Urodynamic Evaluation in Patients After Spinal Cord Injury

Urodynamic Evaluation Neurgenic Bladder in Patients After Spinal Cord Injury

Retrospective study, which analyzed 100 medical histories of patients who were admitted o the Neurological Rehabilitation Ward of the Rehabilitation Clinic in the Orthopedic-Rehabilitation Hospital in Poznan in years 2010-2019.

Study Overview

• Status: Unknown
• Conditions: Spinal Cord Injuries; Neurogenic Bladder; Urodynamics
• Intervention / Treatment: Device: Urodynamic testing

Detailed Description

All patients considered for the study underwent routine testing: blood counts, urinalysis, urine culture, and sensitivity.

• Study Type: Observational
• Enrollment (Anticipated): 2

Contacts and Locations

Study Locations

• Poland
  • Poznań, Poland, 61-545
    • Recruiting
    • Department of Rehabilitation and Physiotherapy Rehabilitation,
    • Contact: Ewa Chlebuś, lek; Phone Number: 600195386; Email: ewachlebus@ump.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Eventually, 54 patients were enrolled in the study (12 women, 42 men). The incompleteness and level of SCI were diagnosed based on MRI, which was performed directly after the injury in Neurosurgery Ward or Trauma Center.

Description

Inclusion Criteria:

• incomplete spinal cord injuries,
• the results of the urodynamic testing (conducted by the same urologist) by admission,
• urine culture test by admission.

Exclusion Criteria:

• complete spinal cord injury
• without urodynamic test in medical documentation by admission,
• without urine culture test by admission,
• with symptomatic urinary tract infection in urodynamic test

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Demographic and clinical features of the patients; Number of patients Time from injury to hospitalization Time from injury to urodynamic evaluation Duration of hospitalization	Device: Urodynamic testing; All data were obtained using the MMS Alfa 4T by the same urologist with use of an 8 Charr catheter.
Comparison of urodynamic outcomes; Treatment options in patients with level SCI : cervical, thoracical and lumbar spinal cord injury	Device: Urodynamic testing; All data were obtained using the MMS Alfa 4T by the same urologist with use of an 8 Charr catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urethra sensation	2 - preserved, 1- reduced, 0 - absent	30 days after spinal injury,
Urethra sensation	2 - preserved, 1- reduced, 0 - absent	after 3 months of rehabilitation
Intravesical pressure	0- normal, 1- low	30 days after spinal injury,
Intravesical pressure	0- normal, 1- low	after 3 months of rehabilitation
Bladder complaince	2- high, 1- reduced	30 days after spinal injury,
Bladder complaince	2- high, 1- reduced	after 3 months of rehabilitation
Bladder stability	0 -stable, 1- hyperactive	30 days after spinal injury,
Bladder stability	0 -stable, 1- hyperactive	after 3 months of rehabilitation
Bladder sensation	2-preserved,1- reduced, 0- absent	30 days after spinal injury
Bladder sensation	2-preserved,1- reduced, 0- absent	after 3 months of rehabilitation
Bladder capacity	ml ( Average, Median, SD)	30 days after spinal injury
Bladder capacity	ml ( Average, Median, SD)	after 3 months of rehabilitation
Urine volume	ml ( Average, Median,SD)	30 days after spinal injury
Urine volume	ml ( Average, Median,SD)	after 3 months of rehabilitation

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Study Director: Przemysław Lisiński, MPhD, Clinic Rehabilitation, University of Medical Sciences in Poznań

Study record dates

Study Major Dates

• Study Start (Anticipated): January 20, 2020
• Primary Completion (Anticipated): January 31, 2020
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Urodynamics
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries; Urinary Bladder, Neurogenic
• Other Study ID Numbers: 1/2019CReh; 111/19 (Other Identifier: Bioethics Committee by the Poznan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Urodynamic evaluation in patients after spinal cord injury

Drug and device information, study documents

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