A Real World Study to Evaluate the Feasibility, Preliminary Safety and Performance of Rezūm System in BPH Treatment in China (Rezūm RWS Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- International Prostate Symptom Score (IPSS) Change From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure.
研究概览
简要总结
A real world study to evaluate the feasibility, preliminary safety and performance of Rezūm system in BPH treatment in China Rezūm RWS study
详细描述
This RWS study is to evaluate the feasibility, preliminary safety and performance of Rezūm system in BPH treatment in China, to generate local real world data from a Chinese BPH population.
The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men ≥50 years of age with a prostate volume ≥ 30cm3 and ≤80cm3. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The subjects will provide written informed consent form and agree to data collection.
- •The subjects who were diagnosed as BPH and treated by Rezūm procedure in Hainan medical pilot zone will be enrolled in this study.
排除标准
- •This is a retrospective study without any formal exclusion criteria.
结局指标
主要结局
International Prostate Symptom Score (IPSS) Change From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure.
时间窗: from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure
International prostate symptom score (IPSS) is a questionnaire used to indicate the severity of LUTS symptoms, There are 7 questions relating to different symptoms subjects be experiencing. 7 questions about patients' urinating include Incomplete emptying, Frequency, Intermittency, Urgency, Weak stream, Straining and Nocturia, every question have 0-5 scores according to Prostate Symptom, the higher score mean patient have more severe the symptoms. IPSS total score: the minimum score is 0 and maximum score are 35. IPSS total 0-7 scores are mild symptoms, IPSS total 8-19 scores are moderate symptoms and IPSS total 20-35 scores are severe symptoms The change was the value at the baseline minus the value at last follow-up date, anywhere between month 3 - month 6 minus
Device Related Serious Complications From Rezūm Procedure to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure.
时间窗: from Rezūm procedure to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure.
Composite device related serious complications for this endpoint are defined as: 1. Device perforation of the rectum or GI tract; 2. Device related formation of fistula between the rectum and urethra; 3. De novo severe urinary retention lasting more than 21 consecutive days post treatment.
次要结局
- Length of Catheterization(1 month post Rezum procedure)
- The Change of Peak Flow Rate (Qmax) From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure.(from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure.)
- The Change of International Index of Erectile Function(IIEF) From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6(From baseline to the last follow-up date, anywhere between month 3 - month 6)
- Rezūm Procedure Time(During Rezūm procedure)
- Post Void Residual Urine Volume (PVR）(from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure.)
- Quality of Life (Qol)(from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezum procedure)
- Ejective Function (MSHQ-EjD)(from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezum procedure)