Evaluation of Safety and Tolerability of Nitric Oxide Impregnated Urinary Catheters
Condition: Urinary Tract Infection; Bacteriuria
MeSH terms: Urinary Tract Infections; Bacteriuria
Study type: Interventional
Phase: Phase 1

Summary: 
      According to the World Health Organization, hundreds of millions of patients are affected by
      health-care associated infections worldwide each year, resulting in prolonged hospital stays,
      long-term disabilities, deaths, and financial losses for health systems. The most common
      hospital-acquired infection is Urinary Tract Infection (UTI), accounting for almost 40% of
      all nosocomial infections. Most hospital-acquired UTIs are associated with catheterization.
      In fact, urinary catheter-related bacteriuria is the most common health care associated
      infection worldwide. Catheter-associated UTI (CAUTI) develops following adhesion of
      planktonic bacteria to the surface of the catheter and colonization, creating a persistent
      environment called a biofilm. The nature of biofilm structure together with the physiological
      attributes of biofilm organisms confers an inherent resistance to various antimicrobial
      agents such as antibiotics, disinfectants or germicides, augmenting the potential of these
      pathogens to cause infections in catheterized patients.

      Nitric oxide (NO) is a naturally-produced gas molecule with broad-spectrum antimicrobial
      activity. NO is used in the clinics to treat pulmonary hypertension in neonates and adults.
      Studies have shown that low-dose NO is associated with prevention of biofilm formation,
      biofilm dispersal and elimination of bacteria. It is suggested that NO prevents bacteria
      attachment to catheter surfaces and inhibits biofilm formation in a mechanism involving
      reduction and modification of proteins that mediate cell-substrate and cell-cell
      interactions.

      The investigators team, using a proprietary technology impregnate urinary catheters with NO
      (i.e. NO-impregnated catheters). These catheters release low concentration of NO following
      exposure to urine over a 14-day period. In vitro studies showed that NO-impregnated catheters
      prevent bacterial colonization and biofilm formation of Escherichia coli on exterior and
      luminal surfaces of the catheters. In addition, NO released from these catheters is able to
      eradicate up to 4log colony forming unit/ml of bacteria within the surrounding media.
      Moreover, NO-impregnated catheters exhibit superior performance compared to silver-coated
      catheters, and similar anti-infective properties compared to antibiotic-coated catheters.

      Primary objectives: To assess the safety and tolerability of NO-impregnated catheters in
      patients older than 18 years old undergoing radical prostatectomy and catheterized for 7-14
      days.
    


Intervention name(s): Nitric Oxide impregnated catheter
Intervention type(s): Device
Intervention description(s): Patients undergoing radical prostatectomy will be catheterized for 7-14 days with Nitric Oxide impregnated Foley catheters
Intervention MeSH terms: Nitric Oxide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention