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OpenTrials
Completed

NCT Number: NCT04307303

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

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.

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Key information

Conditions

Neurogenic Bowel Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salisbury NHS Foundation Trust

Salisbury, SP2 9BJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:
  • People with a diagnosis of spinal cord injury
  • Age =>18 years of age
  • Injury level at or above T12
  • complete or incomplete spinal cord lesion
  • Medically stable condition
  • Reflex bowel
  • =>1 year post spinal cord injury
  • Exclusion Criteria:
  • A history of organic bowel obstruction
  • Frequent opioid use,
  • Intrathecal baclofen or percutaneous endoscopic gastrostomy
  • Inflammatory bowel disease
  • Recent abdominal hernia
  • Recent gastrointestinal or abdominal surgery
  • Lower motor neuron lesions,
  • Suspected strictures or fistulae along the gastrointestinal tract
  • Physiologic gastrointestinal obstruction.
  • Other causes of constipation such as hypothyroidism, hypercalcaemia
  • Constipation predominant irritable bowel syndrome prior to diagnosis of SCI
  • Involvement in other research trial interventions likely to impact current trial
  • Poorly controlled epilepsy,
  • Cardiac pacemaker in situ
  • Other implanted electrical devices
  • Pregnancy or pregnancy planned
  • Cancerous tissue in the abdominal region
  • Any major skin disorders affecting the abdominal area)
  • Severe autonomic dysreflexia (tested at initial assessment).

Treatment and study plan

abdominal functional electrical stimulation

Device

functional electrical stimulation of the abdominal muscles

Other names: ABFES

Primary outcomes

  1. Time required for defecation

    Time frame: 8 weeks

    Time taken to have a bowel movement

Secondary outcomes

  1. Neurogenic bowel dysfunction score

    Time frame: 8 weeks

    Participants can score between 0 and 47 (0=minimum and 47=maximum score) a higher score = greater severity of symptoms

Sponsors and collaborators

Lead sponsor

Salisbury NHS Foundation Trust

Other Gov

Collaborators

  • Inspire Foundation

Registry information

Official study title

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

Acronym: BOWMAN

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2020
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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