NCT04307303

Electrical Stimulation of Abdominal Muscles for Bowel Management in People With Spinal Cord Injury

A Randomised Sham-controlled, Proof of Principle Study of Abdominal Functional Electrical Stimulation (ABFES) for Bowel Management in Spinal Cord Injury (SCI)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Salisbury NHS Foundation Trust · Other Government
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

A well-managed bowel program is an essential part of daily life for many people with a SCI. Nevertheless, constipation is frequently reported (42-95%). Constipation embraces a spectrum of harms including both physical \& psychological distress. Initial exploratory studies suggest abdominal FES may be useful for decreasing overall bowel management time, decreasing colonic transit time and reducing discomfort. The current study will seek to reproduce previous findings in a 12 week study, using overall bowel management time as a benchmark for establishing proof of principle. The study will include 36 people with a spinal cord injury aged 18 and over with an above T12 injury, a complete or incomplete lesion in a medically stable condition, one year or more after injury. Participants will be randomised into two groups. One group will receive abdominal electrical stimulation and the other group low dose abdominal electrical stimulation. Participants will be asked to keep a bowel diary and complete questionnaires examining quality of life and bowel management.

Conditions

• Neurogenic Bowel

Interventions

Type	Name	Description
DEVICE	abdominal functional electrical stimulation	functional electrical stimulation of the abdominal muscles

Timeline

• Start date: 2021-07-07
• Primary completion: 2025-05-30
• Completion: 2025-06-11
• First posted: 2020-03-13
• Last updated: 2025-11-24

Locations

1 site across 1 country: United Kingdom