Comparison of the Efficacy and Safety of Glue with Calibrated Microparticles in Prostatic Artery Embolisation As a Treatment for Symptomatic Benign Prostatic Hyperplasia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Efficacy of embolisation
研究概览
简要总结
Prostatic artery embolisation (PAE) is an alternative treatment to surgery for benign prostatic hyperplasia (BPH). It has been practised since 2012 and numerous publications have proved not only its safety but also its efficacy.
The principle of PAE is to occlude the prostatic arteries with an 'embolising agent', which will result in ischaemia and necrosis of part of the adenomatous tissue of the prostate.
The reference embolisation agent is a suspension of calibrated trisacryl microparticles 300-500 microns in size.
Recently, the use of glue has been retrospectively studied with acceptable efficacy and safety.
In this context, where only the results of retrospective studies are available, it is necessary to initiate comparative prospective studies to assess the efficacy and safety of the glue compared with calibrated microparticles.
详细描述
Prostatic artery embolisation (PAE) is an alternative treatment to surgery for benign prostatic hyperplasia (BPH), and its place is recognised in the recommendations of the Male Voiding Disorders Committee (French Urological Association). It has been practised since 2012 (Carnevale et al, 2020), and numerous publications have proved not only its safety but also its efficacy (Malling et al, 2019).
The principle of PAE is to occlude the prostatic arteries with an 'embolising agent', which will result in ischaemia and necrosis of part of the adenomatous tissue of the prostate.
The reference embolisation agent, used by the majority of expert prostate embolisation teams, is a suspension of calibrated trisacryl microparticles 300-500 microns in size.
Recently, the use of glue has been retrospectively studied with acceptable efficacy and safety (Loffroy et al, 2021). Another retrospective comparative study (Salet et al, 2022) reported no significant difference in clinical efficacy between the use of glue and 300-500 micron trisacryl particles.
In this context, where only the results of retrospective studies are available, it is necessary to initiate comparative prospective studies to assess the efficacy and safety of the glue compared with calibrated microparticles.
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
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patient aged ≥ 50 years and ≤ 80 years
- •Patient with symptomatic BPH (prostatic volume ≥ 40 ml measured on prostatic MRI, IPSS ≥ 8, uroflowmetry < 15 ml/s).
- •Patient failing or intolerant to drug treatment (tadalafil and/or one of the alpha-blockers, alfuzosin, tamsulosin, silodosin or doxazosin).
排除标准
- •Patient with advanced and complicated BPH on renal and bladder ultrasound:
- •Severe obstruction related bladder wall lesions : >3 micro-diverticula or single or multiple diverticula with a sac diameter > 10 mm.
- •Chronic dilatation of the excretory cavities : diameter of one or both pyelons >15 mm.
- •Patient with suspected prostate or bladder cancer on MRI
- •Patients with moderate or severe chronic renal failure, with creatinine clearance < 40 ml/min.
- •Patient with prostate or bladder cancer diagnosed by biopsy in the 6 months preceding the inclusion visit.
- •Patient with an active urinary tract infection
- •Patient already included and participating in another clinical study.
结局指标
主要结局
Efficacy of embolisation
时间窗: Month 3
Efficacy of embolisation will be assessed with IPSS score (International Prostate Symptoms Score). IPSS questionnaire consists of 7 questions (ranging from 0 to 5) on mictional difficulties for a maximum total of 35 points (0 means no mictional difficulty).
次要结局
- Prostatic infarct areas(Month 3)
- Post-Mictional Residue(Month 1, Month 3 and Month 12)
- Sexual function(Month 1, Month 3 and Month 12)
- Patient quality of life(Month 1, Month 3 and Month 12)
- Prostatic Serum Antigen(Month 1, Month 3 and Month 12)
- Urinary flow(Month 1, Month 3 and Month 12)
- Prostatic volume(Month 3 and Month 12)
- Efficacy of embolisation(Month 1 and Month 12)
- Safety of embolisation(Day 15, Month 3 and Month 12)