Urodynamics of Suprasacral Spinal Cord Injury Patients

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04642170
• Other study ID #: SAHoWMU-CR2020-15-212
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: December 20, 2019

Study information

• Verified date: November 2020
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	maximum urinary flow rate (Qmax)	maximum urinary flow rate in milliliter/second,one of the urodynamic parameters	0-365 days after injury
Other	detrusor pressure at a maximum urinary flow rate(PdetQmax)	detrusor pressure at a maximum urinary flow rate in cmH2O,one of the urodynamic parameters	0-365 days after injury
Primary	detrusor overactivity (DO)	detrusor overactivity in milliliter,one of the urodynamic parameters	0-365 days after injury
Primary	bladder compliance (BC)	bladder compliance in ml/cmH2O,one of the urodynamic parameters	0-365 days after injury
Primary	bladder-filling sensation	bladder-filling sensation,one of the urodynamic parameters	0-365 days after injury
Secondary	maximum cystometric capacity (MCC)	maximum cystometric capacity in milliliter,one of the urodynamic parameters	0-365 days after injury
Secondary	detrusor external sphincter dyssynergia (DESD)	detrusor external sphincter dyssynergia,one of the urodynamic parameters	0-365 days after injury