NCT04231474

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

11 days

First QC Date

November 25, 2019

Last Update Submit

January 13, 2020

Conditions

Spinal Cord InjuriesNeurogenic BladderUrodynamics

Keywords

Urodynamics

Outcome Measures

Primary Outcomes (14)

  • 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

Study Arms (2)

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

Comparison of urodynamic outcomes

Treatment options in patients with level SCI : cervical, thoracical and lumbar spinal cord injury

Device: Urodynamic testing

Interventions

Urodynamic testingDEVICE

All data were obtained using the MMS Alfa 4T by the same urologist with use of an 8 Charr catheter.

Comparison of urodynamic outcomesDemographic and clinical features of the patients

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation and Physiotherapy Rehabilitation,

Poznan, 61-545, Poland

RECRUITING

MeSH Terms

Conditions

Spinal Cord InjuriesUrinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesNeurologic ManifestationsUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Przemysław Lisiński, MPhD

    Clinic Rehabilitation, University of Medical Sciences in Poznań

    STUDY DIRECTOR

Central Study Contacts

Ewa Chlebuś

CONTACT

600195386ewachlebus@ump.edu.pl

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lek.Ewa Chlebuś, Department of Rehabilitation and Physiotherapy Rehabilitation

Study Record Dates

First Submitted

November 25, 2019

First Posted

January 18, 2020

Study Start

January 20, 2020

Primary Completion

January 31, 2020

Study Completion

March 1, 2020

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

PL(1)