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

NCT04307303 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-11-24

No results posted yet for this study

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

DEVICE

abdominal functional electrical stimulation

functional electrical stimulation of the abdominal muscles

Sponsors & Collaborators

  • Inspire Foundation

    collaborator UNKNOWN

  • Salisbury NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Tamsyn Street · Salisbury NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-07
Primary Completion
2025-05-30
Completion
2025-06-11

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04307303 on ClinicalTrials.gov