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Autonomic Dysreflexia in Spinal Cord Injury

This study has been completed.
Information provided by (Responsible Party):
University of Aarhus Identifier:
First received: January 19, 2010
Last updated: October 15, 2012
Last verified: October 2012
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.

Condition Intervention
Autonomic Dysfunction Spinal Cord Injured Procedure: bowel emptying

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Autonom Dysrefleksi Ved Rygmarvsskade

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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. ]

Enrollment: 12
Study Start Date: December 2009
Study Completion Date: March 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01059370

Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Study Chair: Søren Laurberg, Professor University of Århus
  More Information

Responsible Party: University of Aarhus Identifier: NCT01059370     History of Changes
Other Study ID Numbers: 2009-0112
Study First Received: January 19, 2010
Last Updated: October 15, 2012

Keywords provided by University of Aarhus:
Autonomic dysfunction
Spinal cord injured
Neurogenic bowel
Neurogenic bladder

Additional relevant MeSH terms:
Autonomic Nervous System Diseases
Primary Dysautonomias
Autonomic Dysreflexia
Nervous System Diseases
Spinal Cord Injuries
Trauma, Nervous System processed this record on August 18, 2017