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

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

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.

Study Overview

• Status: Completed
• Conditions: Neurogenic Bowel
• Intervention / Treatment: Device: abdominal functional electrical stimulation

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Salisbury, United Kingdom, SP2 9BJ
    • Salisbury Nhs Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abdominal functional electrical stimulation	Device: abdominal functional electrical stimulation; functional electrical stimulation of the abdominal muscles; Other Names: ABFES
Sham Comparator: Low dose abdominal functional electrical stimulation arm	Device: abdominal functional electrical stimulation; functional electrical stimulation of the abdominal muscles; Other Names: ABFES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time required for defecation	Time taken to have a bowel movement	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurogenic bowel dysfunction score	Participants can score between 0 and 47 (0=minimum and 47=maximum score) a higher score = greater severity of symptoms	8 weeks

Collaborators and Investigators

• Sponsor: Salisbury NHS Foundation Trust
• Collaborators: Inspire Foundation
• Investigators: Principal Investigator: Tamsyn Street, Salisbury Nhs Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2021
• Primary Completion (Actual): May 30, 2025
• Study Completion (Actual): June 11, 2025

Study Registration Dates

• First Submitted: March 11, 2020
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Neurogenic Bowel
• Other Study ID Numbers: BOWMAN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No