Prostate Artery Embolization (PAE) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in International Prostate Symptom Score
研究概览
简要总结
This is a investigator-initiated evaluation of the safety and efficacy of treating benign prostatic hyperplasia (BPH) by prostatic artery embolization.
详细描述
This is a investigator-initiated evaluation of the safety and efficacy of treating benign prostatic hyperplasia (BPH) by prostatic artery embolization.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Male, 45 years or older
- •Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hyperplasia refractory to medical therapy for at least 6 months.
- •IPSS score at initial evaluation should be greater than 12, and uroflowmetry (Qmax) of <15mL/s (milliliters per second).
- •All prostate volumes will be > 40gm
- •PSA which meets one of the following criteria:Baseline PSA ≤ 2.5ng/mL, Baseline PSA > 2.5 ng/mL and ≤ 10 ng/mL AND free PSA ≥ 25% of total PSA (no biopsy required);Baseline PSA > 2.5 ng/mL and ≤ 10 ng/mL AND free PSA < 25% of total PSA AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months;Baseline PSA >10 ng/mL AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months;Negative prostate biopsy (minimum 12 cores within 12 months) if abnormal digital rectal examination.
排除标准
- •Patients with active urinary tract infections or recurrent urinary tract infections (> 2/year), prostatitis, or interstitial cystitis.
- •Cases of biopsy proven prostate, bladder, or urethral cancer.
- •Patients on long-term narcotic analgesia, androgen therapy, or GNRH (gonadotropin-releasing hormone) analogue therapy who are unwilling to stop therapy for 2 months prior to the study.
- •Use of anithistamines, anti-convulsants, and antispasmodics within one week of treatment unless they have been treated with the same drug (at the same dosage) for at least 6 months and has an associated stable voiding pattern.
- •Patients who are classified as New York Heart Association Class III (Moderate), or higher, have cardiac arrhythmias, have uncontrolled diabetes, or are known to be immunosuppressed.
- •Hypersensitivity reactions to contrast material not manageable with prophylaxis.
- •Patients with glomerular filtration rates less than 40 who are not already on dialysis
- •Prostate volume <40 mL
- •Patients with bilateral internal iliac arterial occlusion
- •Patients with causes of bladder obstruction not due to BPH (eg urethral stricture, bladder neck contraction, etc)
- •Patients with neurogenic or bladder atonia
- •Prior prostatectomy
- •Cystolithiasis within the last 3 months
- •Patients interested in future fertility
- •Patients with a life expectancy less than 1 year
- •Patients where embolization is not possible distal to collateral vessels feeding non-prostatic tissue
- •Patients with major neurologic illnesses which could have symptoms that may be similar to or confused for BPH (eg Parkinson's disease, multiple sclerosis, Shy-Drager syndrome, spinal cord injury, etc.).
- •Patients with urethral stents
- •Patients who have undergone prior rectal surgery other than hemorrhoidectomy or pelvic irradiation.
- •Patients who have started or changed their dosage of alpha blockers or 5-alpha reductase inhibitors in the month prior to PAE
结局指标
主要结局
Change in International Prostate Symptom Score
时间窗: baseline, 3 months
The International Prostate Symptom Score assesses the severity of symptoms in benign prostatic hypertrophy. The questionnaire contains seven items rated on a scale from zero to five. Total scores are a sum of items scores and range from 0 to 35 with higher scores indicating worse BPH symptoms. Outcome is reported as the change in IPS score from baseline to three months.
Patient Reported Change in Medication Use
时间窗: 3 months
Participants will report change in medication use for prostate symptoms. The number of participants who reduce medications will be reported.
Number of Adverse Events Reported
时间窗: 3 Months
All adverse events will be collected and reviewed. Adverse events are collected by self-report and medical record. Outcome is reported as the total number of adverse events reported.
Change in Quality of Life Scale (QOLS)
时间窗: 3 months
Participants will complete the Quality of Life Scale (QOLS), which contains 15 items measuring five domains of quality of life. Total scores are a sum of item scores and range from 16 to 112, with higher scores indicating a better quality of life.
次要结局
- Efficacy Measured by Medical Therapy of Prostatic Symptoms Questionnaire or Flow Rate Change(3 months)