NCT00802750已完成不适用
A Randomized, Single-blind, Cross-over, Single Centre Study in Healthy Volunteers Evaluating Subject Perception of Urinary Catheters Manufactured in a New Process With New Solvent
适应症
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
- Healthy volunteers perception of catheterization
研究概览
简要总结
The purpose of this study is to evaluate healthy volunteers perception of catheterization with LoFric catheters with new solvents in the manufacturing process. The subjects will be catheterized three times during one visit day.
The hypothesis is that the subjects' perception of catheterization is the same when using the test catheters compared to the reference catheter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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 volunteers
- •Males age 18 years and over
排除标准
- •Known or suspected, current impairment of and/or decreased urethral sensibility
- •History of urethral disease
- •History of urinary tract infection within three months, or ongoing symptomatic urinary tract infection
- •Use of medications that may affect the urethra's dryness (e. g. 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 Trimethoprim
- •Suspected poor compliance with the protocol during the complete study period.
结局指标
主要结局
Healthy volunteers perception of catheterization
时间窗: At each catheterization (three times during one day)
次要结局
未报告次要终点
研究者
研究点 (2)
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