Study to Evaluate NVC-422 for Urinary Catheter Blockage and Encrustation
Status:
Completed
Trial end date:
2013-08-01
Target enrollment:
Participant gender:
Summary
NVC-422 is a topical, non-antibiotic, fast-acting, broad-spectrum anti-microbial, which
exhibits the potential to prevent the growth of urinary pathogens, including Proteus and
others.
The use of a catheter irrigation solution that can prevent biofilm formation and encrustation
leading to blockage may keep the catheter patent longer, resulting in fewer catheter changes,
potentially lower incidence of UTIs, and better patient quality of life.
The study population will include male and female spinal cord injury (SCI) and other
neurogenic bladder patients with chronic indwelling transurethral urinary catheters who have
a recent repeated history of urinary catheter encrustation and/or blockage.
Subjects will receive two treatment regimens: one treatment regimen with NVC-422 sterile
irrigation solution and one treatment regimen with sterile saline irrigation solution. Each
treatment regimen will consist of a total of 8 treatments, with a washout period between
treatment regimens.