A Randomized, Single-blind, Cross-over, Single-centre Study in Healthy Volunteers Evaluating Subject Perception and Friction at Withdrawal of Catheters With Different Activation Times Compared to a Reference Catheter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Subjects' Perception at Withdrawal of Test Catheter Activated for 5 Seconds, Compared to Reference.
研究概览
简要总结
The primary purpose of this study is to compare the subject's perception (separately for each randomized catheter) of practicing catheterization when using catheters with sodium chloride in wetting solution (using two different activation times) with a standard reference catheter. The hypothesis is that the subjects' perception of catheterization is the same or more positive when using the test catheters compared to the reference catheter.
详细描述
The study is designed as a randomized, single-blind, cross-over, single-centre, study in healthy male volunteers.
All subjects will first be catheterized with a reference catheter, which is proven to be well tolerated by most subjects. This catheter will be used as a reference catheter to be compared with the randomized catheters. One more reason for this first test is to withdraw subjects who cannot tolerate catheterizations. Subjects will qualify for the randomized part of the study only if the first catheterization could be performed without significant discomfort.
When the subject is randomized he will be catheterized with two urinary catheters in a randomized order during one day. The activation times for the wetting solution will be 5 seconds and 24 (± 2h) hours.
During each catheterization, the friction at withdrawal will be measured for the catheter using a Tension Test System.
The subjects will be blinded. 25 healthy volunteers will be recruited from a single centre in Sweden.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of written informed consent
- •Healthy volunteer
- •Male aged 18 years or over
排除标准
- •Known or suspected, current impairment of and/or decreased urethral sensibility
- •History of urethral morbidity
- •History of urinary tract infection within three months, or ongoing symptomatic urinary tract infection
- •Use of medications that may affect the urethra´s dryness (anti-cholinergic drugs or cortisone)
- •Current drug, alcohol or other substance abuse
- •Other significant disease or condition (e.g. benign prostate hypertrophy, other prostatic lesions), which may interfere with treatment and/or evaluation
- •Allergy to antibiotics suspected poor compliance with the protocol during the complete study period
结局指标
主要结局
Subjects' Perception at Withdrawal of Test Catheter Activated for 5 Seconds, Compared to Reference.
时间窗: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.
The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding withdrawal?'.
Subjects' Perception at Withdrawal of Test Catheter Activated for 24 Hours, Compared to Reference.
时间窗: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.
The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding withdrawal?'.
Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference.
时间窗: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.
The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding insertion?'.
Subjects' Perception at Insertion of Test Catheter Activated for 24 Hours, Compared to Reference.
时间窗: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.
The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding insertion?'.
次要结局
- Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times.(A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.)
- Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times(A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.)
- Test of Carry-over Effect at Insertion, Mean Rating of Perception on a Scale of 0 to 5(A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.)
- Tension Test System: Ref-24h Work(The Tension test system was performed while withdrawing the catheters up to 5 seconds.)
- Test of Carry-over Effect at Withdrawal, Mean Rating of Perception on a Scale of 0 to 5(A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.)
- Tension Test System: Ref-24h Mean(The Tension test system was performed while withdrawing the catheters up to 5 seconds.)
- Tension Test System: Ref-5s MEAN(The Tension test system was performed while withdrawing the catheters, up to 5 seconds.)
- Tension Test System: Ref-5s WORK(The Tension test system was performed while withdrawing the catheters, up to 5 seconds.)
- Tension Test System: 24h-5s(The Tension test system was performed while withdrawing the catheters, up to 5 seconds.)