Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00318591
Status:
COMPLETED
Last Update Posted:
2021-02-10
First Post:
2006-04-26
Brief Title:
Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections
Sponsor:
Coloplast AS
Organization:
Coloplast AS
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None