Study to Evaluate NVC-422 for Urinary Catheter Blockage and Encrustation

• Incidence of catheter blockage requiring early removal [ Time Frame: 26 days ] [ Designated as safety issue: No ]
  Catheters removed prior to completion of treatment regimen will be assessed for each treatment group
• Assessment of biofilm of catheter [ Time Frame: 26 days ] [ Designated as safety issue: No ]
  Qualitative and quantitative assessment of biofilm of catheter will be determined for all catheters removed
• Assessment of encrustation of catheter [ Time Frame: 26 days ] [ Designated as safety issue: No ]
  Qualitative and quantitative assessment of encrustation of catheter will be determined for all catheters removed

• Incidence of catheter blockage requiring early removal [ Time Frame: 1-15 days ] [ Designated as safety issue: No ]
  Catheters removed prior to completion of treatment regimen will be assessed for each treatment group
• Assessment of biofilm of catheter [ Time Frame: 15 days ] [ Designated as safety issue: No ]
  Qualitative and quantitative assessment of biofilm of catheter will be determined for all catheters removed
• Assessment of encrustation of catheter [ Time Frame: 15 days ] [ Designated as safety issue: No ]
  Qualitative and quantitative assessment of encrustation of catheter will be determined for all catheters removed

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.

• Drug: NVC-422, 0.2%
  0.2% NVC-422 (sterile), 25 ml instilled and retained in catheter for 15 min, 2x/day; 8 treatments administered over a 26 day period
  Other Name: N,N-dichloro-2,2-dimethyltaurine
• Drug: Sterile normal saline, 0.9%
  Saline (sterile), 25 ml instilled and retained in catheter for 15 min, 2x/day; 8 treatments administered over a 26 day period
  Other Name: 0.9% Sodium chloride for injection, USP

• Experimental: NVC-422
  Intervention: Drug: NVC-422, 0.2%
• Placebo Comparator: Saline
  Intervention: Drug: Sterile normal saline, 0.9%

Inclusion Criteria:

• Spinal Cord Injury (SCI) or other neurogenic bladder patient requiring a chronic indwelling urinary catheter with history of catheter blockage and/or encrustation
• Screening within 30 days of first treatment

Exclusion Criteria:

• Systemic antibiotics within 7 days of first treatment
• Investigational drug or device within 30 days of enrollment
• Current infection that requires treatment with systemic antibiotics
• Recent history of significant autonomic dysreflexia (requiring intervention or treatment)