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

NCT01263392 | Completed

• 1 other identifier: Speedi 10
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

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 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

Keywords

Neurogenic bladder; Spina bifida; Intermittent catheterization; Urinary tract infections

Outcome Measures

Primary Outcomes (1)

• Symptomatic urinary tract infection (UTI)

  Symptomatic urinary tract infection (UTI) as per CDC definitions

  6 months and 6 months at crossover

Secondary Outcomes (1)

• Subject satisfaction

  6 months and 6 months at cross over

Other Outcomes (4)

• urinalysis (urine dipstick)

  6 months and 6 months at crossover points

• Antibiotic use for any reason

  6 months and 6 months at cross over points

• Physician or healthcare provider visits

  6 months and 6 months at crossover points

Study Arms (2)

Polyvinyl Chloride Catheter

ACTIVE COMPARATOR

Re-use clean polyvinyl chloride catheters for intermittent catheterization of children with spina bifida.

Device: Intermittent catheterization

Hydrophilic catheter

ACTIVE COMPARATOR

Use hydrophilic catheters (Speedicath) for intermittent catheterization of children with spina bifida.

Device: Intermittent catheterization

Interventions

Intermittent catheterization DEVICE

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.

Also known as: Polyvinyl Chloride, Hydrophillic - Coloplast Speedicath catheter

Hydrophilic catheter; Polyvinyl Chloride Catheter

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (4)

Alberta Children's Hospital

Calgary, Alberta, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2G3, Canada

Location

BC Children's Hospital

Vancouver, British Columbia, Canada

Location

Winnipeg Children's Hospital

Winnipeg, Manitoba, Canada

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Spinal Dysraphism; Urinary Tract Infections

Interventions

Intermittent Urethral Catheterization

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infections

Intervention Hierarchy (Ancestors)

Urinary Catheterization; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Katherine N Moore, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: December 20, 2010
• Study Start: April 1, 2007
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: June 20, 2013

Record last verified: 2013-03

Locations

CA (4)