Prostate Embolization for Benign Prostatic Hyperplasia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Detection of Bladder Injury
研究概览
简要总结
This is a Phase I/II investigator sponsored FDA-approved Investigational Device Exemption protocol, with the primary goal of determining the safety of prostatic artery embolization (PAE) for benign prostatic hyperplasia. Our primary goal is to document the frequency of side effects, particularly bladder and rectal complications, which may occur as a result of this procedure. Secondarily, the study will provide preliminary data to determine its effectiveness in diminishing obstructive symptoms associated with BPH.
详细描述
Objectives of the investigation
This study has a primary goal of determining the safety of prostatic artery embolization (PAE) for benign prostatic hyperplasia. Our primary outcome is the frequency of adverse events, particularly bladder and rectal complications, which may occur as a result of this procedure. Secondarily, the study will allow us to begin to determine its effectiveness in diminishing obstructive symptoms associated with BPH.
Duration of investigation
The investigation will enroll 30 patients, with a target enrollment period of less than 12 months. Each patient will be consented for follow-up up to 5 years, but each patient will reach the first important safety endpoint 1 week after treatment and the first clinical efficacy assessment 3 months after treatment.
Objectives
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
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •You must have symptoms from BPH for at least 6 months
- •Your symptoms must meet the entrance criteria, as determined by a short questionnaire you will be asked to complete.
- •You must have urinary flow rates that meet entrance criteria, as measured by a simple urination test.
- •Enlargement of the prostate, as measured by the urologist, with a volume of between 50 and 100 cc.
- •You must be at least 50 years of age, but not more than 90.
排除标准
- •Prostate Cancer
- •Blockage of major arteries in your pelvis or other arterial abnormalities that prevent embolization or that might increase risks of injury. You will be screened for these conditions if you consent to participate.
- •Significantly decreased kidney function
- •Prior prostate surgery, whether it has been performed via a scope through the penis or with conventional surgery.
- •Bladder or urinary conditions other than BPH requiring therapy. You will be screened for these conditions if you consent to participate.
- •History of cardiac rhythm abnormalities, congestive heart failure, uncontrolled diabetes, significant respiratory disease, or known immunosuppression.
- •History of clotting disorders.
- •Current medications (use of alpha-blockers within two months, 5-alpha-reductase inhibitors within six months, anti-cholinergics within two months, and beta blockers, antihistamines, anticonvulsants, or antispasmodics within one week of treatment unless you have been on the same drug with a stable urination pattern.
- •Active urinary tract infection
- •Allergy to iodinated contrast agents, collagen or gelatin products
- •Acute urinary retention that has NOT been treated by a urinary catheter.
- •Significant retained urine after voiding as measured by ultrasound. In this case, significant means more than 250 ml (about 1 cup).
- •Bladder stones or blood in urine within three months
- •Previous rectal surgery, excluding hemorrhoidectomy (removal of hemorrhoid), or history of rectal disease
- •Prior pelvic irradiation or radical pelvic surgery
- •If you are interested in future fertility
- •Unable to speak and read English.
结局指标
主要结局
Detection of Bladder Injury
时间窗: 3 months after treatment
Bladder injury as detected by cystoscopy
Detection of a Bladder Injury
时间窗: 6 months after treatment
Bladder injury detected by cystoscopy
Number of Participants With Bladder or Rectal Injury
时间窗: Evaluated 1 week after procedure
Bladder injury as detected by cystoscopy. Rectal injury detected by anoscopy.
Detection of a Bladder Injury by Cystoscopy
时间窗: 12 months after the procedure
Number of patients with a bladder injury detected by cystoscopic examination
次要结局
- International Prostate Symptom Score (IPSS)(1week, 3 months, 6months, 12months)
- QMax (Peak Urinary Flow)(1week, 3 months, 6months, 12months)
- International Index of Erectile Function (IIEF)- 5(1week, 3 months, 6months, 12months)
研究者
James B. Spies, MD
Chair, Department of Radiology
Georgetown University