Prostate Embolization for Massive Benign Prostatic Hypertrophy (BPH)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Clinical Improvement in Lower Urinary Tract Symptoms (LUTS)
研究概览
简要总结
This is a prospective, open label single center feasibility study to demonstrate basic safety and effectiveness of prostate artery embolization for the treatment of symptomatic benign prostatic Hyperplasia (BPH) in a small series of patients with large (≥90 grams) glands.
详细描述
This is a prospective, open labeled, non-randomized, single center feasibility study to evaluate the technical and clinical success of prostatic artery embolization utilizing Embosphere microspheres.
At initial consultation patients will be screened to assess the severity of lower urinary tract symptoms (LUTS) related to BPH utilizing the international prostate symptom score (IPSS). After determining eligibility, pre-procedure baseline evaluation will be completed. A baseline prostate ultrasound (TRUS) or MRI will be required to assess prostate mass, and baseline prostate-specific antigen will be measured to help exclude carcinoma and also to follow response to therapy. Patients with suspected malignancy of the prostate will not be enrolled without a negative biopsy finding. Pre- procedure urodynamic studies will be required to assess additional objective measurements and to exclude other causes of LUTS. Cystoscopy will be performed prior to any intervention to help exclude bladder malignancy.
If the patient qualifies by the level of symptoms (IPSS score ≥12), prostate size ≥ 90 grams and max urinary flow rate (Qmax) ≤ 12, the patient will be asked to consider enrolling in the study. A study investigator will review the proposed treatment and baseline/follow-up schedule. If the patient agrees to participate in the study, baseline data will be collected on a case report form and an appointment will be made for prostate artery embolization in the interventional radiology department.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients selected for this study must meet all of the following criteria:
- •Age ≥ 50 years
- •Lower urinary tract symptoms secondary to BPH as defined by:
- •IPSS Symptom Index ≥ 12
- •Maximum Uroflow rate (Qmax) of ≤ 12cc per sec
- •Prostate of ≥ 90 gm as determined by MRI or transrectal ultrasound of the prostate (TRUS)
排除标准
- •Patients meeting any of the following criteria will be excluded from the study.
- •Age less than 50 years
- •Prostate cancer
- •Bladder cancer
- •Severe, life-threatening allergy to iodinated contrast
- •Bilateral internal iliac artery occlusion
- •Causes of obstruction other than BPH such as stricture disease
- •Neurogenic bladder or other causes of bladder atonia
- •Post void residual greater than 250 cc
- •Any contraindication to embolization, including
- •Patients intolerant to occlusion procedures
- •Vascular anatomy or blood flow that precludes catheter placement or embolic agent injection
- •Presence or likely onset of vasospasm
- •Presence or likely onset of hemorrhage
- •Presence of severe atheromatous disease
- •Presence of feeding arteries smaller than distal branches from which they emerge
- •Presence of collateral vessel pathways potentially endangering normal territories during embolization
- •History of any illness or surgery that might confound the results of the study, which produces symptoms that might be confused with those of the disease process under consideration, or which poses additional risk to the patient.
- •Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
- •Confirmed or suspected bladder cancer
- •Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease
- •Previous pelvic irradiation or radical pelvic surgery
- •Recent (within 3 months) cystolithiasis
- •History or presence of urethral strictures, bladder neck contracture, potentially confounding bladder pathology, or (within 5 years) prostatitis
- •Active urinary tract infection
- •Concomitant medications:
- •(i) Use of anti histaminics, anti convulsants, and antispasmodics within 1 week of treatment unless there is documented evidence that the patient has been on the same drug dose for at least 6 months with a stable voiding pattern (the drug dose should not be altered or discontinued for entrance into or throughout the study) (ii) Use of alpha blockers, anti-cholinergics, androgens, and gonadotropins-releasing hormonal analogs within 2 months of treatment (iii) Use of 5 alpha reductase inhibitors within 6 months of treatment
- •Compromised renal function (i.e. serum creatinine level greater than 1.8 mg/dl, or upper-tract disease)
研究组 & 干预措施
Embosphere microspheres
Embospheres are calibrated microspheres which will be percutaneously delivered intra-arterially via a microcatheter under fluoroscopic guidance to occlude the prostatic arteries.
干预措施: Embosphere microspheres (Device)
结局指标
主要结局
Clinical Improvement in Lower Urinary Tract Symptoms (LUTS)
时间窗: 24 months
Questionnaire
次要结局
- Erectile and sexual function questionnaire(24 months)
- Change in serum PSA from baseline(24 months)
- Number of participants with treatment-related adverse events(12 months)
- Change in peak urinary flow (Qmax)(24 months)
- Pain(12 months)
- Change in prostate size(24 months)
- Post void residual bladder volume (PVR)(24 months)
研究者
Albert Scappaticci
PhD, MD
Rhode Island Hospital