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NCT02406859 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by VA Office of Research and Development.

Completed
Registry status
NA
Development phase
50
Enrollment target

NCT02406859: Completed NA study, sponsored by VA Office of Research and Development.

NCT02406859 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02406859, a NA study, has completed, sponsored by VA Office of Research and Development.

COMPLETED
Registry status
NA
Development phase
50 participants
Enrollment target

Study 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.

Interventions

  • BEHAVIORAL Bowel Biofeedback
  • BEHAVIORAL Anorectal Manometry

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2013-07-01
Est. Completion 2017-12-29
Phase NA

Sponsor

VA Office of Research and Development

1,668 total trials

What the Registry Record Tells You About NCT02406859

The ClinicalTrials.gov registry entry for NCT02406859 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Bowel Biofeedback is the first listed.

NCT02406859 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02406859 about?

NCT02406859 is a clinical study titled "Utility of an Animated Bowel Biofeedback Training Routine 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...

What is the current status of trial NCT02406859?

This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2013-07-01. Estimated completion is 2017-12-29.

What interventions are being tested in trial NCT02406859?

The interventions under investigation include: Bowel Biofeedback (BEHAVIORAL), Anorectal Manometry (BEHAVIORAL).

Who is sponsoring clinical trial NCT02406859?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.