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

Completed

• Conditions: Spinal Cord Injury
• Interventions: Other: sonographic measurement of bladder wall thickness

• Registration Number: NCT01299792
• Lead Sponsor: Swiss Paraplegic Research, Nottwil

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-12-10
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-18
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
one arm; neurogenic bladder dysfunction	sonographic measurement of bladder wall thickness	evaluation of the clinical utility of bladder wall thickness as a diagnostic tool in patients with spinal cord injury

Primary Outcome Measures

Name	Time	Method
correlation bladder wall thickness and detrusor compliance	calculated from maximum bladder filling	measurement of detrusor compliance at maximum bladder volume; measurement of bladder wall thickness at maximum bladder volume

Secondary Outcome Measures

Name	Time	Method
correlation bladder wall thickness and maximum detrusor pressure	measurement at maximum bladder capacity	correlation between bladder wall thickness and maximum detrusor pressure during the urodynamic storage phase

Trial Locations

Locations (1)

Swiss paraplecic centre; 🇨🇭 Nottwil, Switzerland