Urodynamic Evaluation in Patients After Spinal Cord Injury

January 13, 2020 updated by: Ewa Chlebus, Poznan University of Medical Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Poland
      • Poznań, Poland, 61-545
        • Recruiting
        • Department of Rehabilitation and Physiotherapy Rehabilitation,
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Urethra sensation
Time Frame: 30 days after spinal injury,
2 - preserved, 1- reduced, 0 - absent
30 days after spinal injury,
Urethra sensation
Time Frame: after 3 months of rehabilitation
2 - preserved, 1- reduced, 0 - absent
after 3 months of rehabilitation
Intravesical pressure
Time Frame: 30 days after spinal injury,
0- normal, 1- low
30 days after spinal injury,
Intravesical pressure
Time Frame: after 3 months of rehabilitation
0- normal, 1- low
after 3 months of rehabilitation
Bladder complaince
Time Frame: 30 days after spinal injury,
2- high, 1- reduced
30 days after spinal injury,
Bladder complaince
Time Frame: after 3 months of rehabilitation
2- high, 1- reduced
after 3 months of rehabilitation
Bladder stability
Time Frame: 30 days after spinal injury,
0 -stable, 1- hyperactive
30 days after spinal injury,
Bladder stability
Time Frame: after 3 months of rehabilitation
0 -stable, 1- hyperactive
after 3 months of rehabilitation
Bladder sensation
Time Frame: 30 days after spinal injury
2-preserved,1- reduced, 0- absent
30 days after spinal injury
Bladder sensation
Time Frame: after 3 months of rehabilitation
2-preserved,1- reduced, 0- absent
after 3 months of rehabilitation
Bladder capacity
Time Frame: 30 days after spinal injury
ml ( Average, Median, SD)
30 days after spinal injury
Bladder capacity
Time Frame: after 3 months of rehabilitation
ml ( Average, Median, SD)
after 3 months of rehabilitation
Urine volume
Time Frame: 30 days after spinal injury
ml ( Average, Median,SD)
30 days after spinal injury
Urine volume
Time Frame: after 3 months of rehabilitation
ml ( Average, Median,SD)
after 3 months of rehabilitation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Poznan University of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Przemysław Lisiński, MPhD, Clinic Rehabilitation, University of Medical Sciences in Poznań

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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