Clinical Trials Directory

Trials / Completed

CompletedNCT01059370

Autonomic Dysreflexia in Spinal Cord Injury

Autonom Dysrefleksi Ved Rygmarvsskade

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
12 (actual)
Sponsor
University of Aarhus · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREbowel emptyingBowel 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.

Timeline

Start date
2009-12-01
Primary completion
2011-11-01
Completion
2012-03-01
First posted
2010-01-29
Last updated
2012-10-16

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT01059370. Inclusion in this directory is not an endorsement.