Antiseptic-coated Intermittent Urinary Catheter: Efficacy and Feasibility of Neurogenic Bladder Management and Prevention of Catheter-associated Urinary Tract Infections in Children
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Number of urinary tract infections
研究概览
简要总结
Study design is a prospective, randomised, double-blind, and interventional. Primary aim of the study is to investigate efficacy of antiseptic-coated intermittent hydrophilic urinary catheters in prevention and reduction of catheter-associated urinary tract infections in children with neurogenic bladder. Secondary aim is to assess feasibility of antiseptic-coated intermittent hydrophilic urinary catheters in neurogenic bladder management. Octenidine chloride will be used as antiseptic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •neurogenic bladder
- •use of intermittent catheterisation for neurogenic bladder management
- •informed oral and written consent from the child and both parents/legal guardian
排除标准
- •Congenital anomalies of urinary tract or genitals
- •Immunodeficiency
- •Urinary tract fistula
研究组 & 干预措施
Antiseptic-coated catheter
Hydrophilic intermittent urinary catheter coated with octenidine chloride
干预措施: Antiseptic-coated catheter (Device)
Antiseptic-coated catheter
Hydrophilic intermittent urinary catheter coated with octenidine chloride
干预措施: Octenidine chloride (Drug)
Hydrophilic catheter
Hydrophilic intermittent urinary catheter
干预措施: Hydrophilic catheter (Device)
结局指标
主要结局
Number of urinary tract infections
时间窗: 6 months after start of intervention
Urinary tract infection is diagnosed when both urinalysis results disclose pyuria and/or bacteriuria and the presence of at least 1000 colony-forming units per mL of a uropathogen cultured from a urine specimen obtained through catheterization
次要结局
- Safety during catheterisation(6 months after start of intervention)
- Adverse reactions(6 months after start of intervention)
- Expenses of infection-associated treatment(6 months after start of intervention)
- Improvement in health-related quality of life measured by PedsQL 4.0 Generic Core questionnaire(6 months after start of intervention)