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 managementitme 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: Not yet recruiting
• Conditions: Neurogenic Bowel
• Intervention / Treatment: Device: abdominal functional electrical stimulation

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

Contacts and Locations

• Study Contact: Name: Tamsyn Street; Phone Number: 5174 01722 336262; Email: Tamsyn.Street@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

People with a diagnosis of SCI (age=>18) above T12 complete or incomplete lesion in a medically stable condition with a reflex bowel =>1 year post spinal injury).

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Exclusion Criteria:

A history of organic bowel obstruction, frequent opioid use, intrathecal baclofen or percutaneous endoscopic gastrostomy, inflammatory bowel disease, abdominal hernia, any gastrointestinal or abdominal surgery (not necessarily excluded unless recent will require further investigation), lower motor neuron lesions, suspected strictures or fistulae along the gastrointestinal tract, physiologic gastrointestinal obstruction. Other causes of constipation such as hypothyroidism, hypercalcaemia and a prior history of constipation predominant IBS prior to diagnosis of SCI. Involvement in other research trial interventions likely to have an impact on the protocol or results of the current study.

Contra indications to electrical stimulation Poorly controlled epilepsy, cardiac pacemaker in situ or other implanted electrical devices (will require further investigation to examine whether there is an interaction between the device and FES) 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).

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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	Time Frame
Time required for defecation	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Neurogenic bowel dysfunction score	8 weeks
Male/Female sexual function index	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 (Anticipated): May 1, 2020
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2023

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): March 13, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries; 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