Cauda Equina SyndromeUCESNCT07235579
Understanding Cauda Equina Syndrome
An observational study of Cauda Equina Syndrome, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Cauda equina syndrome is a potentially devastating condition caused by compression of the cauda equina nerve roots. This can result in bowel, bladder and sexual dysfunction plus lower limb weakness, numbness, and pain. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Cauda Equina Syndrome
- How many people
- 621 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2018to 8 Jan 2022
- Phase
- Observational
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All neurosurgical and orthopaedic units managing patients with CES in the UK will be invited to participate. All patients admitted with radiologically confirmed CES will be identified by the lead local investigator via the screening of referral and admission systems at their spinal unit. All lead local investigators must be members of the clinical team caring for patients with CES in their unit. Capture-recapture methods will be used to ensure complete case ascertainment. In December 2018, June 2019, and December 2019 all local investigators will check their case ascertainment by asking their local coding departments for all discharges coded as CES using the diagnostic code ICD-10 G83.4.
Who may be able to join
- For inclusion in this study, the patient must:
- be over 18 years old;
- be admitted to a specialist spinal service in the UK between 1st June 2018 and 31st May 2019;
- have capacity to provide informed consent for participation in this study; and
- have a diagnosis of clinical CES and structural compression of the cauda equina on imaging as determined by the treating clinician.
- Clinical CES includes any disturbance of saddle sensation, bladder function, bowel function, sexual dysfunction and bilateral sciatica associated with radiological compression of the cauda equina. The cauda equina compression can be due to any cause, including, but not limited to, disc, tumour, infection, etc.
Who cannot join
- • Patients under 18 years old
- Patients undergoing emergent decompression for unilateral motor or sensory symptoms (eg foot drop), without clinical evidence of CES
- Patients referred with suspected CES where the diagnosis is not confirmed, for example:
- o Patients with the clinical symptoms and signs of CES without radiological evidence of cauda equina compression
- Patients not admitted to participating spinal centres in the UK
- Patients admitted to a participating spinal centre before 1st June 2018 or after 31st May 2019
- Patients who are unable to provide informed consent for participation in this study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Neurosciences, Western General Hospital
Edinburgh, EH4 2XU
About this study
Official title: Understanding Cauda Equina Syndrome:
Cauda equina syndrome is a potentially devastating condition caused by compression of the cauda equina nerve roots. This can result in bowel, bladder and sexual dysfunction plus lower limb weakness, numbness, and pain. Cauda equina syndrome occurs infrequently but has serious potential morbidity and medico-legal consequences. This study aims to identify and describe the presentation and management of patients with cauda equina syndrome in the United Kingdom using trainee research collaborative networks. This will provide accurate incidence figures, establish current clinical practice, allow assessment of the adherence to national published standards of care, and determine patient outcomes from this condition. Accurate, up to date information about the presentation, management, and outcome of patients with cauda equina syndrome will inform standards of service design and delivery for this important but infrequent condition and help to identify future research priorities.
Read the detailed description
Understanding Cauda Equina Syndrome (UCES) is a prospective cohort study of patients with confirmed CES managed at specialist spinal centres in the UK.
Cases will be identified by neurosurgical or orthopaedic trainees in each specialist centre through daily screening of tertiary referrals and admissions to specialist spinal services. All patients managed as CES by the treating team will be included in this audit. CES will be divided into CES suspected (CESS), CES incomplete (CESI), and CES retention (CESR).
Data regarding timing and type of symptom onset, referral, investigation, management, and outcome will be recorded anonymously on a secure database by the local trainee investigator during the patient's hospital admission and after discharge. Patient consent will be sought for the use of their data and patients will be asked to complete patient reported outcome measures representing their condition before surgery and up to one year after surgery. This data will be compared with care quality statements and published outcome data for CES.
The study will recruit for one year. Cases will be identified from admissions to spinal units between 1st June 2018 until 31st May 2019. The last one year follow up assessments will be sent to participants on 1st June 2020.
This is an observational study. No changes to routine patient care will occur during this study.
- Conditions
- Cauda Equina Syndrome
- Medical subject headings
- Cauda Equina Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cauda Equina Syndrome | For inclusion in this study, the patient must: * be over 18 years old; * be admitted to a specialist spinal service in the UK between 1st June 2018 and 31st May 2019; * have capacity to provide informed consent for participation in this study; and * have a diagnosis of clinical CES and structural compression of the cauda equina on imaging as determined by the treating clinician. * Clinical CES includes any disturbance of saddle sensation, bladder function, bowel function, sexual dysfunction and bilateral sciatica associated with radiological compression of the cauda equina. The cauda equina compression can be due to any cause, including, but not limited to, disc, tumour, infection, etc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the number of cases of Cauda Equina Syndrome (CES) in the UK in all collaborating centres
Cases will be identified by neurosurgical or orthopaedic trainees in each specialist centre through daily screening of tertiary referrals and admissions to specialist spinal services. All patients managed as CES by the treating team will be counted.
Measured: June 2018-June 2021
Secondary outcomes (5)
Describe the presenting symptoms and signs in patients with CES
Study participants who have consented to participate will also be asked to fill out details about their patient journey to the spinal unit, their symptoms, patient reported outcome measures, and service usage. These will be collected electronically anonymously via the electronic database and linked to the patient record.
Measured: June 2018-June 2021
Describe the pathways of presentation to specialist spinal services for patients with CES in the UK and Ireland
Patients will be asked about their care pathway prior to and after entering hospital
Measured: June 2018-June 2021
Describe the type and timing of investigation of patients with CES
Timing of MRI scans will be gathered by a member of the local clinical care team. Time will be divided into hours from symptom onset (patient and clinician rated).
Measured: June 2018-June 2021
Describe the medical and surgical management of CES
Type and timing of medical or surgical management of patients with cauda equina syndrome will be gathered by a member of the local clinical care team. Time will be divided into hours from symptom onset (patient and clinician rated), type will be a drop down menu of various types of operation and 'other' with room for explanation.
Measured: June 2018- June 2021
Describe clinical outcomes for patients with CES using validated patient reported outcome measures, stratified by presentation, investigations, and management
Patient reported outcome measures will be used such as the ODI.
Measured: June 2018-June 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Jun 2018
- Primary completion8 Jan 2022
- Study completion8 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cauda Equina SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 621 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian, University Hospitals of Derby and Burton NHS Foundation Trust, Royal Brompton & Harefield NHS Foundation Trust, East Kent Hospitals University NHS Foundation Trust, Somerset NHS Foundation Trust, Buckinghamshire Healthcare NHS Trust, Milton Keynes University Hospital NHS Foundation Trust, The Ipswich Hospital NHS Trust, King's College Hospital NHS Trust, Newcastle-upon-Tyne Hospitals NHS Trust, University Hospital Southampton NHS Foundation Trust, Royal Devon and Exeter NHS Foundation Trust, Royal Cornwall Hospitals Trust, Walton Centre NHS Foundation Trust, South Tees Hospitals NHS Foundation Trust, Lancashire Teaching Hospitals NHS Foundation Trust, City Hospitals Sunderland NHS Foundation Trust, Northern Care Alliance NHS Foundation Trust, Hull University Teaching Hospitals NHS Trust, The Leeds Teaching Hospitals NHS Trust, Sheffield Teaching Hospitals NHS Foundation Trust, Nottingham University Hospitals NHS Trust, University Hospital Birmingham NHS Foundation Trust, University Hospitals Coventry and Warwickshire NHS Trust, Cambridge University Hospitals NHS Foundation Trust, Norfolk and Norwich University Hospitals NHS Foundation Trust, Oxford University Hospitals NHS Trust, North Bristol NHS Trust, University Hospital Plymouth NHS Trust, Barts & The London NHS Trust, Barking, Havering and Redbridge University Hospitals NHS Trust, Brighton and Sussex University Hospitals NHS Trust, St George's University Hospitals NHS Foundation Trust, University College London Hospitals, Imperial College Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Julie Woodfield, MBChB PhD, Study chair, University of EdinburghAimun Jamjoom, Study director, University of EdinburghIngrid Hoeritzauer, MBBChBAO, Study director, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235579
- Sponsor's protocol ID
- 160318
- Acronym
- UCES
- Status last verified
- Jun 2024
- First submitted
- 8 May 2019
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ownership of the complete dataset arising from this study resides with the steering committee and the BNTRC. On completion of the study, the data will be analysed and tabulated, and a report will be prepared. Local data collected as part of this study belongs to the local team collecting that data.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Cauda Equina Syndrome:
- ClinicalTrials.gov ID
- NCT07235579
- Acronym / sponsor ID
- UCES / 160318
- Conditions
- Cauda Equina Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 621 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian, University Hospitals of Derby and Burton NHS Foundation Trust, Royal Brompton & Harefield NHS Foundation Trust, East Kent Hospitals University NHS Foundation Trust, Somerset NHS Foundation Trust, Buckinghamshire Healthcare NHS Trust, Milton Keynes University Hospital NHS Foundation Trust, The Ipswich Hospital NHS Trust, King's College Hospital NHS Trust, Newcastle-upon-Tyne Hospitals NHS Trust, University Hospital Southampton NHS Foundation Trust, Royal Devon and Exeter NHS Foundation Trust, Royal Cornwall Hospitals Trust, Walton Centre NHS Foundation Trust, South Tees Hospitals NHS Foundation Trust, Lancashire Teaching Hospitals NHS Foundation Trust, City Hospitals Sunderland NHS Foundation Trust, Northern Care Alliance NHS Foundation Trust, Hull University Teaching Hospitals NHS Trust, The Leeds Teaching Hospitals NHS Trust, Sheffield Teaching Hospitals NHS Foundation Trust, Nottingham University Hospitals NHS Trust, University Hospital Birmingham NHS Foundation Trust, University Hospitals Coventry and Warwickshire NHS Trust, Cambridge University Hospitals NHS Foundation Trust, Norfolk and Norwich University Hospitals NHS Foundation Trust, Oxford University Hospitals NHS Trust, North Bristol NHS Trust, University Hospital Plymouth NHS Trust, Barts & The London NHS Trust, Barking, Havering and Redbridge University Hospitals NHS Trust, Brighton and Sussex University Hospitals NHS Trust, St George's University Hospitals NHS Foundation Trust, University College London Hospitals, Imperial College Healthcare NHS Trust
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 8 Jan 2022 (actual)
- Study completion
- 8 Jan 2022 (actual)
- First posted
- 19 Nov 2025 (actual)
- 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.
Cauda equina syndrome is a potentially devastating condition caused by compression of the cauda equina nerve roots. This can result in bowel, bladder and sexual dysfunction plus lower limb weakness, numbness, and pain. Cauda equina syndrome occurs infrequently but has serious potential morbidity and medico-legal consequences. This study aims to identify and describe the presentation and management of patients with cauda equina syndrome in the United Kingdom using trainee research collaborative networks. This will provide accurate incidence figures, establish current clinical practice, allow assessment of the adherence to national published standards of care, and determine patient outcomes from this condition. Accurate, up to date information about the presentation, management, and outcome of patients with cauda equina syndrome will inform standards of service design and delivery for this important but infrequent condition and help to identify future research priorities.
Detailed description
Understanding Cauda Equina Syndrome (UCES) is a prospective cohort study of patients with confirmed CES managed at specialist spinal centres in the UK.
Cases will be identified by neurosurgical or orthopaedic trainees in each specialist centre through daily screening of tertiary referrals and admissions to specialist spinal services. All patients managed as CES by the treating team will be included in this audit. CES will be divided into CES suspected (CESS), CES incomplete (CESI), and CES retention (CESR).
Data regarding timing and type of symptom onset, referral, investigation, management, and outcome will be recorded anonymously on a secure database by the local trainee investigator during the patient's hospital admission and after discharge. Patient consent will be sought for the use of their data and patients will be asked to complete patient reported outcome measures representing their condition before surgery and up to one year after surgery. This data will be compared with care quality statements and published outcome data for CES.
The study will recruit for one year. Cases will be identified from admissions to spinal units between 1st June 2018 until 31st May 2019. The last one year follow up assessments will be sent to participants on 1st June 2020.
This is an observational study. No changes to routine patient care will occur during this study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cauda Equina Syndrome | – | –For inclusion in this study, the patient must: * be over 18 years old; * be admitted to a specialist spinal service in the UK between 1st June 2018 and 31st May 2019; * have capacity to provide informed consent for participation in this study; and * have a diagnosis of clinical CES and structural compression of the cauda equina on imaging as determined by the treating clinician. * Clinical CES includes any disturbance of saddle sensation, bladder function, bowel function, sexual dysfunction and bilateral sciatica associated with radiological compression of the cauda equina. The cauda equina compression can be due to any cause, including, but not limited to, disc, tumour, infection, etc. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All neurosurgical and orthopaedic units managing patients with CES in the UK will be invited to participate. All patients admitted with radiologically confirmed CES will be identified by the lead local investigator via the screening of referral and admission systems at their spinal unit. All lead local investigators must be members of the clinical team caring for patients with CES in their unit. Capture-recapture methods will be used to ensure complete case ascertainment. In December 2018, June 2019, and December 2019 all local investigators will check their case ascertainment by asking their local coding departments for all discharges coded as CES using the diagnostic code ICD-10 G83.4.
Key inclusion criteria (6 listed)
- For inclusion in this study, the patient must:
Key exclusion criteria (7 listed)
- • Patients under 18 years old
- o Patients with the clinical symptoms and signs of CES without radiological evidence of cauda equina compression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identify the number of cases of Cauda Equina Syndrome (CES) in the UK in all collaborating centres
Time frame: June 2018-June 2021
Cases will be identified by neurosurgical or orthopaedic trainees in each specialist centre through daily screening of tertiary referrals and admissions to specialist spinal services. All patients managed as CES by the treating team will be counted.
5 secondary outcomes
Describe the presenting symptoms and signs in patients with CES
Time frame: June 2018-June 2021
Describe the pathways of presentation to specialist spinal services for patients with CES in the UK and Ireland
Time frame: June 2018-June 2021
Describe the type and timing of investigation of patients with CES
Time frame: June 2018-June 2021
Describe the medical and surgical management of CES
Time frame: June 2018- June 2021
Describe clinical outcomes for patients with CES using validated patient reported outcome measures, stratified by presentation, investigations, and management
Time frame: June 2018-June 2021
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 19 Nov 2025.
- Individual participant dataSharing planned: No. Ownership of the complete dataset arising from this study resides with the steering committee and the BNTRC. On completion of the study, the data will be analysed and tabulated, and a report will be prepared. Local data collected as part of this study belongs to the local team collecting that data.
Related trials for Cauda Equina Syndrome
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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.
Julie Woodfield, MBChB PhD study chair
University of Edinburgh
Aimun Jamjoom study director
University of Edinburgh
Ingrid Hoeritzauer, MBBChBAO study director
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cauda Equina Syndrome, run by University of Edinburgh at 1 site in United Kingdom.
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 6 inclusion and 7 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 19 Nov 2025. 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 United Kingdom. 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?
Identify the number of cases of Cauda Equina Syndrome (CES) in the UK in all collaborating centres (time frame: June 2018-June 2021). 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 19 Nov 2025.