To assess the ability of the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter to reduce biofilm formation in subjects that require a long-term indwelling Foley catheter when compared to other commercially available urinary catheters.
A prospective, randomized, multi-center, post-market study in subjects that require a long-term indwelling Foley catheter. A randomly assigned catheter will be inserted using standard techniques. Non-surgical subjects will rate the level of pain associated with the insertion procedure using the visual analog scale (VAS). A urine sample will be collected immediately after catheter insertion, in order to generate a baseline urinalysis and urine culture. Follow-up visits will be performed on Day 28, or upon catheter removal, whichever occurs first. The catheter will be removed on Day 28 or earlier if clinically indicated. The removed catheter will be processed and sent to the core laboratory for analysis. Urine will be collected immediately prior to catheter removal in order to conduct urinalysis and urine culture. Subject will rate level of pain associated with the removal procedure using the VAS. The subject will also fill out a questionnaire about their experience with the catheterization immediately after catheter removal. Subjects will then be exited from the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
158
Foley Catheter inserted for up to 28-days
Urology Associates of Southern Arizona
Tucson, Arizona, United States
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States
West Los Angeles VA Medical Center
Los Angeles, California, United States
Tri Valley Urology Medical Group
Biofilm formation
A core lab will use the BacTiter-Glo Microbial Cell Viability Assay, a well characterized method for quantifying active biomass and biofilm, to determine biofilm formation on explanted catheter samples.
Time frame: 5 to 7 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Murrieta, California, United States
Providence Saint John's Health Center
Santa Monica, California, United States
The Iowa Clinic
West Des Moines, Iowa, United States
Montefiore Medical Center
The Bronx, New York, United States
Evergreen Health
Kirkland, Washington, United States