Neurogenic Bowel DysfunctionNCT02641483
Stimulation for Colonic Motility
A study testing Electrical Rectal Stimulation in people with Neurogenic Bowel Dysfunction, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Bowel Dysfunction
- What is being tested?
- Electrical Rectal Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed neurogenic bowel dysfunction and using digital rectal stimulation
- Neurologically stable
- Skeletally mature
- Suprasacral spinal cord injury, stroke, or multiple sclerosis
- At least 6 months post neurological injury or disease diagnosis
Who cannot join
- Active sepsis
- Open pressure sores on or around pelvis
- Significant colon trauma or colostomy
- History of autonomic dysreflexia
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, 13210
About this study
Official title: Afferent Stimulation to Evoke Recto-colonic Reflex for Colonic Motility
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.
- Conditions
- Neurogenic Bowel Dysfunction
- Being tested
- Electrical Rectal Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Rectal StimulationOther
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. This intervention will compared to individuals' usual mechanical intervention of digital rectal stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Colonic Motility | Experimental | 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. Receives: Other: Electrical Rectal Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Changes in Number of Interventions Used to Complete Bowel Routine, Including Electrical Rectal Stimulation (Treatment) Versus Mechanical Rectal Distension (Control)
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. Typically several bouts of digital rectal stimulation are required to achieve complete bowel emptying. We will compare the number of bouts of digital rectal stimulation (control) with electrical rectal stimulation (treatment) required to achieve complete bowel emptying.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study start1 Jan 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neurogenic Bowel DysfunctionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Dennis Bourbeau, PhD, Principal investigator, Louis Stokes VA Medical Center, Cleveland, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641483
- Sponsor's protocol ID
- B1962-W
- Status last verified
- Nov 2022
- First submitted
- 22 Dec 2015
- Last updated
- 21 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Afferent Stimulation to Evoke Recto-colonic Reflex for Colonic Motility
- ClinicalTrials.gov ID
- NCT02641483
- Acronym / sponsor ID
- B1962-W
- Conditions
- Neurogenic Bowel Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Posted 21 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colonic Motility | Experimental | Other: Electrical Rectal StimulationStudy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed neurogenic bowel dysfunction and using digital rectal stimulation
- Neurologically stable
- Skeletally mature
- Suprasacral spinal cord injury, stroke, or multiple sclerosis
- At least 6 months post neurological injury or disease diagnosis
Key exclusion criteria (4 listed)
- Active sepsis
- Open pressure sores on or around pelvis
- Significant colon trauma or colostomy
- History of autonomic dysreflexia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Rectal StimulationElectrical 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. This intervention will compared to individuals' usual mechanical intervention of digital rectal stimulation. | Other | Colonic Motility |
Primary outcome
Compare Changes in Number of Interventions Used to Complete Bowel Routine, Including Electrical Rectal Stimulation (Treatment) Versus Mechanical Rectal Distension (Control)
Time frame: 1 month
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. Typically several bouts of digital rectal stimulation are required to achieve complete bowel emptying. We will compare the number of bouts of digital rectal stimulation (control) with electrical rectal stimulation (treatment) required to achieve complete bowel emptying.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Bourbeau, PhD principal investigator
Louis Stokes VA Medical Center, Cleveland, OH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Rectal Stimulation in people with Neurogenic Bowel Dysfunction, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare Changes in Number of Interventions Used to Complete Bowel Routine, Including Electrical Rectal Stimulation (Treatment) Versus Mechanical Rectal Distension (Control) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.