An interventional study of bowel emptying in Autonomic Dysfunction and Spinal Cord Injured, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-10-16.
Sponsored by University of Aarhus · Not applicable, Interventional, and Prevention
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.
166 studies on the registry are indexed under Autonomic Nervous System Diseases; 36 are open to participants now.
This study's enrollment of 12 is below the median of 40 across 107 interventional studies indexed under Autonomic Nervous System Diseases.
Browse Autonomic Nervous System Diseases studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
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.
Also known as: Peristeen, Finometer Pro
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.
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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Autonomic Nervous System Diseases→
University of Aarhus