Stomasense: A New Route to the Proactive Detection and Management of Leaks Within Ostomy Pouches
Living with an ileostomy can be challenging, and worrying about leaks from the pouch is a big concern for many people. Leaks can cause stress, lead to changes in lifestyle like avoiding social events, and even affect diet. Researchers at Ulster University have developed a new small device called Stomasense. This device can be worn discreetly with any stoma pouch and is designed to spot the very first signs of a leak. When it detects a leak, it alerts the user, giving them time to change their pouch before it becomes a bigger problem. The study wants to see how well this device works and if it helps people feel better and live more freely, including eating a healthier diet. Participants will try two versions of the device and fill out questionnaires about their experiences.
At a glance
What is this study about?
If you live with an ileostomy, you know that keeping your pouch secure is really important. Unfortunately, leaks can happen, and this can be very upsetting and stressful. Many people worry constantly about leaks, especially when they are out and about. This worry can make people change their daily lives, like avoiding going out or trying new foods, which can impact their overall health and happiness. When leaks do happen, the contents of the pouch can irritate the skin around the stoma, which can then make it harder for the pouch to stick properly in the future, creating a difficult cycle.
Researchers at Ulster University have been working on a clever new device called Stomasense. This device is designed to be worn discreetly alongside your usual stoma pouch. Its job is to act like an early warning system, detecting the very first signs that a leak might be starting. By letting you know early, it gives you a chance to change your pouch before the leak becomes noticeable or causes discomfort, aiming to prevent those distressing moments and protect your skin.
This study wants to see how well Stomasense works in real life. It also aims to understand if using such a device can help people with ileostomies feel more confident, reduce their worries, and ultimately improve their quality of life. The research team also wants to learn if using the device might help people feel more comfortable eating a wider range of foods, leading to a more balanced diet.
Key takeaways
- It's a study testing a new device called Stomasense for ileostomy leak detection.
- Aims to reduce worry about leaks and improve quality of life for people with ileostomies.
- Participants will try two versions of the device for two weeks each.
- Involves completing questionnaires and keeping a food diary.
- Potential benefits include fewer leaks and increased confidence.
Who may be eligible?
This study is looking for people who currently have an ileostomy, are 18 years old or older, and have had their ileostomy for at least 18 months. It's important that you experience leaks fairly often – meaning more than once a week – and that you manage your stoma care yourself. You'll also need to be able to use a computer or mobile device to fill out surveys and should not have any learning difficulties. Lastly, the study is for people who haven't tried or used other leak detection systems before. Both men and women can participate, but women who are pregnant or breastfeeding cannot join.
Some reasons you might not be able to join include if you've never had an ileostomy, haven't had one for at least 18 months, or are under 18. If you rarely experience leaks (less than once a week), have learning difficulties, have already used other leak detection systems, or if you are pregnant or breastfeeding, this study would not be suitable for you.
- Do you have an ileostomy?
- Have you had your ileostomy for over 18 months?
- Are you 18 years old or older?
- Do you experience leaks from your pouch more than once a week?
- Do you manage your own stoma care?
- Are you able to use a computer or mobile device for surveys?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you'll be asked to try out two different versions of the Stomasense device. You'll use each device for two weeks. At the start and end of each two-week period, you'll complete some questionnaires. These questionnaires will help the research team understand how well the device works and how it affects your daily life and feelings. You'll also be asked to keep a food diary to help researchers see if your diet affects when leaks happen. There are no specific visits to a clinic mentioned, and no medication is involved. The total duration of your active participation will be about four weeks, plus the time to complete questionnaires.
Potential risks and benefits
Locations (1)
- Ulster University, Human Intervention Studies UnitColeraine, United Kingdom
Common questions
What is an ileostomy?
An ileostomy is a surgical procedure where a part of your small intestine (ileum) is brought through an opening in your tummy (abdomen) to create a stoma. Bowel waste then passes out through this stoma and is collected in a special pouch.
What is the Stomasense device?
Stomasense is a new device developed to detect the very early signs of a leak from your ileostomy pouch, aiming to alert you before it becomes a noticeable problem.
Will this device work with my current stoma bag?
The study mentions that the device can be worn alongside 'any stoma pouch system', suggesting it's designed to be compatible with different types.
How long will I need to participate in the study?
If you join, you will be invited to try two versions of the device, each for two weeks, so the active part of the study will be about a month.
Will I have to go to a clinic?
The information provided suggests that you will complete questionnaires and food diaries, but it doesn't mention any required clinic visits.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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