Comparing Urinary Tract Infections in Children With Spina Bifida Using Two Types of Catheters for Catheterization
Condition: Neurogenic Bladder; Spina Bifida
MeSH terms: Infections; Urinary Tract Infections; Urinary Bladder, Neurogenic; Spinal Dysraphism
Study type: Interventional

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.
    

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 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.

      Inclusion Criteria: Child with spina bifida living in the community who either self IC or
      received IC by a consistent person; child/parent/caregiver able to read and understand
      English. Exclusion criteria: Urethral deformities (i.e. stricture, false passage); antibiotic
      prophylaxis; allergy to PVC product; diabetes mellitus; history of bladder pathology (i.e.
      tumours, calculus); surgical history of augmentation (cystoplasty, continent diversion).

      Results: 70 subjects were randomized; 46 had complete data over 48 weeks; 24 dropouts:
      hydrophilic catheter too slippery (15%); refused PVC arm because they preferred hydrophilic
      catheter (5%); booked for continent diversion (4%), other (8%). Mean age 10.6 (SD 6.2), 21
      males and 25 females. All performed IC > 3/day: 52% self and 48% parents/ caregivers; PVC
      catheters were used at least 5 times. Mean total weeks of self-reported UTI was 3.6 (SD 4.7)
      in the hydrophilic group vs. 2.3 (SD 3.3) in the PVC group (p= <.001) but no statistical
      differences in weeks of febrile UTI, antibiotic use, visits to physicians, days missed from
      school, or microscopic haematuria (urine dip). There was a trend to fewer weeks of positive
      leukocytes in the hydrophilic group (Table 1).

      There were no statistically significant differences in Convenience or Comfort. Ease of
      Handling was significantly different with 40% disliking the hydrophilic product compared to
      10% for the PVC product. Fewer participants answered "yes" to "would you continue using the
      product" (hydrophilic vs. the PVC 65% vs. 90% respectively). However, overall satisfaction
      was no different between products (Table 2).

      Interpretation of Results:

      The study was underpowered despite major attempts at recruitment. However the findings are
      clinically relevant. The hydrophilic catheter was more difficult to handle and therefore less
      likely to be continued than the PVC multiuse product. Participants who overcame the handling
      issues found the product excellent. Incidence febrile UTI or of antibiotic treated UTI did
      not appear to be affected by single use vs. multiuse products.

      Conclusions: A hydrophilic catheter does not appear to reduce febrile UTI or antibiotic use
      in community dwelling children using CIC. Attrition was high based on participants' lack of
      adjustment to the hydrophilic product and to study fatigue. The study results are consistent
      with the existing Cochrane Review: there is a lack of evidence to state the incidence of UTI
      is affected by multiuse or hydrophilic catheter use. Large multicentre trials are strongly
      recommended.

      Table 1: Mean number of weeks (of 24) with Symptoms Hydrophilic Single Use PVC multiuse N
      Mean N Mean Leucocytes 50 8.46 52 10.10 Fever 50 .04 49 .06 Other Symptoms ( w no Fever) 50
      3.50 49 2.22 Hematuria 50 2.64 52 3.15 Antibiotics 50 .80 49 .55 Days Missed Activities 50
      .40 52 .13 Note: all comparisons p>0.05

      Table 2: Overall satisfaction with catheter products Hydrophilic Single Use PVC multiuse N %
      Acceptable N % Acceptable Convenience 49 81.6 48 81.3 p>0.05 Comfort 48 87.5 47 95.7 p>0.05
      Ease of handling 49 59.2 48 95.8 p<0.05 Would you continue to use? 49 57.1 48 91.7 p<0.05
      Overall satisfaction 48 72.9 48 87.5 p>0.05
    

Intervention name(s): Intermittent catheterization
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): Polyvinyl Chloride; Hydrophillic - Coloplast Speedicath catheter
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Neurogenic bladder; Spina bifida; Intermittent catheterization; Urinary tract infections