Consumer Evaluation of Intermittent Catheter Product Modifications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Acceptability of Test Hydrophilic Intermittent Catheter
研究概览
简要总结
This study aims to collect feedback from hydrophilic intermittent catheter end-users to assess user acceptance of the test hydrophilic intermittent catheter and generate evidence to support commercial marketing objectives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •A. Inclusion Criteria for Arm 1
- •Subject who:
- •is male and at least 18 years of age
- •has been performing unassisted, self-catheterizations, with a Hollister standard with tip Hydrophilic intermittent catheter, 3 or more times a day for at least 1 month
排除标准
- •Subject who:
- •is currently undergoing chemotherapy, radiation or steroid therapy
- •has a symptomatic urinary tract infection (UTI)
- •is currently using a coude intermittent catheter product to perform catheterization
- •performs non-urethral catheterization
- •C. Inclusion Criteria for Arm 2
- •Subject who:
- •is male and at least 18 years of age
- •has been performing unassisted, self-catheterizations, with a non-standard with tip Hydrophilic intermittent catheter, 3 or more times a day for at least 1 month
- •D. Exclusion Criteria for Arm 2
- •Subject who:
- •is currently undergoing chemotherapy, radiation or steroid therapy
- •has a symptomatic urinary tract infection (UTI)
- •is currently using a coude intermittent catheter product to perform catheterization
- •performs non-urethral catheterization
- •is unable to use a Hollister standard with tip hydrophilic intermittent catheter
研究组 & 干预措施
Current users of Hollister standard with tip hydrophilic intermittent catheters
Subjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters.
干预措施: Test Hydrophilic Intermittent Catheter (Device)
New users of Hollister standard with tip hydrophilic intermittent catheters
Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters.
干预措施: Currently marketed Hydrophillic Intermittent Catheter (Device)
New users of Hollister standard with tip hydrophilic intermittent catheters
Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters.
干预措施: Test Hydrophilic Intermittent Catheter (Device)
结局指标
主要结局
Acceptability of Test Hydrophilic Intermittent Catheter
时间窗: 10 days
Users will rate if Test device is an acceptable alternative to currently marketed device. Acceptability will be rated via a standard 5-point Likert agreement scale. Agreement signifies Test catheter is an acceptable alternative to currently marketed catheter.
Preference of Test Hydrophilic Intermittent Catheter
时间窗: 10 days
Users will rate if Test device is preferred to currently marketed device. Preference will be rated via a standard 5-point Likert agreement scale. Agreement signifies Test catheter is preferred to currently marketed catheter.
次要结局
未报告次要终点