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Utility of an Animated Bowel Biofeedback Training Routine to Improve Bowel Function in Individuals With SCI

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ClinicalTrials.gov Identifier: NCT02406859
Recruitment Status : Completed
First Posted : April 2, 2015
Last Update Posted : March 14, 2018
Sponsor:
Collaborator:
James J. Peters Veterans Affairs Medical Center
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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), 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Constipation Fecal Incontinence Neurogenic Bowel Behavioral: Bowel Biofeedback Behavioral: Anorectal Manometry Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Bowel Biofeedback Training to Improve Bowel Function in Individuals With SCI
Actual Study Start Date : July 1, 2013
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : December 29, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Anorectal Manometry
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.
Behavioral: Anorectal Manometry
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.

Experimental: Bowel Biofeedback Training
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.
Behavioral: Bowel Biofeedback
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.




Primary Outcome Measures :
  1. Baseline motility (anorectal sensation and strength) characteristics [ Time Frame: Years 1 and 2 ]
    We aim to assess baseline motility characteristics (resting pressure, squeezing pressure, high pressure zone, and reflex responses) in persons with chronic spinal cord injury (SCI) and able bodied (AB) subjects.


Secondary Outcome Measures :
  1. Change from Baseline Assessment Due to Training [ Time Frame: Years 1-3 ]

    We aim to identify the characteristics of SCI (level, completeness, baseline manometric parameters) which best predict the outcome of the biofeedback training. Additionally, we aim to assess the efficacy of bowel biofeedback therapy in SCI patients in improving:

    a) Changes in maximum rectal and sphincter pressures generated during "squeeze" and "bear down" maneuvers performed during anorectal manometric studies pre-post treatment.


  2. Change from Baseline Assessment Due to Training [ Time Frame: Years 1-3 ]
    b) Changes to the sensitivity and strength of response of the recto-anal inhibitory reflex (RAIR) reflex in response to rectal distension.

  3. Change in Subjective Bowel Care Due to Training [ Time Frame: Years 1-3 ]
    c) FI and constipation as assessed by the Ten Question Bowel Survey and Incontinence Scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic SCI (duration over 1 year)
  • Able-bodied (no SCI)

Exclusion Criteria:

  • Contraindication to bowel biofeedback
  • Currently pregnant or trying to become pregnant
  • Inability to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406859


Locations
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United States, New York
James J. Peters VA Medical Center, Bronx, NY
Bronx, New York, United States, 10468
Sponsors and Collaborators
VA Office of Research and Development
James J. Peters Veterans Affairs Medical Center
Investigators
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Principal Investigator: Mark A Korsten, MD James J. Peters Veterans Affairs Medical Center
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02406859    
Other Study ID Numbers: B1915-P
KOR-13-010 ( Other Identifier: James J. Peters Veterans Affairs Medical Center )
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Spinal Cord Injury
Constipation
Fecal Incontinence
Neurogenic Bowel
Bowel Biofeedback
Manometry
Additional relevant MeSH terms:
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Fecal Incontinence
Neurogenic Bowel
Spinal Cord Injuries
Constipation
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Signs and Symptoms, Digestive
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases, Functional
Colonic Diseases