Autonomic Dysreflexia in Spinal Cord Injury

October 15, 2012 updated by: University of Aarhus

Autonom Dysrefleksi Ved Rygmarvsskade

Autonomic dysreflexia in high spinal cord-injured can be initiated by a full bladder or bowel, or when trying to empty either. This randomised study aims at evaluating whether irrigation procedure or digital stimulation or evacuation of the rectum is less provocative of autonomic dysreflexia. Participants have their bowels emptied on different days, in the morning fasting. Bladder filling with sterile saline water is evaluated on a third day as a control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. People with a spinal cord injury above th6 and with symptoms of autonomic dysreflexia.
  2. At least one year post injury.
  3. 18 years or older.
  4. Informed consent.

Exclusion Criteria:

  1. Usage of prophylactic anti-autonomic dysreflexia medication.
  2. Pregnant or breastfeeding.
  3. People who is not able to follow the sudy protocol.
  4. No former major surgery in the abdomen or pelvic region.
  5. No former radiotherapy in the pelvic region.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Autonomic dysrefleksia
Autonomic dysreflexia in SCI when emptying bowels or filling bladder
Procedure: bowel emptying
Bowel is emptied using Peristeen® irrigation system one day, by digital stimulation another trial day or filling the bladder with saline water on a third trial day. BP is measured by Finometer Pro®, respiration frequency by BIOPACK and skin conductivity measured by Biopack and nor-epinephrine and epinephrine are measured in plasma three times during each examination.
Other Names:
  • Peristeen
  • Finometer Pro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intervention induces 25 % raise in BP compared to baseline measurements.
Time Frame: Outcome are monitored all through bowel or bladder-procedure at each of three study-days, and compaire to measurements at baseline.
Outcome are monitored all through bowel or bladder-procedure at each of three study-days, and compaire to measurements at baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Study Chair: Søren Laurberg, Professor, University of Århus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

January 19, 2010

First Submitted That Met QC Criteria

January 28, 2010

First Posted (ESTIMATE)

January 29, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 16, 2012

Last Update Submitted That Met QC Criteria

October 15, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-0112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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