Trial Outcomes & Findings for Investigation of New Intermittent Catheter Swelling Media in Healthy Volunteers (NCT NCT04633291)
NCT ID: NCT04633291
Last Updated: 2023-07-17
Results Overview
Discomfort measured for the entire catheterization procedure (performed by nurse), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.
COMPLETED
NA
22 participants
Immediately after the procedure/catheterization, up to 5 min.
2023-07-17
Participant Flow
During November 2019, 22 users were recruited for the study from one site (Denmark) and encompassed the safety population.
The 22 recruited participant were randomized into the two intervention arms, i.e., using a randomization sequence of two. No participants were excluded and none were discontinued. Thus, 22 participants constituted the safety and the intention to treat (ITT) population.
Participant milestones
| Measure |
Original Swelling Media, Then Novel Swelling Media
On two separate and randomly assigned visits, the participants underwent two interventions:
First intervention: Day of catheterization with original swelling media (Comparator).
Washout: 4-14 days. Second intervention: Day of catheterization with novel swelling media (Test device).
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Novel Swelling Media, Then Original Swelling Media
On two separate and randomly assigned visits, the participants underwent two interventions:
First intervention: Day of catheterization with novel swelling media (Test device).
Washout: 4-14 days. Second intervention: Day of catheterization with original swelling media (Comparator).
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|---|---|---|
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Overall Study
STARTED
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11
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11
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Overall Study
COMPLETED
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11
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11
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Total ITT Population
n=22 Participants
Each treatment arm consisted of two test visits with 4-14 washout days between each crossover. On each visit, the participants underwent intermittent catheterization through the urethra, draining the bladder, and tested a different intermittent catheter: The comparator catheter (SpeediCath® Standard male with original swelling media) or the test catheter (SpeediCath® Standard male with novel swelling media). All catheterizations were performed by a trained nurse.
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|---|---|
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Age, Continuous
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34.7 years
STANDARD_DEVIATION 10.4 • n=22 Participants
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Sex: Female, Male
Female
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0 Participants
n=22 Participants
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Sex: Female, Male
Male
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22 Participants
n=22 Participants
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Region of Enrollment
Denmark
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22 Participants
n=22 Participants
|
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Number of participants with presence of hematuria (microscopic)
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0 Participants
n=22 Participants
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PRIMARY outcome
Timeframe: Immediately after the procedure/catheterization, up to 5 min.Population: The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoint.
Discomfort measured for the entire catheterization procedure (performed by nurse), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.
Outcome measures
| Measure |
Novel Swelling Media
n=22 Participants
Participants underwent catheterization with the SpeediCath standard male catheter containing the novel swelling media. The catheterization was performed by a trained nurse.
Novel swelling media: Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
|
Comparator Swelling Media
n=22 Participants
Participants underwent catheterization with CE-marked SpeediCath® standard male containing the original swelling media. The catheterization was performed by a trained nurse.
Comparator swelling media: Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
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|---|---|---|
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Overall Discomfort During Nurse Catheterization
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1.75 cm
Standard Deviation 1.57
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1.79 cm
Standard Deviation 1.86
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SECONDARY outcome
Timeframe: Immediately after the procedure/catheterization, up to 5 min.Population: The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoint.
Discomfort measured for the entire catheterization procedure (performed by nurse), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.
Outcome measures
| Measure |
Novel Swelling Media
n=22 Participants
Participants underwent catheterization with the SpeediCath standard male catheter containing the novel swelling media. The catheterization was performed by a trained nurse.
Novel swelling media: Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
|
Comparator Swelling Media
n=22 Participants
Participants underwent catheterization with CE-marked SpeediCath® standard male containing the original swelling media. The catheterization was performed by a trained nurse.
Comparator swelling media: Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
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|---|---|---|
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Insertion Discomfort During Nurse Catheterization
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2.17 cm
Standard Deviation 1.91
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2.03 cm
Standard Deviation 1.90
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SECONDARY outcome
Timeframe: Immediately after the procedure/catheterization, up to 5 min.Population: The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoint.
Discomfort measured for the entire catheterization procedure (performed by nurse), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.
Outcome measures
| Measure |
Novel Swelling Media
n=22 Participants
Participants underwent catheterization with the SpeediCath standard male catheter containing the novel swelling media. The catheterization was performed by a trained nurse.
Novel swelling media: Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
|
Comparator Swelling Media
n=22 Participants
Participants underwent catheterization with CE-marked SpeediCath® standard male containing the original swelling media. The catheterization was performed by a trained nurse.
Comparator swelling media: Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
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|---|---|---|
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Withdrawal Discomfort During Nurse Catheterization
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1.16 cm
Standard Deviation 1.09
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1.27 cm
Standard Deviation 1.37
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SECONDARY outcome
Timeframe: Immediately after first normal void, up to 5 min.Population: The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoint.
Discomfort measured for the entire catheterization procedure (performed by nurse), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.
Outcome measures
| Measure |
Novel Swelling Media
n=22 Participants
Participants underwent catheterization with the SpeediCath standard male catheter containing the novel swelling media. The catheterization was performed by a trained nurse.
Novel swelling media: Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
|
Comparator Swelling Media
n=22 Participants
Participants underwent catheterization with CE-marked SpeediCath® standard male containing the original swelling media. The catheterization was performed by a trained nurse.
Comparator swelling media: Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
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|---|---|---|
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Urination Discomfort After Catheterization
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0.52 cm
Standard Deviation 0.71
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0.37 cm
Standard Deviation 0.59
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SECONDARY outcome
Timeframe: Immediately after the procedure/catheterization, up to 5 min.Population: The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoint.
Nurse evaluation of how he/she experienced catheter insertion on a 5-point likert scale including the options: Very difficult, difficult, neither difficult nor easy, easy or very easy.
Outcome measures
| Measure |
Novel Swelling Media
n=22 Participants
Participants underwent catheterization with the SpeediCath standard male catheter containing the novel swelling media. The catheterization was performed by a trained nurse.
Novel swelling media: Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
|
Comparator Swelling Media
n=22 Participants
Participants underwent catheterization with CE-marked SpeediCath® standard male containing the original swelling media. The catheterization was performed by a trained nurse.
Comparator swelling media: Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
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Catheter Handling During Insertion
Very easy
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8 Participants
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6 Participants
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Catheter Handling During Insertion
Easy
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7 Participants
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8 Participants
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Catheter Handling During Insertion
Neither difficult nor easy
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4 Participants
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3 Participants
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Catheter Handling During Insertion
Difficult
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1 Participants
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4 Participants
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Catheter Handling During Insertion
Very difficult
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2 Participants
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1 Participants
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SECONDARY outcome
Timeframe: Immediately after the procedure/catheterization, up to 5 min.Population: The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoint.
Nurse evaluation of how he/she experienced catheter withdrawal on a 5-point likert scale including the options: Very difficult, difficult, neither difficult nor easy, easy or very easy.
Outcome measures
| Measure |
Novel Swelling Media
n=22 Participants
Participants underwent catheterization with the SpeediCath standard male catheter containing the novel swelling media. The catheterization was performed by a trained nurse.
Novel swelling media: Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
|
Comparator Swelling Media
n=22 Participants
Participants underwent catheterization with CE-marked SpeediCath® standard male containing the original swelling media. The catheterization was performed by a trained nurse.
Comparator swelling media: Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
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|---|---|---|
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Catheter Handling During Withdrawal
Very easy
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17 Participants
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13 Participants
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Catheter Handling During Withdrawal
Easy
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4 Participants
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8 Participants
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Catheter Handling During Withdrawal
Neither difficult nor easy
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0 Participants
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0 Participants
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Catheter Handling During Withdrawal
Difficult
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0 Participants
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0 Participants
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Catheter Handling During Withdrawal
Very difficult
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1 Participants
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1 Participants
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SECONDARY outcome
Timeframe: Immediately after the procedure/catheterization, up to 5 min.Population: The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoint.
Nurse evaluation of whether or not it was needed to touch the catheter coating during handling and/or catheterization (yes/no).
Outcome measures
| Measure |
Novel Swelling Media
n=22 Participants
Participants underwent catheterization with the SpeediCath standard male catheter containing the novel swelling media. The catheterization was performed by a trained nurse.
Novel swelling media: Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
|
Comparator Swelling Media
n=22 Participants
Participants underwent catheterization with CE-marked SpeediCath® standard male containing the original swelling media. The catheterization was performed by a trained nurse.
Comparator swelling media: Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
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|---|---|---|
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Touch of Catheter Coating
Yes
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4 Participants
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3 Participants
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Touch of Catheter Coating
No
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18 Participants
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19 Participants
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SECONDARY outcome
Timeframe: Immediately after the procedure/catheterization, up to 5 min.Population: The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoint.
Nurse evaluation of if he/she experienced visual blood on either the catheter or in the urine during catheterization (yes/no).
Outcome measures
| Measure |
Novel Swelling Media
n=22 Participants
Participants underwent catheterization with the SpeediCath standard male catheter containing the novel swelling media. The catheterization was performed by a trained nurse.
Novel swelling media: Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
|
Comparator Swelling Media
n=22 Participants
Participants underwent catheterization with CE-marked SpeediCath® standard male containing the original swelling media. The catheterization was performed by a trained nurse.
Comparator swelling media: Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
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|---|---|---|
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Visual Blood During Catheterization
Yes
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1 Participants
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1 Participants
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Visual Blood During Catheterization
No
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21 Participants
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21 Participants
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SECONDARY outcome
Timeframe: Immediately after the procedure/catheterization, up to 30 min.Population: The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoint.
Dipstick analysis of hematuria (erythrocytes) after catheterization using a semi-quantitative color scale with five categories ranging from negative to 3+: Negative (-). 10 erythrocytes/μL (+/-). 25 erythrocytes/μL (1+). 80 erythrocytes/μL (2+). 200 erythrocytes/μL (3+). At least one fully positive response (i.e., either 1+, 2+ or 3+), the endpoint was considered positive and the outcome was analyzed as a binary response (positive/negative).
Outcome measures
| Measure |
Novel Swelling Media
n=22 Participants
Participants underwent catheterization with the SpeediCath standard male catheter containing the novel swelling media. The catheterization was performed by a trained nurse.
Novel swelling media: Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
|
Comparator Swelling Media
n=22 Participants
Participants underwent catheterization with CE-marked SpeediCath® standard male containing the original swelling media. The catheterization was performed by a trained nurse.
Comparator swelling media: Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
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Microscopic Blood in Catheter-collected Urine
Hematuria positive
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6 Participants
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6 Participants
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Microscopic Blood in Catheter-collected Urine
Hematuria negative
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16 Participants
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16 Participants
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Adverse Events
Novel Swelling Media
Comparator Swelling Media
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
Restriction type: LTE60