Urinary Tract Infection
Conditions
Keywords
Spinal cord injuries, Urinary tract infection, Urinary catheters, Protocol, Randomized clinical trial
Brief summary
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
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.
Interventions
DEVICESilver Alloy-Coated Urinary Catheters
DEVICEConventional Urinary Catheter
Sponsors
Asociacion Colaboracion Cochrane Iberoamericana
European Clinical Research Infrastructure Network
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of catheter associated urinary tract infection | at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asymptomatic urinary tract infection | at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first) | 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. |
| Bacteremic urinary tract infection | at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first) | Those with the primary outcome and with a positive blood culture with at least 1 matching uropathogen microorganism to the urine culture. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Direct costs | From catheterization procedure and 30th day, catheter removal or catheter replacement or finalization of complication(s) or related treatment(s), whichever last longer. | Calculation of direct costs attributable to the use of intervention or control urinary catheters and their complications |
| Number of participants with adverse events related to catheterization as a Measure of Safety and Tolerability | at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first) | Any untoward medical occurrence related to urinary catheterization |
Countries
Chile, Italy, Portugal, Spain, Turkey (Türkiye)
Outcome results
None listed