A Prospective, Randomized, Cross-over Study - Evaluation of a New Catheter Material for Intermittent Catheterization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 12
- 主要终点
- Number of Participants With Discomfort
研究概览
简要总结
The hypothesis to be investigated is if the tolerability of intermittent catheterization with Polyolefin Based Elastomer (POBE) 2.0 and Polyvinyl Chloride (PVC) is clinically equal - i.e. clinically non-inferior when using POBE 2.0 compared to PVC.
Secondary objectives are to evaluate the safety and the subject's perception associated with the use of the catheters, assessed by the recording of adverse events and the ease of handling by means of a subjective assessment scale.
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
- 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
- •Provision of informed consent
- •Males, aged 18 years and over
- •Maintained urethra sensibility
- •Practice intermittent self-catheterization at least 2 times daily
- •Using catheters in the length of 40 cm and size charrière (Ch) 12 or Ch 14
- •Experienced practitioners of intermittent self-catheterization defined as a minimum of three months on therapy
- •Experience of using LoFric catheter within the last 12 months prior to study entry
- •Adults able to read, write and understand information given to them regarding the study
排除标准
- •Ongoing, symptomatic urinary tract infection (UTI) at enrolment as judged by investigator
- •Known urethral stricture at enrolment as judged by investigator
- •Involvement in the planning and/or conduct of the study (applies to both Astra Tech staff or staff at the study site)
- •Previous enrolment or randomisation of treatment in the present study
结局指标
主要结局
Number of Participants With Discomfort
时间窗: At 7 and 14 days after randomization, respectively
The primary objective of this study is to compare the subject's tolerability, with regards to perceived discomfort, when using two different urinary catheters. Perception of discomfort (yes/ no) will be assessed in patient questionnaire for each subject. The frequency of discomfort will be compared between the treatments.
次要结局
- Perception of Pain(At 7 and 14 days after randomization, respectively)
- Perception of Burning Sensation(At 7 and 14 days after randomization, respectively)
- Presence of Bleeding(At 7 and 14 days after randomization, respectively)
- Perception of "Other Discomfort"(At 7 and 14 days after randomization, respectively)
- Perception of Stiffness/ Rigidity(At 7 and 14 days after randomization, respectively)
- Perception of Catheter Eyes(At 7 and 14 days after randomization, respectively)
- Perception of Catheter Adherence(At 7 and 14 days after randomization, respectively)
- Perception of Catheter Tip(At 7 and 14 days after randomization, respectively)
- Perception of Slipperiness(At 7 and 14 days after randomization, respectively)
- Perception of Smoothness(At 7 and 14 days after randomization, respectively)
- Perception of Resistance(At 7 and 14 days after randomization, respectively)
- Perception of Discomfort Due to Other Causes(At 7 and 14 days after randomization, respectively)