Reflux in Spinal Cord Injury Patients With Neurogenic Lower Urinary Tract Dysfunction

Completed

• Conditions: Spinal Cord Injury; Vesico-ureteral Reflux

• Registration Number: NCT01297673
• Lead Sponsor: Balgrist University Hospital

Brief Summary

The purpose of this study is to investigate the incidence of reflux in patients with spinal cord injury in relation to the lesion level, duration of injury and bladder management

Detailed Description

Vesico-ureteral reflux was the main cause for renal failure and reduced life expectancy in patients with neurogenic bladder dysfunction due to spinal cord injury. Neurogenic detrusor overactivity leads to high intravesical pressure and may induce reflux. Decreasing intravesical pressure and increasing bladder capacity is necessary to prevent reflux and secondary renal failure.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-08
• Study Completion: 2010-08
• 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: 120

Inclusion Criteria

• Spinal cord injury
• 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
Incidence and degree of vesico ureter renal reflux	average: yearly scheduled control	video urodynamic, ultrasound examination

Secondary Outcome Measures

Name	Time	Method
pdet (cmH2O)	average: yearly scheduled control	urodynamic parameter, detrusor pressure
Medication	average: yearly scheduled examination	name of drugs and applied dosis
possible complications	average: yearly scheduled examination	urinary tract infection, pyelonephritis, renal dysfunction
maximum cystometric capacity	average: yearly scheduled control	the volume at which a patient, with normal sensation, fells he/she can no longer delay micturition
compliance mL/cmH2O	average: yearly scheduled control	Compliance is the change in volume divided by change in detrusor pressure expressed as mL/cmH2O.
bladder management	average: yearly scheduled control	most common: intermittent catheterisation, indwelling catheter, external condom urinal for male patients

Trial Locations

Locations (1)

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