Retention, Urinary
Conditions
Brief summary
Investigation of non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.
Detailed description
The CP322 study investigated a novel non-CE marked intermittent catheter for males and females, designed in two different variants, Variant 1 and Variant 2, respectively. The study was conducted in Denmark and was a randomized, single blinded, cross-over investigation comparing the two new variant catheters with a comparator catheter in 30 adult healthy volunteers. For each participant, the study thus contained three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 30 participants were randomized using a randomization sequence of six (i.e., there were six different random options for the order in which the participants tested the three catheters). There were 4-14 days between the test visits.
Interventions
DEVICESpeediCath® Standard male or female
Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male or female.
DEVICENew intermittent Variant 1 catheter for male or female
Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 for male or female.
DEVICENew intermittent Variant 2 catheter for male or female
Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 for male or female.
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Minimum 18 years of age and with full legal capacity * Written informed consent and signed letter of authority and secrecy agreement given * Willing to comply with not using analgesics 1 up to 24 hours prior to catheterization visits * Urine Multistix negative for erythrocytes (hematuria)
Exclusion criteria
* Participation in any other clinical investigations during this investigation * Known hypersensitivity towards any of the test products * Symptoms of urinary tract infection (UTI) (Investigators judgement) * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residual Urine at 1st Flow-stop | Immediately after the procedure/catheterization, up to 5 min. | The residual urine at 1st flow-stop during catheterization (performed by a nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Catheterization Insertion Discomfort | Immediately after the procedure/catheterization, up to 5 min. | Discomfort measured at catheter insertion, 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. |
| Catheterization Urination Discomfort | Immediately after the procedure/catheterization, up to 5 min. | Discomfort measured during catheter emptying/urination, 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. |
| Post-void Residual Urine | Immediately after the procedure/catheterization, up to 15 min. | The volume of residual urine (urine left in the bladder) post catheterization (performed by the nurse) measured in triplicates using an ultrasound scanner. |
| Overall Catheterization Discomfort | Immediately after the procedure/catheterization, up to 5 min. | Discomfort measured for the overall/entire catheterization procedure, 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. |
| Post-catheterization Urination Discomfort | Immediately after the first normal void following the procedure/catheterization, up to 5 min. | Discomfort measured for the first normal void/urination after the catheterization procedure, 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. |
| Withdrawal Discomfort | Immediately after the procedure/catheterization, up to 5 min. | Discomfort measured during catheter withdrawal, 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. |
Countries
Denmark
Participant flow
Recruitment details
Between March 2020 and September 2020, 30 users were recruited for the study from one site (Denmark) and encompassed the safety population.
Pre-assignment details
The 30 recruited participant were randomized into the three treatment arms, using a randomization sequence of six. No participants were excluded, one was discontinued after Visit 2 due to an adverse event. Two participants total had an adverse event, both were classified as mild, non-serious, 'Possibly related' and 'Not related' (for details; see Adverse Events section). Thus, 30 participants constituted the intention to treat (ITT) population.
Participants by arm
| Arm | Count |
|---|---|
| Female ITT Population Each treatment arm consisted of three test visits with 4-14 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 female), the new Variant 1 female catheter, or the new Variant 2 female catheter. | 15 |
| Male ITT Population Each treatment arm consisted of three test visits with 4-14 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), the new Variant 1 male catheter, or the new Variant 2 male catheter. | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Female ITT Population | Male ITT Population |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 15 Participants | 15 Participants |
| Age, Continuous | 32 years STANDARD_DEVIATION 10 | 31 years STANDARD_DEVIATION 12 | 32 years STANDARD_DEVIATION 8 |
| Hematuria negative | 30 Participants | 15 Participants | 15 Participants |
| Hematuria positive | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment Denmark | 30 Participants | 15 Participants | 15 Participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 0 Participants |
| Sex: Female, Male Male | 15 Participants | 0 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 14 |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 1 / 15 | 0 / 14 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 14 |
Outcome results
Primary
Residual Urine at 1st Flow-stop
The residual urine at 1st flow-stop during catheterization (performed by a nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.
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 endpoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Catheter; SpeediCath® Standard Female | Residual Urine at 1st Flow-stop | 35.0 mL | Standard Deviation 71 |
| New Intermittent Catheter Variant 1 for Female | Residual Urine at 1st Flow-stop | 1.1 mL | Standard Deviation 2.6 |
| New Intermittent Catheter Variant 2 for Female | Residual Urine at 1st Flow-stop | 0.2 mL | Standard Deviation 0.7 |
| Intermittent Catheter; SpeediCath® Standard Male | Residual Urine at 1st Flow-stop | 37.0 mL | Standard Deviation 40 |
| New Intermittent Catheter Variant 1 for Male | Residual Urine at 1st Flow-stop | 2.2 mL | Standard Deviation 6.2 |
| New Intermittent Catheter Variant 2 for Male | Residual Urine at 1st Flow-stop | 1.0 mL | Standard Deviation 4 |
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.0195% CI: [8.3, 57.5]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.00795% CI: [9.8, 58.8]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.90895% CI: [-23.1, 25.9]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.00695% CI: [10.8, 59.8]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.00595% CI: [11.9, 61.8]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.89995% CI: [-23.3, 26.5]Mixed Models Analysis
Secondary
Catheterization Insertion Discomfort
Discomfort measured at catheter insertion, 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 endpoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Catheter; SpeediCath® Standard Female | Catheterization Insertion Discomfort | 0.51 cm | Standard Deviation 0.72 |
| New Intermittent Catheter Variant 1 for Female | Catheterization Insertion Discomfort | 0.81 cm | Standard Deviation 0.96 |
| New Intermittent Catheter Variant 2 for Female | Catheterization Insertion Discomfort | 0.86 cm | Standard Deviation 1.15 |
| Intermittent Catheter; SpeediCath® Standard Male | Catheterization Insertion Discomfort | 2.32 cm | Standard Deviation 2.24 |
| New Intermittent Catheter Variant 1 for Male | Catheterization Insertion Discomfort | 2.31 cm | Standard Deviation 1.97 |
| New Intermittent Catheter Variant 2 for Male | Catheterization Insertion Discomfort | 2.79 cm | Standard Deviation 2.46 |
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.61595% CI: [-1.08, 0.65]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.4895% CI: [-1.17, 0.56]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.83995% CI: [-0.95, 0.77]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.89495% CI: [-0.92, 0.8]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.19595% CI: [-1.46, 0.3]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.24295% CI: [-1.4, 0.36]Mixed Models Analysis
Secondary
Catheterization Urination Discomfort
Discomfort measured during catheter emptying/urination, 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 endpoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Catheter; SpeediCath® Standard Female | Catheterization Urination Discomfort | 0.18 cm | Standard Deviation 0.23 |
| New Intermittent Catheter Variant 1 for Female | Catheterization Urination Discomfort | 0.47 cm | Standard Deviation 0.83 |
| New Intermittent Catheter Variant 2 for Female | Catheterization Urination Discomfort | 0.55 cm | Standard Deviation 0.93 |
| Intermittent Catheter; SpeediCath® Standard Male | Catheterization Urination Discomfort | 0.93 cm | Standard Deviation 1.62 |
| New Intermittent Catheter Variant 1 for Male | Catheterization Urination Discomfort | 0.74 cm | Standard Deviation 0.86 |
| New Intermittent Catheter Variant 2 for Male | Catheterization Urination Discomfort | 1.51 cm | Standard Deviation 2.77 |
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.63995% CI: [-1.2, 0.74]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.49295% CI: [-1.3, 0.63]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.82895% CI: [-1.07, 0.86]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.74495% CI: [-0.81, 1.13]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.20895% CI: [-1.62, 0.36]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.11695% CI: [-1.77, 0.2]Mixed Models Analysis
Secondary
Overall Catheterization Discomfort
Discomfort measured for the overall/entire catheterization procedure, 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 endpoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Catheter; SpeediCath® Standard Female | Overall Catheterization Discomfort | 0.66 cm | Standard Deviation 0.65 |
| New Intermittent Catheter Variant 1 for Female | Overall Catheterization Discomfort | 0.72 cm | Standard Deviation 0.63 |
| New Intermittent Catheter Variant 2 for Female | Overall Catheterization Discomfort | 1.04 cm | Standard Deviation 1.63 |
| Intermittent Catheter; SpeediCath® Standard Male | Overall Catheterization Discomfort | 1.99 cm | Standard Deviation 2.19 |
| New Intermittent Catheter Variant 1 for Male | Overall Catheterization Discomfort | 1.71 cm | Standard Deviation 1.57 |
| New Intermittent Catheter Variant 2 for Male | Overall Catheterization Discomfort | 2.58 cm | Standard Deviation 2.56 |
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.88295% CI: [-0.83, 0.96]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.47895% CI: [-1.21, 0.57]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.39195% CI: [-1.27, 0.51]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.65795% CI: [-0.69, 1.09]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.12595% CI: [-1.62, 0.2]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.05195% CI: [-1.81, 0]Mixed Models Analysis
Secondary
Post-catheterization Urination Discomfort
Discomfort measured for the first normal void/urination after the catheterization procedure, 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 first normal void following 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 endpoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Catheter; SpeediCath® Standard Female | Post-catheterization Urination Discomfort | 0.29 cm | Standard Deviation 0.63 |
| New Intermittent Catheter Variant 1 for Female | Post-catheterization Urination Discomfort | 0.09 cm | Standard Deviation 0.16 |
| New Intermittent Catheter Variant 2 for Female | Post-catheterization Urination Discomfort | 0.35 cm | Standard Deviation 0.72 |
| Intermittent Catheter; SpeediCath® Standard Male | Post-catheterization Urination Discomfort | 0.66 cm | Standard Deviation 1.56 |
| New Intermittent Catheter Variant 1 for Male | Post-catheterization Urination Discomfort | 0.66 cm | Standard Deviation 0.84 |
| New Intermittent Catheter Variant 2 for Male | Post-catheterization Urination Discomfort | 1.88 cm | Standard Deviation 2.7 |
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.87795% CI: [-0.83, 0.97]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.35195% CI: [-1.31, 0.47]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.27895% CI: [-1.38, 0.4]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.71195% CI: [-0.73, 1.06]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.02495% CI: [-1.97, -0.15]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.00995% CI: [-2.14, -0.31]Mixed Models Analysis
Secondary
Post-void Residual Urine
The volume of residual urine (urine left in the bladder) post catheterization (performed by the nurse) measured in triplicates using an ultrasound scanner.
Time frame: Immediately after the procedure/catheterization, up to 15 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 endpoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Catheter; SpeediCath® Standard Female | Post-void Residual Urine | 8.6 mL | Standard Deviation 11.4 |
| New Intermittent Catheter Variant 1 for Female | Post-void Residual Urine | 1.5 mL | Standard Deviation 6.1 |
| New Intermittent Catheter Variant 2 for Female | Post-void Residual Urine | 27.6 mL | Standard Deviation 104.1 |
| Intermittent Catheter; SpeediCath® Standard Male | Post-void Residual Urine | 5.3 mL | Standard Deviation 8.9 |
| New Intermittent Catheter Variant 1 for Male | Post-void Residual Urine | 24.3 mL | Standard Deviation 79.1 |
| New Intermittent Catheter Variant 2 for Male | Post-void Residual Urine | 16.3 mL | Standard Deviation 31.9 |
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.66595% CI: [-31.9, 49.6]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.37595% CI: [-58.7, 22.4]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.18895% CI: [-67.6, 13.6]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.36195% CI: [-59.3, 21.9]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.695% CI: [-52.3, 30.5]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.70795% CI: [-33.5, 49]Mixed Models Analysis
Secondary
Withdrawal Discomfort
Discomfort measured during catheter withdrawal, 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 endpoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Catheter; SpeediCath® Standard Female | Withdrawal Discomfort | 0.79 cm | Standard Deviation 0.7 |
| New Intermittent Catheter Variant 1 for Female | Withdrawal Discomfort | 0.83 cm | Standard Deviation 0.94 |
| New Intermittent Catheter Variant 2 for Female | Withdrawal Discomfort | 1.11 cm | Standard Deviation 1.32 |
| Intermittent Catheter; SpeediCath® Standard Male | Withdrawal Discomfort | 2.05 cm | Standard Deviation 2.55 |
| New Intermittent Catheter Variant 1 for Male | Withdrawal Discomfort | 1.42 cm | Standard Deviation 1.86 |
| New Intermittent Catheter Variant 2 for Male | Withdrawal Discomfort | 2.28 cm | Standard Deviation 2.39 |
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.79895% CI: [-0.75, 0.96]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.55695% CI: [-1.1, 0.6]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.39995% CI: [-1.21, 0.49]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.19895% CI: [-0.3, 1.41]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.36595% CI: [-1.27, 0.48]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.03395% CI: [-1.82, -0.08]Mixed Models Analysis