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临床试验/NCT00318591
NCT00318591已完成不适用

A Prospective, Randomized, Parallel-group, Multi-center Study to Compare the Occurrence of Urinary Tract Infections in Patients With Spinal Cord Injury Using Either Coated or Uncoated Intermittent Catheters.

Coloplast A/S16 个研究点 分布在 2 个国家目标入组 219 人开始时间: 2006年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Coloplast A/S
入组人数
219
试验地点
16
主要终点
Occurrence of Symptomatic Urinary Tract Infections (UTIs)

研究概览

简要总结

The purpose of this study is to investigate the frequency of urinary tract infections with symptoms in spinal cord injured patients requiring intermittent catheterization for emptying the bladder. Patients will use either a coated catheter or an uncoated catheter with gel.

详细描述

Introduction

Spinal cord injured (SCI) constitutes a large group of patients suffering from neurogenic bladder dysfunction, which is often managed by intermittent catheterization (IC). Intermittent catheterization is accepted as a safe and effective method for maintaining bladder and renal health in individuals with neurogenic bladder dysfunction. However, IC several times a day places an individual at risk for urethral trauma, hematuria, and particularly symptomatic urinary tract infections (UTI).

Attempts to control UTI with prophylactic antibiotics or sterile technique have not been overly successful but more recent advances in catheter technology, such as the hydrophilic-coated catheter, offer potential benefit. The hydrophilic-coated catheter has a slippery, pre-lubricated surface (along the entire length of the catheter) when soaked in water, allowing smooth insertion without the need for additional water soluble lubricant. Two proposed advantages over uncoated catheters are 1) reduced incidence of symptomatic UTI, and 2) reduction of urethral irritation or urethral trauma, and lowered risk of urethral strictures. Currently, while there are trends in favour of hydrophilic-coated catheters with respect to UTI overall evidence remains inadequate for clinical decision-making for choice of catheter type. Randomised trials to date have been limited by short follow up, heterogeneity, attrition, imprecise outcome measures, and varying definitions of UTI5. Conclusions of the Cochrane group in 20076 were echoed in a recent comprehensive re-view of all studies on hydrophilic-coated catheters - there is modest evidence favouring hydrophilic-coated catheter in reduction of UTI, but further robust research is required.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • •Traumatic spinal cord injury within 3 months prior to inclusion
  • •Neurogenic bladder dysfunction requiring intermittent catheterization at least 3 times daily

排除标准

  • •Has symptoms of UTI at inclusion
  • •Treated with prophylactic antibiotics to prevent UTIs
  • •Has a history of unresolved bladder-ureteral reflux and/or stones in the urinary tract
  • •Has used intermittent catheterization for more than 10 days prior to inclusion

研究组 & 干预措施

SpeediCath

Experimental

hydrophilic-coated intermittent catheter

干预措施: SpeediCath (Device)

Conveen Uncoated

Experimental

uncoated urinary intermittent catheter

干预措施: Conveen Uncoated (Device)

结局指标

主要结局

Occurrence of Symptomatic Urinary Tract Infections (UTIs)

时间窗: 4-6 months

Occurrence of symptomatic urinary tract infections (UTIs). Time to first UTI

次要结局

  • UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml(4-6 months)
  • Nurse Evaluation of Catheters - Overall Satisfaction(4-6 months)
  • Device-related or Possibly Device-related AEs(4-6 months)
  • Nurse Time Spent on Catheterization Procedure(4-6 months)
  • Number of Participants With One or More Urinary Tract Infection(4-6 months)
  • Patient or Caregiver's Evaluation of Catheters - Overall Satisfaction(4-6 months)

研究者

发起方
Coloplast A/S
申办方类型
Industry
责任方
Sponsor

研究点 (16)

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