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

Primary Purpose

Electric Stimulation Therapy, Bowel Dysfunction, Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Neuromuscular electrical stimulation
Sponsored by
Swiss Paraplegic Research, Nottwil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Electric Stimulation Therapy focused on measuring Spinal Cord Injuries, Electrical Stimulation, Bowel Management, Transit Time, Incontinence, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Swiss Paraplegic CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NMES Group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Corn Test
"Corn Test" assessing bowel transit time
Bristol Stool Form Scale (BSFS)
BSFS for stool consistency

Full Information

First Posted
May 31, 2021
Last Updated
March 13, 2023
Sponsor
Swiss Paraplegic Research, Nottwil
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1. Study Identification

Unique Protocol Identification Number
NCT04914975
Brief Title
The Effect of NMES on Bowel Management in People With Chronic SCI
Acronym
FES_Bowel
Official Title
The Effect of Neuromuscular Electrical Stimulation on Bowel Management in People With Chronic Spinal Cord Injury - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Swiss Paraplegic Research, Nottwil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Electric Stimulation Therapy, Bowel Dysfunction, Spinal Cord Injuries, Defecation Disorder
Keywords
Spinal Cord Injuries, Electrical Stimulation, Bowel Management, Transit Time, Incontinence, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
repeated measures interventional single subject design
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NMES Group
Arm Type
Experimental
Arm Description
Participants will receive neuromuscular electrical stimulation of the abdominal wall before defaecation for 30 minutes over the course of 16 weeks.
Intervention Type
Other
Intervention Name(s)
Neuromuscular electrical stimulation
Intervention Description
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 Outcome Measure Information:
Title
Neurogenic Bowel Dysfunction Score (NBDS) and the defaecation time from the stimulation protocol
Description
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
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Corn Test
Description
"Corn Test" assessing bowel transit time
Time Frame
24 weeks; 5 time points
Title
Bristol Stool Form Scale (BSFS)
Description
BSFS for stool consistency
Time Frame
24 weeks; at each defaecation
Other Pre-specified Outcome Measures:
Title
Qualiveen Short Form (SF)
Description
Qualiveen SF to assess bladder function
Time Frame
24 weeks; 5 times
Title
International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI)
Description
International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI)
Time Frame
24 weeks; 5 times
Title
Questionnaire of treatment effectiveness
Description
Questionnaire of treatment effectiveness containing 3 questions about the application of the stimulation
Time Frame
24 weeks; 2 times

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ines Bersch, PhD
Phone
+41 41 939 42 06
Email
ines.bersch@paraplegie.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Kathrin Dopke, MPH
Phone
+41 41 939 43 34
Email
kathrin.dopke@paraplegie.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ines Bersch, PhD
Organizational Affiliation
International FES Centre - Swiss Paraplegic Centre Nottwil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swiss Paraplegic Centre
City
Nottwil
State/Province
LU
ZIP/Postal Code
6207
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ines Bersch, PhD
Phone
+41 41 939 4206
Email
ines.bersch@paraplegie.ch

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12036401
Citation
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.
Results Reference
background
PubMed Identifier
15273902
Citation
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.
Results Reference
result
PubMed Identifier
20212501
Citation
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.
Results Reference
result
PubMed Identifier
23217889
Citation
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.
Results Reference
result

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

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