Status:
COMPLETED
Comparing Urinary Tract Infections in Children With Spina Bifida Using Two Types of Catheters for Catheterization
Lead Sponsor:
University of Alberta
Conditions:
Neurogenic Bladder
Spina Bifida
Eligibility:
All Genders
3-18 years
Phase:
NA
Brief 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 pe...
Detailed Description
Intermittent catheterisation (IC) is accepted management for maintaining bladder and renal health in individuals with incomplete bladder emptying. Two common products are available for IC: polyvinyl c...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01263392
Start Date
April 1 2007
End Date
January 1 2013
Last Update
June 20 2013
Active Locations (4)
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1
Alberta Children's Hospital
Calgary, Alberta, Canada
2
University of Alberta
Edmonton, Alberta, Canada, T6G 2G3
3
BC Children's Hospital
Vancouver, British Columbia, Canada
4
Winnipeg Children's Hospital
Winnipeg, Manitoba, Canada