PDF(Pubmed)
Abstract：
UNASSIGNED: Foley catheters have been subject to limited development in the last few decades. They fulfil their basic function of draining urine from the bladder but cause other associated problems. T-Control is a new silicone Foley catheter with an integrated fluid control valve whose design aims to reduce the risks associated with bladder catheterization by a multifactorial approach. The general purpose of this study is to determine the effectiveness, comfort, and experience of the patient catheterized with T-Control® compared with patients with a conventional Foley catheter.
UNASSIGNED: This trial is a mixed-method study comprising a two-arm, pilot comparative study with random allocation to T-Control catheter or traditional Foley catheter in patients with long-term catheterization and a study with qualitative methodology, through discussion groups.
UNASSIGNED: The comfort and acceptability of the T-Control® device (qualitative) and the quality of life related to self-perceived health (quantitative) will be analysed as primary endpoints. As secondary endpoints, the following will be analysed: magnitude and rate of infections (symptomatic and asymptomatic); days free of infection; indication of associated antibiotic treatments; determination of biofilm; number of catheter-related adverse events; use of each type of catheterization\'s healthcare resources; and level of satisfaction and workload of health professionals.
UNASSIGNED: Eligible patients are male and female adults aged ≥18 years, who require a change of long-term bladder catheter. The estimated sample size is 50 patients. Patient follow-up includes both the time of catheter insertion and its removal or change 4 weeks later, plus the time until the discussion groups take place.
UNASSIGNED: This trial is a mixed-method study comprising a two-arm, pilot comparative study with random allocation to T-Control catheter or traditional Foley catheter in patients with long-term catheterization and a study with qualitative methodology, through discussion groups.
UNASSIGNED: The comfort and acceptability of the T-Control® device (qualitative) and the quality of life related to self-perceived health (quantitative) will be analysed as primary endpoints. As secondary endpoints, the following will be analysed: magnitude and rate of infections (symptomatic and asymptomatic); days free of infection; indication of associated antibiotic treatments; determination of biofilm; number of catheter-related adverse events; use of each type of catheterization\'s healthcare resources; and level of satisfaction and workload of health professionals.
UNASSIGNED: Eligible patients are male and female adults aged ≥18 years, who require a change of long-term bladder catheter. The estimated sample size is 50 patients. Patient follow-up includes both the time of catheter insertion and its removal or change 4 weeks later, plus the time until the discussion groups take place.
摘要：
Foley导管在过去的几十年中发展有限。它们实现了从膀胱排出尿液的基本功能，但会引起其他相关问题。T-Control是一种新型硅胶Foley导管，带有集成的流体控制阀，其设计旨在通过多因素方法降低与膀胱导管插入相关的风险。这项研究的一般目的是确定有效性，comfort,与使用传统Foley导管的患者相比，使用T-Control®导管的患者的经验。
■该试验是一项混合方法研究，包括两臂，在长期导管插入患者中随机分配给T-Control导管或传统Foley导管的试点比较研究，以及采用定性方法的研究，通过讨论小组。
■将分析T-Control®设备的舒适度和可接受性（定性）以及与自我感知健康相关的生活质量（定量）作为主要终点。作为次要终点，将分析以下内容:感染的程度和发生率(有症状和无症状);无感染天数;相关抗生素治疗的适应症;生物膜的测定;导管相关不良事件的数量;每种类型的导管医疗资源的使用;以及卫生专业人员的满意度和工作量.
■符合条件的患者为≥18岁的男性和女性成年人，需要更换长期膀胱导管的人。估计样本量为50名患者。患者随访包括导管插入时间和4周后拔除或更换时间。加上讨论小组举行的时间。
■该试验是一项混合方法研究，包括两臂，在长期导管插入患者中随机分配给T-Control导管或传统Foley导管的试点比较研究，以及采用定性方法的研究，通过讨论小组。
■将分析T-Control®设备的舒适度和可接受性（定性）以及与自我感知健康相关的生活质量（定量）作为主要终点。作为次要终点，将分析以下内容:感染的程度和发生率(有症状和无症状);无感染天数;相关抗生素治疗的适应症;生物膜的测定;导管相关不良事件的数量;每种类型的导管医疗资源的使用;以及卫生专业人员的满意度和工作量.
■符合条件的患者为≥18岁的男性和女性成年人，需要更换长期膀胱导管的人。估计样本量为50名患者。患者随访包括导管插入时间和4周后拔除或更换时间。加上讨论小组举行的时间。
