Prostatic Artery Embolization vs. Conventional Transurethral Prostatectomy in the Treatment of Benign Prostatic Hyperplasia: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Changes in the International Prostate Symptom Score
研究概览
简要总结
Benign prostatic hyperplasia (BPH) is a prevalent entity, affecting over 50% of men older than 60 years. The clinical picture of the disease includes lower urinary tract symptoms such as interrupted and weak urinary stream, nocturia, urgency and leaking and even sexual dysfunction in some individuals. Medical therapy is usually the first-line treatment. However, the efficacy of drugs like alpha-blockers is limited, and as disease progresses more invasive treatment options have to be taken into consideration. In cases with moderate to severe lower urinary tract symptoms (LUTS) transurethral resection of the prostate (TUR-P) is the standard treatment. TURP, however, is limited to prostates smaller than 60-80ml and the procedure is associated with a complication rate. The cumulative short-term morbidity rate is around 11% and the necessity for surgical revision is as high as 6%. Bleeding requiring transfusions and transurethral resection syndrome represent potentially serious threats to elderly and frail patients. Prostatic artery embolization (PAE) has been suggested as a minimal invasive alternative procedure, which can be performed in an outpatient setting with rapid recovery and low morbidity.
The investigators hypothesize that PAE is non-inferior in the treatment of symptomatic BPH compared to conventional and established 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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men older than 40
- •Patient must be a candidate for TURP
- •Refractory to medical therapy or patient is not willing to consider (further) medical treatment
- •Patient has a prostate size of at least 25 ml and not more than 80 ml, measured by ultrasound
- •Qmax<12 and/or urinary retention
- •Written informed consent
排除标准
- •Mild symptoms (IPSS <8)
- •Severe atherosclerosis
- •Severe tortuosity in the aortic bifurcation or internal iliac arteries
- •Acontractile detrusor
- •Neurogenic lower urinary tract dysfunction
- •Urethral stenosis
- •Bladder diverticulum
- •Bladder stone with surgical indication
- •Allergy to intravenous contrast media
- •Contraindication for MRI imaging
- •Preinterventionally proven adenocarcinoma of the prostate
- •Renal failure (GFR<60ml/min)
结局指标
主要结局
Changes in the International Prostate Symptom Score
时间窗: Baseline and 12 weeks after intervention
次要结局
- Pre- and postoperative changes in C-reactive Protein, Prostate-specific antigen (PSA), serum amyloid A, Interleukin-6 and Interleukin-10(Baseline and 1 day, 2 days, 1 and 6 weeks post intervention)
- Changes in urodynamic parameters(Baseline and 12 and 24 months after intervention)
- Changes of prostate volume using Magnetic Resonance Imaging(Baseline, 12 weeks and 24 months after intervention)
- Duration of hospitalization post procedure(hospital discharge)
- Changes in bladder diary(Baseline and at all follow up controls)
- Duration of post procedure catheterization(baseline and post intervention)
- Changes in the CPSI and IIEF(baseline and at all follow-up controls after the intervention)
- Percentage of prostate tissue devascularized, based on contrast-enhanced MRI(12 weeks and 24 months after intervention)
- Comparison of prostate size, measured preoperatively by TRUS and MRI at baseline Comparison of prostate size, measured preoperatively by TRUS and MRI at baseline Comparison of prostate size measured by TRUS and MRI(baseline)
- Procedure time and radiation parameters(after intervention)
研究者
Daniel Stephan Engeler
Dr. med.
Cantonal Hospital of St. Gallen