Post-void Bladder Scanning in Acute Cauda Equina Syndrome
Stopped: Ethical approval declined
United Kingdom0Started 2016-09
Plain-language summary
Expedient diagnosis and management of acute cauda equina syndrome (CES) is essential to prevent long-term neurological sequelae for these patients. The clinical diagnosis of CES is confirmed using magnetic resonance imaging (MRI). However the clinical features of CES (secondary to bladder and bowel sphincter dysfunction) are variable and are common presenting features of other pathologies of the bladder and bowel, therefore most patients who undergo MRI for suspected CES have no compressive lesion evident on the MRI, excluding the diagnosis of CES. Urgent MRI scanning performed out of hours is therefore often unnecessary, however, the morbidity to the patient due to a delay in diagnosis is so significant that urgent MRI scanning is the current gold standard and duty of care in all cases of suspected CES. More objective methods of assessing patients with suspected acute CES could allow rationing of out of hours MRI scanning and reduce inappropriate admission without impacting patient safety.
The aim of this study is to evaluate the effectiveness of a clinical algorithm which utilises digital rectal examination and ultrasound bladder scanning to stratify patients into high and low risk groups. Patients considered high risk will be admitted and sent for urgent MRI, whereas low risk patients will be discharged and undergo MRI scan within 5 days of presentation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with suspected CES
* Minimum age 18 years.
* Both sexes
* Able to provide informed consent for their data to be included in the study
Exclusion Criteria:
* Patients with pre-existing urinary tract pathologies (neuropathic bladder, urologic pathologies or surgery, history of urinary incontinence.)
* Under age of 18 years.
* Patients with urinary catheter for whatever reason.
* Prisoners.
* Patients unable to provide informed consent for themselves.
* Previous spinal surgery
* Patients with urinary tract infections
* Patients with pre-existing neurological conditions affecting:
* Central nervous system such as multiple sclerosis
* Peripheral nervous system such as diabetic neuropathy, B12 deficiencies, thyroid abnormalities
* Autonomic nervous system such as multiple system atrophy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Successful risk stratification
Timeframe: 36 months
Trial details
NCT IDNCT02806167
SponsorRoyal Devon and Exeter NHS Foundation Trust