Trial Outcomes & Findings for Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections (NCT NCT00318591)
NCT ID: NCT00318591
Last Updated: 2021-02-10
Results Overview
Occurrence of symptomatic urinary tract infections (UTIs). Time to first UTI
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
219 participants
Primary outcome timeframe
4-6 months
Results posted on
2021-02-10
Participant Flow
Participant milestones
| Measure |
SpeediCath
Hydrophilic coated intermittent catheter
|
Conveen Uncoated
Uncoated intermittent catheter
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
114
|
|
Overall Study
COMPLETED
|
45
|
69
|
|
Overall Study
NOT COMPLETED
|
60
|
45
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections
Baseline characteristics by cohort
| Measure |
SpeediCath
n=105 Participants
Hydrophilic coated intermittent catheter
|
Conveen Uncoated
n=114 Participants
Uncoated intermittent catheter
|
Total
n=219 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.2 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
35.1 years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
36.1 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
22 participants
n=5 Participants
|
20 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
83 participants
n=5 Participants
|
93 participants
n=7 Participants
|
176 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=5 Participants
|
86 participants
n=7 Participants
|
166 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
25 participants
n=5 Participants
|
28 participants
n=7 Participants
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4-6 monthsPopulation: ITT-population, symptomatic urinary tract infections treated with antibiotics
Occurrence of symptomatic urinary tract infections (UTIs). Time to first UTI
Outcome measures
| Measure |
SpeediCath Catheter
n=105 Participants
Hydrophilic coated intermittent catheter
|
Conveen Uncoated
n=114 Participants
uncoated intermittent catheter
|
|---|---|---|
|
Occurrence of Symptomatic Urinary Tract Infections (UTIs)
Free of UTIs from study start to day 30
|
19 participants
0
|
20 participants
0
|
|
Occurrence of Symptomatic Urinary Tract Infections (UTIs)
Free of UTIs from study start to day 150
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 4-6 monthsPopulation: Descriptive only
UTIs with bacteriuria \>=100 Colony Forming Units (CFU)/ml. Descriptive analysis
Outcome measures
| Measure |
SpeediCath Catheter
n=105 Participants
Hydrophilic coated intermittent catheter
|
Conveen Uncoated
n=114 Participants
uncoated intermittent catheter
|
|---|---|---|
|
UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml
|
101 UTI
|
151 UTI
|
SECONDARY outcome
Timeframe: 4-6 monthsPopulation: 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)
Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)
Outcome measures
| Measure |
SpeediCath Catheter
n=59 Participants
Hydrophilic coated intermittent catheter
|
Conveen Uncoated
n=73 Participants
uncoated intermittent catheter
|
|---|---|---|
|
Nurse Evaluation of Catheters - Overall Satisfaction
|
8.1 scores on a scale
Standard Deviation 2.3
|
8.3 scores on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 4-6 monthsPopulation: ITT population
Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)
Outcome measures
| Measure |
SpeediCath Catheter
n=44 Participants
Hydrophilic coated intermittent catheter
|
Conveen Uncoated
n=61 Participants
uncoated intermittent catheter
|
|---|---|---|
|
Patient or Caregiver's Evaluation of Catheters - Overall Satisfaction
|
9.3 scores on a scale
Standard Deviation 1.4
|
8.6 scores on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 4-6 monthsPopulation: ITT-population
Outcome measures
| Measure |
SpeediCath Catheter
n=38 Participants
Hydrophilic coated intermittent catheter
|
Conveen Uncoated
n=53 Participants
uncoated intermittent catheter
|
|---|---|---|
|
Nurse Time Spent on Catheterization Procedure
|
337 seconds
Standard Deviation 44
|
278 seconds
Standard Deviation 25
|
SECONDARY outcome
Timeframe: 4-6 monthsOutcome measures
| Measure |
SpeediCath Catheter
n=105 Participants
Hydrophilic coated intermittent catheter
|
Conveen Uncoated
n=114 Participants
uncoated intermittent catheter
|
|---|---|---|
|
Device-related or Possibly Device-related AEs
|
16 Events
|
14 Events
|
SECONDARY outcome
Timeframe: 4-6 monthsOutcome measures
| Measure |
SpeediCath Catheter
n=105 Participants
Hydrophilic coated intermittent catheter
|
Conveen Uncoated
n=114 Participants
uncoated intermittent catheter
|
|---|---|---|
|
Number of Participants With One or More Urinary Tract Infection
|
47 participants
|
82 participants
|
Adverse Events
SpeediCath
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
Conveen Uncoated
Serious events: 6 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SpeediCath
n=105 participants at risk
Hydrophilic coated intermittent catheter
|
Conveen Uncoated
n=114 participants at risk
Uncoated intermittent catheter
|
|---|---|---|
|
Renal and urinary disorders
Urinary tract infection
|
0.95%
1/105 • Number of events 1
|
2.6%
3/114 • Number of events 3
|
|
Gastrointestinal disorders
diarrhea
|
0.95%
1/105 • Number of events 1
|
0.00%
0/114
|
|
Psychiatric disorders
suicidal ideation
|
0.95%
1/105 • Number of events 1
|
0.00%
0/114
|
|
General disorders
subdural hematoma
|
0.95%
1/105 • Number of events 1
|
0.00%
0/114
|
|
Blood and lymphatic system disorders
deep vein thrombosis
|
0.95%
1/105 • Number of events 1
|
0.00%
0/114
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/105
|
1.8%
2/114 • Number of events 2
|
|
Renal and urinary disorders
urosepsis
|
0.00%
0/105
|
0.88%
1/114 • Number of events 1
|
|
Renal and urinary disorders
perforated bladder/cystitis/decreased oxygen saturation
|
0.00%
0/105
|
0.88%
1/114 • Number of events 1
|
Other adverse events
| Measure |
SpeediCath
n=105 participants at risk
Hydrophilic coated intermittent catheter
|
Conveen Uncoated
n=114 participants at risk
Uncoated intermittent catheter
|
|---|---|---|
|
Renal and urinary disorders
renal and urinary disorders
|
15.2%
16/105 • Number of events 16
|
11.4%
13/114 • Number of events 13
|
|
Reproductive system and breast disorders
reproductive system and breast disorders
|
0.00%
0/105
|
0.88%
1/114 • Number of events 1
|
Additional Information
Anna Karina Busch, Intl. Senior Scientific Manager
Coloplast
Phone: +45 49112350
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60