Trial Outcomes & Findings for Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Prototype Micro Hole Zone Catheter (NCT NCT05224544)
NCT ID: NCT05224544
Last Updated: 2025-12-12
Results Overview
Change in appearance of the bladder mucosa (∆=pre-catheterisation at baseline and post-catheterization and visit 2) rated on a 4-point scale. The 4-point scale defined as such: 1. no lesions evident; 2. minor mucosal and blood vessel lesions; 3. major blood vessel lesions, and 4. major mucosal and blood vessel lesions,
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
2 days
Results posted on
2025-12-12
Participant Flow
Participant milestones
| Measure |
Prototype Catheter
Healthy volunteers to test the prototype intermittent catheter.
Prototype device: The test device is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.
|
Comparator Catheter
Healthy volunteers to test the comparator.
Comparator: The comparator is a urinary catheter for bladder drainage through the urethra for intermittent use.
|
|---|---|---|
|
V1, Visualization of the Bladder
STARTED
|
21
|
22
|
|
V1, Visualization of the Bladder
COMPLETED
|
21
|
22
|
|
V1, Visualization of the Bladder
NOT COMPLETED
|
0
|
0
|
|
V2, Catheterization and Visualization
STARTED
|
21
|
22
|
|
V2, Catheterization and Visualization
COMPLETED
|
19
|
21
|
|
V2, Catheterization and Visualization
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Prototype Catheter
Healthy volunteers to test the prototype intermittent catheter.
Prototype device: The test device is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.
|
Comparator Catheter
Healthy volunteers to test the comparator.
Comparator: The comparator is a urinary catheter for bladder drainage through the urethra for intermittent use.
|
|---|---|---|
|
V2, Catheterization and Visualization
Adverse Event
|
2
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Prototype Catheter
n=21 Participants
Healthy volunteers to test the prototype investigational intermittent catheter.
Test Catheter: The test product is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.
|
Comparator Catheter
n=22 Participants
Healthy volunteers to test the comparator catheter.
Comparator catheter: The comparator is a urinary catheter for bladder drainage through the urethra, for intermittent use.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 14.7 • n=21 Participants
|
38.4 years
STANDARD_DEVIATION 16.7 • n=22 Participants
|
39.7 years
STANDARD_DEVIATION 15.6 • n=43 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=21 Participants
|
22 Participants
n=22 Participants
|
43 Participants
n=43 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=43 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Prophylactic antibiotics
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=43 Participants
|
PRIMARY outcome
Timeframe: 2 daysPopulation: Intention to treat (ITT)
Change in appearance of the bladder mucosa (∆=pre-catheterisation at baseline and post-catheterization and visit 2) rated on a 4-point scale. The 4-point scale defined as such: 1. no lesions evident; 2. minor mucosal and blood vessel lesions; 3. major blood vessel lesions, and 4. major mucosal and blood vessel lesions,
Outcome measures
| Measure |
Change in Bladder Mucosa Pre- and Post-catheterization for the Prototype Catheter
n=19 Participants
Change in appearance of the bladder mucosa with prototype catheter, post- and pre-catheterization (∆), rated on a 4-point scale of:
1. no lesions evident;
2. minor mucosal and blood vessel lesions;
3. major blood vessel lesions, and
4. major mucosal and blood vessel lesions, post-catheterization (Visit 2).
|
Change in Bladder Mucosa Pre- and Post-catheterization for the Comparator Catheter
n=21 Participants
Change in appearance of the bladder mucosa with comparator catheter, post- and pre-catheterization (∆), rated on a 4-point scale of:
1. no lesions evident;
2. minor mucosal and blood vessel lesions;
3. major blood vessel lesions, and
4. major mucosal and blood vessel lesions, post-catheterization (Visit 2).
|
|---|---|---|
|
Change in Appearance of the Bladder Mucosa (∆=Pre-catheterisation at Baseline and Post-catheterization and Visit 2) Rated on a 4-point Scale.
|
0.84 score on a scale
Interval 0.58 to 1.11
|
0.76 score on a scale
Interval 0.51 to 1.01
|
Adverse Events
Prototype Catheter
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Comparator Catheter
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Prototype Catheter
n=19 participants at risk
Adverse event upon catheterization with prototype catheter
|
Comparator Catheter
n=21 participants at risk
Adverse event upon catheterization with comparator catheter
|
|---|---|---|
|
Renal and urinary disorders
Hematuria
|
36.8%
7/19 • Number of events 7 • The study consisted of one inclusion visit (Visit 0) and two test visits (Visits 1 and 2) of approximately 1-2 hrs. The inclusion visit, and the first test visit were completed on the same day, when possible, and in those circumstances took two days to complete. For participants where V0 and V1 were not performed on the same days, the study took three days.
|
4.8%
1/21 • Number of events 1 • The study consisted of one inclusion visit (Visit 0) and two test visits (Visits 1 and 2) of approximately 1-2 hrs. The inclusion visit, and the first test visit were completed on the same day, when possible, and in those circumstances took two days to complete. For participants where V0 and V1 were not performed on the same days, the study took three days.
|
|
Respiratory, thoracic and mediastinal disorders
Urinary tract infection
|
0.00%
0/19 • The study consisted of one inclusion visit (Visit 0) and two test visits (Visits 1 and 2) of approximately 1-2 hrs. The inclusion visit, and the first test visit were completed on the same day, when possible, and in those circumstances took two days to complete. For participants where V0 and V1 were not performed on the same days, the study took three days.
|
4.8%
1/21 • Number of events 1 • The study consisted of one inclusion visit (Visit 0) and two test visits (Visits 1 and 2) of approximately 1-2 hrs. The inclusion visit, and the first test visit were completed on the same day, when possible, and in those circumstances took two days to complete. For participants where V0 and V1 were not performed on the same days, the study took three days.
|
|
Renal and urinary disorders
Burning sensation
|
5.3%
1/19 • Number of events 1 • The study consisted of one inclusion visit (Visit 0) and two test visits (Visits 1 and 2) of approximately 1-2 hrs. The inclusion visit, and the first test visit were completed on the same day, when possible, and in those circumstances took two days to complete. For participants where V0 and V1 were not performed on the same days, the study took three days.
|
0.00%
0/21 • The study consisted of one inclusion visit (Visit 0) and two test visits (Visits 1 and 2) of approximately 1-2 hrs. The inclusion visit, and the first test visit were completed on the same day, when possible, and in those circumstances took two days to complete. For participants where V0 and V1 were not performed on the same days, the study took three days.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Number of events 1 • The study consisted of one inclusion visit (Visit 0) and two test visits (Visits 1 and 2) of approximately 1-2 hrs. The inclusion visit, and the first test visit were completed on the same day, when possible, and in those circumstances took two days to complete. For participants where V0 and V1 were not performed on the same days, the study took three days.
|
0.00%
0/21 • The study consisted of one inclusion visit (Visit 0) and two test visits (Visits 1 and 2) of approximately 1-2 hrs. The inclusion visit, and the first test visit were completed on the same day, when possible, and in those circumstances took two days to complete. For participants where V0 and V1 were not performed on the same days, the study took three days.
|
Additional Information
Malene Hornbak Landauro, Medical writer of Clinical strategies
Coloplast, Clinical strategies
Phone: +4549112057
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60