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

Oxys Medical

Status and phase: Unknown; Phase 1

Conditions: Urinary Infections

Treatments: Device: Oxys Catheter; Device: Covidien Mona-Therm Foley catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT02658903

Oxys-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Study arm with Oxys-Cathter

Experimental group

Description:

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.

Treatment:

Device: Oxys Catheter

Control-arm with commercial catheter

Other group

Description:

The control group is treated with a commercial urinary catheter. The intervention is the insertion of the control urinary catheter (foley) into the bladder,

Treatment:

Device: Covidien Mona-Therm Foley catheter