NCT05155891进行中（未招募）不适用
Prospective, Non-Randomized, Controlled Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of Prostate for the Treatment of Symptomatic Benign Prostatic Hyperplasia in Prostate Glands Larger Than 80 Grams
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in BPH symptoms as measured by the IPSS
研究概览
简要总结
The purpose of this research study is to evaluate prostate artery embolization (PAE) compared to Holmium laser enucleation of prostate (HoLEP) in improving a patient's overall prostate related symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patient is age 50 or older.
- •Patient has signed informed consent and agrees to attend all follow-up study visits.
- •Patient has had LUTS secondary to BPH or any complications secondary to BPH and qualifying for active intervention.
- •Patient has a baseline IPSS Score > 13 at baseline.
- •Patient has a prostate size of at least 80 grams and not more than 250 grams, measured by magnetic resonance imaging (MRI) or transrectal ultrasonography (TRUS).
- •Patient has BPH symptoms refractory to medical treatment or for whom medication is contraindicated, not tolerated, or refused.
- •Patient must be a candidate for HoLEP or PAE.
排除标准
- •Subject has untreated active infection (e.g., active urinary tract infection or prostatitis)
- •Subject has a diagnosis or received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis).
- •Patients with indwelling urinary catheters or those performing self-catheterization.
- •Biopsy proven prostate or bladder cancer.
- •- Patient with elevated PSA will be counselled by urologist and a shared decision will be made with the patient after discussion about pros and cons of prostate biopsy.
- •Patients with neurogenic bladder disorder.
- •Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition.
- •Patients with prior history transurethral resection of the prostate (TURP), Green Light laser treatment, or other prostate surgical treatments within past year(12 months).
- •Any known condition that limits catheter-based intervention or is a contraindication to embolization, such as intolerance to a vessel occlusion procedure or severe atherosclerosis.
- •Cardiac condition including congestive heart failure or arrhythmia, uncontrolled diabetes mellitus, significant respiratory disease or known immunosuppression which required hospitalization within the previous 6 months.
- •Acute myocardial infarction, open heart surgery, or cardiac arrest within 180 days prior to the date of informed consent.
- •Patient is interested in future fertility and wish to preserve ejaculation will be excluded from HoLEP arm
- •History of coagulation cascade disorders (which are not normalized by medical treatment before the procedure) or disorders that affect platelet count or function (e.g., von Willebrand disease) that would put the subject at risk for intraoperative or postoperative bleeding.
- •History of major allergic reaction to iodinated contrast agents will be excluded from PAE arm.
- •History of hypersensitivity to gelatin products will be excluded from PAE arm.
- •Subject has a life expectancy of less than 2 yrs.
- •Post void residual more than 500 ml at baseline.
- •Participation in any other BPH trials during the time of study.
研究组 & 干预措施
Embosphere Microspheres group
Experimental
Participants in this group who are undergoing standard of care (SOC) prostate artery embolization (PAE) for treatment of their symptomatic benign prostatic hyperplasia (BPH) will receive Embosphere Microspheres during scheduled SOC PAE surgery.
干预措施: Embosphere Microspheres (Device)
HoLEP Group
Active Comparator
Participants in this group who are undergoing SOC PAE for treatment of their symptomatic benign prostatic hyperplasia (BPH) will receive SOC Holmium laser enucleation of prostate (HoLEP).
干预措施: HoLEP Procedure (Procedure)
结局指标
主要结局
Change in BPH symptoms as measured by the IPSS
时间窗: Baseline, 3 months
The International Prostate Symptom Score (IPSS) has a total score ranging from 0-35 with the higher score indicating more severe symptoms
次要结局
- Change in post-void residual urinary volume (PVR)(Baseline, 12 months)
- Change in BPH symptoms as measured by IPSS(Baseline, 12 months)
- Change in peak urine flow rate(Baseline, 12 months)
- Change in erectile function as measured by the IIEF(Baseline, 12 Months)
- Change in incontinence as measured by the ICIQ - UI SF(Baseline, 12 Months)
- Incidence of adverse events(Up to 12 Months)
- Incidence of procedure-related adverse events(Up to 12 Months)
- Duration of hospitalization after the procedure(up to 48 hours)
- Change in retrograde ejaculation as measured by the Ejaculatory questionnaire(Baseline, 12 Months)
- Change in prostate specific antigen (PSA) levels(Baseline, 12 Months)
- Duration of urinary catheterization after the procedure(up to 48 hours)
- Change in mean prostate volume(Baseline, 12 months)
- Change in medication use related to BPH-LUTS(Baseline, 12 Months)
研究者
Hemendra Shah
Professor of Clinical Urology
University of Miami
研究点 (1)
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