Utility of an Animated Bowel Biofeedback Training Routine to Improve Bowel Function in Individuals With SCI
Condition: Spinal Cord Injury; Constipation; Fecal Incontinence; Neurogenic Bowel
MeSH terms: Fecal Incontinence; Neurogenic Bowel; Spinal Cord Injuries; Constipation
Study type: Interventional

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.
    

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.
    

Intervention name(s): Bowel Biofeedback; Anorectal Manometry
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Spinal Cord Injury; Constipation; Fecal Incontinence; Neurogenic Bowel; Bowel Biofeedback; Manometry