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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urinary Tract Infections
- Sponsor
- Coloplast A/S
- Enrollment
- 219
- Locations
- 16
- Primary Endpoint
- Occurrence of Symptomatic Urinary Tract Infections (UTIs)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Traumatic spinal cord injury within 3 months prior to inclusion
- •Neurogenic bladder dysfunction requiring intermittent catheterization at least 3 times daily
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Occurrence of Symptomatic Urinary Tract Infections (UTIs)
Time Frame: 4-6 months
Occurrence of symptomatic urinary tract infections (UTIs). Time to first UTI
Secondary Outcomes
- 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)