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Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for females with a comparator catheter.
The CP324 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 female IC users.
For each participant, the study thus contained 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent catheter; SpeediCath® Standard female | Active Comparator | Participants underwent two catheterizations with standard of care intermittent catheter: The first was performed by a trained nurse, the second by the participant later the same day. |
|
| New intermittent catheter Variant 1 for females | Experimental | Participants underwent two catheterizations with the new intermittent catheter variant 1 for females: The first was performed by a trained nurse, the second by the participant later the same day. |
|
| New intermittent catheter Variant 2 for females | Experimental | Participants underwent two catheterizations with the new intermittent catheter variant 2 for females: The first was performed by a trained nurse, the second by the participant later the same day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpeediCath® Standard female | Device | Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard female. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after the procedure/catheterization, up to 5 min. |
| Residual Urine at 1st Flow-stop During Self-catheterization | The residual urine at 1st flow-stop during self-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. | Immediately after the procedure/catheterization, up to 5 min. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after the procedure/catheterization, up to 15 min. |
| Post-void Residual Urine After Self-catheterization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Bagi, MD | Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urologisk klinik, Afsnit 2112, Rigshospitalet | Copenhagen | 2100 | Denmark |
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The 15 recruited participant were randomized into the three treatment arms, using a randomization sequence of six. No participants were excluded or discontinued.
Two participants had an adverse event, both were classified as mild, non-serious and 'Possibly related' (for details; see Adverse Events section).
Thus, 15 participants constituted the intention to treat (ITT) population.
Between December 2020 and May 2021,15 users were recruited for the study from one site (Denmark) and encompassed the safety population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Comparator, Then Variant 2, Then Variant 1 | On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Comparator. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 1. |
| FG001 | Variant 2, Then Variant 1, Then Comparator | On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Third intervention: Day of catheterization with Comparator. |
| FG002 | Comparator, Then Variant 1, Then Variant 2 | On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Comparator. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 2. |
| FG003 | Variant 1, Then Comparator, Then Variant 2 | On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Second intervention: Day of catheterization with Comparator. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 2. |
| FG004 | Variant 1, Then Variant 2, Then Comparator | On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Third intervention: Day of catheterization with Comparator. |
| FG005 | Variant 2, Then Comparator, Then Variant 1 | On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Second intervention: Day of catheterization with Comparator. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Total ITT Population Baseline Measures | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | mL | Immediately after the procedure/catheterization, up to 5 min. |
|
Each participant was enrolled for 3 x 4-14 days for the entire investigation, thus a maximum of 42 days. The Adverse Event Time Frame reported include the Time Frame for which All Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored.
The relationship to the investigational or comparator products was collected. The safety population constituted the subjects who had given informed consent and were thus 15 participants.
An adverse event was reported as either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the comparator to the Variant 1 or Variant 2 products.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intermittent Catheter, Comparator; SpeediCath® Standard Female | Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suspected urinary tract infection (UTI) based on itching in the genital area | Reproductive system and breast disorders | Systematic Assessment | Suspected urinary tract infection (UTI) based on itching in the genital area |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Medical Affairs | Coloplast A/S | +454911 1111 | clinical-studies@coloplast.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 16, 2021 | Aug 15, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| New intermittent Variant 1 catheter for females | Device | Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 catheter. |
|
| New intermittent Variant 2 catheter for females | Device | Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 catheter. |
|
The volume of residual urine (urine left in the bladder) post catheterization (performed by the participant) measured in triplicates using an ultrasound scanner. |
| Immediately after the procedure/catheterization, up to 15 min. |
| 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. | Immediately after the procedure/catheterization, up to 5 min. |
| 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. | Immediately after the procedure/catheterization, up to 5 min. |
| 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. | Immediately after the procedure/catheterization, up to 5 min. |
| 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. | Immediately after the procedure/catheterization, up to 5 min. |
| 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. | Immediately after the procedure/catheterization, up to 5 min. |
| 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. | Immediately after the procedure/catheterization, up to 5 min. |
| 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. | Immediately after the procedure/catheterization, up to 5 min. |
| 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. | Immediately after the procedure/catheterization, up to 5 min. |
| Participants |
|
| Age, Continuous | Mean | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Number of participants with neurogenic bladder dysfunction | Count of Participants | Participants |
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| Number of participants with non-neurogenic bladder dysfunction | Count of Participants | Participants |
|
| Number of participants with in sitting catheterization position | Count of Participants | Participants |
|
| Number of participants with in standing catheterization position | Count of Participants | Participants |
|
| OG000 | Intermittent Catheter, Comparator; SpeediCath® Standard Female | Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants. |
| OG001 | New Intermittent Catheter Variant 1 for Females | Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants. |
| OG002 | New Intermittent Catheter Variant 2 for Females | Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants. |
|
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| Primary | Residual Urine at 1st Flow-stop During Self-catheterization | The residual urine at 1st flow-stop during self-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. | 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. | Posted | Mean | Standard Deviation | mL | Immediately after the procedure/catheterization, up to 5 min. |
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| 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. | 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. | Posted | Mean | Standard Deviation | mL | Immediately after the procedure/catheterization, up to 15 min. |
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| 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. | 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. | Posted | Mean | Standard Deviation | mL | Immediately after the procedure/catheterization, up to 15 min. |
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| 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. | 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. | Posted | Mean | Standard Deviation | cm, score on a scale | Immediately after the procedure/catheterization, up to 5 min. |
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| 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. | 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. | Posted | Mean | Standard Deviation | cm | Immediately after the procedure/catheterization, up to 5 min. |
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| 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. | 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. | Posted | Mean | Standard Deviation | cm | Immediately after the procedure/catheterization, up to 5 min. |
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| 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. | 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. | Posted | Mean | Standard Deviation | cm | Immediately after the procedure/catheterization, up to 5 min. |
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| 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. | 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. | Posted | Mean | Standard Deviation | cm | Immediately after the procedure/catheterization, up to 5 min. |
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| 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. | 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. | Posted | Mean | Standard Deviation | cm | Immediately after the procedure/catheterization, up to 5 min. |
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| 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. | 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. | Posted | Mean | Standard Deviation | cm | Immediately after the procedure/catheterization, up to 5 min. |
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| 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. | 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. | Posted | Mean | Standard Deviation | cm | Immediately after the procedure/catheterization, up to 5 min. |
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|
| 0 |
| 15 |
| 0 |
| 15 |
| 1 |
| 15 |
| EG001 | New Intermittent Catheter Variant 1 for Females | Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants. | 0 | 15 | 0 | 15 | 1 | 15 |
| EG002 | New Intermittent Catheter Variant 2 for Females | Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants. | 0 | 15 | 0 | 15 | 0 | 15 |
|
| Suspected urinary tract infection (UTI) based on odorous urine. | Renal and urinary disorders | Non-systematic Assessment | Suspected urinary tract infection (UTI) based on odorous urine. |
|
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects. | <0.001 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | 29.7 | 2-Sided | 95 | 13.5 | 46.0 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects. | 0.667 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | 3.5 | 2-Sided | 95 | -12.6 | 19.7 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects. | 0.916 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | 0.5 | 2-Sided | 95 | -10.1 | 11.2 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied | Mixed Models Analysis | Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects. | 0.438 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -4.1 | 2-Sided | 95 | -14.8 | 6.5 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects. | 0.118 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -8.5 | 2-Sided | 95 | -19.2 | 2.2 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects. | 0.104 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | 8.8 | 2-Sided | 95 | -1.8 | 19.5 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects. | 0.980 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.01 | 2-Sided | 95 | -0.41 | 0.40 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects. | 0.339 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | 0.20 | 2-Sided | 95 | -0.21 | 0.60 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects. | 0.227 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | 0.32 | 2-Sided | 95 | -0.20 | 0.84 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects. | 0.112 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.42 | 2-Sided | 95 | -0.94 | 0.10 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects. | 0.065 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | 0.73 | 2-Sided | 95 | -0.05 | 1.51 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects. | 0.497 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | 0.27 | 2-Sided | 95 | -0.51 | 1.04 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects. | 0.005 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | 0.60 | 2-Sided | 95 | 0.19 | 1.02 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects. | 0.532 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.13 | 2-Sided | 95 | -0.54 | 0.28 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects. | 0.120 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | 0.32 | 2-Sided | 95 | -0.09 | 0.73 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects. | 0.404 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.17 | 2-Sided | 95 | -0.58 | 0.24 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects. | 0.824 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | 0.06 | 2-Sided | 95 | -0.46 | 0.58 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects. | 0.626 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | 0.13 | 2-Sided | 95 | -0.39 | 0.65 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects. | 0.027 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | 0.88 | 2-Sided | 95 | 0.11 | 1.66 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects. | 0.956 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.02 | 2-Sided | 95 | -0.80 | 0.75 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects. | 0.063 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | 0.39 | 2-Sided | 95 | -0.02 | 0.81 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects. | 0.885 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.03 | 2-Sided | 95 | -0.44 | 0.38 | Superiority |