Prospective Controlled Randomized Study of Prostatic Arteries Embolization (PAE) vs Transurethral Resection of the Prostate (TURP) for Benign Prostatic Hyperplasia (BPH) Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Improvement of symptoms
研究概览
简要总结
The purpose of this prospective randomized controlled study is to compare the improvement of symptoms from benign prostatic hyperplasia (BPH) and the improvement of QoL, in patients undergoing prostatic artery embolization (PAE) or conventional transurethral resection of the prostate (TURP).
详细描述
The purpose of this prospective randomized controlled study is to compare the improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) and the improvement of QoL assessed by QoL questionnaire in patients undergoing prostatic artery embolization (PAE) to patients of similar characteristics undergoing conventional transurethral resection of the prostate (TURP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients evaluated in the Urology Service because of BPH, candidate to TURP.
- •Signed informed consent
- •Lower urinary tract symptoms (LUTS) secondary to BPH for at least 6 months prior to study AND/OR baseline IPSS Score > 13 AND/OR acute urinary retention with impossibility to remove urinary catheter AND/OR BPH symptoms refractory to medical treatment or for whom medication is contraindicated, not tolerated or refused Prostate size of at least 50 grams measured by MRI
- •Patient must meet ONE of the following criteria:
- •Baseline Prostate Specific Antigen (PSA) <4 ng/mL (no prostate biopsy required)
- •Baseline PSA >4 ng/mL and ≤10 ng/mL AND free PSA > 15% of total PSA (no prostate biopsy required)
- •Baseline PSA >4 ng/mL and ≤10 ng/mL AND free PSA <15% of total PSA AND a negative prostate biopsy result (minimum 12 core biopsy)
- •Baseline PSA >10 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy)
排除标准
- •Active urinary tract infection
- •Patients with cystoscopy findings suspicious for bladder cancer must undergo biopsy and have a negative histopathology report to be enrolled in the study
- •Biopsy proven prostate or bladder cancer
- •The following patients must undergo prostate biopsy with a minimum of 12 cores and have a negative histopathology report to be enrolled in the study:
- •Patients with digital rectal examination (DRE) findings suspicious for prostate cancer
- •Patients with baseline PSA levels > 10 ng/mL
- •Patients with baseline PSA levels >4 ng/mL and < 10 ng/mL AND free PSA < 15% of total PSA
- •Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (eg multiple sclerosis, Parkinson's disease, spinal cord injuries, etc)
- •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
- •Allergy to iodinated contrast agents
- •Hypersensitivity to gelatin products
- •Previous non-medical BPH treatment, including surgery, TURP, needle ablation, microwave or laser therapy, balloon dilation, stent implantation, or any other invasive treatment to the prostate
- •Known major iliac arterial occlusive disease or any known condition that catheterization of the prostatic arteries or is a contraindication to embolization, as vasospasm, anatomical variations that imply a risk of embolization, bleeding, prostatic arteries diameter inferior to microcatheter profile, pelvic inflammatory disease
- •Contraindication to magnetic resonance imaging
- •History of prostatitis in the last 5 years, not totally controlled with medical treatment
- •History of pelvic irradiation or radical pelvic surgery
- •Coagulation disturbances not normalized by medical treatment
研究组 & 干预措施
Prostate artery embolization
Prostatic artery embolization (PAE) To perform embolization, gelatin microspheres (300-500 microns) will be used in this arm
干预措施: PAE (Procedure)
Prostate artery embolization
Prostatic artery embolization (PAE) To perform embolization, gelatin microspheres (300-500 microns) will be used in this arm
干预措施: Gelatin microspheres (Device)
Transurethral resection of the prostate
Transurethral resection of the prostate (TURP) A bipolar electrosurgery generator will be used to perform TURP
干预措施: TURP (Procedure)
Transurethral resection of the prostate
Transurethral resection of the prostate (TURP) A bipolar electrosurgery generator will be used to perform TURP
干预措施: Bipolar electrosurgery generator (Device)
结局指标
主要结局
Improvement of symptoms
时间窗: 12 months
Improvement (change) of symptoms assessed by IPSS Score (International Prostate Symptom Score )
次要结局
- Improvement in QoL(12 months)
- Duration of hospitalization post procedure(3 weeks)
- Preservation of erectile function(12 months)
研究者
José A. Guirola, MD
MD
Group of Research in Minimally Invasive Techniques