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

NCT01299792 | Completed

• 2 other identifiers: 2009-07EK900
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

spinal cord injury; urodynamics; ultrasound; neurogenic bladder dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• correlation bladder wall thickness and maximum detrusor pressure

  measurement at maximum bladder capacity

Study Arms (1)

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

Interventions

sonographic measurement of bladder wall thickness OTHER

measurement of bladder wall thickness by ultrasound at different filling states of the bladder during urodynamic investigation

one arm; neurogenic bladder dysfunction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

individuals with neurogenic bladder dysfunction due to spinal cord injury

You may qualify if:

• neurogenic bladder dysfunction due to spinal cord injury
• ability to understand German language
• willingness and capability to undergo urodynamic testing
• age \> or = 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

Study Sites (1)

Swiss paraplecic centre

Nottwil, 6007, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Juergen Pannek, MD

  Swiss Paraplegic Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2010
• First Posted: February 18, 2011
• Study Start: August 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

CH (1)