Status:
COMPLETED
Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections
Lead Sponsor:
Coloplast A/S
Conditions:
Urinary Tract Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the frequency of urinary tract infections with symptoms in spinal cord injured patients requiring intermittent catheterization for emptying the bladder. Pat...
Detailed Description
Introduction: Spinal cord injured (SCI) constitutes a large group of patients suffering from neurogenic bladder dysfunction, which is often managed by intermittent catheterization (IC). Intermittent ...
Eligibility Criteria
Inclusion
- Traumatic spinal cord injury within 3 months prior to inclusion
- Neurogenic bladder dysfunction requiring intermittent catheterization at least 3 times daily
Exclusion
- Has symptoms of UTI at inclusion
- Treated with prophylactic antibiotics to prevent UTIs
- Has a history of unresolved bladder-ureteral reflux and/or stones in the urinary tract
- Has used intermittent catheterization for more than 10 days prior to inclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT00318591
Start Date
April 1 2006
End Date
October 1 2009
Last Update
February 10 2021
Active Locations (16)
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1
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States, 90242
2
Santa Clara Valley Medical Center
San Jose, California, United States, 95128
3
Craig Hospital
Englewood, Colorado, United States, 80113
4
University of Miami
Miami, Florida, United States, 33101