This Phase II SBIR project builds upon previous research of two novel functional gel compositions for use with intermittent and indwelling catheters to establish the prototype design, dose of prototype units, and the urinary tract infection (UTI) pathogenic burden on ex-vivo models; and to evaluate pre-clinical safety. There is a high incidence of life-long recurrent UTIs in individuals with neuro-urologic disorders who use these catheters. The continuous, repeated catheterization, and compromises in hygiene and the natural mucosal barrier result in chronic inflammation, recurrent UTI episodes, stone formation, and continuous antibiotic use. Multi-resistant organisms in neurogenic bladder populations are common, leading to nosocomial infections in rehabilitation units. Currently, there is no proven prophylaxis for UTI in these populations. Phase II outcomes include successful clinical testing, FDA approval, and commercialization of this impactful prophylactic product to reduce urinary symptoms and inflammatory response due to UTI in the neurogenic bladder patient population.
