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

Spinal Cord Injury Clinical Trial

Official title:

Vesico-ureteral Reflux in a Contemporary Series of Spinal Cord Injury Patients With Neurogenic Lower Urinary Tract Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01297673
• Other study ID #: EK 2010-0207/02
• Status: Completed
• Phase: N/A
• First received: February 16, 2011
• Last updated: December 15, 2016
• Start date: January 2010
• Est. completion date: August 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

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Spinal Cord Injuries
• Spinal Cord Injury
• Vesico-ureteral Reflux
• Wounds and Injuries

Intervention

Procedure:
• video-urodynamic examination
Assessment of bladder function during video urodynamic determine of incidence degree and localization of vesico ureteral reflux based on the result of video urodynamics

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