- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07419165
Correlation of Ultrasound-Measured Detrusor and Bladder Wall Thickness With Urodynamic Parameters in Spinal Cord Injury
Correlation of Suprapubic Ultrasound-Measured Detrusor and Bladder Wall Thickness With Urodynamic Parameters in Patients With Spinal Cord Injury
Study Overview
Status
Detailed Description
This single-center, prospective cross-sectional observational study was conducted to evaluate the association between detrusor and bladder wall thickness measured by suprapubic ultrasound and urodynamic parameters in patients with spinal cord injury. Patients with spinal cord injury were prospectively enrolled and underwent suprapubic ultrasonography and urodynamic evaluation as part of the study protocol.
Detrusor wall thickness and bladder wall thickness were measured using suprapubic ultrasonography according to a standardized protocol. Urodynamic parameters, including detrusor pressure and other relevant measurements, were recorded during routine urodynamic assessment. The relationship between ultrasonographic measurements and urodynamic findings was analyzed to assess their correlation.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Çankaya
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Ankara, Çankaya, Turkey (Türkiye), 06800
- Ankara Bilkent City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- ≥18-65 years of age
- Traumatic and non-traumatic SCI
- Willingness to participate and able to provide written informed consent
Exclusion Criteria:
- Neurogenic lower urinary tract dysfunction not caused by spinal cord injury
- History of brain surgery
- History of augmentative urinary surgery or invasive bladder procedures (e.g., bladder tumor resection, botulinum toxin injection)
- History of urinary tract malignancy
- Prior overactive bladder or urinary incontinence, or prior surgery for benign prostatic hyperplasia
- Bladder outlet obstruction
- Cognitive impairment that would interfere with participation
- Active urinary tract infection preventing urodynamic evaluation
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Correlation between ultrasound-measured detrusor and bladder wall thickness and urodynamic parameters
Time Frame: Ultrasonographic measurements were performed during the same clinical evaluation period, either on the same day as or within one day prior to the urodynamic study.
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The association between suprapubic ultrasound-measured bladder wall thickness and detrusor wall thickness and urodynamic parameters, including cystometric capacity, maximum cystometric capacity, maximum detrusor pressure, leak point pressure, bladder capacity at the time of leakage, total leakage volume, bladder compliance, presence of bladder sensation, presence of detrusor overactivity, presence of sphincter hyperactivity, maximum flow rate, detrusor pressure at maximum flow, voided volume, and postvoid residual urine volume.
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Ultrasonographic measurements were performed during the same clinical evaluation period, either on the same day as or within one day prior to the urodynamic study.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Association of bladder and detrusor wall thickness with clinical characteristics
Time Frame: During the same clinical evaluation period as the urodynamic study, either on the same day as or one day prior to urodynamic testing.
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The association between suprapubic ultrasound-measured bladder wall thickness and detrusor wall thickness (measured in millimeters, mm) and clinical characteristics, including sex (male/female), neurological level of injury, distribution of paralysis (paraplegia/tetraplegia), injury severity according to the ASIA Impairment Scale (AIS A-E), duration since injury (months), etiology of spinal cord injury, bladder emptying method, use of anticholinergic medication (yes/no), presence of pressure ulcers (yes/no), and history of recurrent urinary tract infections (yes/no).
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During the same clinical evaluation period as the urodynamic study, either on the same day as or one day prior to urodynamic testing.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hakan Tunç, Professor doctor, Ankara City Hospital Bilkent
Publications and helpful links
General Publications
- Pannek J, Bartel P, Gocking K, Frotzler A. Clinical usefulness of ultrasound assessment of detrusor wall thickness in patients with neurogenic lower urinary tract dysfunction due to spinal cord injury: urodynamics made easy? World J Urol. 2013 Jun;31(3):659-64. doi: 10.1007/s00345-012-0970-6. Epub 2012 Oct 17.
- Silva JA, Gonsalves Mde C, de Melo RT, Carrerette FB, Damiao R. Association between the bladder wall thickness and urodynamic findings in patients with spinal cord injury. World J Urol. 2015 Jan;33(1):131-5. doi: 10.1007/s00345-014-1265-x. Epub 2014 Feb 27.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2-24-12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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