A Multi-centre, Double-blind, Randomized, Parallel Groups Study Comparing PVC and Polyolefin-based Elastomer (POBE) as Catheter Materials, Outcomes Will be Measured by Subject Perception.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 13
- 主要终点
- Subject's Sensation When Using Test Catheter
研究概览
简要总结
The study is designed as a randomized, double-blind, parallel-group, multi centre study comparing perception and tolerability of investigational product and comparator. In the randomized part of the study the subjects will be given either LoFric Primo (POBE) or the comparator LoFric Primo (PVC) for use over 4 weeks. The hypothesis is that subject perception and satisfaction of POBE is equal to or better than for PVC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Provision of informed consent
- •Males and females aged 18 years and over
- •Experienced users of LoFric Primo with a minimum of one month of use
- •Practice CIC with LoFric Primo at least 3 times per day
- •Adults able to read, write and understand information given to them regarding the study
排除标准
- •Ongoing symptomatic UTI
- •Suspicions of possible poor compliance with CIC during the study period
- •Previous enrolment or randomisation of treatment in the present study
- •Pregnancy
- •Subjects not able to perform self-catheterisation
研究组 & 干预措施
LoFric Primo (POBE) single-use urinary catheter
干预措施: LoFric Primo (POBE) single-use urinary catheter (Device)
LoFric Primo (PVC) single-use urinary catheter
干预措施: LoFric Primo (PVC) single-use urinary catheter (Device)
结局指标
主要结局
Subject's Sensation When Using Test Catheter
时间窗: At 4 weeks
Subject's sensation when using test catheter, measured by mean score on a scale from 1 (Comfortable) to 6 (Severe pain)
Subject's Perception Regarding Handling of Test Catheter Before Insertion
时间窗: At 4 weeks
Subject's perception regarding handling of test catheter before insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)
Subject's Perception Regarding Handling of Test Catheter at Insertion
时间窗: At 4 weeks
Subject's perception regarding handling of test catheter at insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)
Subject's Perception Regarding Handling of Test Catheter at Withdrawal
时间窗: At 4 weeks
Subject's perception regarding handling of test catheter at withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)
Subject's Perception Regarding Handling of Test Catheter After Withdrawal
时间窗: At 4 weeks
Subject's perception regarding handling of test catheter after withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)
Subject's General Satisfaction With Test Catheter
时间窗: At 4 weeks
Subject's general satisfaction with test catheter, measured by mean score on a scale from 1 (Very satisfied) to 5 (Absolutely not satified)
次要结局
未报告次要终点