Clinical Trial: Post-void Bladder Scanning in Acute Cauda Equina Syndrome

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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.


Detailed Summary:

All patients with suspected CES will be seen and assessed by a member of the on-call team i.e. either a spinal fellow, spinal SpR, orthopaedic SpR or junior doctor, on presentation. Clinical features will be documented and stored in the patient notes. This document will then be photocopied for use in the study. Digital rectal examination will be performed to assess anal sphincter tone, voluntary control (anal contraction) and sensation of sharp and light touch with a chaperone present. Those with abnormal perianal sensation will be admitted and referred for urgent MRI. (NB: For the purposes of this study, these patients will also undergo pre and post-micturition bladder scans in order to allow the correlation between perianal sensation and residual urine volume to be assessed thoroughly.)

Bladder scanning will be used to measure pre and post-micturition residual urine volume in patients with normal perianal sensation. The on-call spinal registrar, fellow or consultant will conduct the bladder scanning using the BARDSCAN IIs ultrasound device. Patients with residual urine volume greater than 100ml will be admitted and referred for urgent MRI. Patients with normal perianal sensation and residual urine volume less than 100ml however will be discharged and receive an MRI scan as an outpatient within 5 days of presentation. These patients will be advised that if there is any progression of their symptoms that they should re-attend hospital. Any patient who re-attends, whilst waiting for their out-patient MRI, will be admitted for an urgent MRI.

Assessment of patients unable to void following pre-micturition bladder scan will depend upon bladder volume. Those measuring greater than 100ml will be catheterised and sent for MRI, whereas patients with less than 100ml will be encouraged to try again in 1 hour. Patients who fail to vo
Sponsor: Royal Devon and Exeter NHS Foundation Trust

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Royal Devon and Exeter NHS Foundation Trust

Dates:
Date Received: June 15, 2016
Date Started: September 2016
Date Completion: November 2019
Last Updated: June 15, 2016
Last Verified: May 2016