Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Device: SpeediCath
* Device: Conveen Uncoated


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SpeediCath<br>hydrophilic-coated intermittent catheter | Device: SpeediCath<br>* hydrophilic coated urinary intermittent catheter<br>* Other names: Coated Catheter;|
| Experimental: Conveen Uncoated<br>uncoated urinary intermittent catheter | Device: Conveen Uncoated<br>* Uncoated urinary intermittent catheter<br>* Other names: Uncoated catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Symptomatic Urinary Tract Infections (UTIs) | Occurrence of symptomatic urinary tract infections (UTIs). Time to first UTI | 4-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml | UTIs with bacteriuria >=100 Colony Forming Units (CFU)/ml. Descriptive analysis | 4-6 months | 
| Nurse Evaluation of Catheters - Overall Satisfaction | Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction) | 4-6 months | 
| Patient or Caregiver's Evaluation of Catheters - Overall Satisfaction | Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction) | 4-6 months | 
| Nurse Time Spent on Catheterization Procedure |  | 4-6 months | 
| Device-related or Possibly Device-related AEs |  | 4-6 months | 
| Number of Participants With One or More Urinary Tract Infection |  | 4-6 months |