Urinary Tract Infections
Conditions
Keywords
Foley, UTI, Biofilm, DNA
Brief summary
This is a 2-week, single-site, randomized study in adults requiring short-term (≤ 14 days) catheterization. Subjects will be randomized 1:1 to either the biofilm disrupting gel (BLASTX) or SOC (McKesson Jelly) lubricated catheters. Urine and/or catheter DNA analysis will be obtained at catheter insertion, 2, 5, 7 and 14 days after catheterization.
Detailed description
This is a 2-week, single-site, randomized controlled pilot study in adults requiring short-term \< 14 days catheterization. Subjects will be randomized 1:1 to either the BLASTX or SOC lubricated catheters. Urine and catheter DNA analysis will be obtained at catheter insertion, 2 to 3 days after catheterization and at 5, 7 and 14 days if catheterization was indicated for either duration. Informed consent discussion will be completed, ICF will be signed, prior to any study procedures. Subjects will be included only if all of the inclusion criteria and none of the exclusion criteria have been met. After randomization, subjects will be followed, urine samples will be collected at each scheduled visit and the catheters will be collected upon removal.
Interventions
DEVICEBLASTX Gel
Foley Catheter lubricated with BLASTX Gel
DEVICEMcKesson Jelly
Foley Catheter lubricated with McKesson Jelly
Sponsors
Next Science TM
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years or older 2. Absence of symptomatic UTI 3. Absence of upper/lower tract obstructions 4. No known allergies to the study products 5. Willing to comply with all study procedures and available for the duration of the study
Exclusion criteria
1. 17 years or younger 2. Symptomatic UTI 3. Presence of upper/lower tract obstructions 4. Known allergic reaction to the study products 5. Unable to provide signed and dated informed consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine microorganisms DNA analysis | Up to 14 days | Change in microorganisms in the test group compared to the control group. |
| Catheter microorganisms DNA analysis | Up to 14 days | Change in microorganisms in the test group compared to the control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Urinary Tract Infections (UTIs) | 14 days | Number of instances of clinically symptomatic UTI in the test versus the control group |
Countries
United States
Outcome results
None listed