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Trial record 22 of 25 for:    Spinal Cord Injuries | ( Map: Minnesota, United States )

Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections

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ClinicalTrials.gov Identifier: NCT00318591
Recruitment Status : Completed
First Posted : April 27, 2006
Results First Posted : May 25, 2011
Last Update Posted : August 24, 2015
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Urinary Tract Infections
Interventions Device: SpeediCath
Device: Conveen Uncoated
Enrollment 219
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SpeediCath Conveen Uncoated
Hide Arm/Group Description Hydrophilic coated intermittent catheter Uncoated intermittent catheter
Period Title: Overall Study
Started 105 114
Completed 45 69
Not Completed 60 45
Arm/Group Title SpeediCath Conveen Uncoated Total
Hide Arm/Group Description Hydrophilic coated intermittent catheter Uncoated intermittent catheter Total of all reporting groups
Overall Number of Baseline Participants 105 114 219
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 105 participants 114 participants 219 participants
37.2  (14.4) 35.1  (13.2) 36.1  (13.8)
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 105 participants 114 participants 219 participants
Female 22 20 42
Male 83 93 176
[1]
Measure Description: Gender is unknown for one participant
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 105 participants 114 participants 219 participants
United States 80 86 166
Canada 25 28 53
1.Primary Outcome
Title Occurrence of Symptomatic Urinary Tract Infections (UTIs)
Hide Description Occurrence of symptomatic urinary tract infections (UTIs). Time to first UTI
Time Frame 4-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-population, symptomatic urinary tract infections treated with antibiotics
Arm/Group Title SpeediCath Catheter Conveen Uncoated
Hide Arm/Group Description:
Hydrophilic coated intermittent catheter
uncoated intermittent catheter
Overall Number of Participants Analyzed 105 114
Measure Type: Number
Unit of Measure: participants
Free of UTIs from study start to day 30 19 20
Free of UTIs from study start to day 150 2 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SpeediCath Catheter, Conveen Uncoated
Comments 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.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The additional explanatory variables were removed using backwards-elimination removing the least significant additional variable for each iteration, until the effect of all included additional variables was significant on α=0.05 significant level. The null-hypothesis of no catheter difference was to be rejected on α=0.05 significant level.
Statistical Test of Hypothesis P-Value 0.0383
Comments p-value is adjusted for the following explanatory variables: catheterization frequency, technique (clean/sterile), procedure (participant/nurse), setting (hospital/community) and demographic measures.
Method Kaplan-Meier
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.502
Confidence Interval (2-Sided) 95%
1.022 to 2.207
Estimation Comments [Not Specified]
2.Secondary Outcome
Title UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml
Hide Description UTIs with bacteriuria >=100 Colony Forming Units (CFU)/ml. Descriptive analysis
Time Frame 4-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Descriptive only
Arm/Group Title SpeediCath Catheter Conveen Uncoated
Hide Arm/Group Description:
Hydrophilic coated intermittent catheter
Uncoated intermittent catheter
Overall Number of Participants Analyzed 105 114
Measure Type: Number
Unit of Measure: UTI
101 151
3.Secondary Outcome
Title Nurse Evaluation of Catheters - Overall Satisfaction
Hide Description Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)
Time Frame 4-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title SpeediCath Conveen Uncoated
Hide Arm/Group Description:
Hydrophilic coated intermittent catheter
Uncoated intermittent catheter
Overall Number of Participants Analyzed 59 73
Mean (Standard Deviation)
Unit of Measure: scores on a scale
8.1  (2.3) 8.3  (2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SpeediCath, Conveen Uncoated
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments ANOVA analysis. Limit of significant difference <0.05
Statistical Test of Hypothesis P-Value 0.7670
Comments baseline characteristics were used as covariates, catheterization procedure (participant or caregiver) as well as technique (sterile or clean). Backward elimination was used.
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Patient or Caregiver's Evaluation of Catheters - Overall Satisfaction
Hide Description Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)
Time Frame 4-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title SpeediCath Conveen Uncoated
Hide Arm/Group Description:
Hydrophilic coated intermittent catheter
Uncoated intermittent catheter
Overall Number of Participants Analyzed 44 61
Mean (Standard Deviation)
Unit of Measure: scores on a scale
9.3  (1.4) 8.6  (1.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SpeediCath, Conveen Uncoated
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments ANOVA. Level of significant difference <0.05
Statistical Test of Hypothesis P-Value 0.0074
Comments baseline characteristics were used as covariates, catheterization procedure (participant or caregiver) as well as technique (sterile or clean). Backward elimination was used.
Method ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title Nurse Time Spent on Catheterization Procedure
Hide Description [Not Specified]
Time Frame 4-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-population
Arm/Group Title SpeediCath Conveen Uncoated
Hide Arm/Group Description:
Hydrophilic coated intermittent catheter
Uncoated intermittent catheter
Overall Number of Participants Analyzed 38 53
Mean (Standard Deviation)
Unit of Measure: seconds
337  (44) 278  (25)
6.Secondary Outcome
Title Device-related or Possibly Device-related AEs
Hide Description [Not Specified]
Time Frame 4-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SpeediCath Conveen Uncoated
Hide Arm/Group Description:
Hydrophilic coated intermittent catheter
Uncoated intermittent catheter
Overall Number of Participants Analyzed 105 114
Measure Type: Number
Unit of Measure: Events
16 14
7.Secondary Outcome
Title Number of Participants With One or More Urinary Tract Infection
Hide Description [Not Specified]
Time Frame 4-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SpeediCath Conveen Uncoated
Hide Arm/Group Description:
Hydrophilic coated intermittent catheter
Uncoated intermittent catheter
Overall Number of Participants Analyzed 105 114
Measure Type: Number
Unit of Measure: participants
47 82
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SpeediCath Conveen Uncoated
Hide Arm/Group Description Hydrophilic coated intermittent catheter Uncoated intermittent catheter
All-Cause Mortality
SpeediCath Conveen Uncoated
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
SpeediCath Conveen Uncoated
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/105 (4.76%)      6/114 (5.26%)    
Blood and lymphatic system disorders     
deep vein thrombosis *  1/105 (0.95%)  1 0/114 (0.00%)  0
Gastrointestinal disorders     
diarrhea *  1/105 (0.95%)  1 0/114 (0.00%)  0
General disorders     
subdural hematoma * [1]  1/105 (0.95%)  1 0/114 (0.00%)  0
Psychiatric disorders     
suicidal ideation *  1/105 (0.95%)  1 0/114 (0.00%)  0
Renal and urinary disorders     
Urinary tract infection *  1/105 (0.95%)  1 3/114 (2.63%)  3
urosepsis *  0/105 (0.00%)  0 1/114 (0.88%)  1
perforated bladder/cystitis/decreased oxygen saturation *  0/105 (0.00%)  0 1/114 (0.88%)  1
Respiratory, thoracic and mediastinal disorders     
Pneumonia *  0/105 (0.00%)  0 2/114 (1.75%)  2
*
Indicates events were collected by non-systematic assessment
[1]
not device-related
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
SpeediCath Conveen Uncoated
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/105 (15.24%)      14/114 (12.28%)    
Renal and urinary disorders     
renal and urinary disorders *  16/105 (15.24%)  16 13/114 (11.40%)  13
Reproductive system and breast disorders     
reproductive system and breast disorders *  0/105 (0.00%)  0 1/114 (0.88%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Anna Karina Busch, Intl. Senior Scientific Manager
Organization: Coloplast
Phone: +45 49112350
Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00318591     History of Changes
Other Study ID Numbers: DK046CC
First Submitted: April 26, 2006
First Posted: April 27, 2006
Results First Submitted: February 23, 2011
Results First Posted: May 25, 2011
Last Update Posted: August 24, 2015