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

Phase 1

• Conditions: Urinary Infections

• 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

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