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Autonomic Dysreflexia in Spinal Cord Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01059370
First received: January 19, 2010
Last updated: October 15, 2012
Last verified: October 2012
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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. ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059370

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

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01059370     History of Changes
Other Study ID Numbers: 2009-0112
Study First Received: January 19, 2010
Last Updated: October 15, 2012
Health Authority: Denmark: Danish Dataprotection Agency

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

ClinicalTrials.gov processed this record on November 25, 2014