Autonomic DysfunctionNCT01059370
Autonomic Dysreflexia in Spinal Cord Injury
A study testing bowel emptying in people with Autonomic Dysfunction and Spinal Cord Injured, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autonomic Dysfunction, Spinal Cord Injured
- What is being tested?
- bowel emptying
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2009to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autonom Dysrefleksi Ved Rygmarvsskade
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
- Being tested
- bowel emptying
- Keywords
- Autonomic dysfunction, Spinal cord injured, Neurogenic bowel, Neurogenic bladder
- Medical subject headings
- Primary Dysautonomias, Neurogenic Bowel, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bowel emptyingProcedure or surgery
Also called Peristeen, Finometer Pro
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.
| Study group | Role | What they receive |
|---|---|---|
| Autonomic dysrefleksia | Experimental | Autonomic dysreflexia in SCI when emptying bowels or filling bladder Receives: Procedure: bowel emptying |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention induces 25 % raise in BP compared to baseline measurements.
Measured: Outcome are monitored all through bowel or bladder-procedure at each of three study-days, and compaire to measurements at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionNov 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic DysfunctionStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Søren Laurberg, Professor, Study chair, University of Århus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059370
- Sponsor's protocol ID
- 2009-0112
- Status last verified
- Oct 2012
- First submitted
- 19 Jan 2010
- Last updated
- 16 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonom Dysrefleksi Ved Rygmarvsskade
- ClinicalTrials.gov ID
- NCT01059370
- Acronym / sponsor ID
- 2009-0112
- Conditions
- Autonomic Dysfunction, Spinal Cord Injured
- Keywords
- Autonomic dysfunction, Spinal cord injured, Neurogenic bowel, Neurogenic bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 29 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autonomic dysrefleksia | Experimental | Procedure: bowel emptyingAutonomic dysreflexia in SCI when emptying bowels or filling bladder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bowel emptyingAlso: Peristeen, Finometer ProBowel 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. | Procedure or surgery | Autonomic dysrefleksia |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Søren Laurberg, Professor study chair
University of Århus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bowel emptying in people with Autonomic Dysfunction and Spinal Cord Injured, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2012.