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Trial record 2 of 2 for:    "Glanders"

Post-void Bladder Scanning in Acute Cauda Equina Syndrome

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified May 2016 by Royal Devon and Exeter NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Royal Devon and Exeter NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT02806167
First received: June 15, 2016
Last updated: NA
Last verified: May 2016
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Royal Devon and Exeter NHS Foundation Trust:

Primary Outcome Measures:
  • 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:
  • 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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02806167

Contacts
Contact: Oliver Stokes, FRCS 01395403590 oliverstokes@nhs.net

Locations
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
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