Trial record 3 of 45 for:    Spina Bifida

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01263392
First received: December 16, 2010
Last updated: June 19, 2013
Last verified: March 2013
  Purpose

The primary aim of this study was to determine if using the SpeediCath hydrophilic catheter would reduce the incidence of symptomatic urinary tract infections (UTI)in children with spina bifida who perform clean intermittent catheterization for bladder management. The hypothesis was that the incidence of symptomatic urinary tract infections would be significantly reduced (by 25%) in users of the SpeediCath hydrophilic catheter when compared to users of a reused polyvinyl chloride (PVC) catheter. Subjects were randomly assigned to either starting the study with PVC catheter for 6 months followed by the hydrophilic catheter for 6 months or visa versa. Each subject kept a weekly diary recording urinary tract infections symptoms, hematuria determined by urine dipstick, physician visits, days of missed school and other activities. At the end of each 6 months subjects completed a questionnaire recording their comfort and satisfaction in using the PVC or hydrophilic coated catheter. 70 subjects were randomized and 46 had complete data. There were no differences in febrile UTI, antibiotic use, healthcare visits or school days missed. The incidence of self reported UTI was lower in the PVC group than the hydrophilic group. 40% of subjects indicated that the hydrophilic coated catheter was slippery and difficult to handle compared to 10% for the PVC catheter. However overall satisfaction was no different between products. The study results are consistent with the current Cochrane Review that there is a lack of evidence to state that the incidence of UTI is affected by multiuse or hydrophilic catheter use.


Condition Intervention
Neurogenic Bladder
Spina Bifida
Device: Intermittent catheterization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Symptomatic urinary tract infection (UTI) [ Time Frame: 6 months and 6 months at crossover ] [ Designated as safety issue: No ]
    Symptomatic urinary tract infection (UTI) as per CDC definitions


Secondary Outcome Measures:
  • Subject satisfaction [ Time Frame: 6 months and 6 months at cross over ] [ Designated as safety issue: No ]
    Comparative data between polyvinyl chloride (PVC) and hydrophilic catheter on convenience, comfort, ease of handling, continuing to use, and overall satisfaction recorded on validated Satisfaction Questionnaire by subject


Other Outcome Measures:
  • urinalysis (urine dipstick) [ Time Frame: 6 months and 6 months at crossover points ] [ Designated as safety issue: No ]
    urinalysis --- presence of leukocytes, haematuria as measured by subject and recorded in weekly diary

  • Antibiotic use for any reason [ Time Frame: 6 months and 6 months at cross over points ] [ Designated as safety issue: No ]
    Antibiotic use recorded by subject

  • Physician or healthcare provider visits [ Time Frame: 6 months and 6 months at crossover points ] [ Designated as safety issue: No ]
    physician visits for any reason

  • Effect on daily activities [ Time Frame: 6 months and 6 months at crossover ] [ Designated as safety issue: No ]
    days missed of school or activities as recorded by subject in weekly diary


Enrollment: 46
Study Start Date: April 2007
Study Completion Date: January 2013
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 in a diary on urinary tract infections (UTIs), urine dip for haematuria & leukocytes, antibiotic use, and days missed school; and will answer a Satisfaction questionnaire at the end of each 6 month arm.
Other Names:
  • Polyvinyl Chloride
  • 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 in a diary on urinary tract infections (UTIs), urine dip for haematuria & leukocytes, antibiotic use, and days missed school; and will answer a Satisfaction questionnaire at the end of each 6 month arm.
Other Names:
  • Polyvinyl Chloride
  • Hydrophillic - Coloplast Speedicath catheter

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy 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: June 19, 2013
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Spinal Dysraphism
Urinary Bladder, Neurogenic
Urinary Tract Infections
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 April 17, 2014