Retention, Urinary
Conditions
Brief summary
Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for males with a comparator catheter
Detailed description
The CP323 study investigated a novel non-CE marked intermittent catheter, designed in two different variants, Variant 1 and Variant 2, respectively, and was conducted in Denmark. The study was a randomized, single blinded, cross-over investigation, comparing the two new variant catheters with a comparator catheter in 15 male IC users. For each participant, the study thus contains three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 15 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
Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male.
DEVICENew intermittent Variant 1 catheter for males
Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 catheter.
DEVICENew intermittent Variant 2 catheter for males
Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 catheter.
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
No
Inclusion criteria
* Male * Minimum 18 years of age and with full legal capacity * Daily intermittent catheterization for bladder management, with at least two catheters used on average pr. day, during the last 3 months * Ability to self-catheterize * Written informed consent, signed letter of authority and signed secrecy agreement given
Exclusion criteria
* Participation in any other clinical study during this investigation * Symptoms of urinary tract infection as judged by the investigator * Any know allergies towards ingredients in the products * Relevant medical history that would prevent the subject from participation in the investigation (investigators judgement)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residual Urine at 1st Flow-stop During Nurse Catheterization | Immediately after the procedure/catheterization, up to 5 min. | The residual urine at 1st flow-stop during nurse catheterization (i.e., catheterization performed by the 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. |
| Residual Urine at 1st Flow-stop During Self-catheterization | Immediately after the procedure/catheterization, up to 5 min. | The residual urine at 1st flow-stop during nurse catheterization (i.e., catheterization performed by the participant) 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 |
|---|---|---|
| Insertion Discomfort During Nurse Catheterization | Immediately after the procedure/catheterization, up to 5 min. | Discomfort measured at catheter insertion (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 During Nurse Catheterization | Immediately after the procedure/catheterization, up to 5 min. | Discomfort measured during catheter urination/emptying (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. |
| Withdrawal Discomfort During Nurse Catheterization | Immediately after the procedure/catheterization, up to 5 min. | Discomfort measured during catheter withdrawal (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. |
| 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. |
| Post-void Residual Urine After Nurse Catheterization | 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. |
| Urination Discomfort During Self-catheterization | Immediately after the procedure/catheterization, up to 5 min. | Discomfort measured during catheter urination/emptying (performed by participant), 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 During Self-catheterization | Immediately after the procedure/catheterization, up to 5 min. | Discomfort measured during catheter withdrawal (performed by participant), 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. |
| Overall Discomfort During Self-catheterization | Immediately after the procedure/catheterization, up to 5 min. | Discomfort measured for the entire catheterization procedure (performed by participant), 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. |
| Insertion Discomfort During Self-catheterization | Immediately after the procedure/catheterization, up to 5 min. | Discomfort measured at catheter insertion (performed by participant), 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 After Self-catheterization | Immediately after the procedure/catheterization, up to 15 min. | The volume of residual urine (urine left in the bladder) post catheterization (performed by the participant) measured in triplicates using an ultrasound scanner. |
Countries
Denmark
Participant flow
Recruitment details
Between June 2020 and January 2021,16 users were recruited for the study from one site (Denmark) and encompassed the safety population.
Pre-assignment details
The 16 recruited participant were randomized into the three treatment arms, using a randomization sequence of six. No participants were excluded, but two were discontinued at own wish after the baseline visit. Three participants had an adverse event; all were classified as mild, non-serious, two as 'Possibly related' and one as 'Unlikely related' (for details; see Adverse Events section). Thus, 14 participants constituted the intention to treat (ITT) population.
Participants by arm
| Arm | Count |
|---|---|
| Total 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 catheter, or the new Variant 2 catheter. For each visit and catheter tested, the participants underwent two catheterizations; the first catheterization was performed by a trained nurse and was followed by later same-day self-catheterization (i.e. performed by the participant). | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total ITT Population | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 7 Participants | — |
| Age, Categorical Between 18 and 65 years | 7 Participants | — |
| Age, Continuous | 55 years | — |
| Number of participants in sitting catheterization position | 8 Participants | — |
| Number of participants in standing catheterization position | 6 Participants | — |
| Number of participants with neurogenic bladder dysfunction | 9 Participants | — |
| Number of participants with non-neurogenic bladder dysfunction | 5 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Denmark | 14 Participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 14 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 1 / 16 | 0 / 16 | 2 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 | 0 / 16 |
Outcome results
Primary
Residual Urine at 1st Flow-stop During Nurse Catheterization
The residual urine at 1st flow-stop during nurse catheterization (i.e., catheterization performed by the 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 Male | Residual Urine at 1st Flow-stop During Nurse Catheterization | 59.4 mL | Standard Deviation 99.6 |
| New Intermittent Catheter Variant 1 for Males | Residual Urine at 1st Flow-stop During Nurse Catheterization | 13.1 mL | Standard Deviation 26.7 |
| New Intermittent Catheter Variant 2 for Males | Residual Urine at 1st Flow-stop During Nurse Catheterization | 0.4 mL | Standard Deviation 1.66 |
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.07495% CI: [-4.5, 94.5]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.02295% CI: [8.5, 109.1]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.58795% CI: [-64.2, 36.6]Mixed Models Analysis
Primary
Residual Urine at 1st Flow-stop During Self-catheterization
The residual urine at 1st flow-stop during nurse catheterization (i.e., catheterization performed by the participant) 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 Male | Residual Urine at 1st Flow-stop During Self-catheterization | 61.8 mL | Standard Deviation 117.7 |
| New Intermittent Catheter Variant 1 for Males | Residual Urine at 1st Flow-stop During Self-catheterization | 5.7 mL | Standard Deviation 19.7 |
| New Intermittent Catheter Variant 2 for Males | Residual Urine at 1st Flow-stop During Self-catheterization | 0.0 mL | Standard Deviation 0 |
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.0395% CI: [5.3, 104.4]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.01595% CI: [12.5, 111.2]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.7895% CI: [-56.5, 42.5]Mixed Models Analysis
Secondary
Insertion Discomfort During Nurse Catheterization
Discomfort measured at catheter insertion (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 endpoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Catheter; SpeediCath® Standard Male | Insertion Discomfort During Nurse Catheterization | 0.59 cm | Standard Deviation 1.01 |
| New Intermittent Catheter Variant 1 for Males | Insertion Discomfort During Nurse Catheterization | 0.66 cm | Standard Deviation 1.16 |
| New Intermittent Catheter Variant 2 for Males | Insertion Discomfort During Nurse Catheterization | 1.20 cm | Standard Deviation 1.59 |
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.76695% CI: [-0.7, 0.52]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.03295% CI: [-1.3, -0.06]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.06395% CI: [-0.03, 1.21]Mixed Models Analysis
Secondary
Insertion Discomfort During Self-catheterization
Discomfort measured at catheter insertion (performed by participant), 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 Male | Insertion Discomfort During Self-catheterization | 0.24 cm | Standard Deviation 0.33 |
| New Intermittent Catheter Variant 1 for Males | Insertion Discomfort During Self-catheterization | 0.53 cm | Standard Deviation 0.73 |
| New Intermittent Catheter Variant 2 for Males | Insertion Discomfort During Self-catheterization | 0.73 cm | Standard Deviation 0.93 |
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.30995% CI: [-0.92, 0.3]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.10995% CI: [-1.1, 0.11]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.55595% CI: [-0.43, 0.79]Mixed Models Analysis
Secondary
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 endpoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Catheter; SpeediCath® Standard Male | Overall Discomfort During Nurse Catheterization | 0.66 cm | Standard Deviation 1.68 |
| New Intermittent Catheter Variant 1 for Males | Overall Discomfort During Nurse Catheterization | 0.79 cm | Standard Deviation 1.78 |
| New Intermittent Catheter Variant 2 for Males | Overall Discomfort During Nurse Catheterization | 0.72 cm | Standard Deviation 1.09 |
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.70195% CI: [-0.8, 0.54]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.43895% CI: [-0.96, 0.42]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.68995% CI: [-0.55, 0.83]Mixed Models Analysis
Secondary
Overall Discomfort During Self-catheterization
Discomfort measured for the entire catheterization procedure (performed by participant), 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 Male | Overall Discomfort During Self-catheterization | 0.16 cm | Standard Deviation 0.24 |
| New Intermittent Catheter Variant 1 for Males | Overall Discomfort During Self-catheterization | 0.38 cm | Standard Deviation 0.49 |
| New Intermittent Catheter Variant 2 for Males | Overall Discomfort During Self-catheterization | 0.72 cm | Standard Deviation 1.25 |
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.30695% CI: [-0.33, 1.02]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.52595% CI: [-0.89, 0.46]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.09895% CI: [-1.24, 0.11]Mixed Models Analysis
Secondary
Post-void Residual Urine After Nurse Catheterization
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 Male | Post-void Residual Urine After Nurse Catheterization | 24.6 mL | Standard Deviation 39.8 |
| New Intermittent Catheter Variant 1 for Males | Post-void Residual Urine After Nurse Catheterization | 36.4 mL | Standard Deviation 56.5 |
| New Intermittent Catheter Variant 2 for Males | Post-void Residual Urine After Nurse Catheterization | 12.7 mL | Standard Deviation 26.6 |
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.28195% CI: [-37.9, 11.2]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.59795% CI: [-18.3, 31.7]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.11695% CI: [-45.1, 5]Mixed Models Analysis
Secondary
Post-void Residual Urine After Self-catheterization
The volume of residual urine (urine left in the bladder) post catheterization (performed by the participant) 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 Male | Post-void Residual Urine After Self-catheterization | 33.9 mL | Standard Deviation 43.9 |
| New Intermittent Catheter Variant 1 for Males | Post-void Residual Urine After Self-catheterization | 29.0 mL | Standard Deviation 53.16 |
| New Intermittent Catheter Variant 2 for Males | Post-void Residual Urine After Self-catheterization | 27.0 mL | Standard Deviation 41.8 |
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.78795% CI: [-21.2, 27.9]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.57695% CI: [-17.6, 31.3]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.77595% CI: [-28.1, 21]Mixed Models Analysis
Secondary
Urination Discomfort During Nurse Catheterization
Discomfort measured during catheter urination/emptying (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 endpoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Catheter; SpeediCath® Standard Male | Urination Discomfort During Nurse Catheterization | 0.44 cm | Standard Deviation 1.22 |
| New Intermittent Catheter Variant 1 for Males | Urination Discomfort During Nurse Catheterization | 0.22 cm | Standard Deviation 0.33 |
| New Intermittent Catheter Variant 2 for Males | Urination Discomfort During Nurse Catheterization | 0.17 cm | Standard Deviation 0.24 |
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.21395% CI: [-0.12, 0.54]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.29195% CI: [-0.16, 0.51]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.86895% CI: [-0.31, 0.36]Mixed Models Analysis
Secondary
Urination Discomfort During Self-catheterization
Discomfort measured during catheter urination/emptying (performed by participant), 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 Male | Urination Discomfort During Self-catheterization | 0.17 cm | Standard Deviation 0.26 |
| New Intermittent Catheter Variant 1 for Males | Urination Discomfort During Self-catheterization | 0.18 cm | Standard Deviation 0.28 |
| New Intermittent Catheter Variant 2 for Males | Urination Discomfort During Self-catheterization | 0.34 cm | Standard Deviation 0.59 |
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.89695% CI: [-0.35, 0.31]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.3295% CI: [-0.49, 0.16]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.3995% CI: [-0.19, 0.47]Mixed Models Analysis
Secondary
Withdrawal Discomfort During Nurse Catheterization
Discomfort measured during catheter withdrawal (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 endpoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Catheter; SpeediCath® Standard Male | Withdrawal Discomfort During Nurse Catheterization | 0.41 cm | Standard Deviation 0.89 |
| New Intermittent Catheter Variant 1 for Males | Withdrawal Discomfort During Nurse Catheterization | 0.32 cm | Standard Deviation 0.44 |
| New Intermittent Catheter Variant 2 for Males | Withdrawal Discomfort During Nurse Catheterization | 0.59 cm | Standard Deviation 1.16 |
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.66195% CI: [-0.35, 0.55]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.21895% CI: [-0.75, 0.17]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.195% CI: [-0.08, 0.85]Mixed Models Analysis
Secondary
Withdrawal Discomfort During Self-catheterization
Discomfort measured during catheter withdrawal (performed by participant), 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 Male | Withdrawal Discomfort During Self-catheterization | 0.15 cm | Standard Deviation 0.24 |
| New Intermittent Catheter Variant 1 for Males | Withdrawal Discomfort During Self-catheterization | 0.21 cm | Standard Deviation 0.31 |
| New Intermittent Catheter Variant 2 for Males | Withdrawal Discomfort During Self-catheterization | 0.55 cm | Standard Deviation 1.14 |
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.80295% CI: [-0.51, 0.4]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.08295% CI: [-0.85, 0.05]Mixed Models Analysis
Comparison: Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.p-value: 0.13795% CI: [-0.11, 0.8]Mixed Models Analysis