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

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 chloride (PVC) and single use hydrophilic coated PVC. In 2004 the UK spent around £33 million on hydrophilic catheters compared to £3 million for PVC catheters. Proposed advantages of the lubricated hydrophilic catheter over PVC catheters are:

1. lower incidence of symptomatic urinary tract infections (UTI) and
2. lower incidence of urethral irritation, trauma and urethral strictures from repeated IC.

Complications and UTIs are costly to the individual and the system but despite over 25 RCTs on the topic, there remains a lack of evidence indicating superiority of one product over another in community dwelling IC users.

Purpose: To compare the incidence of symptomatic UTI in children with spina bifida using single use hydrophilic (SpeediCath™) or PVC catheters for IC. Secondary aims: compare differences in weekly urinalysis for blood and leukocytes; physician visits, antibiotic use, days missed of school or activities; subject and care provider satisfaction with study catheter products.

Study Design, materials and methods: Randomised crossover two arm trial at four Western Canada paediatric sites: each arm was 24 weeks of single use hydrophilic or PVC catheters cleaned with soap and water (standard of care). Symptomatic UTI defined as positive leukocytes plus > 1 fever, flank pain, increased incontinence, malaise, cloudy or odorous urine requiring antibiotic treatment. Randomisation was determined at the study centre using a computer generated list into random block sizes of 8. Subject assignments were placed in opaque envelopes and sealed. After consent was obtained the local research assistant contacted the site technician who opened the envelope and gave the assignment. Sample size: With power of 80%, an expected difference of 25% between treatment and control and α 0.05, the total sample size needed was 97 subjects, using methods for correlated binary data and repeated measures. All data was entered by an impartial technician. It was not possible to blind subjects to product. Data were analyzed using a Mixed Within-Subjects Between-Subjects Analysis of Variance where the group was defined by the catheter type on which the trial began. SPSS version 20 was used for all analyses.