Urinary Infections
Conditions
Keywords
Foley, Infection, Hospital acquired, catheter associated, urinary
Brief summary
The safety and efficacy of a urinary catheter designed to prevent catheter associated urinary infections is studied.
Detailed description
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.
Interventions
DEVICEOxys Catheter
The study catheter is inserted over the urethra in the bladder as a foley catheter. The study foley catheter delivers electromagnetic therapy.
DEVICECovidien Mona-Therm Foley catheter
The control arm catheter is inserted over the urethra in the bladder. The control catheter is a Mona-Therm catheter from Covidien.
Sponsors
Oxys Medical AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bacterial biofilm on catheter, assessed by ultrasonic culture of catheter tip removed at the end of the study. | 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Significant bacteriuria assessed by weekly bacterial cultures. | every week during 4 weeks | — |
| Clinically symptomatic catheter associated lower urinary infections. | 4 weeks | — |
| occurence of adverse events | within 4 weeks | safety endpoint |
Countries
Switzerland
Contacts
Primary ContactChristoph Scharf, MD
Backup ContactChristine Tivig, MD
Outcome results
None listed