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

Phase 1

• Conditions: Urinary Infections
• Interventions: Device: Oxys Catheter; Device: Covidien Mona-Therm Foley catheter

• Registration Number: NCT02658903
• Lead Sponsor: Oxys Medical AG

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.

Study Timeline

• Study First Submitted: 2015-11-20
• Status Verified: 2016-01
• Study Start: 2016-01
• Study First Submitted QC: 2016-01-19
• Last Update Submitted: 2016-01-19
• Study First Posted: 2016-01-20
• Last Update Posted: 2016-01-20
• Primary Completion: 2017-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study arm with Oxys-Cathter	Oxys Catheter	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.
Control-arm with commercial catheter	Covidien Mona-Therm Foley catheter	The control group is treated with a commercial urinary catheter. The intervention is the insertion of the control urinary catheter (foley) into the bladder,

Primary Outcome Measures

Name	Time	Method
Bacterial biofilm on catheter, assessed by ultrasonic culture of catheter tip removed at the end of the study.	4 weeks

Secondary Outcome Measures

Name	Time	Method
Significant bacteriuria assessed by weekly bacterial cultures.	every week during 4 weeks
occurence of adverse events	within 4 weeks	safety endpoint
Clinically symptomatic catheter associated lower urinary infections.	4 weeks

Trial Locations

Locations (1)

University Hospital Balgrist; 🇨🇭 Zurich, Switzerland