A Multi Centre, Single-blind, Randomized, Cross-over Study Comparing Two Female Catheters With Different Length in Terms of Residual Urine After Intermittent Catheterization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Bladder Scan Measurements of Residual Urine Volume
研究概览
简要总结
A study comparing a 10 cm catheter with a 7 cm catheter in a group of female patients who, on a routine bases, empty their bladder using urinary catheters, by measuring residual urine after intermittent catheterization.
详细描述
The study personnel will conduct three bladder scans after each catheterization in order to obtain the mean residual urine volume. Each patient will catheterize herself two times with each product, i.e. a total of four catheterizations.
Diagnosis and BMI will be collected at visit 1 to assess whether the residual urine volume differs between these subgroups.
The hypothesis that the mean residual volumes were equal when using the 7 and the 10 centimeter catheters was tested by means of the Wilcoxon signed rank test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The subjects were handed out numbered boxes with the catheter randomised to be used and then cathererisized by herself.
The investigator was blinded to which catheter was used.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provision of signed informed consent
- •Female subjects aged 18 years and over
- •Experienced users of CIC with a minimum of one month of use
- •Practice CIC a minimum of 1 time per day
- •Practice CIC with female catheters with a maximum length of 20 cm
- •Perform self-catheterization
- •Sufficient hand function to be able to open and handle catheter packages
- •Use catheters with Ch 10, 12 or 14
排除标准
- •Pregnancy
- •Ongoing symptomatic UTI
- •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
- •Participation in another clinical study during the study period
- •Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
结局指标
主要结局
Bladder Scan Measurements of Residual Urine Volume
时间窗: Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.
Measurements were performed with the bladder scan BVI 3000. The primary outcome variable was average residual urine volume (mL) calculated from repetitive bladder scans performed after each catheterization. Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated.
次要结局
- Number of Subjects With a Residual Volume >30mL or ≤30mL(Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.)
- Number of Subjects With a Residual Volume >10mL or ≤10mL(Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.)
- Number of Subjects With a Residual Volume >50mL or ≤50mL(Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.)
- Number of Subjects With a Residual Volume >5mL or ≤5mL(Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. At least 2 hours had to pass between 2 catheterizations.)
- Does the Subject's Bladder Feel Completely Empty After Catheterisation (All Subjects)(Question asked minutes after catheterization.)