Canadian Cohort of Aquablation, a Robotically Executed, Surgeon-guided, High-pressure Water Jet Ablation Therapy for Endoscopic Resection of Prostate Tissue, in Benign Prostatic Hyperplasia (BPH).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Maximum flow rate (Q-max)
研究概览
简要总结
To document the clinical outcome of Aquablation therapy for BPH patient in Canadian cohort.
详细描述
Patients will be followed up for 3 years as standard of care.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of Benign Prostate Hypertrophy (BPH)
- •Male subjects of ≥ 18 years of age
- •Candidate for Aquablation therapy as per clinical decision of Investigator
- •Willing and able to accurately complete questionnaires
- •Willing and able to provide signed and dated informed consent
排除标准
- •Characteristics indicating a poor compliance with study protocol requirements.
- •Disease or other health condition that is not suitable for this study.
- •Unable or unwilling to provide signed informed consent.
结局指标
主要结局
Maximum flow rate (Q-max)
时间窗: 36 months after surgery
Standard of care
Post-Void Residual (PVR) volume
时间窗: 36 months after surgery
Standard of care
Questionnaires
时间窗: 36 months after surgery
IPSS
Adverse Events
时间窗: 36 months after surgery
Adverse Events
Prostate Volume
时间窗: 12 months after surgery
Standard of care
Maximum flow rate (Q-max)
时间窗: Baseline
Standard of care
Post-Void Residual (PVR) volume
时间窗: Baseline
Standard of care
Maximum flow rate (Q-max)
时间窗: 1 month after surgery
Standard of care
Post-Void Residual (PVR) volume
时间窗: 1 month after surgery
Standard of care
Maximum flow rate (Q-max)
时间窗: 3 months after surgery
Standard of care
Post-Void Residual (PVR) volume
时间窗: 3 months after surgery
Standard of care
Maximum flow rate (Q-max)
时间窗: 6 months after surgery
Standard of care
Post-Void Residual (PVR) volume
时间窗: 6 months after surgery
Standard of care
Maximum flow rate (Q-max)
时间窗: 12 months after surgery
Standard of care
Post-Void Residual (PVR) volume
时间窗: 12 months after surgery
Standard of care
Maximum flow rate (Q-max)
时间窗: 24 months after surgery
Standard of care
Post-Void Residual (PVR) volume
时间窗: 24 months after surgery
Standard of care
Prostate Volume
时间窗: Baseline
Standard of care
Questionnaires
时间窗: Baseline
IPSS
Questionnaires
时间窗: 1 month after surgery
IPSS
Questionnaires
时间窗: 3 months after surgery
IPSS
Questionnaires
时间窗: 6 months after surgery
IPSS
Questionnaires
时间窗: 12 months after surgery
IPSS
Questionnaires
时间窗: 24 months after surgery
IPSS
Adverse Events
时间窗: Baseline
Adverse Events
Adverse Events
时间窗: 1 day of Surgery
Adverse Events
Adverse Events
时间窗: 1 month after surgery
Adverse Events
Adverse Events
时间窗: 3 months after surgery
Adverse Events
Adverse Events
时间窗: 6 months after surgery
Adverse Events
Adverse Events
时间窗: 12 months after surgery
Adverse Events
Adverse Events
时间窗: 24 months after surgery
Adverse Events
次要结局
未报告次要终点
研究者
Dean Elterman
Urologist
University Health Network, Toronto