Stoma Ileostomy
Conditions
Brief summary
People with intestinal stomas (especially an ileostomy) can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively. To overcome this, Coloplast has developed a new supporting ostomy product, which has an adhesive sensor layer that should be place underneath the baseplate normally used by the subject. Single arm design. Open-labelled Study duration: 21 days + 3 days.
Detailed description
Test product is a Digital Leakage Notification System. It consist of a sensor layer (worn beneath the baseplate), a transmitter attached to the sensor layer, a charger for charging of transmitter and an app, to be installed on a smartphone, which notifies the user of the status of their baseplate such as everything looks okay or there is a possible leakage. Subjects are asked to use test product for 21 days. n=15 were using a phone with Android operating system and n=10 a phone with iOS operating system.
Interventions
DEVICECP321
The primary objective is to evaluate the system performance of the test product. This is done by asking subjects to answer questions throughout the study
Sponsors
Coloplast A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Single arm, open label study. Subjects are allocated to use test product for 3 weeks. Subjects will complete questionnaires at baseline (V1) and again after 3 weeks use of test product (V2). Comparative tests included: Baseline vs. follow-up measures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have given written informed consent 2. Be at least 18 years of age and have full legal capacity 3. Have had a stoma for more than three months 4. Have intact skin on the area used in the evaluation meaning no broken skin and only minor discoloration of the skin (assessed by investigator) 5. Be able to use one of the five sensor layer sizes (i.e. Ø40, Ø50, Ø60, Ø70, Ø80 mm) 6. Ileo- or colostomists with liquid output (Bristol scale type 6-7). 7. Currently using a Coloplast product (1pc/2pc Flat/Convex/Concave) from e.g Assura/SenSura/SenSura Mio 8. Have self-reported problems with leakage\* (three times within 14 days) 9. Have worry of leakage 'to some, high or very high degree' 10. Is familiar with the use of a smartphone \*Leakage: Leakage is defined as output from the stoma on the backside of the baseplate (underneath the baseplate)
Exclusion criteria
1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy 2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment. 3. Are pregnant or breastfeeding 4. Participating in other interventional clinical investigations or have previously participated in this investigation. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System Performance Accuracy of Pictures | 21 days | The primary endpoint is system performance accuracy: * True Negative: No leakage observed on picture and no leakage detected by system * True Positive: Leakage observed in picture and leakage detected by system * False Negative: Leakage observed in picture, but no leakage detected by system * False Positive: No leakage observed in picture, but leakage detected by system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Experience of Leakage Onto Clothes Compared to Only Using Usual Product | V2 (follow-up, Day 21) | Subject own interpretation, Q: to which degree have you experienced leakage onto your clothes with test product? (5-point scale: very low degree/not at all, low degree, some degree, high degree, very high degree). |
| Reliability of Notifications | V2 (follow-up, Day 21) | Subjects are asked to rate, Q: To which degree did you find notifications from the app reliable and trustworthy (5-point scale; very low degree, low degree, some degree, high degree, very high degree) |
| Ability to Move With Test Product | V2 (follow-up, Day 21) | Q: Compared to your usual product, how was your freedom to move with test product? Much better - better - Same - Worse - Much worse |
| Subjects Worry of Leakage Before and After Use of Test Product | At V1 (baseline) and V2 (follow-up, Day 21) | Q: Think back on the last 3 weeks - to which degree have you worried about leakage? Very high degree - High degree - Some degree - Low degree - Very low degree/Not at all |
| Confidence to Avoid Full Leakage With Test Product Compared to Only Using Usual Product | V2 (follow-up, Day 21) | Q: Compared to your usual product, did you feel confident that you could avoid leakage onto clothes? Yes -No |
| Confidence in Daily Life Compared to Only Using Usual Product | V2 (follow-up, Day 21) | Q: Compared to your usual product, to which degree did the test product give you confidence in daily life? Much higher degree- Higher degree- Same degree - Lower degree- Much lower degree |
| Feeling of Control With Test Product Compared to Only Using Usual Product | V2 (follow-up, Day 21) | Q: Compared to your usual product, did test product give you a feeling of leakage control? Yes, higher leakage control No, lower leakage control |
| Control of Leakage Progression With Test Product Compared to Only Using Usual Product | V2 (follow-up, Day 21) | Q: Compared to your usual product, did the test product give you a feeling of control of leakage progression? Yes, higher control of leakage progression No, lower control of leakage progression |
| Feeling of Security With Test Product Compared to Only Using Usual Product | V2 (follow-up, Day 21) | Q: Compared to your usual product, did you feel more or less secure with test product? |
| Frequency of Leakage Onto Clothes Before and After Use of Test Product | At V1 (baseline) and V2 (follow-up, Day 21) | Subjects are asked to recall numbers of leakage events outside baseplate (and/or onto clothes) the past 3 weeks (at baseline and follow-up). Subjects shall give a specific frequency. |
| Evaluation of Sleep With Test Product Compared to Only Using Usual Product | V2 (follow-up, Day 21) | Q: Compared with your usual product, did the test product affect your sleep? Yes, to the better Yes, to the worse No, the same |
| Confidence at Night With Test Product Compared to Only Using Usual Product | V2 (follow-up, Day 21) | Compared with your usual product, to which degree did the test product give you confidence at night? Much higher - Higher - Same - Lower - Much lower |
| Evaluation of Users' Preference | V2 (follow-up, Day 21) | Q: Which product solution do you prefer? Own product - Own product with test product |
| Reason for Preference | V2 (follow-up, Day 21) | Q: What is your reason for preference? (Please tick all that apply) * Body fit * Ability to bend and stretch * Feeling of security * Feeling of confidence * Less fear of leakage onto clothes * Discreet to wear * Discreetness in leakage control * Better sleep * Less embarrassment * Other |
| Evaluation of Users' Peace of Mind With Test Product | V2 (follow-up, Day 21) | Q: To which degree did the test product give you peace of mind? Very high degree- High degree- Low degree- Very low degree |
| To Evaluate Users' Assessment of QoL With Test Product Compared to Usual Product | V2 (follow-up, Day 21) | Overall, do you think the test product can improve your feeling of control and confidence to avoid leakage onto clothes and therefore improve your quality of life? Yes - No |
| Adhesive Residue to Skin | V2 (follow-up, Day 21) | To which degree did you experience adhesive residue to the skin in the area around the transmitter? Very low degree/Not at all - Low degree - Some degree - High degree -Very high degree |
| Adhesive Residue to Transmitter | V2 (follow-up, Day 21) | To which degree did you experience adhesive residue on the backside of the transmitter? Very low degree/Not at all - Low degree - Some degree - High degree -Very high degree |
| Evaluation of Confidence to Increase Social Activities With Test Product Compared to Only Using Usual Product | V2 (follow-up, Day 21) | Q: Compared with your usual product, did the test product affect your confidence to engage in social activities such as seeing friends, and do physical activities? I felt more confident - I felt less confident |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Arm, Intention to Treat All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Test Arm, Intention to Treat | — |
|---|---|---|
| Age, Continuous | 56 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Denmark | 25 Participants | — |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 15 Participants | — |
| Type of stoma Colostomy | 10 Participants | — |
| Type of stoma Ileostomy | 15 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 2 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
System Performance Accuracy of Pictures
The primary endpoint is system performance accuracy: * True Negative: No leakage observed on picture and no leakage detected by system * True Positive: Leakage observed in picture and leakage detected by system * False Negative: Leakage observed in picture, but no leakage detected by system * False Positive: No leakage observed in picture, but leakage detected by system
Time frame: 21 days
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Test Arm, Intention to Treat | System Performance Accuracy of Pictures | True positive | 122 Pictures |
| Test Arm, Intention to Treat | System Performance Accuracy of Pictures | True negative | 126 Pictures |
| Test Arm, Intention to Treat | System Performance Accuracy of Pictures | False positive | 24 Pictures |
| Test Arm, Intention to Treat | System Performance Accuracy of Pictures | False negative | 45 Pictures |
Secondary
Ability to Move With Test Product
Q: Compared to your usual product, how was your freedom to move with test product? Much better - better - Same - Worse - Much worse
Time frame: V2 (follow-up, Day 21)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Arm, Intention to Treat | Ability to Move With Test Product | Much worse | 0 Participants |
| Test Arm, Intention to Treat | Ability to Move With Test Product | Worse | 1 Participants |
| Test Arm, Intention to Treat | Ability to Move With Test Product | Same | 16 Participants |
| Test Arm, Intention to Treat | Ability to Move With Test Product | Better | 4 Participants |
| Test Arm, Intention to Treat | Ability to Move With Test Product | Much better | 2 Participants |
Comparison: For secondary endpoints an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. For ability to move with test product it was tested if the proportion evaluating same or better was significantly different from 50% when using a 5% test level. The answers of 'same, better or much better' was grouped against the answers of 'worse or much worse' ability to move.p-value: <0.000195% CI: [78, 100]Exact test in the binomial distribution
Secondary
Adhesive Residue to Skin
To which degree did you experience adhesive residue to the skin in the area around the transmitter? Very low degree/Not at all - Low degree - Some degree - High degree -Very high degree
Time frame: V2 (follow-up, Day 21)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Arm, Intention to Treat | Adhesive Residue to Skin | Very low degree/Not at all | 6 Participants |
| Test Arm, Intention to Treat | Adhesive Residue to Skin | Low degree | 7 Participants |
| Test Arm, Intention to Treat | Adhesive Residue to Skin | Some degree | 7 Participants |
| Test Arm, Intention to Treat | Adhesive Residue to Skin | High degree | 2 Participants |
| Test Arm, Intention to Treat | Adhesive Residue to Skin | Very high degree | 1 Participants |
Secondary
Adhesive Residue to Transmitter
To which degree did you experience adhesive residue on the backside of the transmitter? Very low degree/Not at all - Low degree - Some degree - High degree -Very high degree
Time frame: V2 (follow-up, Day 21)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Arm, Intention to Treat | Adhesive Residue to Transmitter | Very low degree/Not at all | 9 Participants |
| Test Arm, Intention to Treat | Adhesive Residue to Transmitter | Low degree | 5 Participants |
| Test Arm, Intention to Treat | Adhesive Residue to Transmitter | Some degree | 9 Participants |
| Test Arm, Intention to Treat | Adhesive Residue to Transmitter | High degree | 0 Participants |
| Test Arm, Intention to Treat | Adhesive Residue to Transmitter | Very high degree | 0 Participants |
Secondary
Confidence at Night With Test Product Compared to Only Using Usual Product
Compared with your usual product, to which degree did the test product give you confidence at night? Much higher - Higher - Same - Lower - Much lower
Time frame: V2 (follow-up, Day 21)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Arm, Intention to Treat | Confidence at Night With Test Product Compared to Only Using Usual Product | Much lower degree | 0 Participants |
| Test Arm, Intention to Treat | Confidence at Night With Test Product Compared to Only Using Usual Product | Lower degree | 1 Participants |
| Test Arm, Intention to Treat | Confidence at Night With Test Product Compared to Only Using Usual Product | Same degree | 11 Participants |
| Test Arm, Intention to Treat | Confidence at Night With Test Product Compared to Only Using Usual Product | Higher degree | 7 Participants |
| Test Arm, Intention to Treat | Confidence at Night With Test Product Compared to Only Using Usual Product | Much higher degree | 4 Participants |
p-value: 195% CI: [27, 69]Exact test in the binomial distribution
Secondary
Confidence in Daily Life Compared to Only Using Usual Product
Q: Compared to your usual product, to which degree did the test product give you confidence in daily life? Much higher degree- Higher degree- Same degree - Lower degree- Much lower degree
Time frame: V2 (follow-up, Day 21)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Arm, Intention to Treat | Confidence in Daily Life Compared to Only Using Usual Product | Much lower degree | 1 Participants |
| Test Arm, Intention to Treat | Confidence in Daily Life Compared to Only Using Usual Product | Lower degree | 2 Participants |
| Test Arm, Intention to Treat | Confidence in Daily Life Compared to Only Using Usual Product | Same degree | 5 Participants |
| Test Arm, Intention to Treat | Confidence in Daily Life Compared to Only Using Usual Product | Higher degree | 10 Participants |
| Test Arm, Intention to Treat | Confidence in Daily Life Compared to Only Using Usual Product | Much higher degree | 5 Participants |
p-value: 0.2195% CI: [43, 84]Exact test in the binomial distribution
Secondary
Confidence to Avoid Full Leakage With Test Product Compared to Only Using Usual Product
Q: Compared to your usual product, did you feel confident that you could avoid leakage onto clothes? Yes -No
Time frame: V2 (follow-up, Day 21)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Arm, Intention to Treat | Confidence to Avoid Full Leakage With Test Product Compared to Only Using Usual Product | No | 5 Participants |
| Test Arm, Intention to Treat | Confidence to Avoid Full Leakage With Test Product Compared to Only Using Usual Product | Yes | 18 Participants |
p-value: 0.010695% CI: [56, 93]Exact test in the binomial distribution
Secondary
Control of Leakage Progression With Test Product Compared to Only Using Usual Product
Q: Compared to your usual product, did the test product give you a feeling of control of leakage progression? Yes, higher control of leakage progression No, lower control of leakage progression
Time frame: V2 (follow-up, Day 21)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Arm, Intention to Treat | Control of Leakage Progression With Test Product Compared to Only Using Usual Product | Yes, higher control of leakage progression | 16 Participants |
| Test Arm, Intention to Treat | Control of Leakage Progression With Test Product Compared to Only Using Usual Product | No, lower control of leakage progression | 7 Participants |
p-value: 0.09395% CI: [47, 87]Exact test in the binomial distribution
Secondary
Evaluation of Confidence to Increase Social Activities With Test Product Compared to Only Using Usual Product
Q: Compared with your usual product, did the test product affect your confidence to engage in social activities such as seeing friends, and do physical activities? I felt more confident - I felt less confident
Time frame: V2 (follow-up, Day 21)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Arm, Intention to Treat | Evaluation of Confidence to Increase Social Activities With Test Product Compared to Only Using Usual Product | I felt less confident | 2 Participants |
| Test Arm, Intention to Treat | Evaluation of Confidence to Increase Social Activities With Test Product Compared to Only Using Usual Product | I felt more confident | 21 Participants |
p-value: <0.000195% CI: [72, 99]Exact test in the binomial distribution
Secondary
Evaluation of Sleep With Test Product Compared to Only Using Usual Product
Q: Compared with your usual product, did the test product affect your sleep? Yes, to the better Yes, to the worse No, the same
Time frame: V2 (follow-up, Day 21)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Arm, Intention to Treat | Evaluation of Sleep With Test Product Compared to Only Using Usual Product | Yes, to the better | 8 Participants |
| Test Arm, Intention to Treat | Evaluation of Sleep With Test Product Compared to Only Using Usual Product | Yes, to the worse | 0 Participants |
| Test Arm, Intention to Treat | Evaluation of Sleep With Test Product Compared to Only Using Usual Product | No, the same | 15 Participants |
p-value: 0.2195% CI: [16, 57]Exact test in the binomial distribution
Secondary
Evaluation of Users' Peace of Mind With Test Product
Q: To which degree did the test product give you peace of mind? Very high degree- High degree- Low degree- Very low degree
Time frame: V2 (follow-up, Day 21)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Arm, Intention to Treat | Evaluation of Users' Peace of Mind With Test Product | Very high degree | 6 Participants |
| Test Arm, Intention to Treat | Evaluation of Users' Peace of Mind With Test Product | High degree | 10 Participants |
| Test Arm, Intention to Treat | Evaluation of Users' Peace of Mind With Test Product | Low degree | 5 Participants |
| Test Arm, Intention to Treat | Evaluation of Users' Peace of Mind With Test Product | Very low degree | 2 Participants |
p-value: 0.093195% CI: [47, 87]Exact test in the binomial distribution
Secondary
Evaluation of Users' Preference
Q: Which product solution do you prefer? Own product - Own product with test product
Time frame: V2 (follow-up, Day 21)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Arm, Intention to Treat | Evaluation of Users' Preference | Own product | 10 Participants |
| Test Arm, Intention to Treat | Evaluation of Users' Preference | Own product with test product | 13 Participants |
p-value: 0.67895% CI: [34, 77]Exact test in the binomial distribution
Secondary
Experience of Leakage Onto Clothes Compared to Only Using Usual Product
Subject own interpretation, Q: to which degree have you experienced leakage onto your clothes with test product? (5-point scale: very low degree/not at all, low degree, some degree, high degree, very high degree).
Time frame: V2 (follow-up, Day 21)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Arm, Intention to Treat | Experience of Leakage Onto Clothes Compared to Only Using Usual Product | Very high degree | 0 Participants |
| Test Arm, Intention to Treat | Experience of Leakage Onto Clothes Compared to Only Using Usual Product | High degree | 0 Participants |
| Test Arm, Intention to Treat | Experience of Leakage Onto Clothes Compared to Only Using Usual Product | Some degree | 2 Participants |
| Test Arm, Intention to Treat | Experience of Leakage Onto Clothes Compared to Only Using Usual Product | Low degree | 3 Participants |
| Test Arm, Intention to Treat | Experience of Leakage Onto Clothes Compared to Only Using Usual Product | Very low degree / Not at all | 18 Participants |
Comparison: For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers).p-value: <0.000195% CI: [72, 99]Exact test in the binomial distribution
Secondary
Feeling of Control With Test Product Compared to Only Using Usual Product
Q: Compared to your usual product, did test product give you a feeling of leakage control? Yes, higher leakage control No, lower leakage control
Time frame: V2 (follow-up, Day 21)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Arm, Intention to Treat | Feeling of Control With Test Product Compared to Only Using Usual Product | Yes, higher leakage control | 18 Participants |
| Test Arm, Intention to Treat | Feeling of Control With Test Product Compared to Only Using Usual Product | No, lower leakage control | 5 Participants |
p-value: 0.010695% CI: [56, 93]Exact test in the binomial distribution
Secondary
Feeling of Security With Test Product Compared to Only Using Usual Product
Q: Compared to your usual product, did you feel more or less secure with test product?
Time frame: V2 (follow-up, Day 21)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Arm, Intention to Treat | Feeling of Security With Test Product Compared to Only Using Usual Product | I felt less secure | 1 Participants |
| Test Arm, Intention to Treat | Feeling of Security With Test Product Compared to Only Using Usual Product | I felt more secure | 22 Participants |
p-value: <0.000195% CI: [78, 100]Exact test in the binomial distribution
Secondary
Frequency of Leakage Onto Clothes Before and After Use of Test Product
Subjects are asked to recall numbers of leakage events outside baseplate (and/or onto clothes) the past 3 weeks (at baseline and follow-up). Subjects shall give a specific frequency.
Time frame: At V1 (baseline) and V2 (follow-up, Day 21)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Test Arm, Intention to Treat | Frequency of Leakage Onto Clothes Before and After Use of Test Product | V1 | 2.84 Leakage episodes onto clothes |
| Test Arm, Intention to Treat | Frequency of Leakage Onto Clothes Before and After Use of Test Product | V2 | 0.51 Leakage episodes onto clothes |
p-value: <0.00195% CI: [0.07, 0.49]Poisson loglinear model
Secondary
Reason for Preference
Q: What is your reason for preference? (Please tick all that apply) * Body fit * Ability to bend and stretch * Feeling of security * Feeling of confidence * Less fear of leakage onto clothes * Discreet to wear * Discreetness in leakage control * Better sleep * Less embarrassment * Other
Time frame: V2 (follow-up, Day 21)
Population: The 13 subjects with a preference for test product were asked for the reason(s) for this preference and the the 10 subjects with a preference for own product were asked for the reason(s) for this preference.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test Arm, Intention to Treat | Reason for Preference | Preference for test product : Body fit | 2 Participants |
| Test Arm, Intention to Treat | Reason for Preference | Preference for test product : Ability to bend and stretch | 1 Participants |
| Test Arm, Intention to Treat | Reason for Preference | Preference for test product : Feeling of security | 10 Participants |
| Test Arm, Intention to Treat | Reason for Preference | Preference for test product : Feeling of confidence | 2 Participants |
| Test Arm, Intention to Treat | Reason for Preference | Preference for test product : Less fear of leakage onto clothes | 9 Participants |
| Test Arm, Intention to Treat | Reason for Preference | Preference for test product : Discreet to wear | 2 Participants |
| Test Arm, Intention to Treat | Reason for Preference | Preference for test product : Discreetness in leakage control | 10 Participants |
| Test Arm, Intention to Treat | Reason for Preference | Preference for test product : Better sleep | 5 Participants |
| Test Arm, Intention to Treat | Reason for Preference | Preference for test product : Less embarrassment | 1 Participants |
| Test Arm, Intention to Treat | Reason for Preference | Preference for test product : Other | 0 Participants |
| Test Arm, Intention to Treat | Reason for Preference | Preference for own product : Body fit | 5 Participants |
| Test Arm, Intention to Treat | Reason for Preference | Preference for own product : Ability to bend and stretch | 3 Participants |
| Test Arm, Intention to Treat | Reason for Preference | Preference for own product : Feeling of security | 3 Participants |
| Test Arm, Intention to Treat | Reason for Preference | Preference for own product : Feeling of confidence | 0 Participants |
| Test Arm, Intention to Treat | Reason for Preference | Preference for own product : Less fear of leakage onto clothes | 1 Participants |
| Test Arm, Intention to Treat | Reason for Preference | Preference for own product : Discreet to wear | 3 Participants |
| Test Arm, Intention to Treat | Reason for Preference | Preference for own product : Discreetness in leakage control | 4 Participants |
| Test Arm, Intention to Treat | Reason for Preference | Preference for own product : Better sleep | 0 Participants |
| Test Arm, Intention to Treat | Reason for Preference | Preference for own product : Less embarrassment | 0 Participants |
| Test Arm, Intention to Treat | Reason for Preference | Preference for own product : Other | 1 Participants |
Secondary
Reliability of Notifications
Subjects are asked to rate, Q: To which degree did you find notifications from the app reliable and trustworthy (5-point scale; very low degree, low degree, some degree, high degree, very high degree)
Time frame: V2 (follow-up, Day 21)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Arm, Intention to Treat | Reliability of Notifications | Very high degree | 5 Participants |
| Test Arm, Intention to Treat | Reliability of Notifications | High degree | 7 Participants |
| Test Arm, Intention to Treat | Reliability of Notifications | Some degree | 6 Participants |
| Test Arm, Intention to Treat | Reliability of Notifications | Low degree | 3 Participants |
| Test Arm, Intention to Treat | Reliability of Notifications | Very low degree / Not at all | 2 Participants |
Comparison: For secondary endpoints an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For reliability answered on a 5-point scale the answers some, high, or very high degree was considered acceptable and grouped against answers of 'low or very low' degree of reliability.p-value: 0.010695% CI: [56, 93]Exact test in the binomial distribution
Secondary
Subjects Worry of Leakage Before and After Use of Test Product
Q: Think back on the last 3 weeks - to which degree have you worried about leakage? Very high degree - High degree - Some degree - Low degree - Very low degree/Not at all
Time frame: At V1 (baseline) and V2 (follow-up, Day 21)
Population: Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Test Arm, Intention to Treat | Subjects Worry of Leakage Before and After Use of Test Product | V1 | Very high degree | 1 Participants |
| Test Arm, Intention to Treat | Subjects Worry of Leakage Before and After Use of Test Product | V1 | High degree | 11 Participants |
| Test Arm, Intention to Treat | Subjects Worry of Leakage Before and After Use of Test Product | V1 | Some degree | 11 Participants |
| Test Arm, Intention to Treat | Subjects Worry of Leakage Before and After Use of Test Product | V1 | Low degree | 2 Participants |
| Test Arm, Intention to Treat | Subjects Worry of Leakage Before and After Use of Test Product | V1 | Very low degree / Not at all | 0 Participants |
| Test Arm, Intention to Treat | Subjects Worry of Leakage Before and After Use of Test Product | V2 | Very high degree | 0 Participants |
| Test Arm, Intention to Treat | Subjects Worry of Leakage Before and After Use of Test Product | V2 | High degree | 1 Participants |
| Test Arm, Intention to Treat | Subjects Worry of Leakage Before and After Use of Test Product | V2 | Some degree | 6 Participants |
| Test Arm, Intention to Treat | Subjects Worry of Leakage Before and After Use of Test Product | V2 | Low degree | 8 Participants |
| Test Arm, Intention to Treat | Subjects Worry of Leakage Before and After Use of Test Product | V2 | Very low degree / Not at all | 8 Participants |
p-value: <0.001Proportional odds ratio model
Secondary
To Evaluate Users' Assessment of QoL With Test Product Compared to Usual Product
Overall, do you think the test product can improve your feeling of control and confidence to avoid leakage onto clothes and therefore improve your quality of life? Yes - No
Time frame: V2 (follow-up, Day 21)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Arm, Intention to Treat | To Evaluate Users' Assessment of QoL With Test Product Compared to Usual Product | Yes | 20 Participants |
| Test Arm, Intention to Treat | To Evaluate Users' Assessment of QoL With Test Product Compared to Usual Product | No | 3 Participants |
p-value: 0.000595% CI: [66, 97]Exact test in the binomial distribution