Clinical trial NCT01803919: Efficacy Study of Antimicrobial Catheters to Avoid Urinary Infections in Spinal Cord Injured Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urinary Tract Infection
Keywords: Spinal cord injuries
Urinary tract infection
Urinary catheters
Protocol
Randomized clinical trial
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Asociacion Colaboracion Cochrane Iberoamericana
name: European Clinical Research Infrastructure Network
First posted: 2013-03-04
Enrollment: 489
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of catheter associated urinary tract infection
timeFrame: at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)
Secondary outcomes:
measure: Asymptomatic urinary tract infection
timeFrame: at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)
measure: Bacteremic urinary tract infection
timeFrame: at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)
Other outcomes:
measure: Direct costs
timeFrame: From catheterization procedure and 30th day, catheter removal or catheter replacement or finalization of complication(s) or related treatment(s), whichever last longer.
measure: Number of participants with adverse events related to catheterization as a Measure of Safety and Tolerability
timeFrame: at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)
Locations:
city: Santiago de Chile
country: Chile
facility: Mutual de la Seguridad Chilena
city: Ancona
country: Italy
facility: Azienda Ospedaliero-Universitaria - Ospedali Riuniti di Ancona - Unità Spinale
city: Bari
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico di Bari- Unità Operativa di Medicina Fisica e Riabilitazione e Unità Spinale Unipolare
city: Ceglie Messapica
country: Italy
facility: Unità Operative Recupero e Riabilitazione Funzionale e Gravi Cerebrolesioni Acquisite
city: Rome
country: Italy
facility: Unità Spinale Unipolare
city: Alcoitão
country: Portugal
facility: Centro de Medicina de Reabilitação de Alcoitão
state: Alcabideche
city: Braga
country: Portugal
facility: Centro Clínico Académico - Braga, Associação (2CA-Braga)
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Badalona
country: Spain
facility: Hospital de Neurorrehabilitación Instituto Guttmann
state: Barcelona
city: Las Palmas de Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular - Materno Infantil de Canarias
state: Las Palmas
city: Barakaldo
country: Spain
facility: Hospital Universitario Cruces
state: Vizcaya
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Toledo
country: Spain
facility: Hospital Nacional de Parapléjicos
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Alsancak
country: Turkey
facility: Dokuz Eylul University Dept. of Physical Medicine and Rehabilitation
state: Izmir
city: Bornova
country: Turkey
facility: Ege University Dept. of Physical Medicine and Rehabilitation
state: İzmir
Study officials:
affiliation: Asociacion Colaboracion Cochrane Iberoamericana
name: Xavier Bonfill, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bonfill X, Rigau D, Jauregui-Abrisqueta ML, Barrera Chacon JM, de la Barrera SS, Aleman-Sanchez CM, Bea-Munoz M, Moraleda Perez S, Borau Duran A, Espinosa Quiros JR, Ledesma Romano L, Fuertes ME, Araya I, Martinez-Zapata MJ. A randomized controlled trial to assess the efficacy and cost-effectiveness of urinary catheters with silver alloy coating in spinal cord injured patients: trial protocol. BMC Urol. 2013 Jul 30;13:38. doi: 10.1186/1471-2490-13-38.