Canadian Cohort of Convective Thermal Therapy Using Rezūm System 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
- 50
- 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 Rezūm therapy for BPH patient in Canadian cohort.
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
- •Male subjects of ≥ 18 years of age.
- •Primary diagnosis of Benign Prostate Hypertrophy (BPH).
- •Candidate for Rezūm therapy as per clinical decision of Investigator.
- •Willing and able to accurately complete the required 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: Baseline
Maximum flow rate (Q-max)
Prostate Volume measured by transrectal ultrasound (TRUS)
时间窗: Baseline
Prostate Volume measured by transrectal ultrasound (TRUS)
Questionnaire
时间窗: Baseline
IPSS
Adverse Events
时间窗: Baseline
Adverse Events
Change of Adverse Events
时间窗: 36 months after surgery
Change of Adverse Events
Change of Post-Void Residual (PVR) volume
时间窗: 36 months after surgery
Change of Post-Void Residual (PVR) volume
Change of Prostate Volume measured by transrectal ultrasound (TRUS)
时间窗: 12 months after surgery
Change of Prostate Volume measured by transrectal ultrasound (TRUS)
Change of Maximum flow rate (Q-max)
时间窗: 36 months after surgery
Change of Maximum flow rate (Q-max)
Post-Void Residual (PVR) volume
时间窗: Baseline
Post-Void Residual (PVR) volume
Change of Questionnaire
时间窗: 36 months after surgery
Change of IPSS score
Change of Maximum flow rate (Q-max)
时间窗: 1 month after surgery
Change of Maximum flow rate (Q-max)
Change of Maximum flow rate (Q-max)
时间窗: 3 months after surgery
Change of Maximum flow rate (Q-max)
Change of Maximum flow rate (Q-max)
时间窗: 6 months after surgery
Change of Maximum flow rate (Q-max)
Change of Maximum flow rate (Q-max)
时间窗: 12 months after surgery
Change of Maximum flow rate (Q-max)
Change of Maximum flow rate (Q-max)
时间窗: 24 months after surgery
Change of Maximum flow rate (Q-max)
Change of Post-Void Residual (PVR) volume
时间窗: 1 month after surgery
Change of Post-Void Residual (PVR) volume
Change of Post-Void Residual (PVR) volume
时间窗: 3 months after surgery
Change of Post-Void Residual (PVR) volume
Change of Post-Void Residual (PVR) volume
时间窗: 6 months after surgery
Change of Post-Void Residual (PVR) volume
Change of Post-Void Residual (PVR) volume
时间窗: 12 months after surgery
Change of Post-Void Residual (PVR) volume
Change of Post-Void Residual (PVR) volume
时间窗: 24 months after surgery
Change of Post-Void Residual (PVR) volume
Change of Questionnaire
时间窗: 1 month after surgery
Change of IPSS score
Change of Questionnaire
时间窗: 3 months after surgery
Change of IPSS score
Change of Questionnaire
时间窗: 6 months after surgery
Change of IPSS score
Change of Questionnaire
时间窗: 12 months after surgery
Change of IPSS score
Change of Questionnaire
时间窗: 24 months after surgery
Change of IPSS score
Change of Adverse Events
时间窗: 1 month after surgery
Change of Adverse Events
Change of Adverse Events
时间窗: 3 months after surgery
Change of Adverse Events
Change of Adverse Events
时间窗: 6 months after surgery
Change of Adverse Events
Change of Adverse Events
时间窗: 12 months after surgery
Change of Adverse Events
Change of Adverse Events
时间窗: 24 months after surgery
Change of Adverse Events
次要结局
未报告次要终点
研究者
Dean Elterman
Urologist
University Health Network, Toronto