Status:
UNKNOWN
Gentamicin Bladder Instillation Trial
Lead Sponsor:
Gillette Children's Specialty Healthcare
Conditions:
Urinary Tract Infections
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief Summary
Recurrent UTIs are common among patients on IC. These create significant patient morbidity and healthcare burden. In desperation, many physicians prescribe prophylactic oral or intravesical antibiotic...
Detailed Description
In the Gillette Lifetime Urology clinic, gentamicin bladder instillation (GBI) for UTI prophylaxis is common practice among our neurogenic bladder patients in IC. However, as previously shown, the evi...
Eligibility Criteria
Inclusion
- Patients (\>=16 years of age) with any diagnosis on IC of the bladder.
- Patients may catheterize either thru the urethra or a stoma (e.g. Mitrofanoff).
- A history of recurrent symptomatic UTI's (at least 3 per year).
- Patient must be able to travel to Gillette's Lifetime clinic for quarterly urine cultures
- Patient must have an "informed other" that can supplement any missing study information (incident UTI, treatment information, etc.)
Exclusion
- Patients currently on oral or intravesical antibiotic prophylaxis refusing to or not able to discontinue prophylaxis.
- Patients colonized with gentamicin-resistant bacteria on baseline urine culture or a gentamicin allergy.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01884467
Start Date
May 1 2013
End Date
December 1 2016
Last Update
April 9 2015
Active Locations (1)
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1
Gillette Lifetime Specialty Healthcare
Saint Paul, Minnesota, United States, 55130