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Comparing Urinary Tract Infections in Children With Spina Bifida Using Two Types of Catheters for Catheterization

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01263392
First received: December 16, 2010
Last updated: July 11, 2012
Last verified: July 2012
History of Changes
  Purpose

The primary aim of this study is to determine if using the SpeediCath hydrophilic catheter will reduce the incidence of symptomatic urinary tract infections in children with spina bifida who perform clean intermittent catheterization for bladder management. The hypothesis is that the incidence of symptomatic urinary tract infections will be significantly reduced (by 25%) in users of the SpeediCath hydrophilic catheter when compared to users of a reused polyvinyl chloride (PVC) catheter. Subjects will be randomly put into one of two groups - one group will use the PVC catheter for 6 months followed by the hydrophilic catheter for 6 months and the other group will use the catheters in reverse order. Each subject will keep a weekly diary recording urinary tract infections, blood in the urine as determined by urine dipstick, doctor visits, and days of missed school and other activities. At the end of each 6 months the subject will fill out a questionnaire recording their comfort and satisfaction in using that catheter.


Condition Intervention
Neurogenic Bladder
Spina Bifida
 Device: Intermittent catheterization

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Comparison of the Incidence of Symptomatic Urinary Tract Infections in Children With Spina Bifida Using Hydrophilic or Non-hydrophilic Polyvinyl Chloride Catheters for Clean Intermittent Catheterization: a Randomized Cross Over Trial

Resource links provided by NLM:

Drug Information available for: Chlorine
U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Symptomatic urinary tract infection (UTI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Symptomatic urinary tract infection (UTI) as per CDC definitions


Secondary Outcome Measures:
  • Subject satisfaction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Comparative data between polyvinyl chloride (PVC) and hydrophilic catheter


Estimated Enrollment: 97
Study Start Date: April 2007
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Polyvinyl Chloride Catheter
Re-use clean polyvinyl chloride catheters for intermittent catheterization of children with spina bifida.
 Device: Intermittent catheterization
Subjects will use each type of catheter for 6 months and will report weekly on urinary tract infections (UTIs), urine dip for haematuria, antibiotic use, and days missed school; and will answer a questionnaire on their comfort and satisfaction with the use of each catheter at the end of the 6 months.
Other Names:
  • Polyvinyl Chloride - Coloplast Conveen catheter
  • Hydrophillic - Coloplast Speedicath catheter
Active Comparator: Hydrophilic catheter
Use hydrophilic catheters (Speedicath) for intermittent catheterization of children with spina bifida.
 Device: Intermittent catheterization
Subjects will use each type of catheter for 6 months and will report weekly on urinary tract infections (UTIs), urine dip for haematuria, antibiotic use, and days missed school; and will answer a questionnaire on their comfort and satisfaction with the use of each catheter at the end of the 6 months.
Other Names:
  • Polyvinyl Chloride - Coloplast Conveen catheter
  • Hydrophillic - Coloplast Speedicath catheter

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Child with spina bifida who requires clean intermittent catheterization (CIC) for ongoing bladder management.
  • Child either self catheterizes or receives catheterization by a consistent person.
  • Child/parent/caregiver able to read and understand English in order to consent to participation in the study and to respond to verbal questions about the experience and satisfaction with the catheter.

Exclusion Criteria:

  • Urethral deformities (i.e. stricture, false passage)
  • Antibiotic prophylaxis
  • Allergy to PVC product
  • Diabetes Mellitus
  • Unwilling to reuse catheters
  • History of bladder pathology (ie. tumours, calculus)
  • Surgical history of augmentation (cystoplasty, continent diversion)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263392

Locations
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada, T6G 2G3
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada
Canada, Manitoba
Winnipeg Children's Hospital
Winnipeg, Manitoba, Canada
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Katherine N Moore, PhD University of Alberta
  More Information

No publications provided

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01263392     History of Changes
Other Study ID Numbers: Speedi 10
Study First Received: December 16, 2010
Last Updated: July 11, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
Neurogenic bladder
Spina bifida
Intermittent catheterization
Urinary tract infections

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Urinary Tract Infections
Spinal Dysraphism
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
 Urologic Diseases
Signs and Symptoms
Infection
Neural Tube Defects
Nervous System Malformations
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 16, 2013