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

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

Detailed Description
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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.

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

Conditions
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Urinary Infections

Intervention / Treatment
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* Device: Oxys Catheter
* Device: Covidien Mona-Therm Foley catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm with Oxys-Cathter<br>The study group is treated with a modified urinary catheter, which delivers electromagnetic therapy to prevent and treat bacterial colonization during the study period. The intervention is the insertion of the study urinary catheter (foley) into the bladder. | Device: Oxys Catheter<br>* The study catheter is inserted over the urethra in the bladder as a foley catheter. The study foley catheter delivers electromagnetic therapy.<br>|
| Other: Control-arm with commercial catheter<br>The control group is treated with a commercial urinary catheter. The intervention is the insertion of the control urinary catheter (foley) into the bladder, | Device: Covidien Mona-Therm Foley catheter<br>* The control arm catheter is inserted over the urethra in the bladder. The control catheter is a Mona-Therm catheter from Covidien.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial biofilm on catheter, assessed by ultrasonic culture of catheter tip removed at the end of the study. |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | safety endpoint | within 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Foley, Infection, Hospital acquired, catheter associated, urinary