Clinical trial NCT06914804: Stomasense: A New Route to the Proactive Detection and Management of Leaks Within Ostomy Pouches
Official title: Stomasense: A New Route to the Proactive Detection and Management of Leaks Within Ostomy Pouches
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Ileostomy - Stoma
Keywords: Ileostomy
Stoma-pouch leakage
peristomal skin
dietary intake
quality of life
Lead sponsor: University of Ulster
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: People living with an ileostomy may often experience leaks from their stoma pouches. Leakages are a highly stressful experience, so it is no surprise that worry about leaks is very common among ileostomates and this can contribute to increased anxiety and impact negatively on quality of life. Ileostomates will make changes to their lifestyle to minimise the occurrence of leaks; they may avoid travelling long distances, steer clear of busy social events and often restrict certain food(s) and / or drink(s). The latter stands in the way of achieving a healthy balanced diet and can put ileostomates at risk of developing nutritional deficiencies.

Researchers at ulster university have developed a leak sensor device which can be worn unobtrusively alongside any stoma pouch. The device can detect the early stages of a leak from the stoma bag and alerts the user, meaning they are able to change their pouch before it's too late. Participants will be asked to trial 2 versions of the device, each over a 2-week period. At the beginning and end of each period participants will complete a series of questionnaires to allow the research team to determine device efficacy and impact on quality of life. Food diaries will also be completed by participants to give an indication of how dietary intake can impact the incidence of pouch leakage.

Detailed description: Surgical diversion of the bowel to create an opening in the abdomen (stoma) is a common procedure in the treatment of various gastrointestinal conditions; 21 000 stomas are created in the UK each year and it is estimated that 176 000 - 205 000 individuals in the UK are living with a stoma. This is a life-changing operation which requires significant physical and psychological adaptation particularly as bowel/bladder content is collected in a disposable pouch that adheres to the abdomen. Leakage, especially in public, is a constant worry resulting in decreased social interactions, increased anxiety and depression and can have a tremendous impact on family and work life. The extent of the problem was confirmed by the Ostomy Life Study (2015) which surveyed some 4000 ostomates from 11 different countries and found the majority (91%) of participants reported that leakage of the pouch was a concern with 69% confirming that it was their prime worry and greatly impacted on their quality of life (QoL). Leakage events are very traumatic emotionally and will impact an individual's practical management of their ostomy; stoma effluent in contact with the epidermal layer is a major contributing factor in the development of peristomal skin complications (PCS), this in turn can cause difficulty in adhesion of the baseplate to the affected skin, therefore further contributing to the future leaks.

To put an end to this cycle of worsening skin integrity and subsequent increased frequency of leaks, new leak sensor technology has been developed by Ulster University which can be used with any stoma pouch system to detect the early onset of stoma pouch failure - providing an alert that allows the patient to replace the pouch before catastrophic seepage of bowel/bladder content.

Whilst this new leak sensor technology will be extremely useful in the early detection of leaks, it is important to also consider how an individual's management of their stoma, as well as health and lifestyle behaviours, could be manipulated to further reduce the incidence of leaks and improve QoL. In a previous study, participants identified food consumption (i.e., eating certain foods) as being the most prominent contributor to the incidence of leaks. It has been reported that fruit and vegetables are avoided by ostomates - in particular those with an ileostomy - to help minimise the risk of leaks. Obviously, this is less than ideal, considering the well-established health benefits of consuming a diet rich in fruit and vegetables. At present, there is no evidence confirming the efficacy of restricting dietary intake to reduce the frequency of leaks. Therefore, it is possible that people living with a stoma are unnecessarily restricting their dietary intake and putting themselves at risk of various nutrient deficiencies and associated health conditions.

The over-riding aim of the current proposal is to validate a smart device that can be worn unobtrusively alongside existing stoma pouch systems whilst monitoring the condition of the adhesive skin wafer, such that erosion of the bond can be detected before a leak occurs. This would enable the wearer to replace the pouch avoiding the consequences of leakage and accompanying distress, therefore improving QoL and psychological well-being. The impact of the device on participant well-being will be assessed using a series of validated questionnaires. The sensor is not a medical device as it only interacts with the stoma bag and flange and does not interact directly with the participant or their bodily fluids.

The sensing device will:

1. Accurately detect the onset of leaks.
2. Provide a discrete personal alert (vibration).
3. Allow for wireless connectivity for those requiring carer / nursing support.
4. Allow for differences in patient dexterity; two distinct probe systems (microbutton or microwire sensor) will be validated.

Therefore, this study seeks to test the sensor technology with ileostomates in a cross over study involving microbutton and microwire sensors. This study hopes to achieve an 85% success rate in the accurate detection of leaks.

The secondary aim of this study is to determine associations between dietary intake and the incidence of leakages. This information will have the potential to inform the development of dietary guidelines for those living with a stoma, and to therefore improve overall nutritional status and health of this patient group.

Eligibility criteria: Inclusion Criteria:

* Living with an ileostomy
* ≥1.5-years post-operative
* Aged 18+ years
* Experiencing frequent leaks (i.e., more than once per week)
* Males and females (not currently pregnant/lactating)
* Self-manging their own stoma
* Access to computer / mobile device for survey completion
* No learning or other disabilities
* Have never used / trialled other leak detection systems

Exclusion Criteria:

* Never had an ileostomy,
* Individuals with previous ileostomy or ostomy (colostomy or urostomy)
* \<1.5-year post-operative
* \<18 years
* Do not experience frequent leaks (i.e., less than once per week)
* Adults with learning or other disabilities
* Have previously used other leak detection systems
* Pregnant/lactating female

Primary outcomes:
measure: Psychiatric morbidity
timeFrame: Comparison between treatments over a 2-week period.
measure: Psychological well-being
timeFrame: Comparison between treatments over a 2-week period.
measure: General quality of life
timeFrame: Comparison between treatments over a 2-week period.
measure: General quality of life
timeFrame: Comparison between treatments over a 2-week period.
measure: Stress and coping
timeFrame: Change over 2 weeks comparison between treatments
measure: Resillience
timeFrame: Change over 2 weeks comparison between treatments
measure: Stoma related quality of life
timeFrame: Comparison between treatments over a 2-week period.
Secondary outcomes:
measure: Device accuracy
timeFrame: Measured over 2 weeks comparison between treatments
measure: Device usability
timeFrame: Measured at 2 weeks comparison between treatments
measure: Dietary intake
timeFrame: Measured over 2 weeks comparison between treatments
measure: Peristomal skin condition
timeFrame: Comparison between treatments over a 2-week period.
Other outcomes:
Locations:
city: Coleraine
country: United Kingdom
facility: Ulster University, Human Intervention Studies Unit
state: Co. Derry
Study officials:
References: