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

NCT04914975 | Completed

• 2 other identifiers: 2020-272021-00880
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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).

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Corn Test

  24 weeks; 5 time points

• Bristol Stool Form Scale (BSFS)

  24 weeks; at each defaecation

Other Outcomes (3)

• Qualiveen Short Form (SF)

  24 weeks; 5 times

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

  24 weeks; 5 times

• Questionnaire of treatment effectiveness

  24 weeks; 2 times

Study Arms (1)

NMES Group

EXPERIMENTAL

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

Interventions

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.

NMES Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

Related Publications (5)

• 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.

  PMID: 15273902 BACKGROUND

• 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.

  PMID: 20212501 BACKGROUND

• 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.

  PMID: 23217889 BACKGROUND

• 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.

  PMID: 12036401 BACKGROUND

• Bersch 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.

  PMID: 41146588 DERIVED

MeSH Terms

Conditions

Intestinal Diseases; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Ines Bersch, PhD

  International FES Centre - Swiss Paraplegic Centre Nottwil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: repeated measures interventional single subject design

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 7, 2021
• Study Start: July 4, 2021
• Primary Completion: August 31, 2024
• Study Completion: October 30, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)