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Completed

NCT Number: NCT04642170

Urodynamics of Suprasacral Spinal Cord Injury Patients

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).

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

were:

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

Exclusion criteria

The patient with voiding dysfunction before the injury were excluded.

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

Urodynamic Findings in Patients With Complete and Incomplete Suprasacral Spinal Cord Injury at Different Stages After Injury

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 24, 2020
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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