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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

December 16, 2010
July 11, 2012
April 2007
January 2013   (final data collection date for primary outcome measure)
Symptomatic urinary tract infection (UTI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Symptomatic urinary tract infection (UTI) as per CDC definitions
Symptomatic UTI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Symptomatic UTI as per CDC definitions
Complete list of historical versions of study NCT01263392 on ClinicalTrials.gov Archive Site
Subject satisfaction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Comparative data between polyvinyl chloride (PVC) and hydrophilic catheter
Subject satisfaction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Comparative data between PVC and hydrophilic catheter
Not Provided
Not Provided
 
Comparing Urinary Tract Infections in Children With Spina Bifida Using Two Types of Catheters for Catheterization
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

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Neurogenic Bladder
  • 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: Polyvinyl Chloride Catheter
    Re-use clean polyvinyl chloride catheters for intermittent catheterization of children with spina bifida.
    Intervention: Device: Intermittent catheterization
  • Active Comparator: Hydrophilic catheter
    Use hydrophilic catheters (Speedicath) for intermittent catheterization of children with spina bifida.
    Intervention: Device: Intermittent catheterization
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
97
Not Provided
January 2013   (final data collection date for primary outcome measure)

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)
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01263392
Speedi 10
No
University of Alberta
University of Alberta
Not Provided
Principal Investigator: Katherine N Moore, PhD University of Alberta
University of Alberta
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP