Spinal Cord InjuryNCT02406859
Utility of an Animated Bowel Biofeedback Training Routine to Improve Bowel Function in Individuals With SCI
A study testing Bowel Biofeedback and Anorectal Manometry in people with Spinal Cord Injury and Constipation, run by VA Office of Research and Development at 1 site in United States.
Trial summary
An injury to the spinal cord results in a number of secondary medical problems, including the inability to voluntarily control the bowels. Depending on the severity and location of the injury, remaining bowel function differs, and can include any combination of the following: constipation (prolonged stool retention)… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injury, Constipation, Fecal Incontinence
- What is being tested?
- Bowel Biofeedback and Anorectal Manometry
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2013to 29 Dec 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic SCI (duration over 1 year)
- Able-bodied (no SCI)
Who cannot join
- Contraindication to bowel biofeedback
- Currently pregnant or trying to become pregnant
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468
About this study
Official title: Bowel Biofeedback Training to Improve Bowel Function in Individuals With SCI
An injury to the spinal cord results in a number of secondary medical problems, including the inability to voluntarily control the bowels. Depending on the severity and location of the injury, remaining bowel function differs, and can include any combination of the following: constipation (prolonged stool retention), difficulty with evacuation (difficultly moving bowels), fecal incontinence (problems retaining stool until it is appropriate to move the bowels). Most of the current medications and treatment options address problems of constipation and difficulty with evacuation, but there are few options for individuals who suffer from incontinency. In this study, the investigators propose to study, in detail, anorectal muscle function in individuals with spinal injury - the investigators will do so using new technology called high resolution manometry - which will present the investigator with a 3 dimensional representation of the pressure profile of the anorectal muscles as the subject attempts different maneuvers. A subgroup with representatives of all levels and completeness of injury and anorectal muscle function will be enrolled to participate in six weeks of biofeedback training to see if their bowel function can be improved. During these six weeks, the subjects will be asked to visit the laboratory twice a week in order to be trained by the research team on how to improve their anorectal strength and function in response to visual cues. After the six weeks, another manometry study will be performed. Subjects will then be sent home and asked to perform a series of home exercises for another 6 weeks, after which they will asked to return for a third and final manometry study.
Read the detailed description
Neurogenic bowel characteristics differ among spinal cord injured (SCI) individuals, and appear to depend primarily on the level and completeness of injury. It is thought that upper motor neuron lesions in the spinal cord above L1-2 results in a hyperreflexive bowel with increased colonic wall tone and loss of cortical control over the relaxation of the external anal sphincter (EAS). These changes result in chronic high sphincter tone and dyssynergic defecation. The main symptoms in these patients are constipation and fecal retention, or difficulty with evacuation (DWE). In many of these individuals, some nerve connections between the spinal cord and the colon may be preserved, and stool propulsion and reflex coordination may remain intact and under control of the central nervous system. Furthermore, individuals with spinal lesions above T7 experience loss of voluntary control over abdominal muscles and an inability to increase intra-abdominal pressure, which results in more DWE and constipation. Lower motor neuron (LMN) lesions in the spinal cord below L1-2 result in the interruption of the centrally mediated innervation to the bowel, which causes slowing of peristalsis, a flaccid EAS, and atonic levator ani muscles. This is also called an areflexic bowel. The main symptoms in these patients are constipation from slowed peristalsis and fecal incontinence (FI) from atonic EAS and levator ani muscles. While the symptoms of bowel dysfunction in persons with SCI are known, function and motility of the anal canal have not been documented in this population. Anorectal manometry can provide valuable information about sphincter strength, defecation dynamics and reflex mechanisms. New high-resolution anorectal manometric systems (Given Imaging, Duluth, GA), simultaneously captures pressure data from the rectum, IAS, EAS and atmosphere. High resolution manometry also allows for much clearer display of pressure events compared to line tracing series, and direction of contractions are much easier to discern. To date, anorectal high resolution topographical studies have not been conducted in a SCI population.
Modalities in which the patient can be trained to control the internal anal sphincter (IAS) and EAS are promising solutions to FI, and have been shown to be useful in able bodied (AB) populations. For example, anorectal biofeedback methods teach patients to recognize sensations of a distended rectum while also teaching abdominal or pelvic muscles to voluntarily contract for short periods of time in order to improve continence. Such biofeedback modalities have also been shown to decrease constipation in AB populations by teaching proper external sphincter relaxation and rectal muscle contraction. The concept of biofeedback is based on principles of operant conditioning, in which information concerning a normally subconscious physiological function in relayed to patients and that become actively engaged in learning to consciously control this function. During bowel (re)training programs, patients are provided with visual feedback on voluntary and reflex sphincter and rectal muscle contractions, so that they can learn to recognize diffuse sensations and gradually regain control.
- Conditions
- Spinal Cord Injury, Constipation, Fecal Incontinence, Neurogenic Bowel
- Being tested
- Bowel Biofeedback, Anorectal Manometry
- Keywords
- Spinal Cord Injury, Constipation, Fecal Incontinence, Neurogenic Bowel, Bowel Biofeedback, Manometry
- Medical subject headings
- Spinal Cord Injuries, Constipation, Fecal Incontinence, Neurogenic Bowel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bowel BiofeedbackBehavioural
Subjects will complete 2 sessions twice a week for 6 weeks of bowel biofeedback training. Subjects will be asked to squeeze and bear down for a period of 5 seconds followed by rest for 10seconds. Following the training, each subject will complete similar training at home for 6 weeks.
Anorectal ManometryBehavioural
Subjects will undergo an anorectal manometry to establish baseline pressure characteristics. If subjects qualify for biofeedback training, they will complete two additional manometries to track the changes occuring during training.
| Study group | Role | What they receive |
|---|---|---|
| Anorectal Manometry | Experimental | Part 1 [Anorectal Manometry]: Fifty SCI subjects and 15 AB subjects will undergo anorectal manometry and a baseline assessment of level of constipation or frequency of fecal incontinence (FI). Additional 10 able-bodied subjects will be enrolled to serve as controls. The 10 Question Bowel Survey and Incontinence Scale will be administered. Receives: Behavioral: Anorectal Manometry |
| Bowel Biofeedback Training | Experimental | Part 2 [Bowel Biofeedback]: A subgroup of 20 subjects who participated in the first arm of the study (Anorectal Motility) and report either constipation or fecal incontinence will be asked to participate in 12 weeks of twice weekly, biofeedback training. The biofeedback training will consist of in-lab exercises that are paired with a visual feedback. Anorectal manometry and bowel surveys will be repeated after the training session to assess the effects of bowel biofeedback on anorectal function. Receives: Behavioral: Bowel Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Motility (Anorectal Sensation and Strength) Characteristics
We aim to assess the following baseline motility characteristics: maximum sphincter pressure (resting and squeezing pressure), mean sphincter pressure, residual anal and intrarectal pressure (high pressure zone), and recto-anal pressure differential (difference of intrarectal and residual anal pressures) in persons with chronic spinal cord injury (SCI) and able bodied (AB) subjects.
Measured: 1 Session (Baseline Anorectal Manometry Assessment)
Secondary outcomes (3)
Change in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.
Changes in maximum rectal and sphincter pressures generated during "squeeze" and "bear down" maneuvers performed during anorectal manometric studies pre-biofeedback training (baseline) and post-guided (part 1) and self-guided (part 2) biofeedback training.
Measured: Baseline, post- 6 week guided biofeedback training (weeks 1-6), post- 6 week self-guided biofeedback training (weeks 7-12).
Changes in Recto-anal Inhibitory Reflex (RAIR) Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.
Changes to the sensitivity and strength of response of the recto-anal inhibitory reflex (RAIR) in response to rectal distension.
Outcome measure clarification: Minimal balloon volume, in cc, which was the threshold at which anorectal sensation was perceived by subjects with incomplete SCI, as assessed through High Resolution Manometry (HRM)
Measured: Baseline, post- 6 week guided biofeedback training (weeks 1-6), post- 6 week self-guided biofeedback training (weeks 7-12).
Change in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCI
Constipation and fecal Incontinence was assessed in participants with incomplete SCI by the Ten Question Bowel Survey. This survey is based on a scale 1-5; a lower score represents fewer bowel management difficulties (better functioning). Survey was administered at baseline (pre-training), and post- guided (part 1) and self-guided (part 2) bowel biofeedback training.
Measured: Baseline, post- 6 week guided biofeedback training (weeks 1-6), post- 6 week self-guided biofeedback training (weeks 7-12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study start1 Jul 2013
- Primary completion30 Jun 2017
- Study completion29 Dec 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- James J. Peters Veterans Affairs Medical Center
- Responsible party
- Sponsor
- Investigators
- Mark A Korsten, MD, Principal investigator, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406859
- Sponsor's protocol ID
- B1915-P
- Other IDs
- KOR-13-010
- Status last verified
- Aug 2021
- First submitted
- 19 Feb 2015
- Last updated
- 17 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aloysius MM, Korsten MA, Radulovic M, Singh K, Lyons BL, Cummings T, Hobson J, Kahal S, Spungen AM, Bauman WA. Lack of improvement in anorectal manometry parameters after implementation of a pelvic floor/anal sphincter biofeedback in persons with motor-incomplete spinal cord injury. Neurogastroenterol Motil. 2023 Nov;35(11):e14667. doi: 10.1111/nmo.14667. Epub 2023 Sep 25.
PubMed 37743783
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bowel Biofeedback Training to Improve Bowel Function in Individuals With SCI
- ClinicalTrials.gov ID
- NCT02406859
- Acronym / sponsor ID
- B1915-P
- Conditions
- Spinal Cord Injury, Constipation, Fecal Incontinence, Neurogenic Bowel
- Keywords
- Spinal Cord Injury, Constipation, Fecal Incontinence, Neurogenic Bowel, Bowel Biofeedback, Manometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- James J. Peters Veterans Affairs Medical Center
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 2 Apr 2015 (estimated)
- Results
- Posted 17 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An injury to the spinal cord results in a number of secondary medical problems, including the inability to voluntarily control the bowels. Depending on the severity and location of the injury, remaining bowel function differs, and can include any combination of the following: constipation (prolonged stool retention), difficulty with evacuation (difficultly moving bowels), fecal incontinence (problems retaining stool until it is appropriate to move the bowels). Most of the current medications and treatment options address problems of constipation and difficulty with evacuation, but there are few options for individuals who suffer from incontinency. In this study, the investigators propose to study, in detail, anorectal muscle function in individuals with spinal injury - the investigators will do so using new technology called high resolution manometry - which will present the investigator with a 3 dimensional representation of the pressure profile of the anorectal muscles as the subject attempts different maneuvers. A subgroup with representatives of all levels and completeness of injury and anorectal muscle function will be enrolled to participate in six weeks of biofeedback training to see if their bowel function can be improved. During these six weeks, the subjects will be asked to visit the laboratory twice a week in order to be trained by the research team on how to improve their anorectal strength and function in response to visual cues. After the six weeks, another manometry study will be performed. Subjects will then be sent home and asked to perform a series of home exercises for another 6 weeks, after which they will asked to return for a third and final manometry study.
Detailed description
Neurogenic bowel characteristics differ among spinal cord injured (SCI) individuals, and appear to depend primarily on the level and completeness of injury. It is thought that upper motor neuron lesions in the spinal cord above L1-2 results in a hyperreflexive bowel with increased colonic wall tone and loss of cortical control over the relaxation of the external anal sphincter (EAS). These changes result in chronic high sphincter tone and dyssynergic defecation. The main symptoms in these patients are constipation and fecal retention, or difficulty with evacuation (DWE). In many of these individuals, some nerve connections between the spinal cord and the colon may be preserved, and stool propulsion and reflex coordination may remain intact and under control of the central nervous system. Furthermore, individuals with spinal lesions above T7 experience loss of voluntary control over abdominal muscles and an inability to increase intra-abdominal pressure, which results in more DWE and constipation. Lower motor neuron (LMN) lesions in the spinal cord below L1-2 result in the interruption of the centrally mediated innervation to the bowel, which causes slowing of peristalsis, a flaccid EAS, and atonic levator ani muscles. This is also called an areflexic bowel. The main symptoms in these patients are constipation from slowed peristalsis and fecal incontinence (FI) from atonic EAS and levator ani muscles. While the symptoms of bowel dysfunction in persons with SCI are known, function and motility of the anal canal have not been documented in this population. Anorectal manometry can provide valuable information about sphincter strength, defecation dynamics and reflex mechanisms. New high-resolution anorectal manometric systems (Given Imaging, Duluth, GA), simultaneously captures pressure data from the rectum, IAS, EAS and atmosphere. High resolution manometry also allows for much clearer display of pressure events compared to line tracing series, and direction of contractions are much easier to discern. To date, anorectal high resolution topographical studies have not been conducted in a SCI population.
Modalities in which the patient can be trained to control the internal anal sphincter (IAS) and EAS are promising solutions to FI, and have been shown to be useful in able bodied (AB) populations. For example, anorectal biofeedback methods teach patients to recognize sensations of a distended rectum while also teaching abdominal or pelvic muscles to voluntarily contract for short periods of time in order to improve continence. Such biofeedback modalities have also been shown to decrease constipation in AB populations by teaching proper external sphincter relaxation and rectal muscle contraction. The concept of biofeedback is based on principles of operant conditioning, in which information concerning a normally subconscious physiological function in relayed to patients and that become actively engaged in learning to consciously control this function. During bowel (re)training programs, patients are provided with visual feedback on voluntary and reflex sphincter and rectal muscle contractions, so that they can learn to recognize diffuse sensations and gradually regain control.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anorectal Manometry | Experimental | Behavioral: Anorectal ManometryPart 1 [Anorectal Manometry]: Fifty SCI subjects and 15 AB subjects will undergo anorectal manometry and a baseline assessment of level of constipation or frequency of fecal incontinence (FI). Additional 10 able-bodied subjects will be enrolled to serve as controls. The 10 Question Bowel Survey and Incontinence Scale will be administered. |
| Bowel Biofeedback Training | Experimental | Behavioral: Bowel BiofeedbackPart 2 [Bowel Biofeedback]: A subgroup of 20 subjects who participated in the first arm of the study (Anorectal Motility) and report either constipation or fecal incontinence will be asked to participate in 12 weeks of twice weekly, biofeedback training. The biofeedback training will consist of in-lab exercises that are paired with a visual feedback. Anorectal manometry and bowel surveys will be repeated after the training session to assess the effects of bowel biofeedback on anorectal function. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic SCI (duration over 1 year)
- Able-bodied (no SCI)
Key exclusion criteria (3 listed)
- Contraindication to bowel biofeedback
- Currently pregnant or trying to become pregnant
- Inability to provide informed consent
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 |
|---|---|---|
| Bowel BiofeedbackSubjects will complete 2 sessions twice a week for 6 weeks of bowel biofeedback training. Subjects will be asked to squeeze and bear down for a period of 5 seconds followed by rest for 10seconds. Following the training, each subject will complete similar training at home for 6 weeks. | Behavioural | Bowel Biofeedback Training |
| Anorectal ManometrySubjects will undergo an anorectal manometry to establish baseline pressure characteristics. If subjects qualify for biofeedback training, they will complete two additional manometries to track the changes occuring during training. | Behavioural | Anorectal Manometry |
Primary outcome
Baseline Motility (Anorectal Sensation and Strength) Characteristics
Time frame: 1 Session (Baseline Anorectal Manometry Assessment)
We aim to assess the following baseline motility characteristics: maximum sphincter pressure (resting and squeezing pressure), mean sphincter pressure, residual anal and intrarectal pressure (high pressure zone), and recto-anal pressure differential (difference of intrarectal and residual anal pressures) in persons with chronic spinal cord injury (SCI) and able bodied (AB) subjects.
3 secondary outcomes
Change in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.
Time frame: Baseline, post- 6 week guided biofeedback training (weeks 1-6), post- 6 week self-guided biofeedback training (weeks 7-12).
Changes in Recto-anal Inhibitory Reflex (RAIR) Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.
Time frame: Baseline, post- 6 week guided biofeedback training (weeks 1-6), post- 6 week self-guided biofeedback training (weeks 7-12).
Change in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCI
Time frame: Baseline, post- 6 week guided biofeedback training (weeks 1-6), post- 6 week self-guided biofeedback training (weeks 7-12).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37743783Aloysius MM, Korsten MA, Radulovic M, Singh K, Lyons BL, Cummings T, Hobson J, Kahal S, Spungen AM, Bauman WA. Lack of improvement in anorectal manometry parameters after implementation of a pelvic floor/anal sphincter biofeedback in persons with motor-incomplete spinal cord injury. Neurogastroenterol Motil. 2023 Nov;35(11):e14667. doi: 10.1111/nmo.14667. Epub 2023 Sep 25.
- 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.
Mark A Korsten, MD principal investigator
James J. Peters Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bowel Biofeedback and Anorectal Manometry in people with Spinal Cord Injury and Constipation, run by VA Office of Research and Development at 1 site 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 2 inclusion and 3 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 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 17 Sep 2021). 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?
Baseline Motility (Anorectal Sensation and Strength) Characteristics (time frame: 1 Session (Baseline Anorectal Manometry Assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02406859, which also lists 1 linked publication.
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 17 Sep 2021.