| 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) | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | milliliters | | Tested at site visit after 14 days of device home use. | | | | ID | Title | Description |
|---|
| OG000 | Investigational Device - Newly Developed Intermittent Catheter | Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use. Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period. Investigational 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. | | OG001 | Comparator Device | The comparator device used was randomized evenly between SpeediCath Eve or SpeediCath Compact Plus Female (CH12 and CH14). Both comparators are CE marked Coloplast products and both are conventional-eyelet compact female catheters. The similarity of these products were the reason for their combination into one group. Comparator device #1 - SpeediCath Eve: Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The comparator device is for single use. Comparator device #2 - SpeediCath Compact Plus Female: Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The comparator device is for single use. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00023.22(4.65 to 41.80)
- OG00115.87(6.09 to 25.65)
|
|
| |
| 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) | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | Number of flow-stops | | Tested at site visit after 14 days of device home use. | | | | ID | Title | Description |
|---|
| OG000 | Investigational Device - Newly Developed Intermittent Catheter | Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use. Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period. Investigational 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. | | OG001 | Comparator Device (#1 OR #2) | |
|
| Secondary | Number of Flow-stops (Catheterisation Profile, Self-catheterisation) | Number of flow-stop episodes derived from a catheterisation profile (self-catheterisation) | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | Number of flow-stops | | Tested at site visit after 14 days of device home use. | | | | ID | Title | Description |
|---|
| OG000 | Investigational Device - Newly Developed Intermittent Catheter | Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use. Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period. Investigational 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. | | OG001 | Comparator Device (#1 OR #2) | The comparator device used was randomized evenly between SpeediCath Eve or SpeediCath Compact Plus Female (CH12 and CH14). Both comparators are CE marked Coloplast products and both are conventional-eyelet compact female catheters. The similarity of these products were the reason for their combination into one group. Comparator device #1 - SpeediCath Eve: Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The comparator device is for single use. Comparator device #2 - SpeediCath Compact Plus Female: Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The comparator device is for single use. |
|
| 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) | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | milliliters | | Tested at site visit after 14 days of device home use. | | | | ID | Title | Description |
|---|
| OG000 | Investigational Device - Newly Developed Intermittent Catheter | Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use. Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period. Investigational 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. | | OG001 | Comparator Device (#1 OR #2) | |
|
| Secondary | Average Residual Volume Post Catheterisation (Bladder Scan) | Average residual volume post catheterisation measured with the BladderScanner (triplicate measurements) | 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. | Posted | | Least Squares Mean | Standard Deviation | milliliters | | Tested at site visit after 14 days of device home use. | | | | ID | Title | Description |
|---|
| OG000 | Investigational Device - Newly Developed Intermittent Catheter | Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use. Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period. Investigational 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. | | OG001 | Comparator Device (#1 OR #2) | The comparator device used was randomized evenly between SpeediCath Eve or SpeediCath Compact Plus Female (CH12 and CH14). Both comparators are CE marked Coloplast products and both are conventional-eyelet compact female catheters. The similarity of these products were the reason for their combination into one group. Comparator device #1 - SpeediCath Eve: Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The comparator device is for single use. Comparator device #2 - SpeediCath Compact Plus Female: Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The comparator device is for single use. |
|
| Secondary | Number of Adverse Events | Number of Adverse events (number) | 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. | Posted | | Number | | Adverse events | | From Week 0-4 | | | | ID | Title | Description |
|---|
| OG000 | Investigational Device - Newly Developed Intermittent Catheter | Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use. Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period. Investigational 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. | | OG001 | Comparator Device (#1 OR #2) | The comparator device used was randomized evenly between SpeediCath Eve or SpeediCath Compact Plus Female (CH12 and CH14). Both comparators are CE marked Coloplast products and both are conventional-eyelet compact female catheters. The similarity of these products were the reason for their combination into one group. Comparator device #1 - SpeediCath Eve: Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The comparator device is for single use. Comparator device #2 - SpeediCath Compact Plus Female: Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The comparator device is for single use. |
|
| 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 | 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. | Posted | | Count of Participants | | Participants | | Tested at site visit after 14 days of device home use. | | | | ID | Title | Description |
|---|
| OG000 | Investigational Device - Newly Developed Intermittent Catheter | Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use. Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period. Investigational 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. | | OG001 | Comparator Device (#1 OR #2) |
|
| 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 | 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. | Posted | | Count of Participants | | Participants | | Tested at site visit after 14 days of device home use. | | | | ID | Title | Description |
|---|
| OG000 | Investigational Device - Newly Developed Intermittent Catheter | Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use. Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period. Investigational 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. | | OG001 | Comparator Device (#1 OR #2) |
|
| 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. | 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. | Posted | | Mean | 95% Confidence Interval | percentage of catheterisations | | Tested at site visit after 14 days of device home use. | | | | ID | Title | Description |
|---|
| OG000 | Investigational Device - Newly Developed Intermittent Catheter | Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use. Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period. Investigational 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. |
|
| 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. | 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. | Posted | | Mean | 95% Confidence Interval | percentage of catheterisations | | Tested at site visit after 14 days of device home use. | | | | ID | Title | Description |
|---|
| OG000 | Investigational Device - Newly Developed Intermittent Catheter | Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use. Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period. Investigational 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. |
|