Trial Outcomes & Findings for A Study Evaluating a Urinary Catheter With Different Activation Times for the Wetting Solution, in Healthy Male Volunteers. (NCT NCT00748033)
NCT ID: NCT00748033
Last Updated: 2021-05-06
Results Overview
The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding insertion?'.
COMPLETED
NA
25 participants
A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.
2021-05-06
Participant Flow
This is a study with a crossover design between the test catheters. The subjects were first catheterized with a reference catheter and then catheterisized in a randomized order with the two test catheters. All subjects participated in all arms except one that participated only in 2 arms due to an adverse event. The subjects were catheterized three times during one day.. A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes.
Participant milestones
| Measure |
LoFric POBE Hydro-Kit II, 5 Seconds and Then LoFric POBE Hydro-Kit II, 24 Hours
Catheterizasion order:
1. Reference Catheter, then washout for 2 hours
2. LoFric POBE Hydro-Kit II activation time 5 seconds, then washout for 2 hours
3. LoFric POBE Hydro-Kit II activation time 24 hours
|
LoFric POBE Hydro-Kit II, 24 Hours and Then LoFric POBE Hydro-Kit II, 5 Seconds
Catheterizasion order:
1. Reference Catheter, then washout for 2 hours
2. LoFric POBE Hydro-Kit II activation time 24 hours, then washout for 2 hours
3. LoFric POBE Hydro-Kit II activation time 5 seconds
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
LoFric POBE Hydro-Kit II, 5 Seconds and Then LoFric POBE Hydro-Kit II, 24 Hours
Catheterizasion order:
1. Reference Catheter, then washout for 2 hours
2. LoFric POBE Hydro-Kit II activation time 5 seconds, then washout for 2 hours
3. LoFric POBE Hydro-Kit II activation time 24 hours
|
LoFric POBE Hydro-Kit II, 24 Hours and Then LoFric POBE Hydro-Kit II, 5 Seconds
Catheterizasion order:
1. Reference Catheter, then washout for 2 hours
2. LoFric POBE Hydro-Kit II activation time 24 hours, then washout for 2 hours
3. LoFric POBE Hydro-Kit II activation time 5 seconds
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
A Study Evaluating a Urinary Catheter With Different Activation Times for the Wetting Solution, in Healthy Male Volunteers.
Baseline characteristics by cohort
| Measure |
LoFric POBE Hydro-Kit II, 5 Seconds and Then LoFric POBE Hydro-Kit II, 24 Hours
n=12 Participants
All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.
After randomisation this group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds.
Then the next test catheter was used, LoFric POBE Hydro-Kit II, activation time 24 hours.
|
LoFric POBE Hydro-Kit II, 24 Hours and Then LoFric POBE Hydro-Kit II, 5 Seconds
n=13 Participants
All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.
After randomisation this group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 24 hours.
Then the next test catheter was used LoFric POBE Hydro-Kit II, activation time 5 seconds.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
29.42 years
STANDARD_DEVIATION 6.10 • n=5 Participants
|
26.17 years
STANDARD_DEVIATION 4.11 • n=7 Participants
|
27 years
STANDARD_DEVIATION 5.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.Population: The study was analysed using a per protocol approach only. One subject (Subject ID 125) was catheterized with the reference catheter and the catheter activated 24 hours, but not with the catheter activated 5 seconds. After discussions it has, however, been decided to use all available data. In conclusion all subjects fulfilling the inclusion criteria but none of the exclusion criteria were included in the Per-Protocol (PP) analysis set.
The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding insertion?'.
Outcome measures
| Measure |
LoFric POBE Hydro-Kit II, 5 Seconds
n=24 Participants
All subjects were first catheterizised with the reference catheter. After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then the test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
The other group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
|
LoFric POBE Hydro-Kit II, 24 Hours
All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds.
|
|---|---|---|
|
Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference.
Very negative
|
3 participants
|
—
|
|
Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference.
Slightly negative
|
10 participants
|
—
|
|
Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference.
Same
|
5 participants
|
—
|
|
Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference.
Slightly positive
|
6 participants
|
—
|
|
Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference.
Very positive
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.Population: The study was analysed using a per protocol approach only. One subject (Subject ID 125) was catheterized with the reference catheter and the catheter activated 24 hours, but not with the catheter activated 5 seconds. After discussions it has, however, been decided to use all available data. In conclusion all subjects fulfilling the inclusion criteria but none of the exclusion criteria were included in the Per-Protocol (PP) analysis set.
The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding insertion?'.
Outcome measures
| Measure |
LoFric POBE Hydro-Kit II, 5 Seconds
n=25 Participants
All subjects were first catheterizised with the reference catheter. After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then the test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
The other group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
|
LoFric POBE Hydro-Kit II, 24 Hours
All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds.
|
|---|---|---|
|
Subjects' Perception at Insertion of Test Catheter Activated for 24 Hours, Compared to Reference.
Very negative
|
4 Participants
|
—
|
|
Subjects' Perception at Insertion of Test Catheter Activated for 24 Hours, Compared to Reference.
Slightly negative
|
8 Participants
|
—
|
|
Subjects' Perception at Insertion of Test Catheter Activated for 24 Hours, Compared to Reference.
Same
|
5 Participants
|
—
|
|
Subjects' Perception at Insertion of Test Catheter Activated for 24 Hours, Compared to Reference.
Slightly positive
|
7 Participants
|
—
|
|
Subjects' Perception at Insertion of Test Catheter Activated for 24 Hours, Compared to Reference.
Very positive
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.Population: Subjects fulfilling the inclusion criteria but none of the exclusion criteria were included in the Per-Protocol (PP) analysis set.
The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding withdrawal?'.
Outcome measures
| Measure |
LoFric POBE Hydro-Kit II, 5 Seconds
n=24 Participants
All subjects were first catheterizised with the reference catheter. After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then the test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
The other group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
|
LoFric POBE Hydro-Kit II, 24 Hours
All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds.
|
|---|---|---|
|
Subjects' Perception at Withdrawal of Test Catheter Activated for 5 Seconds, Compared to Reference.
Very negative
|
4 Participants
|
—
|
|
Subjects' Perception at Withdrawal of Test Catheter Activated for 5 Seconds, Compared to Reference.
Slightly negative
|
6 Participants
|
—
|
|
Subjects' Perception at Withdrawal of Test Catheter Activated for 5 Seconds, Compared to Reference.
Same
|
4 Participants
|
—
|
|
Subjects' Perception at Withdrawal of Test Catheter Activated for 5 Seconds, Compared to Reference.
Slightly positive
|
8 Participants
|
—
|
|
Subjects' Perception at Withdrawal of Test Catheter Activated for 5 Seconds, Compared to Reference.
Very positive
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.Population: The study was analysed using a per protocol approach only. One subject (Subject ID 125) was catheterized with the reference catheter and the catheter activated 24 hours, but not with the catheter activated 5 seconds. After discussions it has, however, been decided to use all available data. In conclusion all subjects fulfilling the inclusion criteria but none of the exclusion criteria were included in the Per-Protocol (PP) analysis set.
The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding withdrawal?'.
Outcome measures
| Measure |
LoFric POBE Hydro-Kit II, 5 Seconds
n=25 Participants
All subjects were first catheterizised with the reference catheter. After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then the test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
The other group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
|
LoFric POBE Hydro-Kit II, 24 Hours
All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds.
|
|---|---|---|
|
Subjects' Perception at Withdrawal of Test Catheter Activated for 24 Hours, Compared to Reference.
Very negative
|
6 participants
|
—
|
|
Subjects' Perception at Withdrawal of Test Catheter Activated for 24 Hours, Compared to Reference.
Slightly negative
|
6 participants
|
—
|
|
Subjects' Perception at Withdrawal of Test Catheter Activated for 24 Hours, Compared to Reference.
Same
|
11 participants
|
—
|
|
Subjects' Perception at Withdrawal of Test Catheter Activated for 24 Hours, Compared to Reference.
Slightly positive
|
2 participants
|
—
|
|
Subjects' Perception at Withdrawal of Test Catheter Activated for 24 Hours, Compared to Reference.
Very positive
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.Population: The study was analysed using a per protocol approach only.
Comparison of the perception at insertion between the catheters with 5s and 24h activation times.
Outcome measures
| Measure |
LoFric POBE Hydro-Kit II, 5 Seconds
n=24 Participants
All subjects were first catheterizised with the reference catheter. After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then the test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
The other group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
|
LoFric POBE Hydro-Kit II, 24 Hours
n=24 Participants
All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds.
|
|---|---|---|
|
Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times
Very negative
|
3 participants
|
3 participants
|
|
Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times
Slightly negative
|
10 participants
|
8 participants
|
|
Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times
Same
|
5 participants
|
5 participants
|
|
Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times
Slightly positive
|
6 participants
|
7 participants
|
|
Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times
Very positive
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.Population: The study was analysed using a per protocol approach only.
Comparison of the perception at withdrawal between the catheters with 5s and 24h activation times.
Outcome measures
| Measure |
LoFric POBE Hydro-Kit II, 5 Seconds
n=24 Participants
All subjects were first catheterizised with the reference catheter. After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then the test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
The other group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
|
LoFric POBE Hydro-Kit II, 24 Hours
n=24 Participants
All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds.
|
|---|---|---|
|
Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times.
Slightly positive
|
8 participants
|
2 participants
|
|
Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times.
Very negative
|
4 participants
|
5 participants
|
|
Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times.
Slightly negative
|
6 participants
|
6 participants
|
|
Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times.
Same
|
4 participants
|
11 participants
|
|
Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times.
Very positive
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.Population: The study was analysed using a per protocol approach only. One subject (Subject ID 125) was catheterized with the reference catheter and the catheter activated 24 hours, but not with the catheter activated 5 seconds. After discussions it has, however, been decided to use all available data. In conclusion all subjects fulfilling the inclusion criteria but none of the exclusion criteria were included in the Per-Protocol (PP) analysis set.
The subjects perception of the catheterization will be classified as very negative, slightly negative, same, slightly positive or very positive. The mean perception of the 5s and the 24h catheter is calculated for each subject. The perception was measured on a scale from 1 (=very negative compared to the reference catheter) to 5 (=very positive compared to the reference catheter) and a 3 indicating that the perception was the same for the test catheter as for the reference catheter. Before doing any statistics all answers were reduced by 3 resulting in values from -2 (=very negative compared to the reference catheter) to +2 (=very positive compared to the reference catheter) and a 0 indicating that the perception was the same for the test catheter as for the reference catheter.
Outcome measures
| Measure |
LoFric POBE Hydro-Kit II, 5 Seconds
n=12 Participants
All subjects were first catheterizised with the reference catheter. After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then the test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
The other group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
|
LoFric POBE Hydro-Kit II, 24 Hours
n=12 Participants
All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds.
|
|---|---|---|
|
Test of Carry-over Effect at Insertion, Mean Rating of Perception on a Scale of 0 to 5
|
-0.17 Scores on a scale
Standard Deviation 0.807
|
-0.46 Scores on a scale
Standard Deviation 0.865
|
SECONDARY outcome
Timeframe: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.Population: The study was analysed using a per protocol approach only. One subject (Subject ID 125) was catheterized with the reference catheter and the catheter activated 24 hours, but not with the catheter activated 5 seconds. After discussions it has, however, been decided to use all available data. In conclusion all subjects fulfilling the inclusion criteria but none of the exclusion criteria were included in the Per-Protocol (PP) analysis set.
They had five alternative answers.The subjects perception of the catheterization will be classified as very negative, slightly negative, same, slightly positive or very positive. The mean perception of the 5s and the 24h catheter is calculated for each subject. The perception was measured on a scale from 1 (=very negative compared to the reference catheter) to 5 (=very positive compared to the reference catheter) and a 3 indicating that the perception was the same for the test catheter as for the reference catheter. Before doing any statistics all answers were reduced by 3 resulting in values from -2 (=very negative compared to the reference catheter) to +2 (=very positive compared to the reference catheter) and a 0 indicating that the perception was the same for the test catheter as for the reference catheter.
Outcome measures
| Measure |
LoFric POBE Hydro-Kit II, 5 Seconds
n=12 Participants
All subjects were first catheterizised with the reference catheter. After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then the test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
The other group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
|
LoFric POBE Hydro-Kit II, 24 Hours
n=12 Participants
All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds.
|
|---|---|---|
|
Test of Carry-over Effect at Withdrawal, Mean Rating of Perception on a Scale of 0 to 5
|
-0.33 Score on a scale
Standard Deviation 0.835
|
-0.33 Score on a scale
Standard Deviation 0.807
|
SECONDARY outcome
Timeframe: The Tension test system was performed while withdrawing the catheters up to 5 seconds.Population: The study was analysed using a per protocol approach only.
Tension test system (friction) at withdrawal. Comparison between the reference catheter and the 24 hours activation time. The MEAN for the withdrawal friction was measured in Newton (N).
Outcome measures
| Measure |
LoFric POBE Hydro-Kit II, 5 Seconds
n=24 Participants
All subjects were first catheterizised with the reference catheter. After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then the test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
The other group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
|
LoFric POBE Hydro-Kit II, 24 Hours
All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds.
|
|---|---|---|
|
Tension Test System: Ref-24h Mean
|
0.077 Newton
Standard Deviation 0.088
|
—
|
SECONDARY outcome
Timeframe: The Tension test system was performed while withdrawing the catheters up to 5 seconds.Population: The study was analysed using a per protocol approach only.
Tension test system (friction) at withdrawal. Comparison between the reference catheter and the 24 hours activation time. The WORK for the withdrawal friction was measured in Joule (J).
Outcome measures
| Measure |
LoFric POBE Hydro-Kit II, 5 Seconds
n=24 Participants
All subjects were first catheterizised with the reference catheter. After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then the test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
The other group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
|
LoFric POBE Hydro-Kit II, 24 Hours
All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds.
|
|---|---|---|
|
Tension Test System: Ref-24h Work
|
0.011 Joule
Standard Deviation 0.024
|
—
|
SECONDARY outcome
Timeframe: The Tension test system was performed while withdrawing the catheters, up to 5 seconds.Population: The study was analysed using a per protocol approach only.
Tension test system (friction) at withdrawal. Comparison between the reference catheter and the 5 seconds activation time. The MEAN for the withdrawal friction was measured in Newton (N).
Outcome measures
| Measure |
LoFric POBE Hydro-Kit II, 5 Seconds
n=23 Participants
All subjects were first catheterizised with the reference catheter. After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then the test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
The other group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
|
LoFric POBE Hydro-Kit II, 24 Hours
All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds.
|
|---|---|---|
|
Tension Test System: Ref-5s MEAN
|
0.073 Newton
Standard Deviation 0.122
|
—
|
SECONDARY outcome
Timeframe: The Tension test system was performed while withdrawing the catheters, up to 5 seconds.Population: The study was analysed using a per protocol approach only.
Tension test system (friction) at withdrawal. Comparison between the reference catheter and the 5 seconds activation time. The WORK for the withdrawal friction was measured in Joule (J).
Outcome measures
| Measure |
LoFric POBE Hydro-Kit II, 5 Seconds
n=23 Participants
All subjects were first catheterizised with the reference catheter. After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then the test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
The other group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
|
LoFric POBE Hydro-Kit II, 24 Hours
All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds.
|
|---|---|---|
|
Tension Test System: Ref-5s WORK
|
0.009 Joule
Standard Deviation 0.030
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SECONDARY outcome
Timeframe: The Tension test system was performed while withdrawing the catheters, up to 5 seconds.Population: The study was analysed using a per protocol approach only.
Tension test system (friction) at withdrawal. Comparison between the catheters with 24h activation time and the 5 seconds activation time. The MEAN for the withdrawal friction was measured in Newton (N).
Outcome measures
| Measure |
LoFric POBE Hydro-Kit II, 5 Seconds
n=24 Participants
All subjects were first catheterizised with the reference catheter. After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then the test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
The other group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then test catheter LoFric POBE Hydro-Kit II activation time 24 hours.
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LoFric POBE Hydro-Kit II, 24 Hours
All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds.
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|---|---|---|
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Tension Test System: 24h-5s
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-0.013 Newton
Standard Deviation 0.4092
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Adverse Events
LoFric POBE Hydro-Kit II, 5 Seconds
LoFric POBE Hydro-Kit II, 24 Hours
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LoFric POBE Hydro-Kit II, 5 Seconds
n=24 participants at risk
All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds.
|
LoFric POBE Hydro-Kit II, 24 Hours
n=25 participants at risk
All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.
After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds.
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|---|---|---|
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Renal and urinary disorders
Discomfort during insertion of test catheter
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54.2%
13/24 • Number of events 13 • Each subjects visited the clinic during one day. The subjects were catheterized for 3 minutes with each catheter. All subjects were catheterized with 3 catheters each, except one subject, who discontinued after test catheter 1 and was therefore only catheterized twice. At least 2 hours elapsed between each catheterization.
In this study all adverse events will be judged as adverse device effect. Adverse events were not monitored during reference testing.
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48.0%
12/25 • Number of events 12 • Each subjects visited the clinic during one day. The subjects were catheterized for 3 minutes with each catheter. All subjects were catheterized with 3 catheters each, except one subject, who discontinued after test catheter 1 and was therefore only catheterized twice. At least 2 hours elapsed between each catheterization.
In this study all adverse events will be judged as adverse device effect. Adverse events were not monitored during reference testing.
|
|
Renal and urinary disorders
Discomfort during withdrawal of test catheter
|
41.7%
10/24 • Number of events 10 • Each subjects visited the clinic during one day. The subjects were catheterized for 3 minutes with each catheter. All subjects were catheterized with 3 catheters each, except one subject, who discontinued after test catheter 1 and was therefore only catheterized twice. At least 2 hours elapsed between each catheterization.
In this study all adverse events will be judged as adverse device effect. Adverse events were not monitored during reference testing.
|
44.0%
11/25 • Number of events 11 • Each subjects visited the clinic during one day. The subjects were catheterized for 3 minutes with each catheter. All subjects were catheterized with 3 catheters each, except one subject, who discontinued after test catheter 1 and was therefore only catheterized twice. At least 2 hours elapsed between each catheterization.
In this study all adverse events will be judged as adverse device effect. Adverse events were not monitored during reference testing.
|
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Renal and urinary disorders
Discomfort during micturition after test catheter
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12.5%
3/24 • Number of events 3 • Each subjects visited the clinic during one day. The subjects were catheterized for 3 minutes with each catheter. All subjects were catheterized with 3 catheters each, except one subject, who discontinued after test catheter 1 and was therefore only catheterized twice. At least 2 hours elapsed between each catheterization.
In this study all adverse events will be judged as adverse device effect. Adverse events were not monitored during reference testing.
|
8.0%
2/25 • Number of events 2 • Each subjects visited the clinic during one day. The subjects were catheterized for 3 minutes with each catheter. All subjects were catheterized with 3 catheters each, except one subject, who discontinued after test catheter 1 and was therefore only catheterized twice. At least 2 hours elapsed between each catheterization.
In this study all adverse events will be judged as adverse device effect. Adverse events were not monitored during reference testing.
|
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Renal and urinary disorders
Hematuria after test catheter is removed
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0.00%
0/24 • Each subjects visited the clinic during one day. The subjects were catheterized for 3 minutes with each catheter. All subjects were catheterized with 3 catheters each, except one subject, who discontinued after test catheter 1 and was therefore only catheterized twice. At least 2 hours elapsed between each catheterization.
In this study all adverse events will be judged as adverse device effect. Adverse events were not monitored during reference testing.
|
4.0%
1/25 • Number of events 1 • Each subjects visited the clinic during one day. The subjects were catheterized for 3 minutes with each catheter. All subjects were catheterized with 3 catheters each, except one subject, who discontinued after test catheter 1 and was therefore only catheterized twice. At least 2 hours elapsed between each catheterization.
In this study all adverse events will be judged as adverse device effect. Adverse events were not monitored during reference testing.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place