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Clinical Trials/NCT01299792
NCT01299792CompletedNot Applicable

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

Swiss Paraplegic Research, Nottwil1 site in 1 country60 target enrollmentStarted: August 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
correlation bladder wall thickness and detrusor compliance

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

correlation bladder wall thickness and detrusor compliance

Time Frame: calculated from maximum bladder filling

measurement of detrusor compliance at maximum bladder volume; measurement of bladder wall thickness at maximum bladder volume

Secondary Outcomes

  • correlation bladder wall thickness and maximum detrusor pressure(measurement at maximum bladder capacity)

Investigators

Sponsor
Swiss Paraplegic Research, Nottwil
Sponsor Class
Network
Responsible Party
Sponsor

Study Sites (1)

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