Pilot study of a non-return catheter valve for reducing catheter-associated urinary tract infections in critically ill patients

Objective: To determine the effectiveness of a non-return catheter valve vs. the standard urine bag for prevention of catheter-associated urinary tract infections (CAUTI) in critically ill patients. Material and Method: This was a pilot, randomized, stratified, open-label controlled trial (ClinicalTrials.gov, number NCT01963013). Ninety-six critically ill patients requiring indwelling urinary catheter were assigned with either a non-return catheter valve or the standard urine bag. Symptoms and signs of CAUTI before and after enrollment for all patients were recorded. If CAUTI was suspected, urine for microbiological testing was collected. The primary outcome was the incidence density rate of symptomatic CAUTI and bacteriurial presence. Results: The 96 patients were randomized into two groups. Baseline patient characteristics were similar in both groups except for the sex distribution. The incidence rate ratio was 0.71 for symptomatic CAUTI in the non-return catheter valve group (95% CI 0.25-1.98, p-value = 0.51). The crude incidence rate ratio of bacteriuria in the non-return valve group was 0.66 (95% CI 0.3-1.46, p-value = 0.31). The sex-adjusted incidence rate ratio of bacteriuria in the non-return catheter valve group was 0.64 (95% CI 0.29-1.41, p-value = 0.27). Conclusion: Using a non-return catheter valve might not prevent CAUTI among critically ill patients.