NCT04307303

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 7, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2025

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

3.9 years

First QC Date

March 11, 2020

Last Update Submit

November 19, 2025

Conditions

Neurogenic Bowel

Outcome Measures

Primary Outcomes (1)

  • Time required for defecation

    Time taken to have a bowel movement

    8 weeks

Secondary Outcomes (1)

  • Neurogenic bowel dysfunction score

    8 weeks

Study Arms (2)

Abdominal functional electrical stimulation

EXPERIMENTAL
Device: abdominal functional electrical stimulation

Low dose abdominal functional electrical stimulation arm

SHAM COMPARATOR
Device: abdominal functional electrical stimulation

Interventions

abdominal functional electrical stimulationDEVICE

functional electrical stimulation of the abdominal muscles

Also known as: ABFES
Abdominal functional electrical stimulationLow dose abdominal functional electrical stimulation arm

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salisbury NHS Foundation Trust

Salisbury, SP2 9BJ, United Kingdom

Location

MeSH Terms

Conditions

Neurogenic Bowel

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Tamsyn Street

    Salisbury NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2020

First Posted

March 13, 2020

Study Start

July 7, 2021

Primary Completion

May 30, 2025

Study Completion

June 11, 2025

Last Updated

November 24, 2025

Record last verified: 2025-11

Locations

GB(1)