Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections
NCT ID: NCT00318591
Last Updated: 2021-02-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
219 participants
INTERVENTIONAL
2006-04-30
2009-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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SpeediCath
hydrophilic-coated intermittent catheter
SpeediCath
hydrophilic coated urinary intermittent catheter
Conveen Uncoated
uncoated urinary intermittent catheter
Conveen Uncoated
Uncoated urinary intermittent catheter
Interventions
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SpeediCath
hydrophilic coated urinary intermittent catheter
Conveen Uncoated
Uncoated urinary intermittent catheter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Neurogenic bladder dysfunction requiring intermittent catheterization at least 3 times daily
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Coloplast A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Diana Cardenas, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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Rancho Los Amigos National Rehabilitation Center
Downey, California, United States
Santa Clara Valley Medical Center
San Jose, California, United States
Craig Hospital
Englewood, Colorado, United States
University of Miami
Miami, Florida, United States
Shepherd Center
Atlanta, Georgia, United States
Boston Medical School
Boston, Massachusetts, United States
University of Michigan Helaths Systems
Ann Arbor, Michigan, United States
Mayo Clinic, Saint Mary Hospital MB3CF Rehabilitation
Rochester, Minnesota, United States
Kessler Institute for Rehabilitation
West Orange, New Jersey, United States
Mount Sinai School of Medicine
New York, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
The Institute for Rehabilitation and Research (TIRR)
Houston, Texas, United States
University of Alberta
Edmonton, Alberta, Canada
G.F.Strong Rehabilitation Centre
Vancouver, British Columbia, Canada
Parkwood Rehabilitation Centre
London, Ontario, Canada
Toronto Rehabilitation Centre
Toronto, Ontario, Canada
Countries
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Other Identifiers
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DK046CC
Identifier Type: -
Identifier Source: org_study_id
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