Urinary Tract Infections
Conditions
Brief summary
The purpose of this study is to investigate the frequency of urinary tract infections with symptoms in spinal cord injured patients requiring intermittent catheterization for emptying the bladder. Patients will use either a coated catheter or an uncoated catheter with gel.
Detailed description
Introduction: Spinal cord injured (SCI) constitutes a large group of patients suffering from neurogenic bladder dysfunction, which is often managed by intermittent catheterization (IC). Intermittent catheterization is accepted as a safe and effective method for maintaining bladder and renal health in individuals with neurogenic bladder dysfunction. However, IC several times a day places an individual at risk for urethral trauma, hematuria, and particularly symptomatic urinary tract infections (UTI). Attempts to control UTI with prophylactic antibiotics or sterile technique have not been overly successful but more recent advances in catheter technology, such as the hydrophilic-coated catheter, offer potential benefit. The hydrophilic-coated catheter has a slippery, pre-lubricated surface (along the entire length of the catheter) when soaked in water, allowing smooth insertion without the need for additional water soluble lubricant. Two proposed advantages over uncoated catheters are 1) reduced incidence of symptomatic UTI, and 2) reduction of urethral irritation or urethral trauma, and lowered risk of urethral strictures. Currently, while there are trends in favour of hydrophilic-coated catheters with respect to UTI overall evidence remains inadequate for clinical decision-making for choice of catheter type. Randomised trials to date have been limited by short follow up, heterogeneity, attrition, imprecise outcome measures, and varying definitions of UTI5. Conclusions of the Cochrane group in 20076 were echoed in a recent comprehensive re-view of all studies on hydrophilic-coated catheters - there is modest evidence favouring hydrophilic-coated catheter in reduction of UTI, but further robust research is required.
Interventions
DEVICESpeediCath
hydrophilic coated urinary intermittent catheter
DEVICEConveen Uncoated
Uncoated urinary intermittent catheter
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Traumatic spinal cord injury within 3 months prior to inclusion * Neurogenic bladder dysfunction requiring intermittent catheterization at least 3 times daily
Exclusion criteria
* Has symptoms of UTI at inclusion * Treated with prophylactic antibiotics to prevent UTIs * Has a history of unresolved bladder-ureteral reflux and/or stones in the urinary tract * Has used intermittent catheterization for more than 10 days prior to inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Symptomatic Urinary Tract Infections (UTIs) | 4-6 months | Occurrence of symptomatic urinary tract infections (UTIs). Time to first UTI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nurse Evaluation of Catheters - Overall Satisfaction | 4-6 months | Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction) |
| Patient or Caregiver's Evaluation of Catheters - Overall Satisfaction | 4-6 months | Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction) |
| UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml | 4-6 months | UTIs with bacteriuria \>=100 Colony Forming Units (CFU)/ml. Descriptive analysis |
| Device-related or Possibly Device-related AEs | 4-6 months | — |
| Number of Participants With One or More Urinary Tract Infection | 4-6 months | — |
| Nurse Time Spent on Catheterization Procedure | 4-6 months | — |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SpeediCath Hydrophilic coated intermittent catheter | 105 |
| Conveen Uncoated Uncoated intermittent catheter | 114 |
| Total | 219 |
Baseline characteristics
| Characteristic | SpeediCath | Conveen Uncoated | Total |
|---|---|---|---|
| Age, Continuous | 37.2 years STANDARD_DEVIATION 14.4 | 35.1 years STANDARD_DEVIATION 13.2 | 36.1 years STANDARD_DEVIATION 13.8 |
| Region of Enrollment Canada | 25 participants | 28 participants | 53 participants |
| Region of Enrollment United States | 80 participants | 86 participants | 166 participants |
| Sex/Gender, Customized Female | 22 participants | 20 participants | 42 participants |
| Sex/Gender, Customized Male | 83 participants | 93 participants | 176 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 105 | 14 / 114 |
| serious Total, serious adverse events | 5 / 105 | 6 / 114 |
Outcome results
Primary
Occurrence of Symptomatic Urinary Tract Infections (UTIs)
Occurrence of symptomatic urinary tract infections (UTIs). Time to first UTI
Time frame: 4-6 months
Population: ITT-population, symptomatic urinary tract infections treated with antibiotics
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| SpeediCath Catheter | Occurrence of Symptomatic Urinary Tract Infections (UTIs) | Free of UTIs from study start to day 30 | 19 participants | 0 |
| SpeediCath Catheter | Occurrence of Symptomatic Urinary Tract Infections (UTIs) | Free of UTIs from study start to day 150 | 2 participants | — |
| Conveen Uncoated | Occurrence of Symptomatic Urinary Tract Infections (UTIs) | Free of UTIs from study start to day 30 | 20 participants | 0 |
| Conveen Uncoated | Occurrence of Symptomatic Urinary Tract Infections (UTIs) | Free of UTIs from study start to day 150 | 0 participants | — |
Comparison: The analysis was done by comparing Kaplan-Meier estimates of the survival function of the two groups. The analysis was refined by a Cox proportional hazards regression model for survival data.p-value: 0.038395% CI: [1.022, 2.207]Kaplan-Meier
Secondary
Device-related or Possibly Device-related AEs
Time frame: 4-6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SpeediCath Catheter | Device-related or Possibly Device-related AEs | 16 Events |
| Conveen Uncoated | Device-related or Possibly Device-related AEs | 14 Events |
Secondary
Number of Participants With One or More Urinary Tract Infection
Time frame: 4-6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SpeediCath Catheter | Number of Participants With One or More Urinary Tract Infection | 47 participants |
| Conveen Uncoated | Number of Participants With One or More Urinary Tract Infection | 82 participants |
Secondary
Nurse Evaluation of Catheters - Overall Satisfaction
Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)
Time frame: 4-6 months
Population: Analysis were done on evaluations of the ITT-population. Evaluations were made at discharge from hospital. Since some participants discontinued the study prior to discharge and since some did not fill in the evaluation form, the total number of evaluations (132) do not add up to the total of the ITT population (219)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SpeediCath Catheter | Nurse Evaluation of Catheters - Overall Satisfaction | 8.1 scores on a scale | Standard Deviation 2.3 |
| Conveen Uncoated | Nurse Evaluation of Catheters - Overall Satisfaction | 8.3 scores on a scale | Standard Deviation 2 |
p-value: 0.767ANOVA
Secondary
Nurse Time Spent on Catheterization Procedure
Time frame: 4-6 months
Population: ITT-population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SpeediCath Catheter | Nurse Time Spent on Catheterization Procedure | 337 seconds | Standard Deviation 44 |
| Conveen Uncoated | Nurse Time Spent on Catheterization Procedure | 278 seconds | Standard Deviation 25 |
Secondary
Patient or Caregiver's Evaluation of Catheters - Overall Satisfaction
Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)
Time frame: 4-6 months
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SpeediCath Catheter | Patient or Caregiver's Evaluation of Catheters - Overall Satisfaction | 9.3 scores on a scale | Standard Deviation 1.4 |
| Conveen Uncoated | Patient or Caregiver's Evaluation of Catheters - Overall Satisfaction | 8.6 scores on a scale | Standard Deviation 1.3 |
p-value: 0.0074ANOVA
Secondary
UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml
UTIs with bacteriuria \>=100 Colony Forming Units (CFU)/ml. Descriptive analysis
Time frame: 4-6 months
Population: Descriptive only
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SpeediCath Catheter | UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml | 101 UTI |
| Conveen Uncoated | UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml | 151 UTI |