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Efficacy of Prostatic Artery Embolization (PAE) in Patients With Severe Benign Prostatic Hyperplasia (BPH)

2017年9月13日 更新者：University of North Carolina, Chapel Hill

Efficacy of Prostatic Artery Embolization (PAE) in Patients With Severe Benign Prostatic Hyperplasia (BPH) As an Alternative to Open Prostatectomy

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This will be an open label pilot study with a small population undergoing an intervention to determine safety and efficacy.

研究类型

介入性

注册 (实际的)

15

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • North Carolina
      • Chapel Hill、North Carolina、美国、27599
        • Unc Hospitals

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Male
  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：设备可行性
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Prostatic artery embolization
Microspheres measuring 100-300 microns will be injected under fluoroscopic guidance into the left and right prostatic arteries for embolization.
设备：Microspheres
Prostatic artery embolization (PAE) is a new procedure that decreases the size of the prostate by blocking its arterial blood flow. Through a tiny puncture in the upper thigh or forearm a catheter is directed to the prostatic artery using fluoroscopic guidance. Once in place, sub-millimeter particles are injected that obstruct the prostatic arteries resulting in gland ischemia, and ultimately, reduction in size. The technique has only been recently developed in Portugal and Brazil and has similarities to Uterine Artery Embolization used to treat uterine fibroids.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Prostate size (grams)
大体时间：1 year
Reduction in size of the prostate to less than 80 grams
1 year
Lower urinary symptoms (Arbitrary units)
大体时间：1 year
Improvement of LUTS as defined by IPSS score <18.
1 year

次要结果测量

结果测量
措施说明
大体时间
Procedure completion without complication (percentage)
大体时间：1 year
Completion of PAE without major complication
1 year
Sexual Function (Arbitrary units)
大体时间：1 year
Stability or improvement of sexual function as determined by an unchanged or improved score on the International Index of Erectile Function (IIEF) questionnaire
1 year
Quality of Life (Arbitrary units)
大体时间：1 year
Improvement of quality of life as determined by an improved score on Quality of Life questionnaire
1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of North Carolina, Chapel Hill

调查人员

  • 首席研究员：Ari Isaacson, MD、University of North Carolina, Chapel Hill

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2014年7月1日

初级完成 (实际的)

2017年5月1日

研究完成 (实际的)

2017年5月1日

研究注册日期

首次提交

2014年6月17日

首先提交符合 QC 标准的

2014年6月17日

首次发布 (估计)

2014年6月19日

研究记录更新

最后更新发布 (实际的)

2017年9月14日

上次提交的符合 QC 标准的更新

2017年9月13日

最后验证

2017年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 13-3445

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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