Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers
Comparative Study of Two Different Urine Catheters.
研究概览
详细说明
Intermittent catheterization is the preferred method for emptying the bladder in patients with spinal cord injury and neurogenic bladder dysfunction.
Coloplast has developed a new intermittent catheter. In this investigation this new test catheter will be compared with SpeediCath by assessing discomfort and pain associated with catheterization of healthy men. The reason for choosing healthy men is that many catheter users do not have full feeling in their urethra and therefore can not assess the discomfort.
Healthy men who are ≥ 18 years and have no signs of urinary tract infection and do not have abnormalities, disease or have had operational interventions in the urinary tract will be included. They are recruited through advertisements on the website www.forsoegsperson.dk.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Copenhagen、丹麦、2100
- Rigshospitalet, dep. 2112
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 18 years or older
- Male
- signed informed Consent,
- Neg. urine multistix
Exclusion Criteria:
- Abnormalities,
- diseases or surgical procedures performed in the lower urinary-tract
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Monza
nonCE marked intermittent catheter
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intermittent catheterisation
其他名称：
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有源比较器：control
SpeediCath coated catheter
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intermittent catheterisation
其他名称：
intermittent catheterisation
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Discomfort Measured on the Visual Analog Scale (VAS)
大体时间：10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1
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Outcome measured on a 10 cm Visual Analog Scale ranging from "no discomfort" (0cm) to "worst thinkable discomfort" (10cm).
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10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Irritation During Voiding After Catheterization
大体时间：10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
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After each catheterization subjects were asked if they felt any irritation during voiding with answer option yes or no. Yes - they experienced irritation. No - they did not experience irritation. |
10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
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Ease of Use Measured on a 5 Point Scale: Insertion Effort
大体时间：10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
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After each catheterization the nurse who conducted the catheterization answered how the catheter insertion had been. There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy |
10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
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Ease of Use Measured on a 5 Point Scale: Withdrawal Effort
大体时间：10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
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After each catheterization the nurse who conducted the catheterization answered how the catheter withdrawal had been. There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy |
10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
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Visible Blood
大体时间：10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
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Visual blood observed on the catheter or in the urine in connection to catheterization. The nurse who conducted the catheterization could answer yes or no as follows: Yes = visible blood observed. No = no visible blood observed. |
10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
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Haematuria
大体时间：2 hours after catheterisation at visits 1 and 2
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Negative or positive result on a multistix urin analysis. Negative haematuria: 10 erythrocytes/microliter or less. Positive haematuria: above 10 erythrocytes/microliter. |
2 hours after catheterisation at visits 1 and 2
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合作者和调查者
调查人员
- 研究主任：Rikke Otttesen, CTM、Coloplast A/S
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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