Gentamicin Bladder Instillation Trial
Status unconfirmed · Phase 4 · Has a placebo group
Conditions studied: Urinary Tract Infections
In brief
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 antibiotics. This practice is common among our Gillette clinic patients. However, the benefit is unclear and the risks are not insignificant. As such, practice variation is significant. In order to better define the evidence for or against gentamicin bladder irrigation and thus inform clinical practice both locally at our Gillette urology clinic and for practitioners at large we will pursue the following specific aims: 1. Compare rates of symptomatic urinary tract infection and asymptomatic bacteriuria among a population of Gillette patients on IC with and without gentamicin bladder instillation. 2. Compare antibiotic resistance rates among a population of Gillette patients on IC with and without gentamicin bladder instillation.
Key facts
- Study ID
- NCT01884467
- Run by
- Gillette Children's Specialty Healthcare
- People needed
- 24
- Starts
- 2013-05-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2015-04-09
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.)
You may not qualify if…
- 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.
Where it is running
- Gillette Lifetime Specialty Healthcare — Saint Paul, Minnesota, United States (enrolling)
Full record on ClinicalTrials.gov
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