Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections

• Occurrence of Symptomatic Urinary Tract Infections (UTIs) [ Time Frame: 4-6 months ] [ Designated as safety issue: Yes ]
  Occurrence of symptomatic urinary tract infections (UTIs). Time to first UTI
  
  

• UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml [ Time Frame: 4-6 months ] [ Designated as safety issue: Yes ]
  UTIs with bacteriuria >=100 Colony Forming Units (CFU)/ml. Descriptive analysis
  
  
• Nurse Evaluation of Catheters - Overall Satisfaction [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
  Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)
  
  
• Patient or Caregiver's Evaluation of Catheters - Overall Satisfaction [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
  Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)
  
  
• Nurse Time Spent on Catheterization Procedure [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
  
• Health Economic Measures [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
  
• Device-related or Possibly Device-related AEs [ Time Frame: 4-6 months ] [ Designated as safety issue: Yes ]
  
• Number of Participants With One or More Urinary Tract Infection [ Time Frame: 4-6 months ] [ Designated as safety issue: Yes ]
  

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.