Back to resultsAutonomic Dysreflexia in Spinal Cord Injury
Primary Purpose
Autonomic Dysfunction, Spinal Cord Injured
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
bowel emptying
Sponsored by
About this trial
This is an interventional prevention trial for Autonomic Dysfunction focused on measuring Autonomic dysfunction, Spinal cord injured, Neurogenic bowel, Neurogenic bladder
Eligibility Criteria
Inclusion Criteria:
- People with a spinal cord injury above th6 and with symptoms of autonomic dysreflexia.
- At least one year post injury.
- 18 years or older.
- Informed consent.
Exclusion Criteria:
- Usage of prophylactic anti-autonomic dysreflexia medication.
- Pregnant or breastfeeding.
- People who is not able to follow the sudy protocol.
- No former major surgery in the abdomen or pelvic region.
- No former radiotherapy in the pelvic region.
Sites / Locations
- Aarhus University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Autonomic dysrefleksia
Arm Description
Autonomic dysreflexia in SCI when emptying bowels or filling bladder
Outcomes
Primary Outcome Measures
Intervention induces 25 % raise in BP compared to baseline measurements.
Secondary Outcome Measures
Full Information
NCT ID
NCT01059370
First Posted
January 19, 2010
Last Updated
October 15, 2012
Sponsor
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT01059370
Brief Title
Autonomic Dysreflexia in Spinal Cord Injury
Official Title
Autonom Dysrefleksi Ved Rygmarvsskade
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autonomic Dysfunction, Spinal Cord Injured
Keywords
Autonomic dysfunction, Spinal cord injured, Neurogenic bowel, Neurogenic bladder
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Autonomic dysrefleksia
Arm Type
Experimental
Arm Description
Autonomic dysreflexia in SCI when emptying bowels or filling bladder
Intervention Type
Procedure
Intervention Name(s)
bowel emptying
Other Intervention Name(s)
Peristeen, Finometer Pro
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
People with a spinal cord injury above th6 and with symptoms of autonomic dysreflexia.
At least one year post injury.
18 years or older.
Informed consent.
Exclusion Criteria:
Usage of prophylactic anti-autonomic dysreflexia medication.
Pregnant or breastfeeding.
People who is not able to follow the sudy protocol.
No former major surgery in the abdomen or pelvic region.
No former radiotherapy in the pelvic region.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Søren Laurberg, Professor
Organizational Affiliation
University of Århus
Official's Role
Study Chair
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Autonomic Dysreflexia in Spinal Cord Injury
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