Trial Outcomes & Findings for Clinical Trial of New Intermittent Single-use Catheter (NCT NCT05814211)

Last Updated: 2025-02-20

Results Overview

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)

Recruitment status

COMPLETED

Study phase

Target enrollment

82 participants

Primary outcome timeframe

Tested at site visit after 14 days of device home use.

Results posted on

2025-02-20

Participant Flow

Although 82 participants were enrolled, one was excluded to screening failure before randomization. Therefore, only 81 subjects are included in the groups.

Participant milestones

Participant milestones
Measure	Investigational Device First Then Comparator Device 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. Comparator: The study protocol pre-specified that the comparator group 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. 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. Details on the comparator devices are as follows: 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.	Comparator Device First Then Investigational Device Comparator: The study protocol pre-specified that the comparator group 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. 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. Details on the comparator devices are as follows: 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. 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.
First Intervention (14 Days) STARTED	40	41
First Intervention (14 Days) Comparator #1	20	20
First Intervention (14 Days) Comparator #2	20	21
First Intervention (14 Days) COMPLETED	39	40
First Intervention (14 Days) NOT COMPLETED	1	1
Second Intervention (14 Days) STARTED	39	40
Second Intervention (14 Days) Comparator #1	19	19
Second Intervention (14 Days) Comparator #2	20	21
Second Intervention (14 Days) COMPLETED	37	39
Second Intervention (14 Days) NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total ITT Population Baseline Measures n=81 Participants 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
Age, Continuous	54.1 years STANDARD_DEVIATION 12.6 • n=81 Participants
Sex: Female, Male Female	81 Participants n=81 Participants
Sex: Female, Male Male	0 Participants n=81 Participants
Region of Enrollment Denmark	55 participants n=81 Participants
Region of Enrollment United Kingdom	14 participants n=81 Participants
Region of Enrollment France	12 participants n=81 Participants

PRIMARY outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	Investigational Device - Newly Developed Intermittent Catheter n=79 Participants 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.	Comparator Device n=79 Participants 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.
Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP)	23.22 milliliters Interval 4.65 to 41.8	15.87 milliliters Interval 6.09 to 25.65

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Investigational Device - Newly Developed Intermittent Catheter n=79 Participants 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.	Comparator Device n=79 Participants 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.
Number of Flow-stops (Catheterisation Profile, Catheterisation Performed by HCP)	0.21 Number of flow-stops Interval 0.1 to 0.44	0.57 Number of flow-stops Interval 0.39 to 0.82

SECONDARY outcome

Timeframe: Tested at site visit after 14 days of device home use.

Number of flow-stop episodes derived from a catheterisation profile (self-catheterisation)

Outcome measures

Outcome measures
Measure	Investigational Device - Newly Developed Intermittent Catheter n=79 Participants 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.	Comparator Device n=79 Participants 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.
Number of Flow-stops (Catheterisation Profile, Self-catheterisation)	0.28 Number of flow-stops Interval 0.12 to 0.63	0.71 Number of flow-stops Interval 0.52 to 0.95

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Investigational Device - Newly Developed Intermittent Catheter n=79 Participants 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.	Comparator Device n=79 Participants 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.
Residual Volume at 1st Flow-stop	19.88 milliliters Interval 5.73 to 34.04	27.77 milliliters Interval 12.14 to 43.4

SECONDARY outcome

Timeframe: Tested at site visit after 14 days of device home use.

Average residual volume post catheterisation measured with the BladderScanner (triplicate measurements)

Outcome measures

Outcome measures
Measure	Investigational Device - Newly Developed Intermittent Catheter n=79 Participants 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.	Comparator Device n=79 Participants 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.
Average Residual Volume Post Catheterisation (Bladder Scan) HCP-led catheterisation	4.8 milliliters Standard Deviation 16.4	12.0 milliliters Standard Deviation 40.4
Average Residual Volume Post Catheterisation (Bladder Scan) Self-catheterisation	7.7 milliliters Standard Deviation 13.9	9.3 milliliters Standard Deviation 20.5

SECONDARY outcome

Timeframe: From Week 0-4

Number of Adverse events (number)

Outcome measures

Outcome measures
Measure	Investigational Device - Newly Developed Intermittent Catheter n=81 Participants 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.	Comparator Device n=81 Participants 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.
Number of Adverse Events	10 Adverse events	13 Adverse events

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Investigational Device - Newly Developed Intermittent Catheter n=78 Participants 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.	Comparator Device n=77 Participants 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.
Exploratory: Perception Questionnaire, Handling 2. How is it to open the catheter? · Easy	23 Participants	26 Participants
Exploratory: Perception Questionnaire, Handling 2. How is it to open the catheter? · Neither Difficult nor Easy	7 Participants	8 Participants
Exploratory: Perception Questionnaire, Handling 2. How is it to open the catheter? · Very difficult	0 Participants	3 Participants
Exploratory: Perception Questionnaire, Handling 2. How is it to open the catheter? · Very easy	46 Participants	25 Participants
Exploratory: Perception Questionnaire, Handling 2. How is it to open the catheter? · Don't know	0 Participants	0 Participants
Exploratory: Perception Questionnaire, Handling 3. How is it to insert the catheter? · Difficult	2 Participants	7 Participants
Exploratory: Perception Questionnaire, Handling 3. How is it to insert the catheter? · Easy	18 Participants	29 Participants
Exploratory: Perception Questionnaire, Handling 3. How is it to insert the catheter? · Neither Difficult nor Easy	5 Participants	7 Participants
Exploratory: Perception Questionnaire, Handling 3. How is it to insert the catheter? · Very difficult	1 Participants	1 Participants
Exploratory: Perception Questionnaire, Handling 3. How is it to insert the catheter? · Very easy	52 Participants	33 Participants
Exploratory: Perception Questionnaire, Handling 3. How is it to insert the catheter? · Don't know	0 Participants	0 Participants
Exploratory: Perception Questionnaire, Handling 4. How is it to empty the bladder? · Difficult	3 Participants	2 Participants
Exploratory: Perception Questionnaire, Handling 4. How is it to empty the bladder? · Easy	19 Participants	35 Participants
Exploratory: Perception Questionnaire, Handling 4. How is it to empty the bladder? · Neither Difficult nor Easy	5 Participants	10 Participants
Exploratory: Perception Questionnaire, Handling 4. How is it to empty the bladder? · Very difficult	0 Participants	2 Participants
Exploratory: Perception Questionnaire, Handling 4. How is it to empty the bladder? · Very easy	51 Participants	28 Participants
Exploratory: Perception Questionnaire, Handling 4. How is it to empty the bladder? · Don't know	0 Participants	0 Participants
Exploratory: Perception Questionnaire, Handling 5. How is it to handle the catheter during insertion? · Difficult	3 Participants	8 Participants
Exploratory: Perception Questionnaire, Handling 5. How is it to handle the catheter during insertion? · Easy	24 Participants	22 Participants
Exploratory: Perception Questionnaire, Handling 5. How is it to handle the catheter during insertion? · Neither Difficult nor Easy	5 Participants	15 Participants
Exploratory: Perception Questionnaire, Handling 5. How is it to handle the catheter during insertion? · Very difficult	1 Participants	1 Participants
Exploratory: Perception Questionnaire, Handling 5. How is it to handle the catheter during insertion? · Very easy	45 Participants	31 Participants
Exploratory: Perception Questionnaire, Handling 5. How is it to handle the catheter during insertion? · Don't know	0 Participants	0 Participants
Exploratory: Perception Questionnaire, Handling 6. How is it to re-close the catheter? · Difficult	6 Participants	15 Participants
Exploratory: Perception Questionnaire, Handling 6. How is it to re-close the catheter? · Easy	34 Participants	16 Participants
Exploratory: Perception Questionnaire, Handling 6. How is it to re-close the catheter? · Neither Difficult nor Easy	6 Participants	9 Participants
Exploratory: Perception Questionnaire, Handling 6. How is it to re-close the catheter? · Very difficult	2 Participants	10 Participants
Exploratory: Perception Questionnaire, Handling 6. How is it to re-close the catheter? · Very easy	27 Participants	25 Participants
Exploratory: Perception Questionnaire, Handling 6. How is it to re-close the catheter? · Don't know	3 Participants	2 Participants
Exploratory: Perception Questionnaire, Handling 1. How is it to use the catheter? · Difficult	3 Participants	11 Participants
Exploratory: Perception Questionnaire, Handling 1. How is it to use the catheter? · Easy	17 Participants	21 Participants
Exploratory: Perception Questionnaire, Handling 1. How is it to use the catheter? · Neither Difficult nor Easy	1 Participants	7 Participants
Exploratory: Perception Questionnaire, Handling 1. How is it to use the catheter? · Very difficult	0 Participants	0 Participants
Exploratory: Perception Questionnaire, Handling 1. How is it to use the catheter? · Very easy	57 Participants	38 Participants
Exploratory: Perception Questionnaire, Handling 1. How is it to use the catheter? · Don't know	0 Participants	0 Participants
Exploratory: Perception Questionnaire, Handling 2. How is it to open the catheter? · Difficult	2 Participants	15 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Tested at site visit after 14 days of device home use.

Outcome measures

Outcome measures
Measure	Investigational Device - Newly Developed Intermittent Catheter n=78 Participants 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.	Comparator Device n=77 Participants 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.
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 19. I would like to use the catheter in the future · Strongly agree	39 Participants	11 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 19. I would like to use the catheter in the future · Strongly disagree	5 Participants	18 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 20. I would recommend the catheter to others · Agree	16 Participants	24 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 20. I would recommend the catheter to others · Disagree	3 Participants	11 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 20. I would recommend the catheter to others · Don't know	3 Participants	1 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 20. I would recommend the catheter to others · Neither disagree nor agree	13 Participants	16 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 20. I would recommend the catheter to others · Not applicable (lack of sensation)	0 Participants	0 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 20. I would recommend the catheter to others · Strongly agree	41 Participants	12 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 20. I would recommend the catheter to others · Strongly disagree	2 Participants	13 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 15. It is gentle to empty the bladder · Neither disagree nor agree	3 Participants	3 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 7. The catheter is discreet · Agree	19 Participants	21 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 7. The catheter is discreet · Disagree	1 Participants	10 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 7. The catheter is discreet · Don't know	0 Participants	0 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 7. The catheter is discreet · Neither disagree nor agree	7 Participants	8 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 7. The catheter is discreet · Not applicable (lack of sensation)	0 Participants	0 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 7. The catheter is discreet · Strongly agree	50 Participants	34 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 7. The catheter is discreet · Strongly disagree	1 Participants	4 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 8. The catheter is hygienic to use · Agree	20 Participants	18 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 8. The catheter is hygienic to use · Disagree	2 Participants	9 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 8. The catheter is hygienic to use · Don't know	0 Participants	0 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 8. The catheter is hygienic to use · Neither disagree nor agree	2 Participants	9 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 8. The catheter is hygienic to use · Not applicable (lack of sensation)	0 Participants	0 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 8. The catheter is hygienic to use · Strongly agree	50 Participants	40 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 8. The catheter is hygienic to use · Strongly disagree	4 Participants	1 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 9. It is fast to empty my bladder completely using this catheter · Agree	22 Participants	30 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 9. It is fast to empty my bladder completely using this catheter · Disagree	5 Participants	6 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 9. It is fast to empty my bladder completely using this catheter · Don't know	0 Participants	1 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 9. It is fast to empty my bladder completely using this catheter · Neither disagree nor agree	15 Participants	18 Participants
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	0 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 9. It is fast to empty my bladder completely using this catheter · Strongly agree	34 Participants	17 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 9. It is fast to empty my bladder completely using this catheter · Strongly disagree	2 Participants	5 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 10. I feel the catheter has a sufficient length to empty my bladder completely · Agree	16 Participants	35 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 10. I feel the catheter has a sufficient length to empty my bladder completely · Disagree	6 Participants	3 Participants
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	0 Participants
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	10 Participants
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	0 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 10. I feel the catheter has a sufficient length to empty my bladder completely · Strongly agree	48 Participants	27 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 10. I feel the catheter has a sufficient length to empty my bladder completely · Strongly disagree	2 Participants	2 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 11. I feel confident the catheter empties my bladder completely · Agree	24 Participants	29 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 11. I feel confident the catheter empties my bladder completely · Disagree	6 Participants	11 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 11. I feel confident the catheter empties my bladder completely · Don't know	1 Participants	0 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 11. I feel confident the catheter empties my bladder completely · Neither disagree nor agree	4 Participants	12 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 11. I feel confident the catheter empties my bladder completely · Not applicable (lack of sensation)	0 Participants	0 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 11. I feel confident the catheter empties my bladder completely · Strongly agree	43 Participants	22 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 11. I feel confident the catheter empties my bladder completely · Strongly disagree	0 Participants	3 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 12. I don't worry about urine left in my bladder using this catheter · Agree	15 Participants	30 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 12. I don't worry about urine left in my bladder using this catheter · Disagree	5 Participants	11 Participants
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	0 Participants
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	8 Participants
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	0 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 12. I don't worry about urine left in my bladder using this catheter · Strongly agree	47 Participants	24 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 12. I don't worry about urine left in my bladder using this catheter · Strongly disagree	2 Participants	4 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 13. I feel confident using the catheter · Agree	13 Participants	26 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 13. I feel confident using the catheter · Disagree	4 Participants	5 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 13. I feel confident using the catheter · Don't know	0 Participants	0 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 13. I feel confident using the catheter · Neither disagree nor agree	3 Participants	7 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 13. I feel confident using the catheter · Not applicable (lack of sensation)	0 Participants	0 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 13. I feel confident using the catheter · Strongly agree	57 Participants	35 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 13. I feel confident using the catheter · Strongly disagree	1 Participants	4 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 14. It is gentle to insert the catheter · Agree	19 Participants	32 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 14. It is gentle to insert the catheter · Disagree	2 Participants	5 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 14. It is gentle to insert the catheter · Don't know	0 Participants	0 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 14. It is gentle to insert the catheter · Neither disagree nor agree	1 Participants	3 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 14. It is gentle to insert the catheter · Not applicable (lack of sensation)	3 Participants	3 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 14. It is gentle to insert the catheter · Strongly agree	51 Participants	29 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 14. It is gentle to insert the catheter · Strongly disagree	2 Participants	5 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 15. It is gentle to empty the bladder · Agree	16 Participants	30 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 15. It is gentle to empty the bladder · Disagree	1 Participants	6 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 15. It is gentle to empty the bladder · Don't know	0 Participants	0 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 15. It is gentle to empty the bladder · Not applicable (lack of sensation)	3 Participants	2 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 15. It is gentle to empty the bladder · Strongly agree	55 Participants	32 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 15. It is gentle to empty the bladder · Strongly disagree	0 Participants	4 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 16. It is gentle to withdraw the catheter · Agree	18 Participants	28 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 16. It is gentle to withdraw the catheter · Disagree	3 Participants	7 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 16. It is gentle to withdraw the catheter · Don't know	0 Participants	0 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 16. It is gentle to withdraw the catheter · Neither disagree nor agree	1 Participants	5 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 16. It is gentle to withdraw the catheter · Not applicable (lack of sensation)	2 Participants	4 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 16. It is gentle to withdraw the catheter · Strongly agree	54 Participants	26 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 16. It is gentle to withdraw the catheter · Strongly disagree	0 Participants	7 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 17. I feel pinching/stinging during catheterization using this catheter · Agree	3 Participants	11 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 17. I feel pinching/stinging during catheterization using this catheter · Disagree	27 Participants	24 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 17. I feel pinching/stinging during catheterization using this catheter · Don't know	0 Participants	0 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 17. I feel pinching/stinging during catheterization using this catheter · Neither disagree nor agree	2 Participants	5 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 17. I feel pinching/stinging during catheterization using this catheter · Not applicable (lack of sensation)	3 Participants	4 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 17. I feel pinching/stinging during catheterization using this catheter · Strongly agree	1 Participants	7 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 17. I feel pinching/stinging during catheterization using this catheter · Strongly disagree	42 Participants	26 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 18. I am satisfied with the catheter · Agree	22 Participants	30 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 18. I am satisfied with the catheter · Disagree	7 Participants	13 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 18. I am satisfied with the catheter · Don't know	0 Participants	0 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 18. I am satisfied with the catheter · Neither disagree nor agree	6 Participants	9 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 18. I am satisfied with the catheter · Not applicable (lack of sensation)	0 Participants	0 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 18. I am satisfied with the catheter · Strongly agree	41 Participants	16 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 18. I am satisfied with the catheter · Strongly disagree	2 Participants	9 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 19. I would like to use the catheter in the future · Agree	15 Participants	22 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 19. I would like to use the catheter in the future · Disagree	10 Participants	12 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 19. I would like to use the catheter in the future · Don't know	1 Participants	1 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 19. I would like to use the catheter in the future · Neither disagree nor agree	8 Participants	13 Participants
Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction 19. I would like to use the catheter in the future · Not applicable (lack of sensation)	0 Participants	0 Participants

POST_HOC outcome

Timeframe: Tested at site visit after 14 days of device home use.

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.

Outcome measures

Outcome measures
Measure	Investigational Device - Newly Developed Intermittent Catheter n=79 Participants 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.	Comparator Device n=79 Participants 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.
Response to Treatment, Residual Volume of Urine at First Flow-stop Under 10 Milliliter	83 percentage of catheterisations Interval 76.0 to 89.0	71 percentage of catheterisations Interval 63.0 to 78.0

POST_HOC outcome

Timeframe: Tested at site visit after 14 days of device home use.

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.

Outcome measures

Outcome measures
Measure	Investigational Device - Newly Developed Intermittent Catheter n=79 Participants 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.	Comparator Device n=79 Participants 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.
Response to Treatment, 0 Flow-stops	87 percentage of catheterisations Interval 80.0 to 92.0	57 percentage of catheterisations Interval 48.0 to 65.0

Adverse Events

Investigational Device - Newly Developed Intermittent Catheter

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Comparator Device

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Christian Riis Forman, Medical writer

Coloplast A/S

Phone: 49111756

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Investigational Device - Newly Developed Intermittent Catheter n=81 participants at risk 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.	Comparator Device n=81 participants at risk 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. 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. Details on the comparator devices are as follows: 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.
Renal and urinary disorders Urinary tract infection	3.7% 3/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.	1.2% 1/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.
Renal and urinary disorders Haematuria	0.00% 0/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.	1.2% 1/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.
Renal and urinary disorders Tingling sensation when urinating	0.00% 0/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.	1.2% 1/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.
Renal and urinary disorders Urinary discomfort	0.00% 0/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.	1.2% 1/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.
Respiratory, thoracic and mediastinal disorders Common cold	1.2% 1/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.	0.00% 0/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.
Musculoskeletal and connective tissue disorders Muscle pain in back	1.2% 1/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.	1.2% 1/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.
Musculoskeletal and connective tissue disorders Muscle pain in left leg	0.00% 0/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.	1.2% 1/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.
Gastrointestinal disorders Colitis	0.00% 0/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.	1.2% 1/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.
Renal and urinary disorders Cystitis	1.2% 1/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.	2.5% 2/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.
General disorders Tooth ache	1.2% 1/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.	0.00% 0/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.
General disorders Fall	1.2% 1/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.	0.00% 0/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.
Gastrointestinal disorders Gastroenteritis	1.2% 1/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.	0.00% 0/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.
General disorders Flank pain	0.00% 0/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.	1.2% 1/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.
Vascular disorders Vasovagal syncope	0.00% 0/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.	1.2% 1/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.
Renal and urinary disorders Foul smelling urine	0.00% 0/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.	1.2% 1/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.
Infections and infestations Herpes labial	0.00% 0/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.	1.2% 1/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.
Renal and urinary disorders Pyelonefritis	1.2% 1/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.	0.00% 0/81 • 4 weeks 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 of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female. This specification also extended to the collection of adverse events, reporting adverse events of the comparator in combination.