ROPE Registry Project to Determine the Safety and Efficacy of Prostate Artery Embolisation (PAE) for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Enlargement (LUTS BPE).
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 主要终点
- IPSS score change in PAE patients from baseline measurement
研究概览
简要总结
This is a study protocol for the UK ROPE Register for Lower Urinary Tract Symptoms (LUTS). This register enables us to collect data on the treatment of LUTS using prostate artery embolisation (PAE), and other surgical methods to answer the following questions posed by NICE in 2013:
- Is PAE a safe and effective treatment option for LUTS caused by prostate enlargement?
- How does PAE compare with conventional surgical treatments? This will primarily be a surgical procedure called TURP (see below).
- Which patients would most benefit from PAE over the other treatment options? This is a pilot study, and the final register will contain data from roughly 100 patients for PAE and 100 patients for the other surgical interventions, allowing us to answer NICE's research questions, update NICE guidance documentation, and do further research with more patients if necessary.
Our hypothesis is:
• PAE produces significant improvements in the IPSS score 12 months post-procedure
详细描述
This is a pilot study, intended to collect observational data on the PAE procedure as it is disseminated and performed around the UK, and on other comparator interventions. The aim is to give NICE enough information to potentially update their Interventional Procedures Guidance and may form the grounding for further research in the shape of a larger randomised clinical trial.
The ROPE Register project aims are to:
Primary:
• Assess the efficacy of PAE using the IPSS for LUTS BPE 12 months post-procedure.
Secondary:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
IPSS score change in PAE patients from baseline measurement
时间窗: 12 months
Assess the efficacy of PAE using the IPSS for LUTS BPE 12 months post-procedure.
次要结局
- PAE non-inferiority to TURP 12 months post-procedure, using IPSS(12 Months)