Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections

Urinary Tract Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318591
• Other study ID #: DK046CC
• Status: Completed
• Phase: N/A
• Start date: April 2006
• Est. completion date: October 2009

Study information

• Verified date: August 2015
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infections

Intervention

Device:
• SpeediCath
hydrophilic coated urinary intermittent catheter
• Conveen Uncoated
Uncoated urinary intermittent catheter

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	Parkwood Rehabilitation Centre	London	Ontario
Canada	Toronto Rehabilitation Centre	Toronto	Ontario
Canada	G.F.Strong Rehabilitation Centre	Vancouver	British Columbia
United States	University of Michigan Helaths Systems	Ann Arbor	Michigan
United States	Shepherd Center	Atlanta	Georgia
United States	Boston Medical School	Boston	Massachusetts
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Rancho Los Amigos National Rehabilitation Center	Downey	California
United States	Craig Hospital	Englewood	Colorado
United States	The Institute for Rehabilitation and Research (TIRR)	Houston	Texas
United States	University of Miami	Miami	Florida
United States	Mount Sinai School of Medicine	New York	New York
United States	Mayo Clinic, Saint Mary Hospital MB3CF Rehabilitation	Rochester	Minnesota
United States	Santa Clara Valley Medical Center	San Jose	California
United States	Kessler Institute for Rehabilitation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Symptomatic Urinary Tract Infections (UTIs)	Occurrence of symptomatic urinary tract infections (UTIs). Time to first UTI	4-6 months
Secondary	UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml	UTIs with bacteriuria >=100 Colony Forming Units (CFU)/ml. Descriptive analysis	4-6 months
Secondary	Nurse Evaluation of Catheters - Overall Satisfaction	Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)	4-6 months
Secondary	Patient or Caregiver's Evaluation of Catheters - Overall Satisfaction	Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)	4-6 months
Secondary	Nurse Time Spent on Catheterization Procedure		4-6 months
Secondary	Device-related or Possibly Device-related AEs		4-6 months
Secondary	Number of Participants With One or More Urinary Tract Infection		4-6 months