Skip to main content
OpenTrials
Completed

NCT Number: NCT04914975

The Effect of NMES on Bowel Management in People With Chronic SCI

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Neuromuscular electrical stimulation

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Corn Test

    Time frame: 24 weeks; 5 time points

    "Corn Test" assessing bowel transit time

  2. Bristol Stool Form Scale (BSFS)

    Time frame: 24 weeks; at each defaecation

    BSFS for stool consistency

Other outcomes

  1. Qualiveen Short Form (SF)

    Time frame: 24 weeks; 5 times

    Qualiveen SF to assess bladder function

  2. International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI)

    Time frame: 24 weeks; 5 times

    International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI)

  3. Questionnaire of treatment effectiveness

    Time frame: 24 weeks; 2 times

    Questionnaire of treatment effectiveness containing 3 questions about the application of the stimulation

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Official study title

The Effect of Neuromuscular Electrical Stimulation on Bowel Management in People With Chronic Spinal Cord Injury - a Pilot Study

Acronym: FES_Bowel

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 7, 2021
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.