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Urodynamic Evaluation in Patients After Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04231474
Recruitment Status : Unknown
Verified January 2020 by Ewa Chlebus, Poznan University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Ewa Chlebus, Poznan University of Medical Sciences

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Spinal Cord Injuries Neurogenic Bladder Urodynamics Device: Urodynamic testing

Detailed Description:
All patients considered for the study underwent routine testing: blood counts, urinalysis, urine culture, and sensitivity.
Study Design
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Study Type : Observational
Estimated Enrollment : 2 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Urodynamic Evaluation Neurgenic Bladder in Patients After Spinal Cord Injury
Estimated Study Start Date : January 20, 2020
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Urethra sensation [ Time Frame: 30 days after spinal injury, ]
    2 - preserved, 1- reduced, 0 - absent

  2. Urethra sensation [ Time Frame: after 3 months of rehabilitation ]
    2 - preserved, 1- reduced, 0 - absent

  3. Intravesical pressure [ Time Frame: 30 days after spinal injury, ]
    0- normal, 1- low

  4. Intravesical pressure [ Time Frame: after 3 months of rehabilitation ]
    0- normal, 1- low

  5. Bladder complaince [ Time Frame: 30 days after spinal injury, ]
    2- high, 1- reduced

  6. Bladder complaince [ Time Frame: after 3 months of rehabilitation ]
    2- high, 1- reduced

  7. Bladder stability [ Time Frame: 30 days after spinal injury, ]
    0 -stable, 1- hyperactive

  8. Bladder stability [ Time Frame: after 3 months of rehabilitation ]
    0 -stable, 1- hyperactive

  9. Bladder sensation [ Time Frame: 30 days after spinal injury ]
    2-preserved,1- reduced, 0- absent

  10. Bladder sensation [ Time Frame: after 3 months of rehabilitation ]
    2-preserved,1- reduced, 0- absent

  11. Bladder capacity [ Time Frame: 30 days after spinal injury ]
    ml ( Average, Median, SD)

  12. Bladder capacity [ Time Frame: after 3 months of rehabilitation ]
    ml ( Average, Median, SD)

  13. Urine volume [ Time Frame: 30 days after spinal injury ]
    ml ( Average, Median,SD)

  14. Urine volume [ Time Frame: after 3 months of rehabilitation ]
    ml ( Average, Median,SD)


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04231474


Contacts
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Contact: Ewa Chlebuś 600195386 ewachlebus@ump.edu.pl

Locations
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Poland
Department of Rehabilitation and Physiotherapy Rehabilitation, Recruiting
Poznań, Poland, 61-545
Contact: Ewa Chlebuś, lek    600195386    ewachlebus@ump.edu.pl   
Sponsors and Collaborators
Poznan University of Medical Sciences
Investigators
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Study Director: Przemysław Lisiński, MPhD Clinic Rehabilitation, University of Medical Sciences in Poznań
More Information
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Responsible Party: Ewa Chlebus, lek.Ewa Chlebuś, Department of Rehabilitation and Physiotherapy Rehabilitation, Poznan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT04231474    
Other Study ID Numbers: 1/2019CReh
111/19 ( Other Identifier: Bioethics Committee by the Poznan )
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Urodynamic evaluation in patients after spinal cord injury

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ewa Chlebus, Poznan University of Medical Sciences:
Urodynamics
Additional relevant MeSH terms:
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Spinal Cord Injuries
Urinary Bladder, Neurogenic
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
 Neurologic Manifestations
Urinary Bladder Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases