Urodynamics of Suprasacral Spinal Cord Injury Patients

NCT04642170 | Completed

• 1 other identifier: SAHoWMU-CR2020-15-212
• Study Type: observational
• Target: 101
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (3)

• detrusor overactivity (DO)

  detrusor overactivity in milliliter,one of the urodynamic parameters

  0-365 days after injury

• bladder compliance (BC)

  bladder compliance in ml/cmH2O,one of the urodynamic parameters

  0-365 days after injury

• bladder-filling sensation

  bladder-filling sensation,one of the urodynamic parameters

  0-365 days after injury

Secondary Outcomes (2)

• maximum cystometric capacity (MCC)

  0-365 days after injury

• detrusor external sphincter dyssynergia (DESD)

  0-365 days after injury

Other Outcomes (2)

• maximum urinary flow rate (Qmax)

  0-365 days after injury

• detrusor pressure at a maximum urinary flow rate(PdetQmax)

  0-365 days after injury

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Traumatic spinal cord injury patients with voiding dysfunction and had urodynamic examination.

You may qualify if:

• 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.

You may not qualify if:

• The patient with voiding dysfunction before the injury were excluded.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctor

Study Record Dates

• First Submitted: November 14, 2020
• First Posted: November 24, 2020
• Study Start: January 1, 2016
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: November 24, 2020

Record last verified: 2020-11