Autonomic Dysreflexia in Spinal Cord Injury

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.

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Key information

Conditions

Autonomic Dysfunction Autonomic Nervous System Diseases Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Intestinal Diseases Male Urogenital Diseases Nervous System Diseases Neurogenic Bowel Neurologic Manifestations Pathological Conditions, Signs and Symptoms Primary Dysautonomias Signs and Symptoms Spinal Cord Injured Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bowel emptying

Procedure

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Autonom Dysrefleksi Ved Rygmarvsskade

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2012
First posted: Jan 29, 2010
Registry last updated: Oct 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed