Reflux in Spinal Cord Injury Patients With Neurogenic Lower Urinary Tract Dysfunction
Vesico-ureteral Reflux in a Contemporary Series of Spinal Cord Injury Patients With Neurogenic Lower Urinary Tract Dysfunction
1 other identifier
observational
120
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2010
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 16, 2011
CompletedFirst Posted
Study publicly available on registry
February 17, 2011
CompletedDecember 16, 2016
December 1, 2016
7 months
February 16, 2011
December 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence and degree of vesico ureter renal reflux
video urodynamic, ultrasound examination
average: yearly scheduled control
Secondary Outcomes (6)
pdet (cmH2O)
average: yearly scheduled control
Medication
average: yearly scheduled examination
possible complications
average: yearly scheduled examination
maximum cystometric capacity
average: yearly scheduled control
compliance mL/cmH2O
average: yearly scheduled control
- +1 more secondary outcomes
Study Arms (1)
Spinal cord injury
Patients with neurogenic lower urinary tract dysfunction due to spinal cord injury with regular urodynamic examination
Interventions
Assessment of bladder function during video urodynamic determine of incidence degree and localization of vesico ureteral reflux based on the result of video urodynamics
Eligibility Criteria
Ages Eligibility: minimum 18 years Genders Eligibility: female and male
You may qualify if:
- Spinal cord injury
- Neurogenic lower urinary tract dysfunction
- Written informed consent
You may not qualify if:
- Lower urinary tract dysfunction due to other causes than spinal cord injury
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
Zurich, Canton of Zurich, 8008, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD Dr. med.
Study Record Dates
First Submitted
February 16, 2011
First Posted
February 17, 2011
Study Start
January 1, 2010
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
December 16, 2016
Record last verified: 2016-12