Spinal Cord InjuryNCT07419165
Correlation of Ultrasound-Measured Detrusor and Bladder Wall Thickness With Urodynamic Parameters in Spinal Cord Injury
An observational study of Spinal Cord Injury and Neurogenic Lower Urinary Tract Dysfunction, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the correlation between detrusor and bladder wall thickness measured by suprapubic ultrasound and urodynamic parameters in patients with spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury, Neurogenic Lower Urinary Tract Dysfunction
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Feb 2024to 1 Oct 2025
- 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: Patients with spinal cord injury admitted to the inpatient rehabilitation program at Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital, referred to the Urodynamy Laboratory, who met the inclusion criteria and consented to participate in the study.
Who may be able to join
- ≥18-65 years of age
- Traumatic and non-traumatic SCI
- Willingness to participate and able to provide written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Çankaya, 06800
About this study
Official title: Correlation of Suprapubic Ultrasound-Measured Detrusor and Bladder Wall Thickness With Urodynamic Parameters in Patients With Spinal Cord Injury
This study aims to investigate the correlation between detrusor and bladder wall thickness measured by suprapubic ultrasound and urodynamic parameters in patients with spinal cord injury. By evaluating ultrasonographic measurements alongside urodynamic findings, the study seeks to assess their relationship in a prospective cross-sectional setting.
Read the 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.
- Keywords
- Spinal Cord Injury, Neurogenic lower urinary tract dysfunction, Bladder wall thickness, Urodynamic studies, Ultrasonography
- Medical subject headings
- Spinal Cord Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between ultrasound-measured detrusor and bladder wall thickness and urodynamic parameters
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.
Measured: 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.
Secondary outcomes (1)
Association of bladder and detrusor wall thickness with clinical characteristics
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).
Measured: During the same clinical evaluation period as the urodynamic study, either on the same day as or one day prior to urodynamic testing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start21 Feb 2024
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hakan Tunç, Professor doctor, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419165
- Sponsor's protocol ID
- 2-24-12
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23073657Silva 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.
PubMed 24573904
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Suprapubic Ultrasound-Measured Detrusor and Bladder Wall Thickness With Urodynamic Parameters in Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07419165
- Acronym / sponsor ID
- 2-24-12
- Keywords
- Spinal Cord Injury, Neurogenic lower urinary tract dysfunction, Bladder wall thickness, Urodynamic studies, Ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 18 Feb 2026 (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.
This study aims to investigate the correlation between detrusor and bladder wall thickness measured by suprapubic ultrasound and urodynamic parameters in patients with spinal cord injury. By evaluating ultrasonographic measurements alongside urodynamic findings, the study seeks to assess their relationship in a prospective cross-sectional setting.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with spinal cord injury admitted to the inpatient rehabilitation program at Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital, referred to the Urodynamy Laboratory, who met the inclusion criteria and consented to participate in the study.
Key inclusion criteria (3 listed)
- ≥18-65 years of age
- Traumatic and non-traumatic SCI
- Willingness to participate and able to provide written informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
1 secondary outcome
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.
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 18 Feb 2026.
- Background: PubMed 23073657Pannek 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.
- Background: PubMed 24573904Silva 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.
- Individual participant dataSharing planned: No
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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.
Hakan Tunç, Professor doctor principal investigator
Ankara City Hospital Bilkent
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 Injury and Neurogenic Lower Urinary Tract Dysfunction, run by Ankara City Hospital Bilkent 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 3 inclusion and 8 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 18 Feb 2026. 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?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07419165, which also lists 2 linked publications.
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 18 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.