Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections



Status:Completed
Conditions:Other Indications, Infectious Disease, Urology, Urinary Tract Infections
Therapuetic Areas:Immunology / Infectious Diseases, Nephrology / Urology, Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2006
End Date:October 2009

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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.

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.

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.

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
We found this trial at
13
sites
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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Ann Arbor, Michigan 48108
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Atlanta, Georgia 30309
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Boston, Massachusetts 02188
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Downey, CA
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Edmonton, Alberta T6G 2J2
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Englewood, Colorado 80113
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Houston, TX
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New York, New York 10029
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Rochester, MN
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San Jose, California 95128
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West Orange, New Jersey 07052
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West Orange, NJ
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