Stomasense: A New Route to the Proactive Detection and Management of Leaks Within Ostomy Pouches

NCT06914804 | Enrolling By Invitation

• 2 other identifiers: UUREC/24/0074MR W029561
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ileostomy - Stoma

Keywords

Ileostomy; Stoma-pouch leakage; peristomal skin; dietary intake; quality of life

Outcome Measures

Primary Outcomes (7)

• Psychiatric morbidity

  Psychiatric morbidity will be assessed at the beginning and end of each test period using the General Health Questionnaire (GHQ-12).

  Comparison between treatments over a 2-week period.

• Psychological well-being

  Psychological well-being will be assessed at the beginning and end of each test period using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS)

  Comparison between treatments over a 2-week period.

• General quality of life

  General quality of life will be assessed at the beginning and end of each test period using the European Organization for Research and Treatment of Cancer (EORTC) QoL questionnaire for colorectal cancer (EORTCQLQ-CR38).

  Comparison between treatments over a 2-week period.

• General quality of life

  General quality of life will be assessed at the beginning and end of each test period using the The World Health Organization Quality of Life - BREF (WHOQOL-BREF).

  Comparison between treatments over a 2-week period.

• Stress and coping

  Stress and coping will be assessed at the beginning and end of each test period using the Perceived Stress Scale (PSS), which is a global measure of stress

  Change over 2 weeks comparison between treatments

• Resillience

  Resillience will be assessed at the beginning and end of each test period using the Connor-Davidson Resilience Scale (CD-RISC)

  Change over 2 weeks comparison between treatments

• Stoma related quality of life

  Stoma related quality of life will be assessed at the beginning and end of each test period using the Stoma QoL: A Quality-of-Life Questionnaire for People with an Ostomy

  Comparison between treatments over a 2-week period.

Secondary Outcomes (4)

• Device accuracy

  Measured over 2 weeks comparison between treatments

• Device usability

  Measured at 2 weeks comparison between treatments

• Dietary intake

  Measured over 2 weeks comparison between treatments

• Peristomal skin condition

  Comparison between treatments over a 2-week period.

Study Arms (2)

Leak detection device (microbutton probes)

EXPERIMENTAL

Leakage events will be detected by microbutton probes, which are attached to the sensing device

Device: Stomasense

Leak detection device (microwire probes)

EXPERIMENTAL

Leakage events will be detected by microwire probes, which are attached to the sensing device

Device: Stomasense

Interventions

Stomasense DEVICE

A smart device worn alongside stoma pouch systems which detects onset of a leak.

Leak detection device (microbutton probes); Leak detection device (microwire probes)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ulster: lead

Study Sites (1)

Ulster University, Human Intervention Studies Unit

Coleraine, Co. Derry, BT521SA, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 6, 2025
• Study Start: April 14, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)