- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05568862
Ureteric Jet Doppler Waveforms in Patients With Spinal Cord Injury
October 5, 2022 updated by: Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
The Characteristics of Ureteric Jet Doppler Waveforms and Factors Affecting Them in Patients With Spinal Cord Injury
Urinary dysfunction is very common in individuals with spinal cord injury.
The urine flowing from the collecting ducts to the renal calyx stretches the calyces.
ANS controlled peristaltic contractions originate in the proximal renal pelvis and travel down the ureters, pushing urine from the renal pelvis towards the bladder.
The urine bolus delivered from the kidneys through the peristaltic contraction of the ureter creates an image called ureteric jet.
Using the Doppler analysis of ureteral jets, previous studies have examined the changes in the ureteric jet pattern in pathological conditions such as the diagnosis of normal ureteral physiology.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This cross-sectional study was conducted at a tertiary rehabilitation center.
Eighteen spinal cord injury patients who met the inclusion criteria and 24 healthy volunteers were included in the study.
The appearance of üreteric jet form and bladder wall thicknesses were obtained by urinary Doppler ultrasound both in patient and control groups.
Detrusor pressure and bladder volume were measured only in patient group during urodynamic assessment.
Study Type
Observational
Enrollment (Actual)
42
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Çankaya
-
Ankara, Çankaya, Turkey, 06100
- Gaziler PMR, Training and Research Hospital, Department of PMR
-
-
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
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Spinal cord injury patients who were hospitalized in the spinal cord injury Rehabilitation Unit of our rehabilitation center and 32 no spinal cord injury who presented at outpatient clinics.
Description
The case group
Inclusion Criteria:
- With signs of upper motor neuron lesion,
- Suprasacral spinal cord injury,
- Normal urinary ultrasound findings
- Planned urodynamics
Exclusion Criteria:
- Neurological disease other than spinal cord injury
- Urinary tract infection
- Urinary obstruction
- History of urinary tract Stones
- Diabetes, hypertension
- History of urinary surgery,
- Sacral injury
- Second motor neuron lesions (such as cauda equina, or cauda conus)
The control group
Inclusion Criteria:
• Normal urinary ultrasonography
Exclusion Criteria:
- Neurological disease
- Urinary tract infection
- Urinary obstruction
- History of urinary tract Stones
- Diabetes, hypertension
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-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
spinal cord injury
patient with spinal cord injury
|
The patients included in the study group were given 600 cc of water in the morning and the Doppler ultrasound was performed 30 minutes later
A transurethral double lumen catheter was used to measure intravesical pressure in the urodynamic unit for the patients in the study group immediately after the use of the Doppler USG
|
no spinal cord injury
patient without spinal cord injury
|
The patients included in the study group were given 600 cc of water in the morning and the Doppler ultrasound was performed 30 minutes later
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
doppler USG
Time Frame: 15-30 minute
|
The patients included in the study group were given 600 cc of water in the morning and the Doppler USG was performed 30 minutes later
|
15-30 minute
|
Urodynamic assessment.
Time Frame: 30 minute
|
A transurethral double lumen catheter was used to measure intravesical pressure in the urodynamic unit
|
30 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: İlkay Karabay, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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 (Actual)
June 17, 2021
Primary Completion (Actual)
March 20, 2022
Study Completion (Actual)
September 30, 2022
Study Registration Dates
First Submitted
October 1, 2022
First Submitted That Met QC Criteria
October 3, 2022
First Posted (Actual)
October 6, 2022
Study Record Updates
Last Update Posted (Actual)
October 7, 2022
Last Update Submitted That Met QC Criteria
October 5, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ik
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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