Efficacy of BLASTX in Catheter Associated Bacteriuria Versus Standard of Care (SOC)

Efficacy of Bladder Catheters Lubricated With a Biofilm Disruptive Gel, in Reducing Catheter-associated Bacteriuria (CAB) Compared to Standard of Care: A PILOT Clinical Trial

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.

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.

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