Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT00318591
First received: April 26, 2006
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Urinary Tract Infections
Device: SpeediCath
Device: Conveen Uncoated
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Occurrence of Symptomatic Urinary Tract Infections (UTIs) [ Time Frame: 4-6 months ] [ Designated as safety issue: Yes ]
    Occurrence of symptomatic urinary tract infections (UTIs). Time to first UTI


Secondary Outcome Measures:
  • UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml [ Time Frame: 4-6 months ] [ Designated as safety issue: Yes ]
    UTIs with bacteriuria >=100 Colony Forming Units (CFU)/ml. Descriptive analysis

  • Nurse Evaluation of Catheters - Overall Satisfaction [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
    Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)

  • Patient or Caregiver's Evaluation of Catheters - Overall Satisfaction [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
    Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)

  • Nurse Time Spent on Catheterization Procedure [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
  • Health Economic Measures [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
  • Device-related or Possibly Device-related AEs [ Time Frame: 4-6 months ] [ Designated as safety issue: Yes ]
  • Number of Participants With One or More Urinary Tract Infection [ Time Frame: 4-6 months ] [ Designated as safety issue: Yes ]

Enrollment: 219
Study Start Date: April 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SpeediCath
hydrophilic-coated intermittent catheter
Device: SpeediCath
hydrophilic coated urinary intermittent catheter
Other Name: Coated Catheter
Experimental: Conveen Uncoated
uncoated urinary intermittent catheter
Device: Conveen Uncoated
Uncoated urinary intermittent catheter
Other Name: Uncoated catheter

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318591

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

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00318591     History of Changes
Other Study ID Numbers: DK046CC
Study First Received: April 26, 2006
Results First Received: February 23, 2011
Last Updated: October 4, 2011
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee

Additional relevant MeSH terms:
Communicable Diseases
Infection
Urinary Tract Infections
Urologic Diseases

ClinicalTrials.gov processed this record on October 20, 2014