NCT03055624已完成不适用
Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
Investigator-initiated study to evaluate the safety and efficacy of prostate artery embolization for the treatment lower urinary tract symptoms in patients with benign prostatic hyperplasia
详细描述
This is a phase I/II, single center, prospective, single arm, investigational study to evaluate the safety and efficacy of prostate artery embolization (PAE) for treatment of severe lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH) in patients that have either failed or are intolerant to medical management. Once eligibility is confirmed, patients will undergo PAE with Embosphere Microspheres. Embolization will consist of a minimally invasive angiogram and treatment of the prostate arteries with the Embosphere particles to reduce blood flow to the prostate. Following treatment, patients will return for follow-up visits at 1, 6, 12, and 24 months post 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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate volume between 40 and 300 cm3
- •Diagnosis of BPH with moderate to severe lower urinary tract symptoms (LUTS) defined as at least one of the following:
- •a. IPSS greater than 18
- •b. IPSS Quality of Life (QoL) assessment greater than 3
- •c. Qmax less than 12 mL/sec
- •Refractory or intolerant to medical management
- •Ineligibility for or refusal of surgical management
- •One of the following criteria:
- •a. Baseline prostate specific antigen (PSA) ≤2.5 ng/mL
- •b. Baseline PSA >2.5 ng/mL and ≤10 ng/mL AND free PSA ≥25% of total PSA
- •c. Baseline PSA >2.5 ng/mL and ≤10 ng/mL AND free PSA <25% of total PSA AND negative 12 core prostate biopsy in the past 12 months
- •d. Baseline PSA >10 ng/mL AND negative 12 core biopsy within the past 12 months.
排除标准
- •History of prostate, bladder or rectal malignancy. Biopsy proven urethral cancer.
- •History of rectal disease
- •Neurogenic bladder disorder due to multiple sclerosis, Parkinson's disease, spinal cord injury, diabetes, etc., as demonstrated on urodynamic testing.
- •Detrusor muscle failure, urethral stenosis, or urinary obstruction due to causes other than BPH, as demonstrated on urodynamic testing
- •Bladder diverticula greater than 5 cm or bladder stones greater than 2 cm
- •Cystolithiasis within the past three months
- •Baseline serum creatinine greater than 1.8
- •Evidence of tortuous or atherosclerotic blood vessels
- •Presence of collateral vessel pathways potentially endangering normal territories during embolization that cannot be bypassed with the microcatheter
- •Active urinary tract infection, interstitial cystitis, or prostatitis within the last 5 years
- •Coagulation disturbances not normalized by medical treatment
- •Allergy to iodinated contrast agents not responsive to steroid premedication regimen
- •Previous radical pelvic or rectal surgery, or pelvic irradiation
- •Prior surgical prostate intervention
- •Treatment with beta-blocker, antihistamine, anticonvulsant, or antispasmodic medication within 1 week of treatment UNLESS there has been a stable voiding pattern while medicated with the drug(s) for 6 months
- •Use of prostate active medications, including alpha blockers, anti-cholinergics, androgens, anti-androgens, gonadotropins-releasing hormonal analogs, PDE5-inhibitors, 5-alpha reductase inhibitors within 2 months of intervention, unless the medication is necessary to avoid symptom exacerbation and disability, in this case medication should not be initiated or dose adjusted within 1 month of study enrollment and dose should not be adjusted during the study period
- •Interest in future fertility
- •Mental condition or disorder that interferes with participants' ability to provide written informed consent
- •Current severe or uncontrolled disease (metabolic, hematologic, renal, hepatic, pulmonary, neurologic, cardiac, infectious or gastrointestinal) that in the Investigator's judgment makes the patient unsuitable for trial inclusion due to increased risk of complications
- •Known immunosuppression
- •Life expectancy less than 6 months
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 12 months
The study protocol was terminated before completion as the device was FDA approved and determined to be safe for the treated patient population.
次要结局
- Change in International Index of Erectile Dysfunction (IIEF)(baseline, 1 month, 6 month)
- Change in Post-void Residual (PVR) on Ultrasound(baseline, 1 month, 6 month)
- Change in Peak Urinary Flow Rate (Qmax)(Baseline, 1 month, 6 month)
- Change in Prostate Volume (PV)(baseline, 1 month, 6 month)
- Change in International Prostate Symptom Score (IPSS)(baseline, 1 month, 6 month)
研究者
Andrew Picel, MD
Assistant Professor
University of California, San Diego
研究点 (2)
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