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Autonomic Dysreflexia in Spinal Cord Injury

NCT ID: NCT01059370

Last Updated: 2012-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Autonomic Dysfunction Spinal Cord Injured

Keywords

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Autonomic dysfunction Spinal cord injured Neurogenic bowel Neurogenic bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Autonomic dysrefleksia

Autonomic dysreflexia in SCI when emptying bowels or filling bladder

Group Type EXPERIMENTAL

bowel emptying

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Peristeen Finometer Pro

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Søren Laurberg, Professor

Role: STUDY_CHAIR

University of Århus

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2009-0112

Identifier Type: -

Identifier Source: org_study_id