Autonomic Dysfunction, Spinal Cord Injured
Conditions
Keywords
Autonomic dysfunction, Spinal cord injured, Neurogenic bowel, Neurogenic bladder
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.
Interventions
PROCEDUREbowel 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.
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intervention induces 25 % raise in BP compared to baseline measurements. | Outcome are monitored all through bowel or bladder-procedure at each of three study-days, and compaire to measurements at baseline. |
Countries
Denmark
Outcome results
None listed