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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Recruitment Status : Withdrawn (Ethical approval declined)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
Sponsor:
Information provided by (Responsible Party):
Royal Devon and Exeter NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Polyradiculopathy Other: Clinical algorithm Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : November 2019


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United Kingdom
Royal Devon and Exeter NHS Foundation Trust
Exeter, Devon, United Kingdom, EX2 5DW
Sponsors and Collaborators
Royal Devon and Exeter NHS Foundation Trust
Investigators
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Principal Investigator: Oliver Stokes, FRCS Royal Devon and Exeter NHS Foundation Trust

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Responsible Party: Royal Devon and Exeter NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02806167     History of Changes
Other Study ID Numbers: RoyalDevon
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cauda Equina Syndrome
Polyradiculopathy
Nerve Compression Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Polyradiculoneuropathy
Polyneuropathies