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

Neurogenic Bowel Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04307303
• Other study ID #: BOWMAN
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2021
• Est. completion date: May 30, 2024

Study information

• Verified date: April 2024
• Source: Salisbury NHS Foundation Trust
• Contact: Tamsyn Street
• Phone: 01722 336262
• Email: Tamsyn.Street[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

• Inclusion Criteria:

• 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

• Exclusion Criteria:

• 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

• 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).

Related Conditions & MeSH terms

• Neurogenic Bowel
• Spinal Cord Injuries

Intervention

Device:
• abdominal functional electrical stimulation
functional electrical stimulation of the abdominal muscles

Locations

Country	Name	City	State
United Kingdom	Salisbury NHS Foundation Trust	Salisbury

Sponsors (2)

Lead Sponsor	Collaborator
Salisbury NHS Foundation Trust	Inspire Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time required for defecation	Time taken to have a bowel movement	8 weeks
Secondary	Neurogenic bowel dysfunction score	Participants can score between 0 and 47 (0=minimum and 47=maximum score) a higher score = greater severity of symptoms	8 weeks