Efficacy Study of Antimicrobial Catheters to Avoid Urinary Infections in Spinal Cord Injured Patients

Study Overview
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Brief Summary
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The purpose of this trial is to make a comparison between the use of antiseptic silver alloy-coated silicone urinary catheters and the use of conventional silicone urinary catheters in spinal cord injured patients to prevent urinary infections.

Detailed Description
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Antiseptic Silver Alloy-Coated Silicone Urinary Catheters seems to be a promising intervention to reduce urinary tract infections; however, research evidence cannot be extrapolated to spinal cord injured patients. The study is an open, randomized, multicentric, and parallel clinical trial with blinded assessment. The study includes spinal cord injured patients who require at least seven days of urethral catheterization as a method of bladder voiding. Participants are on-line centrally randomized and allocated to one of the two interventions (Antiseptic Urinary Catheters or Conventional Catheters). Catheters are used for a maximum period of 30 days or removed earlier at the clinician criteria. The main outcome is the incidence of urinary tract infections by the time of catheter removal or at day 30 after catheterization, the event that occurs first. Intention-to-treat analysis will be performed, as well as a primary analysis of all patients. The aim of this study is to assess whether silver alloy-coated silicone urinary catheters reduce urinary infections in spinal cord injured patients.

Official Title
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Multicentric, Controlled, Randomized Clinical Trial to Assess the Efficacy and Cost-effectiveness of Urinary Catheters With Silver Alloy Coating Versus Conventional Catheters in Spinal Cord Injured Patients

Conditions
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Urinary Tract Infection

Intervention / Treatment
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* Device: Silver Alloy-Coated Urinary Catheters
* Device: Conventional Urinary Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients with traumatic or medical spinal cord injury Age of 18 years or above Patients who need an indwelling urinary catheter as a method of bladder drainage for at least 7 days. Patients who are willing to participate in the study and give their written informed consent (If a patient is unable to give written consent because of physical or mental disability, an affirmation of consent will be taken in his presence from his relative or legal guardian). Exclusion Criteria: Patients who can benefit from other method of bladder drainage such as intermittent catheterization, suprapubic drainage, reflex voiding or use of an external collector. Patients with urinary tract infection at the moment of inclusion Current antibiotic use or use within 7 days prior to inclusion Outpatients with sporadic medical examinations (less than one per month) Known allergy to latex, silver salts or hydrogels. Patients with surgical interventions in the urinary tract that may interfere, at the investigator criteria, with the study results. Pregnant or breastfeeding woman.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silver Alloy-Coated Urinary Catheters<br>Bactiguard® Infection Protection coating consists of noble metals such as gold, palladium and silver. Trained health staff performs urethral catheterization and select the most adequate catheter size. To ensure aseptic conditions they are asked to strictly follow the current protocol in their respective centers. Indwelling urethral catheters are periodically replaced about 30 days of use; to not interfere with current clinical practice, the policy of each center (or the investigator criteria) for catheter replacement and removal is considered valid for this study. | Device: Silver Alloy-Coated Urinary Catheters<br> <br> * Other names: BIP Foley catheter - Silicone Bactiguard Infection Protection;|
| Other: Conventional Urinary Catheter<br>Conventional or standard urinary catheters are those commonly used in each study center, most of them made of silicone or silicone-latex. Trained health staff performs urethral catheterization and select the most adequate catheter size. To ensure aseptic conditions they are asked to strictly follow the current protocol in their respective centers. Indwelling urethral catheters are periodically replaced about 30 days of use; to not interfere with current clinical practice, the policy of each center (or the investigator criteria) for catheter replacement and removal is considered valid for this study. | Device: Conventional Urinary Catheter<br> <br> * Other names: Foley Euromedical (16 or 18 Ch);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of catheter associated urinary tract infection | Is considered that a patient suffer a urinary tract infection if they have at least one suggestive sign or symptom with no other recognized cause and a positive urine culture with no more than 2 species of microorganisms. An urinary tract infection is considered catheter associated if the specimen collection is performed at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first). | at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asymptomatic urinary tract infection | A positive urine culture with no more than 2 species of microorganisms(collected at any time from catheterization procedure and 30th day, catheter removal or catheter replacement, whichever occurs first), and no signs or symptoms. | at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first) | 
| Bacteremic urinary tract infection | Those with the primary outcome and with a positive blood culture with at least 1 matching uropathogen microorganism to the urine culture. | at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal cord injuries, Urinary tract infection, Urinary catheters, Protocol, Randomized clinical trial