Efficacy of Micro-Patterned Foley Catheter to Reduce Catheter-Associated Urinary Tract Infection

Stopped early · Not applicable

Conditions studied: Urinary Tract Infection

In brief

The purpose of this study is to determine if the study Foley catheter with its patterned external surface can delay the time to the onset of urinary tract infection in spinal cord injury patients who are dependent on a Foley catheter for drainage of their urinary bladder.

Key facts

Study ID

NCT02198833

Run by

Baylor College of Medicine

People needed

2

Starts

2014-09-01

Expected to finish

2015-07-01

Last updated by the study team

2017-04-07

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Veteran
• Hospitalized in one of the two participating Spinal Cord Injury Units
• Require a size 14, 16, or 18 French catheter
• Sign and date the written informed consent document acknowledging his/her desire to participate in the study, or if unable to sign due to spinal cord injury give verbal consent in front of two impartial witnesses who sign and date the informed consent document in the presence of the participant
• Be able to understand and comply with written and verbal protocol requirements, instructions, and protocol-stated restrictions
• Require insertion or exchange of a Foley catheter for no longer than 15 days.

You may not qualify if…

• Unable to provide informed consent
• Has a current symptomatic urinary tract infection
• Has persistent bacteriuria that cannot be cleared with antimicrobial agents to a nominal level of less than 1,000 Colony Forming Units/mL prior to study catheter insertion
• Has a known bloodstream infection or an infection that requires prolonged antibiotic therapy
• Has periurethral inflammation or infection
• Has a known urethral anatomical anomaly which makes catheterization difficult
• Has a known silicone allergy or sensitivity
• Cannot accommodate a size 14,16 or 18 French Foley catheter.

Where it is running

• James A. Haley Veterans' Hospital — Tampa, Florida, United States
• Michael E. DeBakey Veterans Affairs Medical Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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