The UK POST WATERStudy: UK Post-market Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Long-term safety as measured by adverse events at 60 months
研究概览
简要总结
A post-market, non-interventional, two-arm, long-term follow-up study of patients previously enrolled in the WATER Study (NCT02505919) - which was a prospective multi-centre randomized blinded study comparing Aquablation of the prostate with the AQUABEAM Robotic System with standard transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms (LUTS).
详细描述
The study is a post-market, non-interventional, two-arm, long-term follow-up study of patients previously enrolled in the WATER Study (NCT02505919) - which was a prospective multi-centre randomized blinded study comparing Aquablation of the prostate with the AQUABEAM Robotic System with standard transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms (LUTS). In POST WATER, up to 46 WATER Study subjects in the United Kingdom who were active on the study at 36 months will be invited to participate, across 3 clinical study sites in England and Wales. The study will consist of one follow-up time-point at 60 months (5 years) from the time of initial WATER Study treatment date.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject was randomized and received treatment in the WATER Study.
- •Subject is mentally capable and willing to sign a study-specific informed consent form
- •Subject is willing and able to comply with all study requirements
排除标准
- •Dementia or psychiatric condition that prevents the participant from completing required follow up
- •Participating in another investigational study that could affect responses to the study assessments
结局指标
主要结局
Long-term safety as measured by adverse events at 60 months
时间窗: 60 months following original surgical intervention
The proportion of subjects with adverse events classified as Clavien-Dindo Grade 2 or higher or any grade 1 event resulting in persistent disability
Long-term effectiveness as measured by IPSS at 60 months
时间窗: 60 months following original surgical intervention
International Prostate Symptom Score at 60 months as compared to baseline
次要结局
未报告次要终点