Multicentre International Randomized Clinical Study to Assess the Efficacy of the T-Control® Catheter vs. a Conventional Foley-type Catheter
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 12
- 主要终点
- Rate of Catheter-Associated Urinary Tract Infections (symptomatic and asymptomatic)
研究概览
简要总结
The goal of this clinical trial is to learn if the new urinary catheter T-Control® allows a reduction in infections associated with urinary catheters and a better quality of life of urinary catheter patients compared to the conventional Foley-type catheter (the currently used in clinical practice). It will also learn about the safety profile of the T-Control® catheter and its cost-effectiveness. The main questions it aims to answer are:
Does the T-Control® catheter lower the number of infections of the patients who need long-term catheterization? Does he T-Control® catheter implies a better perceived quality of life of long-term catheterization patients?
Participants will:
Be catheterized with T-Control® or Foley catheter. Visit the clinic after 4 weeks for checkups, fullfill questionnaires and tests. Keep a diary of their symptoms and adverse events related to the catheter.
详细描述
This is a comparative, randomized, controlled, multicentric clinical study with two arms in which the T-control® catheter is compared with a conventional Foley-type catheter.
The main objective of this study is to determine the efficacy of T-Control® compared to the conventional Foley-type catheter, by comparing the number of CAUTIs (both symptomatic and asymptomatic) in patients with long-term catheterization. While the secondary objectives are: to determine the Health-related QoL (HRQoL) and analyze the self-perceived QoL of catheterized patients, as well as the acceptability of the T-Control® device, patient's satisfaction and patients' experience framed in the trajectory of the disease; to compare the safety profile between T-Control® and the conventional Foley-type catheter and the antibiotics used; to determine the cost-effectiveness of T-Control® versus the conventional Foley-type catheter, from the perspective of the hospital; and to measure the level of satisfaction of healthcare professionals with the different types of urinary catheters.
Follow-up includes both the time of the catheter insertion until its removal or change, lasting 4 weeks. All the parameters collected during the follow-up visit refer to the 4 weeks during which the patient has had the catheter inserted.
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
Due to the nature of the intervention, it is not possible to blind the patient or the healthcare professional; however, the professional who analyses the data will be unaware of the type of catheter used for each patient.
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
- •Men or women aged ≥18 years
- •Patients who require change of bladder catheter.
- •Patients with indication of bladder catheterization for at least 4 weeks.
- •Patients who maintain cognitive and physical ability for self-monitoring of the catheter valve.
- •Patients who sign ICF prior to the performance of any study-specific procedure.
排除标准
- •Use of current antibiotic treatment or in the 2 weeks prior to the study inclusion.
- •Patients undergoing chemotherapy, radiotherapy, immunosuppressants or retroviral treatment.
- •Patients with bilateral obstructive supravesical uropathy.
- •Inability to read and understand the language of the Hospital's country.
- •Patients who are participating in a clinical trial or intends to participate during the course of this study.
研究组 & 干预措施
Experimental arm (T-Control®)
Patients catheterized with a catheter with a control valve for intermittent drainage
干预措施: T-Control® catheter (Device)
Control arm (Foley)
Patients catheterized with a conventional urinary catheter with continuous drainage
干预措施: Foley-type catheter (Device)
结局指标
主要结局
Rate of Catheter-Associated Urinary Tract Infections (symptomatic and asymptomatic)
时间窗: 4 weeks
Number of infections divided by number of patients. The presence of pathogenic microorganisms in quantities greater than or equal to 1,000 CFU/ml will determine the presence of infection, while, in the absence of symptoms of infection, a determination of microorganisms greater than or equal to 100,000 CFU/ml will indicate asymptomatic infection.
Magnitude of Catheter-Associated Urinary Tract Infections (symptomatic and asymptomatic)
时间窗: 4 weeks
Amount of pathogenic microorganisms present in urine (in CFU/ml) divided by number of patients
次要结局
- Cost-effectiveness(4 weeks)
- Antibiotic treatments(4 weeks)
- Satisfaction of health professionals(9 months)
- Health Related Quality of Life (HRQoL)(4 weeks)
- Adverse events(4 weeks)
- Catheter Related Quality of Life(4 weeks)