Efficacy of Prostatic Artery Embolization (PAE) in Patients With Severe Benign Prostatic Hyperplasia (BPH) As an Alternative to Open Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Prostate size (grams)
研究概览
简要总结
Purpose: To evaluate the efficacy of prostatic artery embolization (PAE) in patients with benign prostatic hyperplasia (BPH) and refractory lower urinary tract symptoms (LUTS) in decreasing the volume of the prostate gland.
Participants: Study participants will be recruited from UNC Urology clinics as well as referring providers. We will include 15 men who are experiencing LUTS not controlled by medication with estimated prostate gland weight between 80 and 150 grams.
Procedures (methods): Enrolled patients will undergo the standard work-up for a surgical prostate procedure. In addition, the patient's arteries will be evaluated with a pelvic CT angiogram. Then, patients will undergo prostatic artery embolization. Follow up visits will be scheduled at 1, 3, 6, and 12 months after the procedure.
At the end of the follow-up period, if reduction in prostate gland size has made the patient eligible for transurethral therapy, they may proceed to such procedure or elect to undergo no further surgical procedure, depending on residual symptoms. Similarly, if insufficient gland size reduction has occurred, the patient may elect to pursue OP or no further procedure if they are no longer bothered by LUTS.
详细描述
This will be an open label pilot study with a small population undergoing an intervention to determine safety and efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Age > 40
- •Prostate gland measures between 80 and 150 grams
- •Have previously taken BPH medication for 6 months without desired improvement of LUTS or has started medication and stopped due to unwanted side effects
- •Moderate to severe LUTS as defined by IPSS score >18
- •Peak urine flow rate (Qmax) <12 ml/sec
- •Capable of giving informed consent
- •Life expectancy greater than 1 year
排除标准
- •Severe cardiac or pulmonary disease
- •Uncontrolled diabetes mellitus
- •Immunosuppression
- •Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.
- •Acute urinary retention
- •Glomerular filtration rate less than 45 as approximated using using serum creatinine levels.
- •Confirmed or suspected bladder cancer
- •Recent (within 3 months) cystolithiasis or gross hematuria
- •Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology
- •Active urinary tract infection
- •Previous rectal surgery or history of rectal disease if PAE, anoscopy or transrectal ultrasound are thought to potentially cause injury to the rectum due to the previous surgery or disease
- •Previous pelvic radiation or radical pelvic surgery
- •Confirmed or suspected malignancy of the prostate based on DRE, TRUS or PSA. (> 10 ng/ml or > 2.5 ng/ml and < 10 ng/ml with free PSA < 25% of total PSA without a negative biopsy)
- •Uncorrectable coagulopathy including INR > 2.5 or platelets < 30,000
研究组 & 干预措施
Prostatic artery embolization
Microspheres measuring 100-300 microns will be injected under fluoroscopic guidance into the left and right prostatic arteries for embolization.
干预措施: Microspheres (Device)
结局指标
主要结局
Prostate size (grams)
时间窗: 1 year
Reduction in size of the prostate to less than 80 grams
Lower urinary symptoms (Arbitrary units)
时间窗: 1 year
Improvement of LUTS as defined by IPSS score \<18.
次要结局
- Procedure completion without complication (percentage)(1 year)
- Sexual Function (Arbitrary units)(1 year)
- Quality of Life (Arbitrary units)(1 year)