Open Prospective Study on Reduction of Bacteriuria Following Bladder Irrigation With Chlorhexidine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Proportion of patients with bacteriuria <10^3 CFU/ml
研究概览
简要总结
This a prospective, non-controlled, open, multi-center study evaluating the reduction of bacteriuria after bladder irrigation with chlorhexidine in spinal cord injured patients with chronic bacteriuria practicing intermittent catheterisation (IC). Patients will be treated with chlorhexidine for bladder irrigation twice daily for a maximum of 7 days.
The study hypothesis is that bladder irrigation with chlorhexidine is efficient for a short term reduction of bacteriuria in patients performing intermittent catheterization (IC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Provision of informed consent
- •Female or male spinal cord injured subject aged 18 years and over
- •Bacteriuria of >10^5 CFU/mL of >1 bacterial species verified during screening visit
- •Regular users of intermittent catheterisation as primary method for bladder management (defined as a normal catheterisation frequency of at least 3 times daily for at least 1 month)
- •Ability to retain fluid in the bladder (approx. 120 ml) for at least 10 minutes, as judged by the investigator
排除标准
- •Signs or symptoms of symptomatic UTI that requires treatment, as judged by the investigator.
- •Ongoing antibiotic treatment
- •Known anatomical pathology of the urinary tract that could compromise results, as judged by investigator
- •Subject with severe catheterisation difficulties, as judged by investigator
- •Known hypersensitivity to chlorhexidine
- •Use of other instillation products
- •Use of medications that may affect the bacterial culture in the urine and bladder (e.g. methenamine hippurate)
- •Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
- •Previous enrolment or allocation of treatment in the present study.
- •Simultaneous participation in another clinical study that may interfere with the present study.
- •Severe non-compliance to protocol as judged by the investigator and/or Wellspect HealthCare
研究组 & 干预措施
Chlorhexidine
干预措施: Chlorhexidine (Device)
结局指标
主要结局
Proportion of patients with bacteriuria <10^3 CFU/ml
时间窗: 7 days
Bacteriuria will be followed by daily urinary cultures, 3 hours after morning irrigation. The proportion of patients with at least one sample \<10\^3 CFU/ml within the 7 day treatment period will be evaluated.
次要结局
- Time (number of days) to reduction of bacteriuria (<10^3 CFU/ml)(7 days)