Spinal Cord InjuriesNCT05568862
Ureteric Jet Doppler Waveforms in Patients With Spinal Cord Injury
An observational study of Spinal Cord Injuries, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Doppler ultrasound, Urodynamic assessment. and Urodynamic assessment.
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jun 2021to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- With signs of upper motor neuron lesion,
- Suprasacral spinal cord injury,
- Normal urinary ultrasound findings
- Planned urodynamics
- Normal urinary ultrasonography
Who cannot join
- Neurological disease other than spinal cord injury
- Urinary tract infection
- Urinary obstruction
- History of urinary tract Stones
- Diabetes, hypertension
- History of urinary surgery,
Show all 14Show fewer
- Sacral injury
- Second motor neuron lesions (such as cauda equina, or cauda conus)
- The control group
- Neurological disease
- Urinary tract infection
- Urinary obstruction
- History of urinary tract Stones
- Diabetes, hypertension
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziler PMR, Training and Research Hospital, Department of PMR
Ankara, Çankaya, 06100
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Doppler ultrasound, Urodynamic assessment., Urodynamic assessment.
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler ultrasound, Urodynamic assessment.Diagnostic test
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
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
| Study group | Role | What they receive |
|---|---|---|
| spinal cord injury | patient with spinal cord injury Receives: Diagnostic Test: Doppler ultrasound, Urodynamic assessment.; Diagnostic Test: Urodynamic assessment. | |
| no spinal cord injury | patient without spinal cord injury Receives: Diagnostic Test: Doppler ultrasound, Urodynamic assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15-30 minute
Urodynamic assessment.
A transurethral double lumen catheter was used to measure intravesical pressure in the urodynamic unit
Measured: 30 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start17 Jun 2021
- Primary completion20 Mar 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- İlkay Karabay, Principal investigator, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568862
- Sponsor's protocol ID
- ik
- Status last verified
- Oct 2022
- First submitted
- 1 Oct 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Characteristics of Ureteric Jet Doppler Waveforms and Factors Affecting Them in Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05568862
- Acronym / sponsor ID
- ik
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 20 Mar 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spinal cord injury | – | Diagnostic Test: Doppler ultrasound, Urodynamic assessment., Diagnostic Test: Urodynamic assessment.patient with spinal cord injury |
| no spinal cord injury | – | Diagnostic Test: Doppler ultrasound, Urodynamic assessment.patient without spinal cord injury |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- With signs of upper motor neuron lesion,
- Suprasacral spinal cord injury,
- Normal urinary ultrasound findings
- Planned urodynamics
- Normal urinary ultrasonography
Key exclusion criteria (14 listed)
- Neurological disease other than spinal cord injury
- Urinary tract infection
- Urinary obstruction
- History of urinary tract Stones
- Diabetes, hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | no spinal cord injury, spinal cord injury |
| 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 | Diagnostic test | spinal cord injury |
Primary outcome
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
Urodynamic assessment.
Time frame: 30 minute
A transurethral double lumen catheter was used to measure intravesical pressure in the urodynamic unit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İlkay Karabay principal investigator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
doppler USG (time frame: 15-30 minute). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.