NCT04304599已完成不适用
Evaluation of a New Female Urinary Catheter Used for Intermittent Catheterization
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- The primary objective of this study is to evaluate the subjects' Quality of Life when practicing IC using LoFric Elle catheters.
研究概览
简要总结
A prospective, multi-centre, interventional study. All subjects will use the study device for two weeks and the angulated handle available with the device must be used by each subject at least 10 times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent.
- •Females aged 18 years and over.
- •Maintained urethra sensibility as judged by the subject. (Can you feel the catheter during catheterization? Yes.).
- •Practice intermittent catheterization at least 2 times daily.
- •Use catheter size available in the study
- •Experienced practitioners of intermittent catheterization defined as a minimum of three months on therapy, but not more than approximately 5 years on therapy.
- •Adults able to read, write and understand information given to them regarding the study.
排除标准
- •Ongoing, symptomatic UTI at enrolment as judged by investigator. The definition of UTI, is a positive urine culture of ≥10^3 CFU/ml of ≥1 bacterial species and presence of symptoms or signs compatible with UTI with no other identified source of infection.
- •Known urethral stricture which, in the opinion of the investigator, could influence the subject's evaluation of the catheters.
- •Involvement in the planning and conduct of the study (applies to both Wellspect staff and staff at the study site).
- •Previous enrolment in the present study.
- •Simultaneous participation in another clinical study that may impact the primary endpoint
- •Expected or severe non-compliance to protocol as judged by the investigator and/or Wellspect.
结局指标
主要结局
The primary objective of this study is to evaluate the subjects' Quality of Life when practicing IC using LoFric Elle catheters.
时间窗: 2 weeks
Primary objective variable is measured by the Intermittent Self-Catheterization Questionnaire (ISC-Q) total score.
次要结局
- Compliance when practicing IC with LoFric Elle.(2 weeks)
- Satisfaction when practicing IC with LoFric Elle.(2 weeks)
- Versatility as in use of the angulated handle when practicing IC with LoFric Elle.(2 weeks)
- The catheter with or without the angulated handle has an ergonomic design which makes it easy to use.(2 weeks)
- Perception when practicing IC with LoFric Elle.(2 weeks)
- The catheter is perceived as slim and discreet which makes it easy to bring, store, and dispose of without obviously being a catheter.(2 weeks)
- The catheter is perceived as ready to use.(2 weeks)
研究者
研究点 (6)
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