NCT07419165

Brief 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. By evaluating ultrasonographic measurements alongside urodynamic findings, the study seeks to assess their relationship in a prospective cross-sectional setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
Last Updated

February 18, 2026

Status Verified

January 1, 2026

Enrollment Period

1.6 years

First QC Date

January 19, 2026

Last Update Submit

February 16, 2026

Conditions

Keywords

Spinal Cord InjuryNeurogenic lower urinary tract dysfunctionBladder wall thicknessUrodynamic studiesUltrasonography

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    During the same clinical evaluation period as the urodynamic study, either on the same day as or one day prior to urodynamic testing.

Eligibility Criteria

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

You may qualify if:

  • ≥18-65 years of age
  • Traumatic and non-traumatic SCI
  • Willingness to participate and able to provide written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 23073657BACKGROUND
  • 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.

    PMID: 24573904BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

  • Hakan Tunç, Professor doctor

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2026

First Posted

February 18, 2026

Study Start

February 21, 2024

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

February 18, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations