Ignite Creation Date:
2024-05-05 @ 11:09 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01263392
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2010-12-16
Brief Title:
Comparing Urinary Tract Infections in Children With Spina Bifida Using Two Types of Catheters for Catheterization
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 UTIin 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 005 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 childparentcaregiver able to read and understand English Exclusion criteria Urethral deformities ie stricture false passage antibiotic prophylaxis allergy to PVC product diabetes mellitus history of bladder pathology ie 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 106 SD 62 21 males and 25 females All performed IC 3day 52 self and 48 parents caregivers PVC catheters were used at least 5 times Mean total weeks of self-reported UTI was 36 SD 47 in the hydrophilic group vs 23 SD 33 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 50 846 52 1010 Fever 50 04 49 06 Other Symptoms w no Fever 50 350 49 222 Hematuria 50 264 52 315 Antibiotics 50 80 49 55 Days Missed Activities 50 40 52 13 Note all comparisons p005
Table 2 Overall satisfaction with catheter products Hydrophilic Single Use PVC multiuse N Acceptable N Acceptable Convenience 49 816 48 813 p005 Comfort 48 875 47 957 p005 Ease of handling 49 592 48 958 p005 Would you continue to use 49 571 48 917 p005 Overall satisfaction 48 729 48 875 p005
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 005 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 childparentcaregiver able to read and understand English Exclusion criteria Urethral deformities ie stricture false passage antibiotic prophylaxis allergy to PVC product diabetes mellitus history of bladder pathology ie 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 106 SD 62 21 males and 25 females All performed IC 3day 52 self and 48 parents caregivers PVC catheters were used at least 5 times Mean total weeks of self-reported UTI was 36 SD 47 in the hydrophilic group vs 23 SD 33 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 50 846 52 1010 Fever 50 04 49 06 Other Symptoms w no Fever 50 350 49 222 Hematuria 50 264 52 315 Antibiotics 50 80 49 55 Days Missed Activities 50 40 52 13 Note all comparisons p005
Table 2 Overall satisfaction with catheter products Hydrophilic Single Use PVC multiuse N Acceptable N Acceptable Convenience 49 816 48 813 p005 Comfort 48 875 47 957 p005 Ease of handling 49 592 48 958 p005 Would you continue to use 49 571 48 917 p005 Overall satisfaction 48 729 48 875 p005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None