We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04307303
Recruitment Status : Unknown
Verified March 2020 by Salisbury NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
First Posted : March 13, 2020
Last Update Posted : March 13, 2020
Sponsor:
Collaborator:
Inspire Foundation
Information provided by (Responsible Party):
Salisbury NHS Foundation Trust

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Neurogenic Bowel Device: abdominal functional electrical stimulation Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Sham-controlled, Proof of Principle Study of Abdominal Functional Electrical Stimulation (ABFES) for Bowel Management in Spinal Cord Injury (SCI)
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Abdominal functional electrical stimulation Device: abdominal functional electrical stimulation
functional electrical stimulation of the abdominal muscles
Other Name: ABFES
Sham Comparator: Low dose abdominal functional electrical stimulation arm Device: abdominal functional electrical stimulation
functional electrical stimulation of the abdominal muscles
Other Name: ABFES


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Time required for defecation [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Neurogenic bowel dysfunction score [ Time Frame: 8 weeks ]
  2. Male/Female sexual function index [ Time Frame: 8 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

-

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04307303


Contacts
Layout table for location contacts
Contact: Tamsyn Street 01722 336262 ext 5174 Tamsyn.Street@nhs.net

Sponsors and Collaborators
Salisbury NHS Foundation Trust
Inspire Foundation
Investigators
Layout table for investigator information
Principal Investigator: Tamsyn Street Salisbury NHS Foundation Trust
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Salisbury NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04307303    
Other Study ID Numbers: BOWMAN
First Posted: March 13, 2020    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neurogenic Bowel
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
 Wounds and Injuries
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases