Urinary Incontinence
Conditions
Brief summary
A multi-centre, open-labelled, randomised, crossover design. The total study duration for the individual subject will be approximately 4 weeks, consisting of four site visits and two 2-week test periods at home. Visits 0 and 1 can be performed on the same day. For visit 2 and 3, 2 catheterisations will be performed in a hospital setting (one HCP catheterisation and one self-catheterisation) for bladder emptying and user experience assessments. Visit 1 and 2 are followed by a home-use test period, followed by visit 3 which terminates the study.
Interventions
DEVICEInvestigational device - newly developed intermittent catheter
Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The investigational device is for single use.
DEVICEComparator device #1 - SpeediCath Eve
During comparator study period, subjects will only receive one of the comparator products. Randomization will decide which one. Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The comparator device is for single use.
DEVICEComparator device #2 - SpeediCath Compact Plus Female
During comparator study period, subjects will only receive one of the comparator products. Randomization will decide which one. Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The comparator device is for single use.
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is Female * Is at least 18 years of age and has full legal capacity * Has signed an informed consent form * Has used clean intermittent self-catheterisation (CISC) (CH12 or CH14) for at least one month up to inclusion * Is using intermittent self-catheterisation for a minimum of 3 times per day for bladder emptying * Has used a compact catheter 50% of the time (or more) for the last two weeks prior to entering the study * Has the ability (assessed by investigator) and willingness to follow study procedures
Exclusion criteria
* Is participating in any other clinical study during this investigation * Has previously participated in this study * Has symptoms of urinary tract infection at time of inclusion, as judged by the investigator (if the patient recovers within the recruitment period, a second inclusion is allowed, under a different subject id) * Is an individual with a history of - suspected to be - or showing signs of producing an excessive amount of mucus or large/clustered sediments or debris * Has any known allergies towards ingredients in the investigational device * Is pregnant * Is breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP) | Tested at site visit after 14 days of device home use. | Residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile (catheterisation performed by a healthcare professional) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Flow-stops (Catheterisation Profile, Catheterisation Performed by HCP) | Tested at site visit after 14 days of device home use. | Number of flow-stop episodes derived from a catheterisation profile (catheterisation performed by a healthcare professional) |
| Number of Flow-stops (Catheterisation Profile, Self-catheterisation) | Tested at site visit after 14 days of device home use. | Number of flow-stop episodes derived from a catheterisation profile (self-catheterisation) |
| Residual Volume at 1st Flow-stop | Tested at site visit after 14 days of device home use. | Residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile (self-catheterisation) |
| Average Residual Volume Post Catheterisation (Bladder Scan) | Tested at site visit after 14 days of device home use. | Average residual volume post catheterisation measured with the BladderScanner (triplicate measurements) |
| Number of Adverse Events | From Week 0-4 | Number of Adverse events (number) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory: Perception Questionnaire, Handling | Tested at site visit after 14 days of device home use. | Perception questions evaluated on a 5-point scale assessed on V2 and V3 (perception questionnaire). Perception questionary based on perception of catheterisations in test period leading up to the visit |
| Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | Tested at site visit after 14 days of device home use. | Perception questions evaluated on a 5-point scale assessed on V2 and V3 (perception questionnaire). Perception questionary based on perception of catheterisations in test period leading up to the visit |
Countries
Denmark, France, United Kingdom
Participant flow
Pre-assignment details
Although 82 participants were enrolled, one was excluded to screening failure before randomization. Therefore, only 81 subjects are included in the groups.
Participants by arm
| Arm | Count |
|---|---|
| Total ITT Population Baseline Measures As this study was a crossover study, each participant underwent catheterizations with both the investigational device and the comparator device. The study consisted of three study visits (V1-V3) and two 2-week test periods at home (T1 and T2). Visit 1 included subject enrollment, and randomization. Randomization was done centralized, randomly assigning subjects to two intervention sequences. Hence, the first group used the investigational device during the first test period at home (T1) and at the first follow-up visit (V2). Subsequently, the comparator device was tested during the next test period at home (T2) followed by a visit 3 which also terminated the study. The second group tested the devices in reversed order. The total study duration was approximately 4 weeks for the individual subject | 81 |
| Total | 81 |
Baseline characteristics
| Characteristic | Total ITT Population Baseline Measures | — |
|---|---|---|
| Age, Continuous | 54.1 years STANDARD_DEVIATION 12.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Denmark | 55 participants | — |
| Region of Enrollment France | 12 participants | — |
| Region of Enrollment United Kingdom | 14 participants | — |
| Sex: Female, Male Female | 81 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 81 | 0 / 81 |
| other Total, other adverse events | 10 / 81 | 13 / 81 |
| serious Total, serious adverse events | 0 / 81 | 0 / 81 |
Outcome results
Primary
Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP)
Residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile (catheterisation performed by a healthcare professional)
Time frame: Tested at site visit after 14 days of device home use.
Population: The study protocol pre-specified that the comparator arm of the study would combine an equal split between two similar conventional-eyelet catheters, to achieve a comparator arm representing this class of devices as closely as possible. Subjects were randomized to receive either one of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female (CH12 and CH14). Both comparators are CE marked products produced by Coloplast.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Investigational Device - Newly Developed Intermittent Catheter | Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP) | 23.22 milliliters |
| Comparator Device | Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP) | 15.87 milliliters |
Secondary
Average Residual Volume Post Catheterisation (Bladder Scan)
Average residual volume post catheterisation measured with the BladderScanner (triplicate measurements)
Time frame: Tested at site visit after 14 days of device home use.
Population: The study protocol pre-specified that the comparator arm of the study would combine an equal split between two similar conventional-eyelet catheters, to achieve a comparator arm representing this class of devices as closely as possible. Subjects were randomized to receive either one of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female (CH12 and CH14). Both comparators are CE marked products produced by Coloplast.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Investigational Device - Newly Developed Intermittent Catheter | Average Residual Volume Post Catheterisation (Bladder Scan) | HCP-led catheterisation | 4.8 milliliters | Standard Deviation 16.4 |
| Investigational Device - Newly Developed Intermittent Catheter | Average Residual Volume Post Catheterisation (Bladder Scan) | Self-catheterisation | 7.7 milliliters | Standard Deviation 13.9 |
| Comparator Device | Average Residual Volume Post Catheterisation (Bladder Scan) | HCP-led catheterisation | 12.0 milliliters | Standard Deviation 40.4 |
| Comparator Device | Average Residual Volume Post Catheterisation (Bladder Scan) | Self-catheterisation | 9.3 milliliters | Standard Deviation 20.5 |
Secondary
Number of Adverse Events
Number of Adverse events (number)
Time frame: From Week 0-4
Population: The study protocol pre-specified that the comparator arm of the study would combine an equal split between two similar conventional-eyelet catheters, to achieve a comparator arm representing this class of devices as closely as possible. Subjects were randomized to receive either one of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female (CH12 and CH14). Both comparators are CE marked products produced by Coloplast.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Investigational Device - Newly Developed Intermittent Catheter | Number of Adverse Events | 10 Adverse events |
| Comparator Device | Number of Adverse Events | 13 Adverse events |
Secondary
Number of Flow-stops (Catheterisation Profile, Catheterisation Performed by HCP)
Number of flow-stop episodes derived from a catheterisation profile (catheterisation performed by a healthcare professional)
Time frame: Tested at site visit after 14 days of device home use.
Population: The study protocol pre-specified that the comparator arm of the study would combine an equal split between two similar conventional-eyelet catheters, to achieve a comparator arm representing this class of devices as closely as possible. Subjects were randomized to receive either one of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female (CH12 and CH14). Both comparators are CE marked products produced by Coloplast.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Investigational Device - Newly Developed Intermittent Catheter | Number of Flow-stops (Catheterisation Profile, Catheterisation Performed by HCP) | 0.21 Number of flow-stops |
| Comparator Device | Number of Flow-stops (Catheterisation Profile, Catheterisation Performed by HCP) | 0.57 Number of flow-stops |
Secondary
Number of Flow-stops (Catheterisation Profile, Self-catheterisation)
Number of flow-stop episodes derived from a catheterisation profile (self-catheterisation)
Time frame: Tested at site visit after 14 days of device home use.
Population: The study protocol pre-specified that the comparator arm of the study would combine an equal split between two similar conventional-eyelet catheters, to achieve a comparator arm representing this class of devices as closely as possible. Subjects were randomized to receive either one of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female (CH12 and CH14). Both comparators are CE marked products produced by Coloplast.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Investigational Device - Newly Developed Intermittent Catheter | Number of Flow-stops (Catheterisation Profile, Self-catheterisation) | 0.28 Number of flow-stops |
| Comparator Device | Number of Flow-stops (Catheterisation Profile, Self-catheterisation) | 0.71 Number of flow-stops |
Secondary
Residual Volume at 1st Flow-stop
Residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile (self-catheterisation)
Time frame: Tested at site visit after 14 days of device home use.
Population: The study protocol pre-specified that the comparator arm of the study would combine an equal split between two similar conventional-eyelet catheters, to achieve a comparator arm representing this class of devices as closely as possible. Subjects were randomized to receive either one of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female (CH12 and CH14). Both comparators are CE marked products produced by Coloplast.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Investigational Device - Newly Developed Intermittent Catheter | Residual Volume at 1st Flow-stop | 19.88 milliliters |
| Comparator Device | Residual Volume at 1st Flow-stop | 27.77 milliliters |
Other Pre-specified
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction
Perception questions evaluated on a 5-point scale assessed on V2 and V3 (perception questionnaire). Perception questionary based on perception of catheterisations in test period leading up to the visit
Time frame: Tested at site visit after 14 days of device home use.
Population: The study protocol pre-specified that the comparator arm of the study would combine an equal split between two similar conventional-eyelet catheters, to achieve a comparator arm representing this class of devices as closely as possible. Subjects were randomized to receive either one of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female (CH12 and CH14). Both comparators are CE marked products produced by Coloplast.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 14. It is gentle to insert the catheter | Disagree | 2 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 10. I feel the catheter has a sufficient length to empty my bladder completely | Not applicable (lack of sensation) | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 14. It is gentle to insert the catheter | Don't know | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 8. The catheter is hygienic to use | Strongly disagree | 4 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 14. It is gentle to insert the catheter | Neither disagree nor agree | 1 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 10. I feel the catheter has a sufficient length to empty my bladder completely | Strongly agree | 48 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 14. It is gentle to insert the catheter | Not applicable (lack of sensation) | 3 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 8. The catheter is hygienic to use | Agree | 20 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 14. It is gentle to insert the catheter | Strongly agree | 51 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 10. I feel the catheter has a sufficient length to empty my bladder completely | Strongly disagree | 2 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 14. It is gentle to insert the catheter | Strongly disagree | 2 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 9. It is fast to empty my bladder completely using this catheter | Agree | 22 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 15. It is gentle to empty the bladder | Agree | 16 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 11. I feel confident the catheter empties my bladder completely | Agree | 24 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 15. It is gentle to empty the bladder | Disagree | 1 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 7. The catheter is discreet | Not applicable (lack of sensation) | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 15. It is gentle to empty the bladder | Don't know | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 11. I feel confident the catheter empties my bladder completely | Disagree | 6 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 15. It is gentle to empty the bladder | Neither disagree nor agree | 3 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 9. It is fast to empty my bladder completely using this catheter | Disagree | 5 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 15. It is gentle to empty the bladder | Not applicable (lack of sensation) | 3 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 11. I feel confident the catheter empties my bladder completely | Don't know | 1 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 15. It is gentle to empty the bladder | Strongly agree | 55 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 8. The catheter is hygienic to use | Disagree | 2 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 15. It is gentle to empty the bladder | Strongly disagree | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 11. I feel confident the catheter empties my bladder completely | Neither disagree nor agree | 4 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 16. It is gentle to withdraw the catheter | Agree | 18 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 9. It is fast to empty my bladder completely using this catheter | Don't know | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 16. It is gentle to withdraw the catheter | Disagree | 3 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 11. I feel confident the catheter empties my bladder completely | Not applicable (lack of sensation) | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 16. It is gentle to withdraw the catheter | Don't know | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 7. The catheter is discreet | Disagree | 1 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 16. It is gentle to withdraw the catheter | Neither disagree nor agree | 1 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 11. I feel confident the catheter empties my bladder completely | Strongly agree | 43 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 16. It is gentle to withdraw the catheter | Not applicable (lack of sensation) | 2 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 9. It is fast to empty my bladder completely using this catheter | Neither disagree nor agree | 15 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 16. It is gentle to withdraw the catheter | Strongly agree | 54 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 11. I feel confident the catheter empties my bladder completely | Strongly disagree | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 16. It is gentle to withdraw the catheter | Strongly disagree | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 8. The catheter is hygienic to use | Don't know | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 17. I feel pinching/stinging during catheterization using this catheter | Agree | 3 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 12. I don't worry about urine left in my bladder using this catheter | Agree | 15 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 17. I feel pinching/stinging during catheterization using this catheter | Disagree | 27 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 9. It is fast to empty my bladder completely using this catheter | Not applicable (lack of sensation) | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 17. I feel pinching/stinging during catheterization using this catheter | Don't know | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 12. I don't worry about urine left in my bladder using this catheter | Disagree | 5 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 17. I feel pinching/stinging during catheterization using this catheter | Neither disagree nor agree | 2 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 12. I don't worry about urine left in my bladder using this catheter | Don't know | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 17. I feel pinching/stinging during catheterization using this catheter | Not applicable (lack of sensation) | 3 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 7. The catheter is discreet | Strongly agree | 50 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 17. I feel pinching/stinging during catheterization using this catheter | Strongly agree | 1 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 12. I don't worry about urine left in my bladder using this catheter | Neither disagree nor agree | 9 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 17. I feel pinching/stinging during catheterization using this catheter | Strongly disagree | 42 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 9. It is fast to empty my bladder completely using this catheter | Strongly agree | 34 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 18. I am satisfied with the catheter | Agree | 22 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 12. I don't worry about urine left in my bladder using this catheter | Not applicable (lack of sensation) | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 18. I am satisfied with the catheter | Disagree | 7 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 8. The catheter is hygienic to use | Neither disagree nor agree | 2 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 18. I am satisfied with the catheter | Don't know | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 12. I don't worry about urine left in my bladder using this catheter | Strongly agree | 47 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 18. I am satisfied with the catheter | Neither disagree nor agree | 6 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 9. It is fast to empty my bladder completely using this catheter | Strongly disagree | 2 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 18. I am satisfied with the catheter | Not applicable (lack of sensation) | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 12. I don't worry about urine left in my bladder using this catheter | Strongly disagree | 2 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 18. I am satisfied with the catheter | Strongly agree | 41 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 7. The catheter is discreet | Neither disagree nor agree | 7 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 18. I am satisfied with the catheter | Strongly disagree | 2 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 13. I feel confident using the catheter | Agree | 13 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 19. I would like to use the catheter in the future | Agree | 15 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 10. I feel the catheter has a sufficient length to empty my bladder completely | Agree | 16 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 19. I would like to use the catheter in the future | Disagree | 10 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 13. I feel confident using the catheter | Disagree | 4 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 19. I would like to use the catheter in the future | Don't know | 1 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 8. The catheter is hygienic to use | Not applicable (lack of sensation) | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 19. I would like to use the catheter in the future | Neither disagree nor agree | 8 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 13. I feel confident using the catheter | Don't know | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 19. I would like to use the catheter in the future | Not applicable (lack of sensation) | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 10. I feel the catheter has a sufficient length to empty my bladder completely | Disagree | 6 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 19. I would like to use the catheter in the future | Strongly agree | 39 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 13. I feel confident using the catheter | Neither disagree nor agree | 3 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 19. I would like to use the catheter in the future | Strongly disagree | 5 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 7. The catheter is discreet | Strongly disagree | 1 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 20. I would recommend the catheter to others | Agree | 16 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 13. I feel confident using the catheter | Not applicable (lack of sensation) | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 20. I would recommend the catheter to others | Don't know | 3 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 10. I feel the catheter has a sufficient length to empty my bladder completely | Don't know | 1 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 20. I would recommend the catheter to others | Neither disagree nor agree | 13 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 13. I feel confident using the catheter | Strongly agree | 57 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 20. I would recommend the catheter to others | Not applicable (lack of sensation) | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 8. The catheter is hygienic to use | Strongly agree | 50 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 20. I would recommend the catheter to others | Strongly agree | 41 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 13. I feel confident using the catheter | Strongly disagree | 1 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 10. I feel the catheter has a sufficient length to empty my bladder completely | Neither disagree nor agree | 5 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 7. The catheter is discreet | Agree | 19 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 14. It is gentle to insert the catheter | Agree | 19 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 7. The catheter is discreet | Don't know | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 20. I would recommend the catheter to others | Disagree | 3 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 20. I would recommend the catheter to others | Strongly disagree | 2 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 19. I would like to use the catheter in the future | Don't know | 1 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 7. The catheter is discreet | Disagree | 10 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 7. The catheter is discreet | Don't know | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 7. The catheter is discreet | Neither disagree nor agree | 8 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 7. The catheter is discreet | Not applicable (lack of sensation) | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 7. The catheter is discreet | Strongly agree | 34 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 7. The catheter is discreet | Strongly disagree | 4 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 8. The catheter is hygienic to use | Agree | 18 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 8. The catheter is hygienic to use | Disagree | 9 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 8. The catheter is hygienic to use | Don't know | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 8. The catheter is hygienic to use | Neither disagree nor agree | 9 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 8. The catheter is hygienic to use | Not applicable (lack of sensation) | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 8. The catheter is hygienic to use | Strongly agree | 40 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 8. The catheter is hygienic to use | Strongly disagree | 1 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 9. It is fast to empty my bladder completely using this catheter | Agree | 30 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 9. It is fast to empty my bladder completely using this catheter | Disagree | 6 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 9. It is fast to empty my bladder completely using this catheter | Don't know | 1 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 9. It is fast to empty my bladder completely using this catheter | Neither disagree nor agree | 18 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 9. It is fast to empty my bladder completely using this catheter | Not applicable (lack of sensation) | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 9. It is fast to empty my bladder completely using this catheter | Strongly agree | 17 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 9. It is fast to empty my bladder completely using this catheter | Strongly disagree | 5 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 10. I feel the catheter has a sufficient length to empty my bladder completely | Agree | 35 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 10. I feel the catheter has a sufficient length to empty my bladder completely | Disagree | 3 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 10. I feel the catheter has a sufficient length to empty my bladder completely | Don't know | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 10. I feel the catheter has a sufficient length to empty my bladder completely | Neither disagree nor agree | 10 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 10. I feel the catheter has a sufficient length to empty my bladder completely | Not applicable (lack of sensation) | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 10. I feel the catheter has a sufficient length to empty my bladder completely | Strongly agree | 27 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 10. I feel the catheter has a sufficient length to empty my bladder completely | Strongly disagree | 2 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 11. I feel confident the catheter empties my bladder completely | Agree | 29 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 11. I feel confident the catheter empties my bladder completely | Disagree | 11 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 11. I feel confident the catheter empties my bladder completely | Don't know | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 11. I feel confident the catheter empties my bladder completely | Neither disagree nor agree | 12 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 11. I feel confident the catheter empties my bladder completely | Not applicable (lack of sensation) | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 11. I feel confident the catheter empties my bladder completely | Strongly agree | 22 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 11. I feel confident the catheter empties my bladder completely | Strongly disagree | 3 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 12. I don't worry about urine left in my bladder using this catheter | Agree | 30 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 12. I don't worry about urine left in my bladder using this catheter | Don't know | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 12. I don't worry about urine left in my bladder using this catheter | Neither disagree nor agree | 8 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 12. I don't worry about urine left in my bladder using this catheter | Not applicable (lack of sensation) | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 12. I don't worry about urine left in my bladder using this catheter | Strongly agree | 24 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 12. I don't worry about urine left in my bladder using this catheter | Strongly disagree | 4 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 13. I feel confident using the catheter | Agree | 26 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 13. I feel confident using the catheter | Disagree | 5 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 13. I feel confident using the catheter | Don't know | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 13. I feel confident using the catheter | Neither disagree nor agree | 7 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 13. I feel confident using the catheter | Not applicable (lack of sensation) | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 13. I feel confident using the catheter | Strongly agree | 35 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 13. I feel confident using the catheter | Strongly disagree | 4 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 14. It is gentle to insert the catheter | Agree | 32 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 14. It is gentle to insert the catheter | Disagree | 5 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 14. It is gentle to insert the catheter | Don't know | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 14. It is gentle to insert the catheter | Neither disagree nor agree | 3 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 14. It is gentle to insert the catheter | Not applicable (lack of sensation) | 3 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 14. It is gentle to insert the catheter | Strongly agree | 29 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 14. It is gentle to insert the catheter | Strongly disagree | 5 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 15. It is gentle to empty the bladder | Agree | 30 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 15. It is gentle to empty the bladder | Disagree | 6 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 15. It is gentle to empty the bladder | Don't know | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 15. It is gentle to empty the bladder | Neither disagree nor agree | 3 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 15. It is gentle to empty the bladder | Not applicable (lack of sensation) | 2 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 15. It is gentle to empty the bladder | Strongly agree | 32 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 15. It is gentle to empty the bladder | Strongly disagree | 4 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 16. It is gentle to withdraw the catheter | Agree | 28 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 16. It is gentle to withdraw the catheter | Disagree | 7 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 16. It is gentle to withdraw the catheter | Don't know | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 16. It is gentle to withdraw the catheter | Neither disagree nor agree | 5 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 16. It is gentle to withdraw the catheter | Not applicable (lack of sensation) | 4 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 16. It is gentle to withdraw the catheter | Strongly agree | 26 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 16. It is gentle to withdraw the catheter | Strongly disagree | 7 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 17. I feel pinching/stinging during catheterization using this catheter | Agree | 11 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 17. I feel pinching/stinging during catheterization using this catheter | Disagree | 24 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 17. I feel pinching/stinging during catheterization using this catheter | Don't know | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 17. I feel pinching/stinging during catheterization using this catheter | Neither disagree nor agree | 5 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 17. I feel pinching/stinging during catheterization using this catheter | Not applicable (lack of sensation) | 4 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 17. I feel pinching/stinging during catheterization using this catheter | Strongly agree | 7 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 17. I feel pinching/stinging during catheterization using this catheter | Strongly disagree | 26 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 18. I am satisfied with the catheter | Agree | 30 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 18. I am satisfied with the catheter | Disagree | 13 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 18. I am satisfied with the catheter | Don't know | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 18. I am satisfied with the catheter | Neither disagree nor agree | 9 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 18. I am satisfied with the catheter | Not applicable (lack of sensation) | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 18. I am satisfied with the catheter | Strongly agree | 16 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 18. I am satisfied with the catheter | Strongly disagree | 9 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 19. I would like to use the catheter in the future | Agree | 22 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 19. I would like to use the catheter in the future | Disagree | 12 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 7. The catheter is discreet | Agree | 21 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 19. I would like to use the catheter in the future | Neither disagree nor agree | 13 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 19. I would like to use the catheter in the future | Not applicable (lack of sensation) | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 19. I would like to use the catheter in the future | Strongly agree | 11 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 19. I would like to use the catheter in the future | Strongly disagree | 18 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 20. I would recommend the catheter to others | Disagree | 11 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 20. I would recommend the catheter to others | Don't know | 1 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 20. I would recommend the catheter to others | Neither disagree nor agree | 16 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 20. I would recommend the catheter to others | Not applicable (lack of sensation) | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 20. I would recommend the catheter to others | Strongly agree | 12 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 20. I would recommend the catheter to others | Strongly disagree | 13 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 12. I don't worry about urine left in my bladder using this catheter | Disagree | 11 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction | 20. I would recommend the catheter to others | Agree | 24 Participants |
Other Pre-specified
Exploratory: Perception Questionnaire, Handling
Perception questions evaluated on a 5-point scale assessed on V2 and V3 (perception questionnaire). Perception questionary based on perception of catheterisations in test period leading up to the visit
Time frame: Tested at site visit after 14 days of device home use.
Population: The study protocol pre-specified that the comparator arm of the study would combine an equal split between two similar conventional-eyelet catheters, to achieve a comparator arm representing this class of devices as closely as possible. Subjects were randomized to receive either one of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female (CH12 and CH14). Both comparators are CE marked products produced by Coloplast.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 6. How is it to re-close the catheter? | Very easy | 27 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 4. How is it to empty the bladder? | Neither Difficult nor Easy | 5 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 6. How is it to re-close the catheter? | Don't know | 3 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 5. How is it to handle the catheter during insertion? | Don't know | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 5. How is it to handle the catheter during insertion? | Easy | 24 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 4. How is it to empty the bladder? | Difficult | 3 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 1. How is it to use the catheter? | Difficult | 3 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 5. How is it to handle the catheter during insertion? | Neither Difficult nor Easy | 5 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 1. How is it to use the catheter? | Easy | 17 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 4. How is it to empty the bladder? | Very difficult | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 1. How is it to use the catheter? | Neither Difficult nor Easy | 1 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 5. How is it to handle the catheter during insertion? | Very difficult | 1 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 1. How is it to use the catheter? | Very difficult | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 3. How is it to insert the catheter? | Don't know | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 1. How is it to use the catheter? | Very easy | 57 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 5. How is it to handle the catheter during insertion? | Very easy | 45 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 1. How is it to use the catheter? | Don't know | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 4. How is it to empty the bladder? | Very easy | 51 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 2. How is it to open the catheter? | Difficult | 2 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 6. How is it to re-close the catheter? | Difficult | 6 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 2. How is it to open the catheter? | Easy | 23 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 4. How is it to empty the bladder? | Easy | 19 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 2. How is it to open the catheter? | Neither Difficult nor Easy | 7 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 6. How is it to re-close the catheter? | Easy | 34 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 2. How is it to open the catheter? | Very difficult | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 4. How is it to empty the bladder? | Don't know | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 2. How is it to open the catheter? | Very easy | 46 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 6. How is it to re-close the catheter? | Neither Difficult nor Easy | 6 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 2. How is it to open the catheter? | Don't know | 0 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 3. How is it to insert the catheter? | Very easy | 52 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 3. How is it to insert the catheter? | Difficult | 2 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 6. How is it to re-close the catheter? | Very difficult | 2 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 3. How is it to insert the catheter? | Easy | 18 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 5. How is it to handle the catheter during insertion? | Difficult | 3 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 3. How is it to insert the catheter? | Neither Difficult nor Easy | 5 Participants |
| Investigational Device - Newly Developed Intermittent Catheter | Exploratory: Perception Questionnaire, Handling | 3. How is it to insert the catheter? | Very difficult | 1 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 3. How is it to insert the catheter? | Neither Difficult nor Easy | 7 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 3. How is it to insert the catheter? | Very difficult | 1 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 3. How is it to insert the catheter? | Very easy | 33 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 3. How is it to insert the catheter? | Don't know | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 4. How is it to empty the bladder? | Difficult | 2 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 4. How is it to empty the bladder? | Easy | 35 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 4. How is it to empty the bladder? | Neither Difficult nor Easy | 10 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 4. How is it to empty the bladder? | Very difficult | 2 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 4. How is it to empty the bladder? | Very easy | 28 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 4. How is it to empty the bladder? | Don't know | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 5. How is it to handle the catheter during insertion? | Difficult | 8 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 5. How is it to handle the catheter during insertion? | Easy | 22 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 5. How is it to handle the catheter during insertion? | Neither Difficult nor Easy | 15 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 5. How is it to handle the catheter during insertion? | Very difficult | 1 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 5. How is it to handle the catheter during insertion? | Very easy | 31 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 6. How is it to re-close the catheter? | Difficult | 15 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 6. How is it to re-close the catheter? | Easy | 16 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 6. How is it to re-close the catheter? | Neither Difficult nor Easy | 9 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 6. How is it to re-close the catheter? | Very difficult | 10 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 6. How is it to re-close the catheter? | Very easy | 25 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 5. How is it to handle the catheter during insertion? | Don't know | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 6. How is it to re-close the catheter? | Don't know | 2 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 1. How is it to use the catheter? | Difficult | 11 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 1. How is it to use the catheter? | Easy | 21 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 1. How is it to use the catheter? | Neither Difficult nor Easy | 7 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 1. How is it to use the catheter? | Very difficult | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 1. How is it to use the catheter? | Very easy | 38 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 1. How is it to use the catheter? | Don't know | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 2. How is it to open the catheter? | Difficult | 15 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 2. How is it to open the catheter? | Easy | 26 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 2. How is it to open the catheter? | Neither Difficult nor Easy | 8 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 2. How is it to open the catheter? | Very difficult | 3 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 2. How is it to open the catheter? | Very easy | 25 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 2. How is it to open the catheter? | Don't know | 0 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 3. How is it to insert the catheter? | Difficult | 7 Participants |
| Comparator Device | Exploratory: Perception Questionnaire, Handling | 3. How is it to insert the catheter? | Easy | 29 Participants |
Post Hoc
Response to Treatment, 0 Flow-stops
Responder analysis involved testing the proportion of all catheterisations which did not experience any flow-stops. In this clinical investigation, responder analyses were introduced as an expansion of the data analyses due to the few extreme RV1 values, which presented a challenge to the predetermined statistical model. (see 'limitations and caveats' section for further details). Responder analyses evaluated the proportion of patients who achieved the positive treatment response threshold, highlighting individual patient responses rather than average effects across the entire population. Successful treatment responses were defined as individuals who achieved the desired outcome of catheterisation, i.e., complete and effective bladder emptying without repositioning, in terms flow-stops defined as zero flow-stops and in terms of complete emptying of the bladder was defined as an RV1\<10 mL.
Time frame: Tested at site visit after 14 days of device home use.
Population: The study protocol pre-specified that the comparator arm of the study would combine an equal split between two similar conventional-eyelet catheters, to achieve a comparator arm representing this class of devices as closely as possible. Subjects were randomized to receive either one of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female (CH12 and CH14). Both comparators are CE marked products produced by Coloplast.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Investigational Device - Newly Developed Intermittent Catheter | Response to Treatment, 0 Flow-stops | 87 percentage of catheterisations |
| Comparator Device | Response to Treatment, 0 Flow-stops | 57 percentage of catheterisations |
Post Hoc
Response to Treatment, Residual Volume of Urine at First Flow-stop Under 10 Milliliter
Responder analysis involved testing the proportion of all catheterisations which achieved a residual volume of urine at first flow-stop of less than 10 milliliter In this clinical investigation, responder analyses were introduced as an expansion of the data analyses due to the few extreme RV1 values, which presented a challenge to the predetermined statistical model. (see 'limitations and caveats' section for further details). Responder analyses evaluated the proportion of patients who achieved the positive treatment response threshold, highlighting individual patient responses rather than average effects across the entire population. Successful treatment responses were defined as individuals who achieved the desired outcome of catheterisation, i.e., complete and effective bladder emptying without repositioning, in terms flow-stops defined as zero flow-stops and in terms of complete emptying of the bladder was defined as an RV1\<10 mL.
Time frame: Tested at site visit after 14 days of device home use.
Population: The study protocol pre-specified that the comparator arm of the study would combine an equal split between two similar conventional-eyelet catheters, to achieve a comparator arm representing this class of devices as closely as possible. Subjects were randomized to receive either one of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female (CH12 and CH14). Both comparators are CE marked products produced by Coloplast.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Investigational Device - Newly Developed Intermittent Catheter | Response to Treatment, Residual Volume of Urine at First Flow-stop Under 10 Milliliter | 83 percentage of catheterisations |
| Comparator Device | Response to Treatment, Residual Volume of Urine at First Flow-stop Under 10 Milliliter | 71 percentage of catheterisations |