Neurogenic BowelBOWMANNCT04307303
Electrical Stimulation of Abdominal Muscles for Bowel Management in People With Spinal Cord Injury
A study testing abdominal functional electrical stimulation in people with Neurogenic Bowel, run by Salisbury NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurogenic Bowel
- What is being tested?
- abdominal functional electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jul 2021to 11 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 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.
- Conditions
- Neurogenic Bowel
- Being tested
- abdominal functional electrical stimulation
- Medical subject headings
- Neurogenic Bowel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal functional electrical stimulationDevice
Also called ABFES
functional electrical stimulation of the abdominal muscles
| Study group | Role | What they receive |
|---|---|---|
| Abdominal functional electrical stimulation | Experimental | Not described Receives: Device: abdominal functional electrical stimulation |
| Low dose abdominal functional electrical stimulation arm | Sham comparator | Not described Receives: Device: abdominal functional electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required for defecation
Time taken to have a bowel movement
Measured: 8 weeks
Secondary outcomes (1)
Neurogenic bowel dysfunction score
Participants can score between 0 and 47 (0=minimum and 47=maximum score) a higher score = greater severity of symptoms
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start7 Jul 2021
- Primary completion30 May 2025
- Study completion11 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic BowelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salisbury NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Inspire Foundation
- Responsible party
- Sponsor
- Investigators
- Tamsyn Street, Principal investigator, Salisbury NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307303
- Sponsor's protocol ID
- BOWMAN
- Acronym
- BOWMAN
- Status last verified
- Nov 2025
- First submitted
- 11 Mar 2020
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Sham-controlled, Proof of Principle Study of Abdominal Functional Electrical Stimulation (ABFES) for Bowel Management in Spinal Cord Injury (SCI)
- ClinicalTrials.gov ID
- NCT04307303
- Acronym / sponsor ID
- BOWMAN / BOWMAN
- Conditions
- Neurogenic Bowel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Salisbury NHS Foundation TrustOther government
- Collaborators
- Inspire Foundation
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal functional electrical stimulation | Experimental | Device: abdominal functional electrical stimulation |
| Low dose abdominal functional electrical stimulation arm | Sham comparator | Device: abdominal functional electrical stimulation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- A history of organic bowel obstruction
- Frequent opioid use,
- Intrathecal baclofen or percutaneous endoscopic gastrostomy
- Inflammatory bowel disease
- Recent abdominal hernia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abdominal functional electrical stimulationAlso: ABFESfunctional electrical stimulation of the abdominal muscles | Device | Abdominal functional electrical stimulation, Low dose abdominal functional electrical stimulation arm |
Primary outcome
Time required for defecation
Time frame: 8 weeks
Time taken to have a bowel movement
1 secondary outcome
Neurogenic bowel dysfunction score
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamsyn Street principal investigator
Salisbury NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing abdominal functional electrical stimulation in people with Neurogenic Bowel, run by Salisbury NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time required for defecation (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.