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

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).

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries; Electric Stimulation Therapy; Bowel Dysfunction; Defecation Disorder
• Intervention / Treatment: Other: Neuromuscular electrical stimulation

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ines Bersch, PhD; Phone Number: +41 41 939 42 06; Email: ines.bersch@paraplegie.ch
• Study Contact Backup: Name: Kathrin Dopke, MPH; Phone Number: +41 41 939 43 34; Email: kathrin.dopke@paraplegie.ch

Study Locations

• Switzerland
  • LU
    • Nottwil, LU, Switzerland, 6207
      • Recruiting
      • Swiss Paraplegic Centre
      • Contact: Ines Bersch, PhD
      • Contact: Phone Number: +41 41 939 4206; Email: ines.bersch@paraplegie.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: NMES Group; Participants will receive neuromuscular electrical stimulation of the abdominal wall before defaecation for 30 minutes over the course of 16 weeks.

Other: Neuromuscular electrical stimulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corn Test	"Corn Test" assessing bowel transit time	24 weeks; 5 time points
Bristol Stool Form Scale (BSFS)	BSFS for stool consistency	24 weeks; at each defaecation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualiveen Short Form (SF)	Qualiveen SF to assess bladder function	24 weeks; 5 times
International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI)	International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI)	24 weeks; 5 times
Questionnaire of treatment effectiveness	Questionnaire of treatment effectiveness containing 3 questions about the application of the stimulation	24 weeks; 2 times

Collaborators and Investigators

• Sponsor: Swiss Paraplegic Centre Nottwil
• Investigators: Principal Investigator: Ines Bersch, PhD, International FES Centre - Swiss Paraplegic Centre Nottwil

Publications and helpful links

General 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.
• Korsten 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.
• Krassioukov 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.
• Clarke 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2021
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: May 31, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Incontinence; Electrical Stimulation; Spinal Cord Injuries; Transit Time; Bowel Management
• Additional Relevant MeSH Terms: Digestive System Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Gastrointestinal Diseases; Trauma, Nervous System; Spinal Cord Diseases; Intestinal Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 2020-27; 2021-00880 (Other Identifier: EKNZ)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No