Clinical trial NCT00318591: Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections
Official title: A Prospective, Randomized, Parallel-group, Multi-center Study to Compare the Occurrence of Urinary Tract Infections in Patients With Spinal Cord Injury Using Either Coated or Uncoated Intermittent Catheters.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 219
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 study is to investigate the frequency of urinary tract infections with symptoms in spinal cord injured patients requiring intermittent catheterization for emptying the bladder. Patients will use either a coated catheter or an uncoated catheter with gel.

Detailed description: Introduction:

Spinal cord injured (SCI) constitutes a large group of patients suffering from neurogenic bladder dysfunction, which is often managed by intermittent catheterization (IC). Intermittent catheterization is accepted as a safe and effective method for maintaining bladder and renal health in individuals with neurogenic bladder dysfunction. However, IC several times a day places an individual at risk for urethral trauma, hematuria, and particularly symptomatic urinary tract infections (UTI).

Attempts to control UTI with prophylactic antibiotics or sterile technique have not been overly successful but more recent advances in catheter technology, such as the hydrophilic-coated catheter, offer potential benefit. The hydrophilic-coated catheter has a slippery, pre-lubricated surface (along the entire length of the catheter) when soaked in water, allowing smooth insertion without the need for additional water soluble lubricant. Two proposed advantages over uncoated catheters are 1) reduced incidence of symptomatic UTI, and 2) reduction of urethral irritation or urethral trauma, and lowered risk of urethral strictures. Currently, while there are trends in favour of hydrophilic-coated catheters with respect to UTI overall evidence remains inadequate for clinical decision-making for choice of catheter type. Randomised trials to date have been limited by short follow up, heterogeneity, attrition, imprecise outcome measures, and varying definitions of UTI5. Conclusions of the Cochrane group in 20076 were echoed in a recent comprehensive re-view of all studies on hydrophilic-coated catheters - there is modest evidence favouring hydrophilic-coated catheter in reduction of UTI, but further robust research is required.

Eligibility criteria: Inclusion Criteria:

* Traumatic spinal cord injury within 3 months prior to inclusion
* Neurogenic bladder dysfunction requiring intermittent catheterization at least 3 times daily

Exclusion Criteria:

* Has symptoms of UTI at inclusion
* Treated with prophylactic antibiotics to prevent UTIs
* Has a history of unresolved bladder-ureteral reflux and/or stones in the urinary tract
* Has used intermittent catheterization for more than 10 days prior to inclusion

Primary outcomes:
measure: Occurrence of Symptomatic Urinary Tract Infections (UTIs)
timeFrame: 4-6 months
Secondary outcomes:
measure: UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml
timeFrame: 4-6 months
measure: Nurse Evaluation of Catheters - Overall Satisfaction
timeFrame: 4-6 months
measure: Patient or Caregiver's Evaluation of Catheters - Overall Satisfaction
timeFrame: 4-6 months
measure: Nurse Time Spent on Catheterization Procedure
timeFrame: 4-6 months
measure: Device-related or Possibly Device-related AEs
timeFrame: 4-6 months
measure: Number of Participants With One or More Urinary Tract Infection
timeFrame: 4-6 months
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Los Amigos National Rehabilitation Center
state: California
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
city: Boston
country: United States
facility: Boston Medical School
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Helaths Systems
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic, Saint Mary Hospital MB3CF Rehabilitation
state: Minnesota
city: West Orange
country: United States
facility: Kessler Institute for Rehabilitation
state: New Jersey
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Houston
country: United States
facility: The Institute for Rehabilitation and Research (TIRR)
state: Texas
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: G.F.Strong Rehabilitation Centre
state: British Columbia
city: London
country: Canada
facility: Parkwood Rehabilitation Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Rehabilitation Centre
state: Ontario
Study officials:
affiliation: University of Miami
name: Diana Cardenas, MD
role: PRINCIPAL_INVESTIGATOR
References: