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Stimulation for Bowel Emptying

Primary Purpose

Neurogenic Bowel Dysfunction

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electrical Rectal Stimulation
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurogenic Bowel Dysfunction

Eligibility Criteria

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

Inclusion Criteria: Suprasacral spinal cord injury Diagnosed neurogenic bowel dysfunction and using digital rectal stimulation Bowel routine requires at least 30 minutes or at least 3 cycles of digital rectal stimulation Neurologically stable At least 18 years old At least 12 months post neurological injury or disease diagnosis Exclusion Criteria: Active sepsis Open pressure sores on or around pelvis Significant colon trauma or colostomy Crohn's disease Colonic obstruction or gastrointestinal surgery within last 3 months Significant history of autonomic dysreflexia

Sites / Locations

  • Syracuse VA Medical Center, Syracuse, NY
  • Louis Stokes VA Medical Center, Cleveland, OH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bowel emptying

Arm Description

Study participants will act as their own controls, first providing data using their usual digital rectal stimulation intervention for bowel care, then providing data using electrical stimulation for bowel care.

Outcomes

Primary Outcome Measures

Time required to complete bowel emptying
Two interventions will be tested, including the clinical standard of digital rectal stimulation and a novel approach using electrical stimulation of rectal sensory afferents, to determine the effect on colonic pressure. We will compare the time required for the participant to complete their bowel emptying routine between a control period with digital rectal stimulation and a treatment period with electrical rectal stimulation.

Secondary Outcome Measures

Full Information

First Posted
October 5, 2023
Last Updated
October 17, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT06078176
Brief Title
Stimulation for Bowel Emptying
Official Title
Electrical Rectal Stimulation to Promote Bowel Emptying After Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators are testing the effect of electrical stimulation of the rectum on colonic motility. Most individuals with spinal cord injury develop neurogenic bowel dysfunction, which includes slowed colonic motility, which means that stools take longer than normal to pass through the colon. This slowed movement may result in chronic constipation and difficulty emptying the bowels. Individuals typically (without or without caregiver assistance) insert a gloved finger into the rectum and gently stretch it to improve colonic motility for a brief period to empty the bowels. The investigators hypothesize that electrically stimulating the rectum, instead of mechanically stretching it, will produce the same beneficial effect of improving colonic motility. Therefore, this study will compare the two methods. If electrical stimulation effectively improves colonic motility, then the investigator shall develop the approach as a therapeutic intervention in future studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Bowel Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bowel emptying
Arm Type
Experimental
Arm Description
Study participants will act as their own controls, first providing data using their usual digital rectal stimulation intervention for bowel care, then providing data using electrical stimulation for bowel care.
Intervention Type
Other
Intervention Name(s)
Electrical Rectal Stimulation
Intervention Description
Electrical stimulation of the rectum will be applied to activate sensory afferent neurons of the rectum and evoke a recto-colonic reflex to improve colonic motility and facilitate bowel emptying. This intervention will compared to individuals' usual mechanical intervention of digital rectal stimulation.
Primary Outcome Measure Information:
Title
Time required to complete bowel emptying
Description
Two interventions will be tested, including the clinical standard of digital rectal stimulation and a novel approach using electrical stimulation of rectal sensory afferents, to determine the effect on colonic pressure. We will compare the time required for the participant to complete their bowel emptying routine between a control period with digital rectal stimulation and a treatment period with electrical rectal stimulation.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Suprasacral spinal cord injury Diagnosed neurogenic bowel dysfunction and using digital rectal stimulation Bowel routine requires at least 30 minutes or at least 3 cycles of digital rectal stimulation Neurologically stable At least 18 years old At least 12 months post neurological injury or disease diagnosis Exclusion Criteria: Active sepsis Open pressure sores on or around pelvis Significant colon trauma or colostomy Crohn's disease Colonic obstruction or gastrointestinal surgery within last 3 months Significant history of autonomic dysreflexia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dennis Bourbeau, PhD
Phone
(216) 791-3800
Ext
4845
Email
Dennis.Bourbeau@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Bourbeau, PhD
Organizational Affiliation
Louis Stokes VA Medical Center, Cleveland, OH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Syracuse VA Medical Center, Syracuse, NY
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210-2716
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cesar Colasante-Garrido, MD
Phone
315-325-4400
Email
cesar.colasante@va.gov
Facility Name
Louis Stokes VA Medical Center, Cleveland, OH
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-1702
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dennis Bourbeau, PhD
Phone
216-791-3800
Ext
4845
Email
Dennis.Bourbeau@va.gov
First Name & Middle Initial & Last Name & Degree
Dennis Bourbeau, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Stimulation for Bowel Emptying

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