Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections

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.

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Device: SpeediCath; Device: Conveen Uncoated

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.

• Study Type: Interventional
• Enrollment (Actual): 219
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2C8
      • University of Alberta
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 2G9
      • G.F.Strong Rehabilitation Centre
  • Ontario
    • London, Ontario, Canada, N6A 4G5
      • Parkwood Rehabilitation Centre
    • Toronto, Ontario, Canada, M4G 3V9
      • Toronto Rehabilitation Centre
• United States
  • California
    • Downey, California, United States, 90242
      • Rancho Los Amigos National Rehabilitation Center
    • San Jose, California, United States, 95128
      • Santa Clara Valley Medical Center
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Craig Hospital
  • Florida
    • Miami, Florida, United States, 33101
      • University of Miami
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Shepherd Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02188
      • Boston Medical School
  • Michigan
    • Ann Arbor, Michigan, United States, 48108
      • University of Michigan Helaths Systems
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic, Saint Mary Hospital MB3CF Rehabilitation
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Kessler Institute for Rehabilitation
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
  • North Carolina
    • Charlotte, North Carolina, United States, 28303
      • Carolinas Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • The Institute for Rehabilitation and Research (TIRR)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SpeediCath; hydrophilic-coated intermittent catheter	Device: SpeediCath; hydrophilic coated urinary intermittent catheter; Other Names: Coated Catheter
Experimental: Conveen Uncoated; uncoated urinary intermittent catheter	Device: Conveen Uncoated; Uncoated urinary intermittent catheter; Other Names: Uncoated catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Symptomatic Urinary Tract Infections (UTIs)	Occurrence of symptomatic urinary tract infections (UTIs). Time to first UTI	4-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml	UTIs with bacteriuria >=100 Colony Forming Units (CFU)/ml. Descriptive analysis	4-6 months
Nurse Evaluation of Catheters - Overall Satisfaction	Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)	4-6 months
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
Nurse Time Spent on Catheterization Procedure		4-6 months
Device-related or Possibly Device-related AEs		4-6 months
Number of Participants With One or More Urinary Tract Infection		4-6 months

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Diana Cardenas, MD, University of Miami

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: April 26, 2006
• First Submitted That Met QC Criteria: April 26, 2006
• First Posted (Estimate): April 27, 2006

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections
• Other Study ID Numbers: DK046CC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No