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

Primary Purpose

Neurogenic Bowel

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
abdominal functional electrical stimulation
Sponsored by
Salisbury NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurogenic Bowel

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

-

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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Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Abdominal functional electrical stimulation

    Low dose abdominal functional electrical stimulation arm

    Arm Description

    Outcomes

    Primary Outcome Measures

    Time required for defecation

    Secondary Outcome Measures

    Neurogenic bowel dysfunction score
    Male/Female sexual function index

    Full Information

    First Posted
    March 11, 2020
    Last Updated
    March 11, 2020
    Sponsor
    Salisbury NHS Foundation Trust
    Collaborators
    Inspire Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04307303
    Brief Title
    Electrical Stimulation of Abdominal Muscles for Bowel Management in People With Spinal Cord Injury
    Acronym
    BOWMAN
    Official Title
    A Randomised Sham-controlled, Proof of Principle Study of Abdominal Functional Electrical Stimulation (ABFES) for Bowel Management in Spinal Cord Injury (SCI)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2020 (Anticipated)
    Primary Completion Date
    May 2022 (Anticipated)
    Study Completion Date
    May 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Salisbury NHS Foundation Trust
    Collaborators
    Inspire Foundation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neurogenic Bowel

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Abdominal functional electrical stimulation
    Arm Type
    Experimental
    Arm Title
    Low dose abdominal functional electrical stimulation arm
    Arm Type
    Sham Comparator
    Intervention Type
    Device
    Intervention Name(s)
    abdominal functional electrical stimulation
    Other Intervention Name(s)
    ABFES
    Intervention Description
    functional electrical stimulation of the abdominal muscles
    Primary Outcome Measure Information:
    Title
    Time required for defecation
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Neurogenic bowel dysfunction score
    Time Frame
    8 weeks
    Title
    Male/Female sexual function index
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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). - 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). -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tamsyn Street
    Phone
    01722 336262
    Ext
    5174
    Email
    Tamsyn.Street@nhs.net
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tamsyn Street
    Organizational Affiliation
    Salisbury NHS Foundation Trust
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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