Trial Outcomes & Findings for Explorative Clinical Study on the Performance and Acceptance of New Intermittent Catheters in Healthy Volunteers (NCT NCT04231149)
NCT ID: NCT04231149
Last Updated: 2025-03-24
Results Overview
On day of study visits 1-5 rate of urine flow through catheter measured in mL/s
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
2 hour
Results posted on
2025-03-24
Participant Flow
10 subjects were screened for eligibility
9 out of 10 were randomized. The one not randomized did not meet the inclusion criteria.
Participant milestones
| Measure |
Test Product 2, Then Test Product 3, Then SpeediCath Flex
Participants were first catheterized with Test Product 2 at Visit 1. After a washout period of minimum 5 days, they were then catheterized with Test Product 3 at Visit 2. After a washout period of minimum 5 days again, they were then catheterized with SpeediCath Flex.
|
Test Product 3, Then Test Product 2, Then SpeediCath Flex
Participants were first catheterized with Test Product 3 at Visit 1. After a washout period of minimum 5 days, they were then catheterized with Test Product 2 at Visit 2. After a washout period of minimum 5 days again, they were then catheterized with SpeediCath Flex.
|
SpeediCath Flex, Then Test Product 2, Then Test Product 3
Participants were first catheterized with SpeediCath Flex at Visit 1. After a washout period of minimum 5 days, they were then catheterized with Test Product 2 at Visit 2. After a washout period of minimum 5 days again, they were then catheterized with Test Product 3.
|
Test Product 2, Then SpeediCath Flex, Then Test Product 3
Participants were first catheterized with Test Product 2 at Visit 1. After a washout period of minimum 5 days, they were then catheterized with SpeediCath Flex at Visit 2. After a washout period of minimum 5 days again, they were then catheterized with Test Product 3.
|
Test Product 3, Then SpeediCath Flex, Then Test Product 2
Participants were first catheterized with Test Product 3 at Visit 1. After a washout period of minimum 5 days, they were then catheterized with SpeediCath Flex at Visit 2. After a washout period of minimum 5 days again, they were then catheterized with Test Product 2.
|
|---|---|---|---|---|---|
|
First Intervention (Visit 1)
STARTED
|
2
|
3
|
2
|
1
|
1
|
|
First Intervention (Visit 1)
COMPLETED
|
2
|
3
|
2
|
1
|
1
|
|
First Intervention (Visit 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Washout (Minimum 5 Days)
STARTED
|
2
|
3
|
2
|
1
|
1
|
|
Washout (Minimum 5 Days)
COMPLETED
|
2
|
2
|
2
|
1
|
1
|
|
Washout (Minimum 5 Days)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
|
Second Intervention (Visit 2)
STARTED
|
2
|
3
|
2
|
1
|
1
|
|
Second Intervention (Visit 2)
COMPLETED
|
2
|
3
|
2
|
1
|
1
|
|
Second Intervention (Visit 2)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention (Visit 3)
STARTED
|
2
|
2
|
2
|
1
|
1
|
|
Third Intervention (Visit 3)
COMPLETED
|
2
|
2
|
2
|
1
|
1
|
|
Third Intervention (Visit 3)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Test Product 2, Then Test Product 3, Then SpeediCath Flex
Participants were first catheterized with Test Product 2 at Visit 1. After a washout period of minimum 5 days, they were then catheterized with Test Product 3 at Visit 2. After a washout period of minimum 5 days again, they were then catheterized with SpeediCath Flex.
|
Test Product 3, Then Test Product 2, Then SpeediCath Flex
Participants were first catheterized with Test Product 3 at Visit 1. After a washout period of minimum 5 days, they were then catheterized with Test Product 2 at Visit 2. After a washout period of minimum 5 days again, they were then catheterized with SpeediCath Flex.
|
SpeediCath Flex, Then Test Product 2, Then Test Product 3
Participants were first catheterized with SpeediCath Flex at Visit 1. After a washout period of minimum 5 days, they were then catheterized with Test Product 2 at Visit 2. After a washout period of minimum 5 days again, they were then catheterized with Test Product 3.
|
Test Product 2, Then SpeediCath Flex, Then Test Product 3
Participants were first catheterized with Test Product 2 at Visit 1. After a washout period of minimum 5 days, they were then catheterized with SpeediCath Flex at Visit 2. After a washout period of minimum 5 days again, they were then catheterized with Test Product 3.
|
Test Product 3, Then SpeediCath Flex, Then Test Product 2
Participants were first catheterized with Test Product 3 at Visit 1. After a washout period of minimum 5 days, they were then catheterized with SpeediCath Flex at Visit 2. After a washout period of minimum 5 days again, they were then catheterized with Test Product 2.
|
|---|---|---|---|---|---|
|
Washout (Minimum 5 Days)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=9 Participants
The baseline measures include all study participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
|
Age, Continuous
|
35.9 years
n=9 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=9 Participants
|
|
Region of Enrollment
Denmark
|
9 participants
n=9 Participants
|
|
Number of Participants with Hematuria at baseline
|
0 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 2 hourOn day of study visits 1-5 rate of urine flow through catheter measured in mL/s
Outcome measures
| Measure |
Test Product 2
n=9 Participants
Test catheter 2
|
Test Product 3
n=9 Participants
Test catheter 3
|
Comparator
n=8 Participants
SpeediCath Flex
|
|---|---|---|---|
|
Urine Flow Rate
|
5.43 mL per second
Interval 3.0 to 8.0
|
5.47 mL per second
Interval 4.0 to 7.0
|
2.88 mL per second
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: 2 hourOn day of study visits 1-5 rate volume of urine left in the bladder post catheterisation (in mL)
Outcome measures
| Measure |
Test Product 2
n=9 Participants
Test catheter 2
|
Test Product 3
n=9 Participants
Test catheter 3
|
Comparator
n=8 Participants
SpeediCath Flex
|
|---|---|---|---|
|
Post-void Residual Urine
|
38.33 mL
Interval 7.0 to 97.0
|
34.63 mL
Interval 12.0 to 88.0
|
27.75 mL
Interval 7.0 to 64.0
|
SECONDARY outcome
Timeframe: 2 hourOn day of study visits 1-5 blood in urine post catheterisation (measured as yes/no to blood in urine)
Outcome measures
| Measure |
Test Product 2
n=9 Participants
Test catheter 2
|
Test Product 3
n=9 Participants
Test catheter 3
|
Comparator
n=8 Participants
SpeediCath Flex
|
|---|---|---|---|
|
Number of Participants With Hematuria
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Test Product 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Test Product 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Comparator
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place