Sonographic Measurement of Bladder Wall Thickness in Patients With Neurogenic Bladder Dysfunction

Spinal Cord Injury Clinical Trial

Official title:

Sonographic Measurement of Bladder Wall Thickness in Patients With Neurogenic Bladder Dysfunction Due to Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01299792
• Other study ID #: 2009-07
• Secondary ID: EK900
• Status: Completed
• Start date: August 2009
• Est. completion date: October 2011

Study information

• Verified date: February 2024
• Source: Swiss Paraplegic Research, Nottwil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Video-urodynamic investigations are regarded as the current standard diagnostics for neurogenic bladder dysfunction in patients with spinal cord injury. This examination is exact, but time consuming, costly and associated with the risk of urinary tract infection.

In patients with lower urinary tract symptoms due to benign prostate hyperplasia, sonographic measurement of bladder wall thickness has been demonstrated to be able to replace urodynamic testing for the diagnosis of infravesical obstruction.

Hypothesis: measurement of bladder wall thickness in patients with neurogenic bladder dysfunction due to spinal cord injury is closely related to the known risk factors for upper urinary tract deterioration (bladder compliance, detrusor leak point pressure) in this group of patients and can therefore replace urodynamic examination in selected cases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• neurogenic bladder dysfunction due to spinal cord injury

• ability to understand German language

• willingness and capability to undergo urodynamic testing

• age > or = 18 years

Exclusion Criteria:

• acute urinary infection at the time of examination

• known bladder tumor or bladder stone

• age < 18 years

• not capable to understand aim and purpose of the examination

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Urinary Bladder, Neurogenic

Intervention

Other:
• sonographic measurement of bladder wall thickness
measurement of bladder wall thickness by ultrasound at different filling states of the bladder during urodynamic investigation

Locations

Country	Name	City	State
Switzerland	Swiss paraplecic centre	Nottwil

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Research, Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation bladder wall thickness and detrusor compliance	measurement of detrusor compliance at maximum bladder volume; measurement of bladder wall thickness at maximum bladder volume	calculated from maximum bladder filling
Secondary	correlation bladder wall thickness and maximum detrusor pressure	correlation between bladder wall thickness and maximum detrusor pressure during the urodynamic storage phase	measurement at maximum bladder capacity