Post-void Bladder Scanning in Acute Cauda Equina Syndrome
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|ClinicalTrials.gov Identifier: NCT02806167|
Recruitment Status : Withdrawn (Ethical approval declined)
First Posted : June 20, 2016
Last Update Posted : April 11, 2018
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 or disease||Intervention/treatment||Phase|
|Polyradiculopathy||Other: Clinical algorithm||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||November 2019|
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02806167
|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|