Status:
COMPLETED
Electrical Stimulation of Abdominal Muscles for Bowel Management in People With Spinal Cord Injury
Lead Sponsor:
Salisbury NHS Foundation Trust
Collaborating Sponsors:
Inspire Foundation
Conditions:
Neurogenic Bowel
Eligibility:
All Genders
18-100 years
Phase:
NA
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 includ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04307303
Start Date
July 7 2021
End Date
June 11 2025
Last Update
November 24 2025
Active Locations (1)
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1
Salisbury NHS Foundation Trust
Salisbury, United Kingdom, SP2 9BJ