Urodynamics of Suprasacral Spinal Cord Injury Patients

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

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).

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries

• Study Type: Observational
• Enrollment (Actual): 101

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
maximum cystometric capacity (MCC)	maximum cystometric capacity in milliliter,one of the urodynamic parameters	0-365 days after injury
detrusor external sphincter dyssynergia (DESD)	detrusor external sphincter dyssynergia,one of the urodynamic parameters	0-365 days after injury

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
maximum urinary flow rate (Qmax)	maximum urinary flow rate in milliliter/second,one of the urodynamic parameters	0-365 days after injury
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): December 20, 2019
• Study Completion (ACTUAL): December 20, 2019

Study Registration Dates

• First Submitted: November 14, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (ACTUAL): November 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: SAHoWMU-CR2020-15-212

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No