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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01297673
Other study ID # EK 2010-0207/02
Secondary ID
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


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
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