured via transrectal ultrasound
- •Peak flow rate (Qmax) <= 15 ml / s,
- •Verified obstruction by urodynamic studies (cystometry)
- •Surgery not contraindicated
排除标准
- •Prostate cancer
- •Severe atherosclerosis
- •Kidney failure
- •Urethral stricture
- •Active cystitis or prostatitis
- •Bladder stone.
- •Neurogenic bladder disorder
- •Contrast product allergy
结局指标
主要结局
Improvement of lower urinary tract symptoms
时间窗: 24 months
Assess the change in the lower urinary tract symptoms using the International Prostate Symptom Score (IPSS) questionnaire before and after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP)
Health care costs
时间窗: 24 months
Assess the health care costs after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP)
次要结局
- Quality of life (Short Form Health Survey [EQ-5D-5L ])(24 months)
- Prostate-Specific Antigen (PSA)(24 months)
- Erectile function(24 months)
- Adverse effects,(24 months)