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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clinical Trial Unit, Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier:
NCT01299792
First received: December 10, 2010
Last updated: November 17, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Spinal Cord Injury
 Other: sonographic measurement of bladder wall thickness

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Sonographic Measurement of Bladder Wall Thickness in Patients With Neurogenic Bladder Dysfunction Due to Spinal Cord Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Swiss Paraplegic Centre Nottwil:

Primary Outcome Measures:
  • correlation bladder wall thickness and detrusor compliance [ Time Frame: calculated from maximum bladder filling ] [ Designated as safety issue: No ]
    measurement of detrusor compliance at maximum bladder volume; measurement of bladder wall thickness at maximum bladder volume


Secondary Outcome Measures:
  • correlation bladder wall thickness and maximum detrusor pressure [ Time Frame: measurement at maximum bladder capacity ] [ Designated as safety issue: No ]
    correlation between bladder wall thickness and maximum detrusor pressure during the urodynamic storage phase


Enrollment: 60
Study Start Date: August 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: one arm; neurogenic bladder dysfunction
evaluation of the clinical utility of bladder wall thickness as a diagnostic tool in patients with spinal cord injury
 Other: sonographic measurement of bladder wall thickness
measurement of bladder wall thickness by ultrasound at different filling states of the bladder during urodynamic investigation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01299792

Locations
Switzerland
Swiss paraplecic centre
Nottwil, Switzerland, 6007
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil
Investigators
Principal Investigator: Juergen Pannek, MD Swiss Paraplegic Centre
  More Information

No publications provided

Responsible Party: Clinical Trial Unit, Jürgen Pannek, Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT01299792     History of Changes
Other Study ID Numbers: JP-001, EK900
Study First Received: December 10, 2010
Last Updated: November 17, 2011
Health Authority: Switzerland: ethical committee of the Kanton Lucerne

Keywords provided by Swiss Paraplegic Centre Nottwil:
spinal cord injury
urodynamics
ultrasound
neurogenic bladder dysfunction

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Spinal Cord Injuries
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
 Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 21, 2013