Autonomic Dysreflexia in Spinal Cord Injury

NCT01059370 | Completed DMC

• 1 other identifier: 2009-0112
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Autonomic Dysfunction; Spinal Cord Injured

Keywords

Autonomic dysfunction; Spinal cord injured; Neurogenic bowel; Neurogenic bladder

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Autonomic dysrefleksia

EXPERIMENTAL

Autonomic dysreflexia in SCI when emptying bowels or filling bladder

Procedure: bowel emptying

Interventions

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.

Also known as: Peristeen, Finometer Pro

Autonomic dysrefleksia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People with a spinal cord injury above th6 and with symptoms of autonomic dysreflexia.
• At least one year post injury.
• years or older.
• Informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Primary Dysautonomias; Neurogenic Bowel; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Søren Laurberg, Professor

  University of Århus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2010
• First Posted: January 29, 2010
• Study Start: December 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: March 1, 2012
• Last Updated: October 16, 2012

Record last verified: 2012-10

Locations

DK (1)