Catheter Site Discomfort, Catheter Site Pain
Conditions
Brief summary
Investigation of novel swelling media for CE marked intermittent urinary catheters. The study was a randomized, single blinded, cross-over investigation comparing a novel swelling media with a comparator swelling media in 22 adult, healthy, male volunteers.
Detailed description
The CP279 study investigated a novel swelling media for male intermittent urinary catheters. The study was conducted in Denmark and was a single-site, randomized, single blinded, cross-over investigation, testing inferiority of a novel catheter swelling media against a comparator swelling media in 22 adult, healthy, male volunteers. Each participant was randomized to one of two treatment arms, using a randomization sequence of two (i.e., with two different random options for the order in which the participants tested the two swelling media). The study thus contained two test visits, for which the 22 participants tested the two different swelling media, respectively. There was 4-14 days between the test visits and all catheterizations were performed by trained nurses. Due to a visual difference between the products, it was only possible to blind the subjects.
Interventions
DEVICENovel swelling media
Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
DEVICEComparator swelling media
Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Written informed consent given * Minimum 18 years of age and with full legal capacity * Male gender * Willing to refrain from using analgesics up to 24 hours prior to catheterization visits * Negative urine multistix analysis for erythrocytes (microscopic hematuria) * Negative urine multistix analysis for leukocytes and nitrite, or if positive, subsequent negative for bacterial growth in urine culture
Exclusion criteria
* Abnormalities, diseases or surgical procedures performed in the lower urinary tract * Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination) * Participating in other clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or previously participation in this investigation * Known hypersensitivity toward any of the investigational device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Discomfort During Nurse Catheterization | Immediately after the procedure/catheterization, up to 5 min. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Withdrawal Discomfort During Nurse Catheterization | Immediately after the procedure/catheterization, up to 5 min. | 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. |
| Urination Discomfort After Catheterization | Immediately after first normal void, up to 5 min. | 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. |
| Catheter Handling During Insertion | Immediately after the procedure/catheterization, up to 5 min. | 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. |
| Insertion Discomfort During Nurse Catheterization | Immediately after the procedure/catheterization, up to 5 min. | 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. |
| Touch of Catheter Coating | Immediately after the procedure/catheterization, up to 5 min. | Nurse evaluation of whether or not it was needed to touch the catheter coating during handling and/or catheterization (yes/no). |
| Visual Blood During Catheterization | Immediately after the procedure/catheterization, up to 5 min. | Nurse evaluation of if he/she experienced visual blood on either the catheter or in the urine during catheterization (yes/no). |
| Microscopic Blood in Catheter-collected Urine | Immediately after the procedure/catheterization, up to 30 min. | 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). |
| Catheter Handling During Withdrawal | Immediately after the procedure/catheterization, up to 5 min. | 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. |
Countries
Denmark
Participant flow
Recruitment details
During November 2019, 22 users were recruited for the study from one site (Denmark) and encompassed the safety population.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Total ITT Population 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. | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | Total ITT Population | — |
|---|---|---|
| Age, Continuous | 34.7 years STANDARD_DEVIATION 10.4 | — |
| Number of participants with presence of hematuria (microscopic) | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Denmark | 22 Participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 22 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
Overall Discomfort During Nurse Catheterization
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Novel Swelling Media | Overall Discomfort During Nurse Catheterization | 1.75 cm | Standard Deviation 1.57 |
| Comparator Swelling Media | Overall Discomfort During Nurse Catheterization | 1.79 cm | Standard Deviation 1.86 |
Comparison: At a 85% power level, the sample size needed to demonstrate non-inferiority of the novel coating to the original the coating was 18 subjects (participants). This was based on a standard deviation of 1.6 cm, a within subject correlation of 0.5 cm, and an assumption of same VAS distribution for the investigational device as for the comparator. With an expected drop-out rate of 20%, 22 subjects were included.p-value: 0.8895% CI: [-0.5, 0.58]Mixed Models Analysis
Secondary
Catheter Handling During Insertion
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.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Novel Swelling Media | Catheter Handling During Insertion | Easy | 7 Participants |
| Novel Swelling Media | Catheter Handling During Insertion | Difficult | 1 Participants |
| Novel Swelling Media | Catheter Handling During Insertion | Neither difficult nor easy | 4 Participants |
| Novel Swelling Media | Catheter Handling During Insertion | Very difficult | 2 Participants |
| Novel Swelling Media | Catheter Handling During Insertion | Very easy | 8 Participants |
| Comparator Swelling Media | Catheter Handling During Insertion | Very difficult | 1 Participants |
| Comparator Swelling Media | Catheter Handling During Insertion | Very easy | 6 Participants |
| Comparator Swelling Media | Catheter Handling During Insertion | Easy | 8 Participants |
| Comparator Swelling Media | Catheter Handling During Insertion | Neither difficult nor easy | 3 Participants |
| Comparator Swelling Media | Catheter Handling During Insertion | Difficult | 4 Participants |
Comparison: Null hypothesis: No difference between the devices.p-value: 0.38195% CI: [0.47, 6.6]Proportional odds model
Secondary
Catheter Handling During Withdrawal
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.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Novel Swelling Media | Catheter Handling During Withdrawal | Easy | 4 Participants |
| Novel Swelling Media | Catheter Handling During Withdrawal | Difficult | 0 Participants |
| Novel Swelling Media | Catheter Handling During Withdrawal | Neither difficult nor easy | 0 Participants |
| Novel Swelling Media | Catheter Handling During Withdrawal | Very difficult | 1 Participants |
| Novel Swelling Media | Catheter Handling During Withdrawal | Very easy | 17 Participants |
| Comparator Swelling Media | Catheter Handling During Withdrawal | Very difficult | 1 Participants |
| Comparator Swelling Media | Catheter Handling During Withdrawal | Very easy | 13 Participants |
| Comparator Swelling Media | Catheter Handling During Withdrawal | Easy | 8 Participants |
| Comparator Swelling Media | Catheter Handling During Withdrawal | Neither difficult nor easy | 0 Participants |
| Comparator Swelling Media | Catheter Handling During Withdrawal | Difficult | 0 Participants |
Comparison: Null hypothesis: No difference between the devices.p-value: 0.54195% CI: [-18.4, 34]Proportional odds model
Secondary
Insertion Discomfort During Nurse Catheterization
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Novel Swelling Media | Insertion Discomfort During Nurse Catheterization | 2.17 cm | Standard Deviation 1.91 |
| Comparator Swelling Media | Insertion Discomfort During Nurse Catheterization | 2.03 cm | Standard Deviation 1.9 |
Comparison: At a 85% power level, the sample size needed to demonstrate non-inferiority of the novel coating to the original the coating was 18 subjects (participants). This was based on a standard deviation of 1.6 cm, a within subject correlation of 0.5 cm, and an assumption of same VAS distribution for the investigational device as for the comparator. With an expected drop-out rate of 20%, 22 subjects were included.p-value: 0.6295% CI: [-0.72, 0.44]Mixed Models Analysis
Secondary
Microscopic Blood in Catheter-collected Urine
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).
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Novel Swelling Media | Microscopic Blood in Catheter-collected Urine | Hematuria positive | 6 Participants |
| Novel Swelling Media | Microscopic Blood in Catheter-collected Urine | Hematuria negative | 16 Participants |
| Comparator Swelling Media | Microscopic Blood in Catheter-collected Urine | Hematuria negative | 16 Participants |
| Comparator Swelling Media | Microscopic Blood in Catheter-collected Urine | Hematuria positive | 6 Participants |
Comparison: Null hypothesis: No difference between the devices.p-value: 195% CI: [0.08, 12.87]Regression, Logistic
Secondary
Touch of Catheter Coating
Nurse evaluation of whether or not it was needed to touch the catheter coating during handling and/or catheterization (yes/no).
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Novel Swelling Media | Touch of Catheter Coating | Yes | 4 Participants |
| Novel Swelling Media | Touch of Catheter Coating | No | 18 Participants |
| Comparator Swelling Media | Touch of Catheter Coating | Yes | 3 Participants |
| Comparator Swelling Media | Touch of Catheter Coating | No | 19 Participants |
Comparison: Null hypothesis: No difference between the devices.p-value: 0.26995% CI: [0.19, 265.95]Regression, Logistic
Secondary
Urination Discomfort After Catheterization
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Novel Swelling Media | Urination Discomfort After Catheterization | 0.52 cm | Standard Deviation 0.71 |
| Comparator Swelling Media | Urination Discomfort After Catheterization | 0.37 cm | Standard Deviation 0.59 |
Comparison: At a 85% power level, the sample size needed to demonstrate non-inferiority of the novel coating to the original the coating was 18 subjects (participants). This was based on a standard deviation of 1.6 cm, a within subject correlation of 0.5 cm, and an assumption of same VAS distribution for the investigational device as for the comparator. With an expected drop-out rate of 20%, 22 subjects were included.p-value: 0.1995% CI: [-0.38, 0.08]Mixed Models Analysis
Secondary
Visual Blood During Catheterization
Nurse evaluation of if he/she experienced visual blood on either the catheter or in the urine during catheterization (yes/no).
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Novel Swelling Media | Visual Blood During Catheterization | Yes | 1 Participants |
| Novel Swelling Media | Visual Blood During Catheterization | No | 21 Participants |
| Comparator Swelling Media | Visual Blood During Catheterization | Yes | 1 Participants |
| Comparator Swelling Media | Visual Blood During Catheterization | No | 21 Participants |
Comparison: Null hypothesis: No difference between the devices.p-value: 195% CI: [0.02, 64.83]Regression, Logistic
Secondary
Withdrawal Discomfort During Nurse Catheterization
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Novel Swelling Media | Withdrawal Discomfort During Nurse Catheterization | 1.16 cm | Standard Deviation 1.09 |
| Comparator Swelling Media | Withdrawal Discomfort During Nurse Catheterization | 1.27 cm | Standard Deviation 1.37 |
Comparison: At a 85% power level, the sample size needed to demonstrate non-inferiority of the novel coating to the original the coating was 18 subjects (participants). This was based on a standard deviation of 1.6 cm, a within subject correlation of 0.5 cm, and an assumption of same VAS distribution for the investigational device as for the comparator. With an expected drop-out rate of 20%, 22 subjects were included.p-value: 0.6395% CI: [-0.36, 0.57]Mixed Models Analysis