Role of Residual Urine and Asymptomatic Prostatitis in the Development of Lower Urinary Tract Infections in Spinal Cord Injury Patients - a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- amount of residual urine
研究概览
简要总结
The purpose of this prospective study is to investigate the association between the amount of residual urine and asymptomatic bacterial prostate infection with the occurrence of recurrent (>2 /year) symptomatic urinary tract infections in patients suffering from chronic (> 1 year) spinal cord injury (SCI) and neurogenic lower urinary tract dysfunction performing intermittent catheterization.
The following hypotheses will be tested:
- The amount of residual urine after intermittent catheterization is significantly greater in SCI patients suffering from frequent (>2 /year) urinary tract infections compared to those without.
- The incidence of asymptomatic bacterial prostate infections is significantly higher in SCI patients suffering from frequent (>2 /year) urinary tract infections compared to those without.
详细描述
To investigate the association between the amount of residual urine and asymptomatic bacterial prostate infection with the occurrence of recurrent (>2 /year) symptomatic urinary tract infections in patients suffering from chronic (> 1 year) spinal cord injury (SCI) and neurogenic lower urinary tract dysfunction performing intermittent catheterization, patients perform self-catheterization twice (before and after urodynamic testing. After each catheterization, residual urine is assessed by ultrasound. Prior to urodynamic testing, prostate massage is performed, bacterial cultures of the fluid and the urine are initiated and the results of these cultures will be analysed .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •male patients with chronic (> 1 year) spinal cord injury
- •bladder management by intermittent catheterization
排除标准
- •symptomatic urinary tract infection
- •prostate pathology
- •immunodeficiency
- •antibiotic therapy
- •missing informed consent
结局指标
主要结局
amount of residual urine
时间窗: change from self-catheterization 10 minutes before and 10 minutes after urodynamic assessment
determined by ultrasound
次要结局
- annual rate of symptomatic urinary tract infections(day 0)
- bacterial prostate infection(5-10 minutes before and after prostate massage)
- number of erythrocytes in urine(5-10 minutes before and after prostate massage)
- bacteriuria(5-10 minutes before and after prostate massage)
- number of leucocytes in urine(5-10 minutes before and after prostate massage)
- type of neurogenic bladder dysfunction(day 0)
- patient characteristics(day 0)
- type of catheter used for intermittent catheterization(day 0)