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

February 9, 2024 updated by: Swiss Paraplegic Research, Nottwil

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nottwil, Switzerland, 6007
        • Swiss paraplecic centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

individuals with neurogenic bladder dysfunction due to spinal cord injury

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
one arm; neurogenic bladder dysfunction
evaluation of the clinical utility of bladder wall thickness as a diagnostic tool in patients with spinal cord injury
measurement of bladder wall thickness by ultrasound at different filling states of the bladder during urodynamic investigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
calculated from maximum bladder filling

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation bladder wall thickness and maximum detrusor pressure
Time Frame: measurement at maximum bladder capacity
correlation between bladder wall thickness and maximum detrusor pressure during the urodynamic storage phase
measurement at maximum bladder capacity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Juergen Pannek, MD, Swiss Paraplegic Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

December 10, 2010

First Submitted That Met QC Criteria

February 16, 2011

First Posted (Estimated)

February 18, 2011

Study Record Updates

Last Update Posted (Actual)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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