Neuro-urological Outcome After Spinal Cord Injury

Urinary Bladder Neurogenic Dysfunction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01297660
• Other study ID #: KEK-2010-0207/01
• Status: Completed
• Phase: N/A
• First received: February 16, 2011
• Last updated: December 15, 2016
• Start date: January 2010
• Est. completion date: September 2010

Study information

• Verified date: December 2016
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

Most patients with spinal cord injury suffer from bladder dysfunction which may - especially in the long-term - impair renal function. Improved treatment during the last decades improved life expectancy and quality of life. This study evaluates the bladder function in the long-term after spinal cord injury.

Description:

Bladder dysfunction is a common consequence of spinal cord injury and depends on the completeness and the level of the lesion. Patients with suprasacral injury usually suffer from neurogenic detrusor overactivity mostly combined with detrusor sphincter dyssynergia. Without adequate treatment, this adverse combination puts the upper urinary tract at risk due to high intravesical pressure often causing vesico-ureteral reflux. Based on improved therapeutic options in the last decades, life expectancy and quality of life constantly increased in spinal cord injury patients. The investigators aim to evaluate the bladder function in the long-term after spinal cord injury.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Spinal cord injury for at least 5 years

• Neurogenic lower urinary tract dysfunction

• Written informed consent

Exclusion Criteria:

• Lower urinary tract dysfunction due to other causes than spinal cord injury

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Urinary Bladder Neurogenic Dysfunction
• Urinary Bladder, Neurogenic

Intervention

Other:
• Video-urodynamic examination

Locations

Country	Name	City	State
Switzerland	Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urodynamic evaluation	Max. cystometric capacity, compliance, detrusor leak point pressure	5 years after SCI, yearly thereafter (participants are followed until death)	No
Secondary	secondary complications	recurrent tract infection, deterioration of the upper urinary tract	5 years after SCI, yearly thereafter (participants are followed until death)	No
Secondary	imaging of the upper urinary tract	videocystography, ultrasound	5 years after SCI, yearly thereafter (participants are followed until death)	No