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Ureteric Jet Doppler Waveforms in Patients With 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: NCT05568862
Recruitment Status : Completed
First Posted : October 6, 2022
Last Update Posted : October 7, 2022
Sponsor:
Information provided by (Responsible Party):
Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Spinal Cord Injuries Diagnostic Test: Doppler ultrasound, Urodynamic assessment. Diagnostic Test: Urodynamic assessment.

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.

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Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Characteristics of Ureteric Jet Doppler Waveforms and Factors Affecting Them in Patients With Spinal Cord Injury
Actual Study Start Date : June 17, 2021
Actual Primary Completion Date : March 20, 2022
Actual Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
spinal cord injury
patient with spinal cord injury
Diagnostic Test: Doppler ultrasound, Urodynamic assessment.
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

Diagnostic Test: Urodynamic assessment.
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
Diagnostic Test: Doppler ultrasound, Urodynamic assessment.
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




Primary Outcome Measures :
  1. 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

  2. Urodynamic assessment. [ Time Frame: 30 minute ]
    A transurethral double lumen catheter was used to measure intravesical pressure in the urodynamic unit



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

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): NCT05568862


Locations
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Turkey
Gaziler PMR, Training and Research Hospital, Department of PMR
Ankara, Çankaya, Turkey, 06100
Sponsors and Collaborators
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Investigators
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Principal Investigator: İlkay Karabay Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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Responsible Party: Yasin Demir, Associate Professor, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
ClinicalTrials.gov Identifier: NCT05568862    
Other Study ID Numbers: ik
First Posted: October 6, 2022    Key Record Dates
Last Update Posted: October 7, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System