Hello Heylo: Novel stoma bag leak detection technology

Heylo is the name of the new stoma bag leak detection technology developed by Coloplast. The stigma of stoma bags is being challenged with multiple models and celebrities coming out with their bedazzled stoma bags in brave and bold fashion such as Molly Pearce and Canadian model Sara Levitt. However, the reality remains that many people dread the life-saving and life-altering procedure that removes part of the intestinal tract.

The importance of advancing stoma bag technology

Why? As a young woman flaunting her own stoma bag, I can tell you the biggest problem in the ostomy community are leaks. Highlighting the need for this revolutionary technology of detecting leaks before they soil clothing, one’s mood and day will change the lives of many. 

Regular leaks significantly reduce the quality of life of those adorning a stoma bag(1) and it’s easy to see why. The taboo of poo (the tabpoo, if you will) and a misunderstanding of stomas result in shame and embarrassment of those experiencing a leak, and in extreme cases, can lead to someone ignoring their health requirements and developing anxiety about leaving the home. 

Stepping into my smelly shoes

If you’re reading with your intestines intact, let me explain the reality and inconvenience of a leak in public. It begins, first, with the underlying anxiety in your day-to-day life that you have a leak. This can come in the form of smelling other people’s flatulence (another reason not to fart in public, people) assuming it’s your own bag leaking that is causing the smell, or it can come as a phantom  ‘I-can-feel-something-dripping’ experience. 

You then must confirm your suspicion by lifting your clothes to visually check, or giving the adhesive base plate a quick tap to check you’re good and dry. In the scenario you’ve made it up in your head you can forget until your next phantom leak and repeat this process. 

In the infinitely more stressful scenario you have just, indeed, confirmed a leak, you have to conceal this leak from the public whilst trying to stop its flow from soiling your clothes further. For this to go as smoothly as possible we must make 4 important assumptions 1) that you have some tissue to stop the flow 2) that you are very close to a disabled toilet and 3) that you have taken with you a spare stoma bag, some dry wipes, adhesive remover spray, a disposable bag and 4) you have spare clothes to replace those soiled by the leak. 

In the more than likely scenario that you have not fulfilled all of 1, 2 and 3, the leak becomes socially embarrassing, stressful and urgent and/or impossible to complete your day as intended. All of this without even going into how leaks cause further issues such as peristomal skin complications(2), which generate a nasty feedback loop of making future leaks more likely. 

Now you can fully appreciate the need of such a technology that can re-write this destiny into an alert on your mobile stating ‘There is a problem, it may be a leakage’, to give you time to find a bathroom, change your bag, and finish your day without the embarrassment, stress or urgency typically associated with a bag leak. 

With wearable technology on the rise, rapidly becoming more advanced than the conventional watch activity tracker with glucose monitors, to temperature sensors in the form of a ring.  It’s no surprise this can, and is being applied to ostomy care. 

So how does it work?

A typical stoma bag has two main components: a skin barrier adhesive base plate (what sticks the bag to the skin) and the bag itself. The Heylo, developed by Coloplast containing the detection technology, also contains a sensor layer. 

Containing an inner and outer sensor ring, the sensor layer enables the interface between the skin and adhesive for moisture, a sign of leakage. The inner ring has three zones while the outer ring is a single zone, allowing information of not only direction of leakage, but also progression. 

A transmitter attached to a connector on this sensor layer enables the readout which is fed to a mobile via an app the user can view the status of their bag and allow push notifications warning the user of the time, direction and progression of the leak. 

It goes without saying the impact this kind of technology is going to have on the quality of life of people living with a stoma bag. The theory of the technology sounds great, but how did the Heylo perform when put to the test? 

How does it perform?

February 2023 a pilot study (3) was published testing Heylo on 25 Coloplast bag users. These participants experienced at least 3 leaks in the 14 days prior to the study and worried about leakage to at least some degree. 

For 18-24 days, participants were asked to use the Heylo baseplate bags , take an image after each change and use the mobile app connected to the sensor on the baseplate. To determine the efficacy of the Heylo system, images were compared to the notifications on the app. Questionnaires were also filled out on days 0, 1 and the termination date to determine feeling of leak control and quality of life around using the product. 

By comparing the baseplate images to the notification system, true positives and negatives were identified. Performance accuracy was determined to be 78% by comparing the sum of true positives and negatives with the sum of total events in the study. The remaining 22% of baseplate changes the app did not deliver the appropriate notification to the user, this was determined to be a result from:

• Software bugs.
• Loss of bluetooth connection between transmitter and phone.
• Early depletion of sensors due to mounting on wet skin. 

The questionnaires determined 78% of subjects deemed the technology trustworthy and 87% of subjects believed the product made it easier to know when to change their baseplate. Product-related quality of life surveys showed significantly improved scores for ‘discreteness’ and ‘confidence’ categories. 

Perhaps most significantly, during the trial period subjects experienced an 82% reduction in leakage onto clothes compared to the 21 days prior to the study. 

What do you think?

Would you use Heylo, the stoma bag leak detection technology? Hopefully those bugs have been ironed out because Coloplast released a statement early May 2024 announcing reimbursement approval for the Heylo leak detection system. I couldn’t be happier with this leap in the right direction. What will be interesting is whether the app will collect data and prompt ‘Is this notification accurate?’ question to determine how effective Heylo is over a larger scale and learn where they can improve. 

This kind of technology can be the difference between living a life full of worry around stoma bag maintenance to living a fulfilled life. I sincerely hope this technology will help those struggling to accept their stoma bag or feel too anxious in social settings will help with feeling more in control and empowered to step into life again. 

Thank you Coloplast for committing yourselves to raise the standard of care for ostomates. The world’s first digital leak detection system will be available in the UK and reimbursed from 1st July 2024. 

References:

(1) Claessens I, Probert R, Tielemans C et al. The Ostomy Life Study: the everyday challenges faced by people living with a stoma in a snapshot. Gastrointestinal Nursing. 2015 ;13(5):18–25. doi: 10.12968/ gasn.2015.13.5.18

(2) Voegeli D, Karlsmark T, Eddes EH et al. Factors influencing the incidence of peristomal skin complications: Evidence from a multinational survey on living with a stoma. Gastrointestinal Nursing. 2020; 1

(3) Brady, R. R. W., Fellows, J., Meisner, S., (2023). A pilot study of ostomy leakage notification system: impact on worry and quality of life. British Journal of Nursing. 2023 ; 32(6):S4-S12. doi: 10.12968/bjon.2023.32.6.S4.