Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter

Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter

The safety and efficacy of a urinary catheter designed to prevent catheter associated urinary infections is studied.

This study is an open randomized controlled trial of 4 weeks duration. The intervention is a novel urinary catheter with an electromagnetic therapy to prevent catheter associated infections. The catheter is used in patients which require longterm urinary catheterization over at least 1 month.

The endpoint is bacteriological exam and the laboratory is blinded to the therapy status. Weekly urinary cultures are drawn and a sonication culture of the catheter tip is performed to detect and characterize the biofilm. A colonization rate of >95% is anticipated in the control arm. Therefore a 50% reduction in colonization can be detected with 54 patients, a 90% reduction in colonization can be detected with 20 patients with a power of 0.9.

Inclusion Criteria:

• Patient with need for an indwelling urinary catheter to be placed at least for 4 weeks, which are willing and capable to provide informed consent. Most patients have spinal cord injury and are treated by the prinicpal investigator.

Exclusion Criteria:

• Need for antibiotic treatment for any infections
• Urological intervention or need for catheter change within study duration of 4 weeks