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Urodynamics of Suprasacral Spinal Cord Injury Patients

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ClinicalTrials.gov Identifier: NCT04642170
Recruitment Status : Completed
First Posted : November 24, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Junyan Lu, Second Affiliated Hospital of Wenzhou Medical University

Study Description
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Brief Summary:
The medical records of 215 patients with spinal cord injury(SCI) at the Department of Rehabilitation Medicine of the 2nd Affiliated Hospital of Wenzhou Medical University, Wenzhou, China were evaluated between January 1, 2016 and December 20, 2019. According to the inclusion criteria and exclusion criteria, 101 patients were included. The patients were dichotomized into two groups: complete SCI group and incomplete SCI group, based on the American Spinal Injury Association Guidelines Impairment Scale (AIS) .The investigators retrospectively collected records of urodynamic evaluations of this patients and then analyze the urodynamic parameters,including detrusor overactivity (DO), bladder compliance (BC), bladder-filling sensation, maximum cystometric capacity (MCC), detrusor external sphincter dyssynergia (DESD), maximum urinary flow rate (Qmax), detrusor pressure at a maximum urinary flow rate(PdetQmax).

Condition or disease
Spinal Cord Injuries

Study Design
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Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Urodynamic Findings in Patients With Complete and Incomplete Suprasacral Spinal Cord Injury at Different Stages After Injury
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 20, 2019
Actual Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. detrusor overactivity (DO) [ Time Frame: 0-365 days after injury ]
    detrusor overactivity in milliliter,one of the urodynamic parameters

  2. bladder compliance (BC) [ Time Frame: 0-365 days after injury ]
    bladder compliance in ml/cmH2O,one of the urodynamic parameters

  3. bladder-filling sensation [ Time Frame: 0-365 days after injury ]
    bladder-filling sensation,one of the urodynamic parameters


Secondary Outcome Measures :
  1. maximum cystometric capacity (MCC) [ Time Frame: 0-365 days after injury ]
    maximum cystometric capacity in milliliter,one of the urodynamic parameters

  2. detrusor external sphincter dyssynergia (DESD) [ Time Frame: 0-365 days after injury ]
    detrusor external sphincter dyssynergia,one of the urodynamic parameters


Other Outcome Measures:
  1. maximum urinary flow rate (Qmax) [ Time Frame: 0-365 days after injury ]
    maximum urinary flow rate in milliliter/second,one of the urodynamic parameters

  2. detrusor pressure at a maximum urinary flow rate(PdetQmax) [ Time Frame: 0-365 days after injury ]
    detrusor pressure at a maximum urinary flow rate in cmH2O,one of the urodynamic parameters


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Traumatic spinal cord injury patients with voiding dysfunction and had urodynamic examination.
Criteria

Inclusion criteria were:

  1. the period of the spinal shock has passed.
  2. patients diagnosed with traumatic suprasacral SCI, based on AIS.
  3. urodynamic investigations were performed by the same urologist.
  4. patients with voiding dysfunction.

Exclusion Criteria:

The patient with voiding dysfunction before the injury were excluded.

Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Junyan Lu, Attending doctor, Second Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT04642170    
Other Study ID Numbers: SAHoWMU-CR2020-15-212
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System