Electric Stimulation TherapyFES_BowelNCT04914975
The Effect of NMES on Bowel Management in People With Chronic SCI
A study testing Neuromuscular electrical stimulation in people with Electric Stimulation Therapy and Bowel Dysfunction, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
It has been reported that 62% of all people with Spinal Cord Injury (SCI) have experienced faecal incontinence and that neurogenic bowel dysfunction (NBD) is a major sequela. As an alternative to abdominal massage or the use of suppositories, the electrical stimulation (ES) of the abdominal wall has been shown to be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Electric Stimulation Therapy, Bowel Dysfunction, Spinal Cord Injuries
- What is being tested?
- Neuromuscular electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Jul 2021to 30 Oct 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic and non-traumatic SCI; > 1 year
- Level of lesion: C2 - L5
- AIS score A/B/C/D
- Age: ≥ 18 years
- Urge to reduce defaecation time
Who cannot join
- Patients during primary rehabilitation
- Bladder stimulator
- Autonomic dysreflexia by application of ES of the abdominal wall
- Pregnancy: test in women of childbearing age (15 - 49 years)
- Opioid use
- Inflammatory bowel disease
- Cancerous tissue in abdominal region
- Patients' inability to follow the study, e.g. mental-health problems, language problems, dementia etc.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
About this study
Official title: The Effect of Neuromuscular Electrical Stimulation on Bowel Management in People With Chronic Spinal Cord Injury - a Pilot Study
It has been reported that 62% of all people with Spinal Cord Injury (SCI) have experienced faecal incontinence and that neurogenic bowel dysfunction (NBD) is a major sequela. As an alternative to abdominal massage or the use of suppositories, the electrical stimulation (ES) of the abdominal wall has been shown to be effective in decreasing the bowel transit time as well as decreasing constipation in children with slow-transit constipation. Due to the intrinsic nature of the guts' innervation, we expect to reproduce these positive effects in people with SCI through administration of neuromuscular electrical stimulation (NMES).
Read the detailed description
A SCI entails devastating changes to a person's life. The extent of these changes depends on the level and degree of the lesion. NBD is one of the most important sequelae occurring in the majority of people with a SCI. It has been reported that 62% of people with SCI had experienced faecal incontinence . In fact, NBD is caused by a disruption of the autonomic nervous system leading to a disturbed colonic peristalsis. The enteric nervous system of the intestines is an intrinsic system that can function independently, but it is widely influenced by the autonomic nervous system. As such, its regulation is perturbed because the parasympathetic and the sympathetic nervous systems do modulate it but do not directly control the smooth muscle cells of the bowel . Depending on the level of the lesion, the bowel function can be affected in various ways ranging from constipation to overflow incontinence.
Hence, NBD has a major impact on the quality of life of paraplegics and tetraplegics. Not only is there a physical component to it consisting of constipation, haemorrhoids or abdominal distension but these gastrointestinal impairments also have a social aspect. People with SCI often end up avoiding social events and tend to isolate because of the fear of incontinence.
The immense expenditure of time for bowel evacuation is a consequence of the dyscoordination of faecal elimination. According to a survey study, 22% of all participants with SCI spend 31 to 60 minutes and 14% more than 60 minutes on bowel care per defecation. For example, people with an upper motor neuron lesion to their bowel are mainly confronted with faecal retention and constipation. Among the methods for bowel evacuation, the application of digital stimulation of the rectum and/or the insertion of a suppository are mostly used. Some people also use abdominal massage just before bowel evacuation . Only a few studies have investigated the effect of ES to the abdominal wall on the defaecation time in people with SCI and an upper motor neuron lesion but none investigated the defecation time in people with SCI with a lesion below the level of Th12. Nevertheless, the results of this therapeutic modality are very promising for different populations such as multiple sclerosis and children with slow-transit constipation by decreasing constipation and increasing transit times respectively.
By means of providing a more efficient and reliable method to support people with SCI in their bowel management strategy.A pilot study with a convenience sample of 20 out- and inpatients of the Swiss Paraplegic Centre will be conducted. Patients who have found a good bowel management method for themselves but claim to invest too much time in this routine are eligible for the study. During their participation, they should follow their usual routine after applying ES for 30 minutes before defaecation.
Based on the recent findings and clinical experience, it is hypothesized that NMES has the potential to reduce defaecation times as well as the bowel transit time in people with SCI experiencing NBD.
- Conditions
- Electric Stimulation Therapy, Bowel Dysfunction, Spinal Cord Injuries, Defecation Disorder
- Being tested
- Neuromuscular electrical stimulation
- Keywords
- Spinal Cord Injuries, Electrical Stimulation, Bowel Management, Transit Time, Incontinence, Quality of Life
- Medical subject headings
- Intestinal Diseases, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulationOther
The stimulation will be conducted at home or at the SPC for half an hour about 30 minutes before the usual bowel emptying time. Four adhesive electrodes are attached to the abdominal wall for the neuromuscular electrical stimulation. The abdominal muscles are stimulated in such a way that activation occurs, i.e. the muscle alternately contracts and relaxes again. The stimulation sessions will be documented with a defined protocol. In addition, the stool consistency is rated according to the Bristol Stool Form Scale.
| Study group | Role | What they receive |
|---|---|---|
| NMES Group | Experimental | Participants will receive neuromuscular electrical stimulation of the abdominal wall before defaecation for 30 minutes over the course of 16 weeks. Receives: Other: Neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurogenic Bowel Dysfunction Score (NBDS) and the defaecation time from the stimulation protocol
Investigation of the effect of NMES on the change in defaecation time (minutes) and its relation to the change in NBDS between the follow-up visits and baseline
Measured: 24 weeks
Secondary outcomes (2)
Corn Test
"Corn Test" assessing bowel transit time
Measured: 24 weeks; 5 time points
Bristol Stool Form Scale (BSFS)
BSFS for stool consistency
Measured: 24 weeks; at each defaecation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start4 Jul 2021
- Primary completion31 Aug 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Electric Stimulation TherapyStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- repeated measures interventional single subject design
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Ines Bersch, PhD, Principal investigator, International FES Centre - Swiss Paraplegic Centre Nottwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914975
- Sponsor's protocol ID
- 2020-27
- Other IDs
- 2021-00880
- Acronym
- FES_Bowel
- Status last verified
- Oct 2024
- First submitted
- 31 May 2021
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benevento BT, Sipski ML. Neurogenic bladder, neurogenic bowel, and sexual dysfunction in people with spinal cord injury. Phys Ther. 2002 Jun;82(6):601-12.
PubMed 12036401Korsten MA, Fajardo NR, Rosman AS, Creasey GH, Spungen AM, Bauman WA. Difficulty with evacuation after spinal cord injury: colonic motility during sleep and effects of abdominal wall stimulation. J Rehabil Res Dev. 2004 Jan-Feb;41(1):95-100. doi: 10.1682/jrrd.2004.01.0095.
PubMed 15273902Krassioukov A, Eng JJ, Claxton G, Sakakibara BM, Shum S. Neurogenic bowel management after spinal cord injury: a systematic review of the evidence. Spinal Cord. 2010 Oct;48(10):718-33. doi: 10.1038/sc.2010.14. Epub 2010 Mar 9.
PubMed 20212501Clarke MC, Catto-Smith AG, King SK, Dinning PG, Cook IJ, Chase JW, Gibb SM, Robertson VJ, Di Simpson, Hutson JM, Southwell BR. Transabdominal electrical stimulation increases colonic propagating pressure waves in paediatric slow transit constipation. J Pediatr Surg. 2012 Dec;47(12):2279-84. doi: 10.1016/j.jpedsurg.2012.09.021.
PubMed 23217889Bersch I, Schafer K, Limacher A, Sonntag U, Baumberger M, Alberty M. The effect of neuromuscular electrical stimulation on bowel management in people with chronic spinal cord injury-An IDEAL 2a pilot study. Colorectal Dis. 2025 Nov;27(11):e70276. doi: 10.1111/codi.70276.
PubMed 41146588
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neuromuscular Electrical Stimulation on Bowel Management in People With Chronic Spinal Cord Injury - a Pilot Study
- ClinicalTrials.gov ID
- NCT04914975
- Acronym / sponsor ID
- FES_Bowel / 2020-27
- Conditions
- Electric Stimulation Therapy, Bowel Dysfunction, Spinal Cord Injuries, Defecation Disorder
- Keywords
- Spinal Cord Injuries, Electrical Stimulation, Bowel Management, Transit Time, Incontinence, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 4 Jul 2021 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 7 Jun 2021 (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.
It has been reported that 62% of all people with Spinal Cord Injury (SCI) have experienced faecal incontinence and that neurogenic bowel dysfunction (NBD) is a major sequela. As an alternative to abdominal massage or the use of suppositories, the electrical stimulation (ES) of the abdominal wall has been shown to be effective in decreasing the bowel transit time as well as decreasing constipation in children with slow-transit constipation. Due to the intrinsic nature of the guts' innervation, we expect to reproduce these positive effects in people with SCI through administration of neuromuscular electrical stimulation (NMES).
Detailed description
A SCI entails devastating changes to a person's life. The extent of these changes depends on the level and degree of the lesion. NBD is one of the most important sequelae occurring in the majority of people with a SCI. It has been reported that 62% of people with SCI had experienced faecal incontinence . In fact, NBD is caused by a disruption of the autonomic nervous system leading to a disturbed colonic peristalsis. The enteric nervous system of the intestines is an intrinsic system that can function independently, but it is widely influenced by the autonomic nervous system. As such, its regulation is perturbed because the parasympathetic and the sympathetic nervous systems do modulate it but do not directly control the smooth muscle cells of the bowel . Depending on the level of the lesion, the bowel function can be affected in various ways ranging from constipation to overflow incontinence.
Hence, NBD has a major impact on the quality of life of paraplegics and tetraplegics. Not only is there a physical component to it consisting of constipation, haemorrhoids or abdominal distension but these gastrointestinal impairments also have a social aspect. People with SCI often end up avoiding social events and tend to isolate because of the fear of incontinence.
The immense expenditure of time for bowel evacuation is a consequence of the dyscoordination of faecal elimination. According to a survey study, 22% of all participants with SCI spend 31 to 60 minutes and 14% more than 60 minutes on bowel care per defecation. For example, people with an upper motor neuron lesion to their bowel are mainly confronted with faecal retention and constipation. Among the methods for bowel evacuation, the application of digital stimulation of the rectum and/or the insertion of a suppository are mostly used. Some people also use abdominal massage just before bowel evacuation . Only a few studies have investigated the effect of ES to the abdominal wall on the defaecation time in people with SCI and an upper motor neuron lesion but none investigated the defecation time in people with SCI with a lesion below the level of Th12. Nevertheless, the results of this therapeutic modality are very promising for different populations such as multiple sclerosis and children with slow-transit constipation by decreasing constipation and increasing transit times respectively.
By means of providing a more efficient and reliable method to support people with SCI in their bowel management strategy.A pilot study with a convenience sample of 20 out- and inpatients of the Swiss Paraplegic Centre will be conducted. Patients who have found a good bowel management method for themselves but claim to invest too much time in this routine are eligible for the study. During their participation, they should follow their usual routine after applying ES for 30 minutes before defaecation.
Based on the recent findings and clinical experience, it is hypothesized that NMES has the potential to reduce defaecation times as well as the bowel transit time in people with SCI experiencing NBD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- repeated measures interventional single subject design
| Arm | Type | Receives |
|---|---|---|
| NMES Group | Experimental | Other: Neuromuscular electrical stimulationParticipants will receive neuromuscular electrical stimulation of the abdominal wall before defaecation for 30 minutes over the course of 16 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Traumatic and non-traumatic SCI; > 1 year
- Level of lesion: C2 - L5
- AIS score A/B/C/D
- Age: ≥ 18 years
- Urge to reduce defaecation time
Key exclusion criteria (8 listed)
- Patients during primary rehabilitation
- Bladder stimulator
- Autonomic dysreflexia by application of ES of the abdominal wall
- Pregnancy: test in women of childbearing age (15 - 49 years)
- Opioid use
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 |
|---|---|---|
| Neuromuscular electrical stimulationThe stimulation will be conducted at home or at the SPC for half an hour about 30 minutes before the usual bowel emptying time. Four adhesive electrodes are attached to the abdominal wall for the neuromuscular electrical stimulation. The abdominal muscles are stimulated in such a way that activation occurs, i.e. the muscle alternately contracts and relaxes again. The stimulation sessions will be documented with a defined protocol. In addition, the stool consistency is rated according to the Bristol Stool Form Scale. | Other | NMES Group |
Primary outcome
Neurogenic Bowel Dysfunction Score (NBDS) and the defaecation time from the stimulation protocol
Time frame: 24 weeks
Investigation of the effect of NMES on the change in defaecation time (minutes) and its relation to the change in NBDS between the follow-up visits and baseline
2 secondary outcomes
Corn Test
Time frame: 24 weeks; 5 time points
Bristol Stool Form Scale (BSFS)
Time frame: 24 weeks; at each defaecation
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 9 Dec 2024.
- Background: PubMed 12036401Benevento BT, Sipski ML. Neurogenic bladder, neurogenic bowel, and sexual dysfunction in people with spinal cord injury. Phys Ther. 2002 Jun;82(6):601-12.
- Results publication: PubMed 15273902Korsten MA, Fajardo NR, Rosman AS, Creasey GH, Spungen AM, Bauman WA. Difficulty with evacuation after spinal cord injury: colonic motility during sleep and effects of abdominal wall stimulation. J Rehabil Res Dev. 2004 Jan-Feb;41(1):95-100. doi: 10.1682/jrrd.2004.01.0095.
- Results publication: PubMed 20212501Krassioukov A, Eng JJ, Claxton G, Sakakibara BM, Shum S. Neurogenic bowel management after spinal cord injury: a systematic review of the evidence. Spinal Cord. 2010 Oct;48(10):718-33. doi: 10.1038/sc.2010.14. Epub 2010 Mar 9.
- Results publication: PubMed 23217889Clarke MC, Catto-Smith AG, King SK, Dinning PG, Cook IJ, Chase JW, Gibb SM, Robertson VJ, Di Simpson, Hutson JM, Southwell BR. Transabdominal electrical stimulation increases colonic propagating pressure waves in paediatric slow transit constipation. J Pediatr Surg. 2012 Dec;47(12):2279-84. doi: 10.1016/j.jpedsurg.2012.09.021.
- Derived from this study: PubMed 41146588Bersch I, Schafer K, Limacher A, Sonntag U, Baumberger M, Alberty M. The effect of neuromuscular electrical stimulation on bowel management in people with chronic spinal cord injury-An IDEAL 2a pilot study. Colorectal Dis. 2025 Nov;27(11):e70276. doi: 10.1111/codi.70276.
- Individual participant dataSharing planned: No
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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.
Ines Bersch, PhD principal investigator
International FES Centre - Swiss Paraplegic Centre Nottwil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation in people with Electric Stimulation Therapy and Bowel Dysfunction, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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 5 inclusion and 8 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 9 Dec 2024. 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 Switzerland. 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. 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?
Neurogenic Bowel Dysfunction Score (NBDS) and the defaecation time from the stimulation protocol (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04914975, which also lists 5 linked publications.
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 9 Dec 2024.