Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Total Bacteria Count Change From Baseline and After 7-14 Days.
研究概览
简要总结
The main objective is to investigate two types of antibacterial catheters regarding their antibacterial efficacy. The study will investigate if silver added to the coating of a urinary catheter exerts antibacterial activity that will have an impact on bacteria quantity in the urine bladder among users of intermittent catheterization.
详细描述
The study was designed as a prospective, randomized, double-blind, single-site study of 24 hours use of a silver coated antibacterial catheter, and 24 hours follow up, in subjects practicing intermittent catheterization.
Twenty male and female subjects using intermittent catheterization, having a confirmed significant bacteriuria were included in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Study subjects, study personnel and laboratory conducting the cultivations and analyses were blinded to the investigational products. The products had the same packaging and visual appearance. The treatment code was never broken during the study.
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/male aged 18 years and over
- •Practicing intermittent catheterization at least 4 times daily for at least 6 weeks
- •A minimum of 104 CFU of bacteriuria
排除标准
- •Ongoing, symptomatic UTI at enrollment
- •Known urethral stricture
- •Basic tumorous disease
- •Previous prostate surgery
- •Subjects known to be immunocompromised e.g. HIV or diabetes
- •Treatment with antibiotics and/or intravesical antiseptics for the past 30 days before study start
- •Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
- •Pregnancy or breast feeding
- •Previous enrolment or randomisation of treatment in the present study
- •Participation in a clinical study that possibly might interfere with the present study, as deemed by the investigator
- •Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
研究组 & 干预措施
Catheter A
Catheterization with Catheter A, which releases silver ions into the urethra and urinary bladder upon catheterization,.
After activation in the wetting solution the coating retains water creating a smooth liquid surface around the catheter.The products are intended for single use. No additional lubricant were used.
The subject will be treated with investigational products during 24 hours. During this period the subject will be catheterized with the study catheter at six occasions (every 4 hours).
干预措施: Silver-nitrate coated catheter ("Catheter A") (Device)
Catheter B
Catheterization with Catheter B, which releases both silver ions and degradable silver particles.. After activation in the wetting solution the coating retains water creating a smooth liquid surface around the catheter.The products are intended for single use. No additional lubricant were used.
The subject will be treated with investigational products during 24 hours. During this period the subject will be catheterized with the study catheter at six occasions (every 4 hours).
干预措施: Degradable silver particle-coated catheter ("Catheter B") (Device)
结局指标
主要结局
Total Bacteria Count Change From Baseline and After 7-14 Days.
时间窗: Baseline and after 7-14 days
Change from baseline and after 7-14 days. Change from baseline (urine sample immediately before first catheterization with study product) to after 7-14 days.
Total Bacteria Count Change From Baseline and After 48 Hours.
时间窗: Baseline and after 48 hours
Change from baseline (urine sample immediately before first catheterization with study product) and after 48 hours of intermittent catheterization. After the baseline sample the subject had 24 hours with study randomized catheter and then changed to 24 hours on non-study sterile intermittent catheterization.
Total Bacteria Count Change From Baseline and After 24 Hours.
时间窗: Baseline and after 24 hours
Change from baseline (urine sample immediately before first catheterization with study product) and after 24 hours of intermittent catheterization with the randomised study catheter.
次要结局
- Urine Silver Concentration Change From Baseline and After 48 Hours(After first catheterization with study product and after 48 hours)
- Urine Silver Concentration Change From Baseline to 7-14 Days(At baseline and after 7-14 days)
- Escherichia Coli Mean Bacteria Count Change From Baseline to 12 Hours(After first catheterization with study product and after 12 hours)
- Escherichia Coli Mean Bacteria Count Change From Baseline to 24 Hours(After first catheterization with study product and after 24 hours)
- Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 12 Hours(After first catheterization with study product and after 12 hours)
- Blood Silver Concentration Change From Baseline and After 24 Hours(After first catheterization with study product and after 24 hours)
- Blood Silver Concentration Change From Baseline and After 7-14 Days(After first catheterization with study product and after 7-14 days)
- Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 24 Hours(After first catheterization with study product and after 24 hours)
- Urine Silver Concentration Change From Baseline to 24 Hours(Baseline to 24 hours)
- Blood Silver Concentration Change From Baseline and After 48 Hours(After first catheterization with study product and after 48 hours)