Ureteric Jet Doppler Waveforms in Patients With Spinal Cord Injury

Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05568862

Collaborator

(none)

Enrollment

Location

15.4

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

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 :

Jun 17, 2021

Actual Primary Completion Date :

Mar 20, 2022

Actual Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

doppler USG [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
Urodynamic assessment. [30 minute]
A transurethral double lumen catheter was used to measure intravesical pressure in the urodynamic unit

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Principal Investigator: İlkay Karabay, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yasin Demir, Associate Professor, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

ClinicalTrials.gov Identifier:

NCT05568862

Other Study ID Numbers:

First Posted:

Oct 6, 2022

Last Update Posted:

Oct 7, 2022

Last Verified:

Oct 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Spinal Cord Injuries

Wounds and Injuries

Study Results

No Results Posted as of Oct 7, 2022