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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2017

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

  • Device: Oxys Catheter
    • The study catheter is inserted over the urethra in the bladder as a foley catheter. The study foley catheter delivers electromagnetic therapy.
  • Device: Covidien 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.

Arms, Groups and Cohorts

  • Experimental: Study arm with Oxys-Cathter
    • 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.
  • Other: Control-arm with commercial 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,

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Oxys Medical AG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Thomas Kessler, MD, Principal Investigator, Universitätsklinik Balgrist Zürich
  • Overall Contact(s)
    • Christoph Scharf, MD, ++41763322969, christoph.scharf@gmail.com

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