Evaluation of a Novel Medical Device to Facilitate Gel Instillation During Change of Long-term Indwelling Urinary Catheters - a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Treatment duration (min)
研究概览
简要总结
A randomized, open label, controlled, parallel group study to investigate difference between regional standard procedure and a novel modified procedure (using an additional novel device to facilitate gel installation) for changing long-term indwelling urinary catheters.
详细描述
This is a randomized, open label, controlled, parallel group study, which comprises one visit that includes: assessment for eligibility, randomization to one of two treatment alternatives, followed by the actual intervention and evaluation of outcomes.
The interventions are either change of catheter according to the regional standard procedure (the comparator group) or change of catheter with the additional use of the novel device to facilitate gel instillation and a slightly modified procedure (the experimental group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Open label
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The patient has an indwelling catheter and a primary diagnosis that justify continued catheter use
- •The patient provides informed consent prior to any study specific procedures
- •The patient is considered to benefit from participation in the clinical study
排除标准
- •The patient do not consent to participate in the study
- •Trauma to urethra or bladder
- •Infection to urethra or bladder
- •Other diagnosis that contraindicates participation in the clinical study as judged by the responsible physician
研究组 & 干预措施
Novel gel installation device procedure
Catheter change with novel device.
Each subject will undergo catheter change with novel gel instillation device procedure
干预措施: Novel gel installation device procedure (Device)
Standard procedure
Catheter change with standard procedure.
Each subject will undergo catheter change with standard procedure
干预措施: Standard procedure (Device)
结局指标
主要结局
Treatment duration (min)
时间窗: During procedure
Treatment duration for procedure
次要结局
- Patient's perceived pain (NRS scale)(During intervention)
- Number of gel syringes used(During intervention)