Prostatic Artery Embolization vs. Pharmacotherapy for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 425
- 主要终点
- International Prostate Symptoms Score (IPSS)
研究概览
简要总结
This study compares safety and efficacy of prostatic artery embolization and pharmacotherapy in the treatment of lower urinary tract symptoms associated wit benign prostatic hyperplasia.
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 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •men ≥45 years of age
- •lower urinary tract symptoms assigned to BPH (diagnosis by medical history and physical examination)
- •IPSS ≥ 8 points
- •QoL ≥ 3 points
- •Qmax ≤ 15 ml/s with a minimum voided volume ≥ 125 ml
- •informed consent for study participation
排除标准
- •renal impairment (GFR < 30ml/min)
- •previous prostatic surgery
- •5-alpha reductase inhibitor (5-ARI) use within 6 mo (or dutasteride within 12 mo) prior to entry, or use of an α-blocker or phytotherapy for BPH within 2 weeks prior to entry
- •history or evidence of prostate cancer
- •absolute indication for surgical treatment of complications related to BPH (i.e. bladder stones, renal impairment due to bladder outlet obstruction)
- •history of neurogenic bladder dysfunction
- •not able to complete questionnaires due to cognitive or thought disorders
- •language skills insufficient for informed consent and / or completion of questionnaires
研究组 & 干预措施
Prostatic Artery Embolization (PAE)
PAE will be performed as an inpatient or outpatient procedure by interventional radiologists who are familiar with the procedure and according to established techniques. A unilateral femoral sheath is placed in the right common femoral artery under local anaesthesia. The prostatic arterial supply is identified by selective internal iliac arteriography. Prostatic arteries are selectively catheterised and embolised by use of 250-600 μm microspheres . PAE is performed bilaterally if possible and considered successful in the absence of the normal blush of the prostate and stasis of flow in the prostate arteries on angiography after embolisation.
干预措施: Prostatic Artery Embolization (PAE) (Procedure)
Pharmocotherapy
Pharmacotherapy will be performed using α1-blockers and 5α-reductase inhibitors in accordance with the EAU recommendations. Thus, patients with a prostate size smaller than 40mL will be treated with 0.4 mg tamsulosin once daily, while patients with larger prostates will be treated with 0.4 mg tamsulosin plus 0.5 mg dutasteride once daily during the complete study follow-up.
干预措施: Pharmacotherapy (Drug)
结局指标
主要结局
International Prostate Symptoms Score (IPSS)
时间窗: 24 months after treatment initiation
The International Prostate Symptoms Score (IPSS) measures the degree of symptoms associated with benign prostatic hyperplasia (BPH). Range of values 0-35 points. Higher values indicate more severe symptoms.
次要结局
- International Prostate Symptoms Score (IPSS)(5 year after treatment initiation)
- Self-assessed goal achievement (SAGA)(5 years after treatment initiation)
- Maximum urinary stream (Qmax)(5 years after treatment initiation)
- Post void residual urine (PVR)(5 years after treatment initiation)
- Prostate volume(5 years after treatment initiation)
- Prostate specific antigen (PSA)(5 years after treatment initiation)
- Safety / adverse events(5 year after treatment initiation)
- Erectile function(5 year after treatment initiation)
- Ejaculatory function(5 years after treatment initiation)
- Need for additional drug treatment, surgical treatment or change of medical treatment assessed(5 years after treatment initiation)
- Analysis of cost-effectiveness using quality-adjusted life years (QALY)(5 years after treatment initiation)
研究者
Dominik Abt
Principal Investigator, Consultant urologist
Cantonal Hospital of St. Gallen