Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia: Single Subject Study Design
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Mean Change in IPSS at 6 Months
研究概览
简要总结
Purpose: The purpose of this study is to determine if prostatic artery embolization (PAE) is as effective as medication (non-inferiority) in reducing urinary symptoms due to benign prostatic hyperplasia (BPH) and to determine if PAE will result in less adverse events compared to medication in individual patients.
Participants: Study subjects will be 30 men who have taken BPH medication for at least 6 months and planning to undergo PAE. Subjects will be enrolled across 3 sites.
Procedures (methods): This will be a single arm, non-blinded study of PAE using HydroPearl Beads. Subjects will be compared to themselves. The study will involve 6 study visits: an enrollment/baseline visit, the PAE procedure, and 1 day, 3 month, 6 month, and 12 month follow-up visits. Subjects will complete questionnaires and uroflowmetry testing at baseline and each follow-up visit. Subjects will also obtain an MRI at baseline and their 6 month follow-up visit.
详细描述
This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of 30 subjects with benign prostate hyperplasia (BPH) to investigate the effectiveness of prostatic artery embolization (PAE) relative to previous medication alone for reducing urinary symptoms due to BPH. Secondary aims will be to assess adverse effects of medication vs adverse events secondary to PAE as well as Quality of Life scores on medication vs after PAE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Prostate gland measures ≥50 grams measured by MRI, CT, or ultrasound
- •Have previously taken BPH medications including either alpha blockers, 5-alpha reductase inhibitors or the combination of both for 6 months
- •Capable of giving informed consent
- •Life expectancy greater than 1 year
排除标准
- •Severe vascular disease as defined by severe arterial calcification seen on prior imaging, history of lower extremity or pelvic bypass grafts or history of lower extremity or pelvic arterial stenting. For patients that do not have prior imaging at UNC, we will rule out suspected severe arterial calcification given their medical history.
- •Uncontrolled diabetes mellitus which is defined as Hemoglobin A1C >8%
- •Patients currently taking SGLT2 inhibitors (cana-, dapa-, empa-, and ertu- gliflozin) due to their diuretic effects
- •A smoking history of 20 pack-year or greater obtained by patient report
- •Prior myocardial infarction
- •A stroke within the last 6 months
- •Unstable angina
- •Immunosuppression
- •Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.
- •Complete urinary retention
- •Impaired kidney function (serum creatinine level > 1.8 mg/dl or a glomerular filtration rate < 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
- •Confirmed or suspected bladder cancer as assessed based on patients' medical history or current hematuria
- •Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology
- •Ongoing urogenital infection. For patients with symptoms of a urogenital infection (dysuria, fever, etc.), a urinalysis will be obtained.
- •Previous pelvic radiation or radical pelvic surgery
- •Confirmed malignancy of the prostate or a history of prostate cancer
- •Contrast hypersensitivity refractory to standard medications (antihistamines, steroids)
结局指标
主要结局
Mean Change in IPSS at 6 Months
时间窗: baseline to 6 months following the procedure
The International Prostate Symptom Score (IPSS) includes 7 Likert-type questions related to symptoms with scores ranging from 0 to 5, where 0 is less severe. The IPSS is a written screening tool used to: screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Total scores are determined to be Mild (1-7), Moderate (8-19), or Severe (20-35).
次要结局
- Mean Change in Urine Flow(Baseline to 6 months following the procedure)
- Mean Change in Quality of Life Scores at 6 Months(baseline to 6 months following the procedure)
- Mean Change in Prostate Volume(baseline to 6 months following the procedure)
- Mean Percent of Prostate Infarcted(6 months following the procedure)
- Incidence of Treatment Related Adverse Events (Proportion)(up to 3 months following the procedure)
- Incidence of Treatment Related Adverse Events (Percent)(up to 3 months following the procedure)