Form cover
Page 1 of 1

EXPLORATORY QUESTIONNAIRE

Estimated completion time: 10–12 minutes

1. Information for participants

We invite you to take part in an exploratory survey on the daily experiences of people living with a colostomy and on their opinions about possible solutions for stoma management.


The questionnaire covers your current experience and, in a separate section, your views on a new device called StomAid, which is under development and for which the regulatory process has been initiated.

There are no right or wrong answers. We are interested in your honest opinions, including any doubts, negative views or inability to form a judgement. Participation is voluntary and you may stop completing the questionnaire at any time.

Your answers will be used for research and development purposes and to better understand needs, preferences and possible concerns. The data controller is the StomAid contractual joint venture between Relavo & Partners S.à r.l. and Medicea Medica S.r.l.; the management of data processing has been entrusted to Relavo & Partners S.à r.l. The full privacy notice, including contact details, legal basis, retention periods, recipients and how to exercise your rights, is available at the following link: [PRIVACY NOTICE LINK].

Please do not include your name or contact details in your answers, unless you are asked to do so separately and with a specific privacy notice.

The information presented about StomAid describes a device that is still under development, whose performance, safety, effectiveness and method of use are still evolving and therefore not yet definitively established; this questionnaire does not in itself constitute clinical evidence or a demonstration of the device's usability.

Consent to participate

I declare that I have read the information above and that I wish to take part in the survey voluntarily.

Consent to the processing of health-related data

Some questions concern your health. I consent to the processing of the information about my health provided in this questionnaire, in anonymous form and solely for the research purposes described above.

2. What is StomAid?

StomAid is a soft, removable device designed to be inserted into the stoma, which does not require surgery. It is designed to provide temporary continence by means of a pneumatic ring retention system.
https://storage.tally.so/f7e60614-d63a-46c6-ba6b-9d27d806a562/Screenshot-2026-10-27-at-15.55.34.png

The aim of the project is to explore an alternative and complementary way of managing continence in people with a permanent end colostomy, allowing the user to choose when to manage evacuation according to their own needs and the activities planned during the day.

The device does not require any additional surgery and has been conceived as a reversible solution, complementary to the traditional pouch.

3. How is it intended to work?

StomAid is gently inserted into the stoma, and the inflation of the ring inside it is designed to provide continence and stable positioning during the period of use.

When the user decides to evacuate, releasing the air reduces the volume of the ring, which aligns with the profile of the stem, and the device can be removed in a controlled way.

StomAid's retention system is designed to operate at low pressures; safety limits are currently being verified.

The system is designed to include an odour filter that allows intestinal gas to be released, and a rapid deflation and removal system for use in an emergency.


Watch the demonstration video below:

The following methods refer to a hypothetical use scenario, developed solely to understand your preferences, expectations and possible ways of using the device.

4. Expected stages of use during the day

4.1 Hypothetical use scenario:


a) Insertion of the device in the morning.
b) Use during normal daily activities. c) Evacuation at a time chosen by the user. d) Reinsertion of the device or return to the traditional pouch.

4.1.1 Option A – Use with a single-use biodegradable collection bag

Where a washbasin or a suitable surface is available, the user could follow a procedure similar to the following:


1. Application of the single-use biodegradable bag below the stoma. 2. Release of the air and removal of the device. 3. Channelling of the output into the bag. 4. Closing and disposal of the bag. 5. Cleaning of the stoma and the device. Reinsertion of StomAid or application of the traditional pouch.

4.1.2 Option B – Use with a single-use biodegradable toilet conduit

Alternatively, the user could use a single-use biodegradable conduit designed to channel the evacuated material directly into the toilet. In this scenario, the patient stands in front of the toilet:


1) Positioning of the conduit inside the toilet. 2) Application of the adhesive end around the stoma. 3) Release of the air and removal of the device. 4) Channelling of the output directly into the toilet. 5) Cleaning of the stoma and the device. 6) Reinsertion of StomAid or application of the traditional pouch.

https://storage.tally.so/1ebd4073-7fe3-44dc-a3d5-dadcf175c279/StomAid_fasi_utilizzo_EN.png

STOMAID EXPLORATORY USE QUESTIONNAIRE

(Hypotheses on User Experience, Preferences and Potential Use)

Preliminary comprehension check

Based on the information provided in the descriptive material and the explanatory video, do you feel you have understood StomAid's operating principle and its intended methods of use well enough to answer the following questions? (one answer only)
A
B
C

Section A – Your current situation

P1. Which country do you live in?

P2. What is your age group? (one answer only)

A
B
C
D
E
F
G
H

P3. Your colostomy is: (one answer only)

A
B
C

P4. What type of colostomy do you have? (one answer only)

A
B
C

P5. What is the usual consistency of your stool? (one answer only)

A
B
C
D
E

P6. Have you ever been diagnosed with a parastomal hernia, a prolapse or a narrowing of the stoma? (one answer only)

A
B
C

A1. How long have you been living with your colostomy? (one answer only)

A
B
C
D
E

A2. Which system do you currently use most often? (one answer only)

A
B
C
D
E

A2a. On average, how many pouches do you use per day? (one answer only)

A
B
C
D
E

A2b. Are your stoma supplies reimbursed by the health service or by insurance? (one answer only)

A
B
C
D

A3. Do you use colostomy irrigation? (one answer only)

A
B
C
D
E

A4. How much does managing your stoma currently affect your daily life? (one answer only)

A
B
C
D
E

A5. Which aspects of stoma management cause you the most difficulty? (multiple answers possible)

A
B
C
D
E
F
G
H
I
J
K
L
M
N

A5a. If you wish, please specify “other” or add a comment:

A6. Of the aspects listed, which one has the greatest impact on your quality of life? (multiple answers possible)

A
B
C
D
E
F
G
H
I
J
K
L

A7. How confident do you feel managing your stoma away from home? (one answer only)

A
B
C
D
E

A8. In the last 12 months, how often have you experienced an unexpected or particularly problematic episode related to managing your stoma? (one answer only)

A
B
C
D
E

A8a. If you wish, briefly describe a significant episode or difficulty:

Section B – Priorities and needs

B1. Indicate the three aspects you consider most important in a solution for managing a colostomy (multiple answers possible)

A
B
C
D
E
F
G
H
I
J
K
L

B2. How satisfied are you with the system you currently use? (one answer only)

A
B
C
D
E
F

B3. What is the main aspect you would like to improve in your current stoma management?

B4. Have you ever used an internal device or a solution other than the traditional pouch to manage your colostomy? (one answer only)

A
B
C

B5. If yes, would you like to tell us which solution you used and what your experience was?

Section C – Information about StomAid

StomAid is a soft device designed to be positioned in the stoma.


Two possible ways of managing evacuation have been described: a single-use biodegradable collection bag or a single-use biodegradable conduit designed to channel the material into the toilet. The final methods, performance and conditions of use are being finalised. 

This description does not imply that the device is already available for use; the regulatory process has been initiated. After reading the description and, where available, viewing the explanatory material, please answer the following questions.

C1. How well do you feel you have understood the operating concept of StomAid? (one answer only)

A
B
C
D

C2. In theory, which of the evacuation methods described seems most compatible with your needs? (one answer only)

A
B
C
D
E

C3. In which setting do you think you could most easily manage evacuation, if StomAid were available? (multiple answers possible)

A
B
C
D
E
F
G
H

C4. Which aspects of the StomAid procedure seem potentially difficult or uncomfortable to you? (multiple answers possible)

A
B
C
D
E
F
G
H
I
J
K
L

C4a. If you wish, explain the main difficulty you foresee:

C5. Based on the information you have received, what would be your view on the possibility of using StomAid? (one answer only)

A
B
C
D
E
F

C6. Could you briefly indicate the reason?

Section D – Possible use and necessary conditions

D1. In which circumstances might you consider using StomAid? (multiple answers possible)

A
B
C
D
E
F
G
H
I
J
K

D2. If StomAid were available, how often do you imagine you might consider using it? (one answer only)

A
B
C
D
E
F
G

D3. To what extent do you think StomAid could complement or replace the system you use today? (one answer only)

A
B
C
D
E

D4. In your opinion, what would be the main condition required for you to consider using StomAid? (multiple answers possible)

A
B
C
D
E
F
G
H
I
J
K

D5. Which aspects would make you more hesitant, or might prevent you from using StomAid? (multiple answers possible)

A
B
C
D
E
F
G
H
I
J
K
L
M

Section E – Reliability, training and support

E1. What information or conditions would you need before feeling sufficiently informed to assess a solution such as StomAid? (multiple answers possible)

A
B
C
D
E
F
G
H
I

E2. What type of training in the use of StomAid would you find most useful? (multiple answers possible)

A
B
C
D
E
F
G
H

E3. In training on how to use the device, which aspect do you think would require the most attention? (multiple answers possible)

A
B
C
D
E
F
G
H
I

E3a. If you wish, add an explanation:

Section F – Economic aspects

F1. How much would the availability or absence of healthcare reimbursement influence your decision to use StomAid? (one answer only)

A
B
C
D
E
F

F2. What monthly cost would you consider appropriate and affordable, assuming the device has been properly evaluated and is available on the market? (one answer only)

A
B
C
D
E
F

F3. Which factors would most affect your satisfaction with the purchase price? (multiple answers possible)

A
B
C
D
E
F
G
H
I

Section G – Final assessment

G1. Considering the information you have received, which opinion would you adopt? (one answer only)

A
B
C
D
E
F

G2. What would make you change your mind?

G3. Which feature of StomAid concerns you most, if any?

G4. What information would you like to have in order to form an opinion?

G5. Would you like to add a comment, reservation or suggestion not covered by the previous questions?

Thank you for sharing your opinions with us. All answers, including critical or unfavourable ones, are important for understanding the needs and expectations of people living with a colostomy.


If further research activities are organised in the future and you would like to take part, you can write to us at contact@stomaid.com