Post-void Bladder Scanning in Acute Cauda Equina Syndrome
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Purpose
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.
| Condition | Intervention |
|---|---|
| Polyradiculopathy | Other: Clinical algorithm |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | A Study Into the Use of Post-Void Bladder Scanning as Part of a Clinical Algorithm for the Assessment of Patients With Suspected Acute Cauda Equina Syndrome |
- Successful risk stratification [ Time Frame: 36 months ]The study will aim to stratify patients into high and low risk of CES though implementation of an algorithm which uses bladder scanning. The algorithm will be deemed successful if no patients are missed.
- Correlation between clinical assessment and residual urine volume [ Time Frame: 36 months ]We will measure pre and post-micturition bladder urine volumes in all consenting patients with normal and abnormal perianal sensation in order to allow the correlation between clinical assessment and residual urine volume to be assessed thoroughly.
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2016 |
| Estimated Study Completion Date: | November 2019 |
| Estimated Primary Completion Date: | September 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Clinical algorithm
This is a single arm study. All eligible patients will be subject to our clinical algorithm.
|
Other: Clinical algorithm
Patients presenting with suspected acute CES will be assessed in accordance with the algorithm previously outlined.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT02806167
| Contact: Oliver Stokes, FRCS | 01395403590 | oliverstokes@nhs.net |
| United Kingdom | |
| Royal Devon and Exeter NHS Foundation Trust | |
| Exeter, Devon, United Kingdom, EX2 5DW | |
| Principal Investigator: | Oliver Stokes, FRCS | Royal Devon and Exeter NHS Foundation Trust |
More Information
| Responsible Party: | Royal Devon and Exeter NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT02806167 History of Changes |
| Other Study ID Numbers: |
RoyalDevon |
| Study First Received: | June 15, 2016 |
| Last Updated: | June 15, 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
|
Polyradiculopathy Polyradiculoneuropathy Polyneuropathies |
Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on July 14, 2017


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