Bacterial Properties With LoFric® Catheters During Clean Intermittent Catheterization
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Characteristics of bacteria discovered in urine of pediatric patients using LoFric® catheters during clean intermittent catheterization
研究概览
简要总结
The primary objective of our study is to examine characteristics of bacteria that are discovered in urine from pediatric patients that utilize either LoFric® or non-LoFric® catheters for self intermittent catheterization. The investigators hypothesize that the hydrophilic nature of the LoFric® catheter will alter the microbial environment and reduce clinically significant urinary tract infections in patients with neurogenic bladder compared to a similar population using standard catheters.
Secondary outcomes will be comparing the incidence of clinical urinary tract infections between patients that use standard catheters and those that use LoFric catheters.
Lastly, patient satisfaction using LoFric catheters compared to standard catheters will be assessed.
详细描述
The investigators will randomize patients with neurogenic bladder into 2 groups after the have been matched for age, gender and mobility.
The first group will continue with their current intermittent catheterization system (a non-LoFric® catheter) while the second group will receive sufficient LoFric® catheters to complete the study. The investigators will collect the urine at the start of the study, and then at 3, 6, 12, and 18 months and sent for culture. If a child develops a urinary tract infection, the investigators will have the patient collect the urine and the urine will be cultured and the organism will be identified.
Using an existing bladder cell line, the investigators will inoculate the bladder cells with any bacteria that grows from any sample and then determine the interleukin-6 response of the bladder cell line following inoculation with the bacteria. This will determine if the initiate a high or low cytokine response which the investigators have correlated to clinical risk of symptomatic urinary tract infection
The investigators will provide a patient satisfaction survey at the start of the study, prior to randomization and at the completion of the study to determine satisfaction with LoFric® catheters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Please close this study at ct.gov as we have not further data at NCH as Dr. Vanderbrink left NCH in 2011.
入排标准
- 年龄范围
- — 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who perform clean intermittent catheterization on a regular basis
排除标准
- •Patients on daily continuous antibiotic therapy
研究组 & 干预措施
LoFric® catheters
LoFric® catheters during clean intermittent catheterization will be compared to non-LoFric® catheters during clean intermittent catheterization
干预措施: LoFric® catheters during clean intermittent catheterization (Device)
结局指标
主要结局
Characteristics of bacteria discovered in urine of pediatric patients using LoFric® catheters during clean intermittent catheterization
时间窗: 18 months
次要结局
未报告次要终点