Preclinical Investigations of a Novel Antimicrobial Urinary Catheter for Improving Genitourinary Dysfunction
Abstract
Background: Spinal cord injuries (SCIs) occur in the theatre of war. Of the U.S. troops wounded in the wars in Iraq and Afghanistan, 11.1% (>5,770) had SCI. Presently, nearly 44,000 veterans with SCI are eligible for U.S. Department of Veterans Affairs medical care. In general, military personnel with war-related SCI are young males who suffer complete spinal cord lesions resulting from a gunshot or explosion. Often, their recovery and functional status after SCI is impacted by additional injuries thus requiring that they receive lifetime (long-term) care. In the civilian population, 81% of SCIs are related to trauma. SCI is medically complex and life-altering; more than 250,000 individuals in the U.S. are living with SCI. Study Objectives: The objective of this research is to develop and test an antiseptic IMSC Foley catheter that promises to reduce UTIs for persons living with and without SCI and relying on an indwelling catheter. Rationale: Following SCI, bladder function undergoes dramatic changes because communication between the brain and the bladder is interrupted. As such, voiding of urine may no longer be possible. For these people, catheterization, (intermittent or indwelling) is necessary. In the SCI patient, bladder dysfunction is fraught with long-term complications, urinary tract infections (UTIs) being most common. The Intervention: The novel antimicrobial Foley catheter will be manufactured (ensuring it meets ASTM F623-19 criteria) and evaluated in a porcine model of UTI to demonstrate uroepithelial tissue compatibility, product operability, and efficacy vs. a control catheter. This novel catheter aligns strongly with the Fiscal Year 2021 Focus Area, genitourinary dysfunction, addressing the needs of individuals with SCI across their lifespan from acute to chronic care. Impact of the Proposed Research: An indwelling catheter that can reduce UTIs for those in the SCI population who rely on them would be the first substantial improvement to this method of bladder management in decades, potentially improving the quality of life among the SCI population (active/retired military, and civilians) and their caregivers. Such a catheter is expected to help reduce healthcare costs attributed to catheter associated UTIs ($600-$800 million/year) and reduce the need for antibiotics used for catheter-associated UTI treatment. Project Duration and Benefits to SCI Patient Care: The project will require 15-months to ready the product for preclinical (clinic-ready) study. Much of this 15-month effort is related to the rigor necessary to fabricate an Food and Drug Administration (FDA)-compliant device that meets FDA safety standards for use in a human population. The overall project is scheduled as a 36-month effort. Contributions to the Field: SCI patients experience multiple UTIs annually. The proposed product addresses the need for a scalable, low-risk, low-cost intervention with the ability to reduce the incidence of UTIs (not treat them) in SCI patients using indwelling catheters. Reducing UTIs in this population will benefit these patients and their caregivers thus broadly improving quality of lives while aiding those in medical systems providing their care.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 28, 2022
- Source ID
- W81XWH2210540
Entities
People
- David Vachon
Organizations
- Iasis Molecular Sciences (United States)
- United States Army