Investigation of a Supporting Ostomy Product Intended for Leakage Detection

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

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.

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).

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)

Q: Compared to your usual product, how was your freedom to move with test product? Much better - better - Same - Worse - Much worse

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

Q: Compared to your usual product, did you feel confident that you could avoid leakage onto clothes? Yes -No

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

Q: Compared to your usual product, did test product give you a feeling of leakage control? Yes, higher leakage control No, lower leakage control

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

Q: Compared to your usual product, did you feel more or less secure with test 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

Q: Compared with your usual product, did the test product affect your sleep? Yes, to the better Yes, to the worse No, the same

Compared with your usual product, to which degree did the test product give you confidence at night? Much higher - Higher - Same - Lower - Much lower

Q: Which product solution do you prefer? Own product - Own product with test product

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

Q: To which degree did the test product give you peace of mind? Very high degree- High degree- Low degree- Very low degree

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

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

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