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

NCT01263392 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2013-06-20

No results posted yet for this study

Summary

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.

Conditions

  • Neurogenic Bladder
  • Spina Bifida

Interventions

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.

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Katherine N Moore, PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
3 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01263392 on ClinicalTrials.gov