Neuro-urological Outcome After Spinal Cord Injury

Completed

• Conditions: Urinary Bladder Neurogenic Dysfunction

• Registration Number: NCT01297660
• Lead Sponsor: Balgrist University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Study First Submitted: 2011-02-16
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-17
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-15
• Last Update Posted: 2016-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Urodynamic evaluation	5 years after SCI, yearly thereafter (participants are followed until death)	Max. cystometric capacity, compliance, detrusor leak point pressure

Secondary Outcome Measures

Name	Time	Method
imaging of the upper urinary tract	5 years after SCI, yearly thereafter (participants are followed until death)	videocystography, ultrasound
secondary complications	5 years after SCI, yearly thereafter (participants are followed until death)	recurrent tract infection, deterioration of the upper urinary tract

Trial Locations

Locations (1)

Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital; 🇨🇭 Zürich, Switzerland