A Randomized Cross-over Study on Urethral Microtrauma After Intermittent Catheterization.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Hematuria
研究概览
简要总结
The study is undertaken to investigate if the urethral microtrauma, caused by intermittent catheterization, differs between three hydrophilic catheters for intermittent catheterization, LoFric; SpeediCath (SC) and SpeediCath Compact Male (SCCM). The study is a prospective, randomised, cross-over, single-centre study.
Each subject will be randomized to use three different catheter types. Three catheterizations will be performed with each catheter type during one day, with at least two hours between each catheterization. The washout period between catheter switch will be at least one week.
The primary objective is to evaluate urethral microtrauma for three hydrophilic catheters with regards to hematuria after intermittent catheterization.
The secondary objectives are to evaluate urethral microtrauma for three hydrophilic catheters with regards to pyuria and subjective evaluation after intermittent catheterization.
The safety of the three catheters will be evaluated in terms of adverse advents, non-serious and serious, rated for causality.
The hypothesis that level of hematuria is equal after using different catheters will be tested using Wilcoxon signed rank test. The hypothesis will be rejected if the p-value is less than 5%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of informed consent
- •Healthy male volunteers aged 18 years and over (half of the included subjects shall be 18-50 years and the other half >50 years old)
- •Negative urine dipstick test (no blood in the urine) before randomization
排除标准
- •Intake of anticoagulants at enrolment and during the study period
- •Intake of antibiotics at enrolment and during the study period
- •Urinary tract infection (UTI) at enrolment and during the study period
- •Known abnormalities or diseases of the lower urinary tract with the exception of BPH
- •Kidney stones
- •Tumour in the urinary tract
- •Known Sexually transferable diseases in the urinary tract during the study period
- •Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
- •Previous enrolment or randomisation of treatment in the present study
- •Simultaneous participation in another clinical study that might interfere with the endpoints of the 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
LoFric - SC - SCCM
Study period 1: LoFric Study period 2: SpeediCath Study period 3: SpeediCath Compact Male In each study period three catheterizations are made, separated by at least 2 hours.
干预措施: LoFric (Device)
LoFric - SC - SCCM
Study period 1: LoFric Study period 2: SpeediCath Study period 3: SpeediCath Compact Male In each study period three catheterizations are made, separated by at least 2 hours.
干预措施: SpeediCath (Device)
LoFric - SC - SCCM
Study period 1: LoFric Study period 2: SpeediCath Study period 3: SpeediCath Compact Male In each study period three catheterizations are made, separated by at least 2 hours.
干预措施: SpeediCath Compact Male (Device)
LoFric - SCCM - SC
Study period 1: LoFric Study period 2: SpeediCath Compact Male Study period 3: SpeediCath In each study period three catheterizations are made, separated by at least 2 hours.
干预措施: LoFric (Device)
LoFric - SCCM - SC
Study period 1: LoFric Study period 2: SpeediCath Compact Male Study period 3: SpeediCath In each study period three catheterizations are made, separated by at least 2 hours.
干预措施: SpeediCath (Device)
LoFric - SCCM - SC
Study period 1: LoFric Study period 2: SpeediCath Compact Male Study period 3: SpeediCath In each study period three catheterizations are made, separated by at least 2 hours.
干预措施: SpeediCath Compact Male (Device)
SC - SCCM - LoFric
Study period 1: SpeediCath Study period 2: SpeediCath Compact Male Study period 3: LoFric In each study period three catheterizations are made, separated by at least 2 hours.
干预措施: LoFric (Device)
SC - SCCM - LoFric
Study period 1: SpeediCath Study period 2: SpeediCath Compact Male Study period 3: LoFric In each study period three catheterizations are made, separated by at least 2 hours.
干预措施: SpeediCath (Device)
SC - SCCM - LoFric
Study period 1: SpeediCath Study period 2: SpeediCath Compact Male Study period 3: LoFric In each study period three catheterizations are made, separated by at least 2 hours.
干预措施: SpeediCath Compact Male (Device)
SC - LoFric - SCCM
Study period 1: SpeediCath Study period 2: LoFric Study period 3: SpeediCath Compact Male In each study period three catheterizations are made, separated by at least 2 hours.
干预措施: LoFric (Device)
SC - LoFric - SCCM
Study period 1: SpeediCath Study period 2: LoFric Study period 3: SpeediCath Compact Male In each study period three catheterizations are made, separated by at least 2 hours.
干预措施: SpeediCath (Device)
SC - LoFric - SCCM
Study period 1: SpeediCath Study period 2: LoFric Study period 3: SpeediCath Compact Male In each study period three catheterizations are made, separated by at least 2 hours.
干预措施: SpeediCath Compact Male (Device)
SCCM - LoFric - SC
Study period 1: SpeediCath Compact Male Study period 2: LoFric Study period 3: SpeediCath In each study period three catheterizations are made, separated by at least 2 hours.
干预措施: LoFric (Device)
SCCM - LoFric - SC
Study period 1: SpeediCath Compact Male Study period 2: LoFric Study period 3: SpeediCath In each study period three catheterizations are made, separated by at least 2 hours.
干预措施: SpeediCath (Device)
SCCM - LoFric - SC
Study period 1: SpeediCath Compact Male Study period 2: LoFric Study period 3: SpeediCath In each study period three catheterizations are made, separated by at least 2 hours.
干预措施: SpeediCath Compact Male (Device)
SCCM - SC - LoFric
Study period 1: SpeediCath Compact Male Study period 2: SpeediCath Study period 3: LoFric In each study period three catheterizations are made, separated by at least 2 hours.
干预措施: LoFric (Device)
SCCM - SC - LoFric
Study period 1: SpeediCath Compact Male Study period 2: SpeediCath Study period 3: LoFric In each study period three catheterizations are made, separated by at least 2 hours.
干预措施: SpeediCath (Device)
SCCM - SC - LoFric
Study period 1: SpeediCath Compact Male Study period 2: SpeediCath Study period 3: LoFric In each study period three catheterizations are made, separated by at least 2 hours.
干预措施: SpeediCath Compact Male (Device)
结局指标
主要结局
Hematuria
时间窗: Approximately 2 hours after last catheterization
Blood in urine (measured by microscopic urine sediment evaluation) will be assessed at the first normal micturition after three catheterizations. Comparison will be made between study catheter/visit days.
次要结局
- Hematuria(At first, second and third catheterization, approximately 2 hours apart)
- Pyuria(Approximately 2 hours after last catheterization)
- Pyuria(At first, second and third catheterization, approximately 2 hours apart)