Urodynamics of Suprasacral Spinal Cord Injury Patients

Sponsor

Second Affiliated Hospital of Wenzhou Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT04642170

Collaborator

(none)

101

Enrollment

47.6

Actual Duration (Months)

Study Details

Study Description

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	Intervention/Treatment	Phase
Spinal Cord Injuries

Study Design

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 :

Jan 1, 2016

Actual Primary Completion Date :

Dec 20, 2019

Actual Study Completion Date :

Dec 20, 2019

Outcome Measures

Primary Outcome Measures

detrusor overactivity (DO) [0-365 days after injury]
detrusor overactivity in milliliter,one of the urodynamic parameters
bladder compliance (BC) [0-365 days after injury]
bladder compliance in ml/cmH2O,one of the urodynamic parameters
bladder-filling sensation [0-365 days after injury]
bladder-filling sensation,one of the urodynamic parameters

Secondary Outcome Measures

maximum cystometric capacity (MCC) [0-365 days after injury]
maximum cystometric capacity in milliliter,one of the urodynamic parameters
detrusor external sphincter dyssynergia (DESD) [0-365 days after injury]
detrusor external sphincter dyssynergia,one of the urodynamic parameters

Other Outcome Measures

maximum urinary flow rate (Qmax) [0-365 days after injury]
maximum urinary flow rate in milliliter/second,one of the urodynamic parameters
detrusor pressure at a maximum urinary flow rate(PdetQmax) [0-365 days after injury]
detrusor pressure at a maximum urinary flow rate in cmH2O,one of the urodynamic parameters

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Second Affiliated Hospital of Wenzhou Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Nov 24, 2020

Last Update Posted:

Nov 24, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Spinal Cord Injuries

Wounds and Injuries

Study Results

No Results Posted as of Nov 24, 2020