Trial Outcomes & Findings for New Coating for Urinary Intermittent Catheters (NCT NCT06985888)
NCT ID: NCT06985888
Last Updated: 2026-08-24
Results Overview
This endpoint was assessed by the subject immediately after completed catheterization, by setting a vertical line to indicate their experience of the overall catheterization.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Immediately after the procedure
Results posted on
2026-08-24
Participant Flow
Between May 2025 and June 2025, 32 healthy male volunteers were recruited for the study from one investigational site.
The 32 recruited participants were randomized into the two intervention arms.
Participant milestones
| Measure |
Investigational Device Then Comparator Device
Investigational device: Male intermittent catheter with new coating: Intermittent catheterization through the urethra draining the bladder, using an intermittent catheter for males in size CH 12 by a HCP
Comparator device: Male intermittent catheter with existing coating: Intermittent catheterization through the urethra draining the bladder, using an intermittent catheter for males in size CH 12 by a HCP
|
Comparator Then Investigational Device
Comparator device: Male intermittent catheter with existing coating: Intermittent catheterization through the urethra draining the bladder, using an intermittent catheter for males in size CH 12 by a HCP
Investigational device: Male intermittent catheter with new coating: Intermittent catheterization through the urethra draining the bladder, using an intermittent catheter for males in size CH 12 by a HCP
|
|---|---|---|
|
Visit 1
STARTED
|
16
|
16
|
|
Visit 1
COMPLETED
|
16
|
16
|
|
Visit 1
NOT COMPLETED
|
0
|
0
|
|
Visit 2
STARTED
|
16
|
16
|
|
Visit 2
COMPLETED
|
16
|
15
|
|
Visit 2
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Investigational Device Then Comparator Device
Investigational device: Male intermittent catheter with new coating: Intermittent catheterization through the urethra draining the bladder, using an intermittent catheter for males in size CH 12 by a HCP
Comparator device: Male intermittent catheter with existing coating: Intermittent catheterization through the urethra draining the bladder, using an intermittent catheter for males in size CH 12 by a HCP
|
Comparator Then Investigational Device
Comparator device: Male intermittent catheter with existing coating: Intermittent catheterization through the urethra draining the bladder, using an intermittent catheter for males in size CH 12 by a HCP
Investigational device: Male intermittent catheter with new coating: Intermittent catheterization through the urethra draining the bladder, using an intermittent catheter for males in size CH 12 by a HCP
|
|---|---|---|
|
Visit 2
Catheterization could not be completed
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
The Full Analysis Set/Safety Population
n=32 Participants
Each investigation arm consisted of two test visits. On each visit, the participants underwent one catheterization with the investigational device or the Comparator catheter, according to the randomization scheme.
|
|---|---|
|
Age, Continuous
|
36.8 years
STANDARD_DEVIATION 11.8 • n=32 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=32 Participants
|
|
Region of Enrollment
Denmark
|
32 Participants
n=32 Participants
|
PRIMARY outcome
Timeframe: Immediately after the procedureThis endpoint was assessed by the subject immediately after completed catheterization, by setting a vertical line to indicate their experience of the overall catheterization.
Outcome measures
| Measure |
Investigational Device
n=31 Participants
The investigational device was a CE-marked, ready-to-use, sterile, hydrophilic-coated Nelaton male catheter for intermittent catheterization, with a new coating. The device was for single use only and was intended to be used for drainage of the bladder through urethra by people with missing or reduced bladder control. The investigational device was provided in size CH12 in this investigation.
|
Comparator Device
n=32 Participants
The comparator was identical to the investigational device, with the exception of the specifications of the coating. I.e. there were no visible differences between the investigational and the comparator device. The comparator device was provided in size CH12 in this investigation.
|
|---|---|---|
|
The Overall Discomfort During Catheterization Was Measured by VAS on a 10 cm Scale Ranging From "no Discomfort" (0 cm) to "Worst Possible Discomfort" (10 cm) Caused by the Catheter.
|
1.72 cm
Interval 1.23 to 2.21
|
1.46 cm
Interval 0.98 to 1.95
|
Adverse Events
Investigational Device
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Comparator Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Investigational Device
n=32 participants at risk
Investigational device: Male intermittent catheter with new coating: Intermittent catheterization through the urethra draining the bladder, using an intermittent catheter for males in size CH 12 by a HCP
|
Comparator Device
n=32 participants at risk
Comparator device: Male intermittent catheter with existing coating: Intermittent catheterization through the urethra draining the bladder, using an intermittent catheter for males in size CH 12 by a HCP
|
|---|---|---|
|
Renal and urinary disorders
Blood in urine
|
3.1%
1/32 • Number of events 1 • From enrollment to visit 2
|
0.00%
0/32 • From enrollment to visit 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place