An Exploratory Investigation of the Effects of Single Use vs. Reuse Catheters in Intermittent Catheterization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Health-related Quality of Life From Baseline (Visit 1) to Termination (Visit 5), Measured by the Intermittent Self-Catheterization Questionnaire Index Score.
研究概览
简要总结
The overall aim of the investigation is to investigate the effect of repeated reuse of intermittent urinary catheters and to observe the impact of switch from single use to multiple reuse catheters.
详细描述
Throughout the investigation, the impact of switch from single use to multiple reuse catheters will be observed and compared with respect to health-related quality of life (HR-QoL), satisfaction, perception, and preference in female and male catheter-users, who use clean intermittent catheterization (CIC) for bladder management.
Furthermore, the investigation intends to identify microbial contamination of reused catheters and compare proportions to a control single use catheter.
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
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age and has full legal capacity
- •Signed informed consent form
- •Use clean intermittent catheterization to the greatest extent possible (at least three times daily) for at least the last 1 month prior to inclusion
- •Ability (assessed by the investigator) and willingness to participate in a 4-week study period with at least three catheterizations a day using the investigational test product
- •Self-catheterize using a single use hydrophilic coated catheter for at least 1 month prior to inclusion
排除标准
- •Participation in any other clinical intervention study during this investigation
- •Previous participation in this investigation
- •Any known allergies towards ingredients in the investigational device
- •Symptoms of UTI at time of inclusion, as judged by the investigator
- •Antibiotic treatment within 2 weeks prior to the Baseline visit (V1)
- •Breastfeeding
结局指标
主要结局
Change in Health-related Quality of Life From Baseline (Visit 1) to Termination (Visit 5), Measured by the Intermittent Self-Catheterization Questionnaire Index Score.
时间窗: Baseline (day 0) and Termination (day 28).
The Intermittent Self-Catheterization Questionnaire is a validated, self-reported questionnaire which is scored on a 5-point Likert scale and is translated to a value ranging from 0 (strongly disagree) to 4 (strongly agree) with higher values corresponding to greater Health-related Quality of Life. The aggregate scores across domains and the total score are calculated by averaging and multiplying by 25 to achieve a 100-point scale. Change = (Termination score - Baseline score)
次要结局
- Adverse Events(28 days)