NCT04807010尚未招募3 期
PROARTE -PROstate ARTery to Reduce the Symptoms of Benign Prostatic Hyperplasia
Society of Interventional Radiology Foundation0 个研究点目标入组 108 人开始时间: 2021年8月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 主要终点
- International Prostate Symptom Score
研究概览
简要总结
This is a trial to demonstrate the superiority of prostate artery embolization (PAE) over sham procedure in men with benign prostatic hyperplasia (BPH) induced lower urinary tract symptoms (LUTS). The trial will aim to enroll 108 patients at a 2:1 allocation over a 2 year period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients and those recording response will be blinded to cohort allocation.
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •• Men ≥45 and ≤90 years presenting with benign prostatic hyperplasia with symptoms for at least 6 months that are refractory to medical management or in whom medications are contraindicated, not tolerated, or refused.
- •International Prostate Symptom Score (I-PSS) score 14 or greater.
- •Quality of Life (QoL) score ≥ 3
- •Peak urinary flow (Qmax) less than or equal to 12 mL/s with void volume >125mL.
- •Prostate volume greater than 30 cc as determined by ultrasound, MRI, or CT.
- •Personal risk <40% based on the University of Texas San Antonio prostate cancer risk calculator or having a negative prostate biopsy for cancer within the last 24 months.
- •Able to provide written consent.
- •Not participating in any other investigational drug or device studies.
排除标准
- •• History of biopsy-proven prostate cancer
- •Renal insufficiency (glomerular filtration rates (GFR) less than 40mL/min/1.73 m2 who are not already on dialysis)
- •Prior prostate surgery or intervention, including trans-urethral resection of the prostate, balloon dilation, stent implantation, laser prostatectomy, radiation, UroLift®, or hyperthermia
- •Other bladder or urethral pathology requiring therapy, either in the past or currently, including neurogenic bladder, sphincteric abnormalities, bladder cancer, or other causes of bladder atonia.
- •Other causes of urinary obstruction, such as strictures of urethra or ureters, not related to BPH
- •Current decompensated congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression.
- •Neurological disease, including multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, and previous spinal nerve surgery
- •Patients with platelet count <50,000/μL or International Normalized Ratio (INR) >1.8, unless corrected for the procedure
- •Active urinary tract infection. Patients must have a negative culture within 7 days of the procedure.
- •Allergy to iodinated contrast agents unless pre-treated by corticosteroids.
- •Acute urinary retention.
- •Post void residual (PVR) > 250 mL with urodynamic evidence of atonic bladder. Patients with a PVR >250 but urodynamic testing consistent with obstruction will be allowed.
- •Bladder stone within three months prior to the procedure.
- •Hematuria not evaluated by Urologist for causes other than BPH.
- •Previous rectal surgery (excluding hemorrhoidectomy) or history of rectal disease.
- •Prior pelvic irradiation or radical pelvic surgery.
- •Imaging exclusion criteria:
- •Internal iliac artery occlusion as determined by either CT or MRI.
结局指标
主要结局
International Prostate Symptom Score
时间窗: 6 months
A survey accessing patient symptomology from BPH induced LUTS
次要结局
- Number of hospital days(1 month)
- International Prostate Symptom Score(1, 3, 6, 9, 12, 24, 36 months)
- Quality of Life(1, 3, 6, 9, 12, 24, 36 months)
- Ejaculatory function(3, 6, 9, 12, 24, 36 months)
- Recover experience(1 month)
- Adverse events(7 days and 1, 3, 6, 9, 12, 24, 36 months)
- Freedom from secondary intervention to treat BPH(1, 3, 6, 9, 12, 24, 36 months)
- Urinary Continence(1, 6, and 12 months)
- Maximal urinary flow rate change from baseline(6, 12, 24, and 36 months)
- International Index of Erectile Function questionnaire (IIEF)(1, 3, 6, 9, 12, 24, 36 months)
- Post void residual change from baseline(6, 12, 24, and 36 months)
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