NCT05568862

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
Last Updated

October 7, 2022

Status Verified

October 1, 2022

Enrollment Period

9 months

First QC Date

October 1, 2022

Last Update Submit

October 5, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • doppler USG

    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.

    A transurethral double lumen catheter was used to measure intravesical pressure in the urodynamic unit

    30 minute

Study Arms (2)

spinal cord injury

patient with spinal cord injury

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

no spinal cord injury

patient without spinal cord injury

Diagnostic Test: Doppler ultrasound, Urodynamic assessment.

Interventions

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

no spinal cord injuryspinal cord injury
Urodynamic assessment.DIAGNOSTIC_TEST

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

spinal cord injury

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • With signs of upper motor neuron lesion,
  • Suprasacral spinal cord injury,
  • Normal urinary ultrasound findings
  • Planned urodynamics

You may not qualify if:

  • 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
  • Normal urinary ultrasonography
  • Neurological disease
  • Urinary tract infection
  • Urinary obstruction
  • History of urinary tract Stones
  • Diabetes, hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziler PMR, Training and Research Hospital, Department of PMR

Ankara, Çankaya, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Ultrasonography, Doppler

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • İlkay Karabay

    Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 1, 2022

First Posted

October 6, 2022

Study Start

June 17, 2021

Primary Completion

March 20, 2022

Study Completion

September 30, 2022

Last Updated

October 7, 2022

Record last verified: 2022-10

Locations