Gentamicin Bladder Instillation Trial



Status:Recruiting
Conditions:Other Indications, Infectious Disease, Urology, Urinary Tract Infections
Therapuetic Areas:Immunology / Infectious Diseases, Nephrology / Urology, Other
Healthy:No
Age Range:16 - Any
Updated:4/2/2016
Start Date:May 2013
End Date:December 2016
Contact:Meghan E Munger, MPH
Email:MeghanEMunger@gillettechildrens.com
Phone:651-229-1757

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Randomized Placebo-Controlled Trial of Gentamicin Bladder Instillation for the Prevention of Urinary Tract Infection in Adults at High Risk for Cystitis Due to Intermittent Catheterization

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.

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 evidence supporting this practice is mixed. Potential risks of this
practice include wasted costs, wasted materials, wasted time and growing antibiotic
resistance. Potential benefits include reduced use of systemic antibiotics, a reduction in
symptomatic UTIs and fewer hospitalizations for febrile UTIs. We seek to define the evidence
for or against this practice by completing a double-blind randomized controlled trial of GBI
vs. NS instillation. Such a trial would benefit our Gillette patients and the community of
patients on IC worldwide.

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.

Inclusion Criteria:

1. Patients (>=16 years of age) with any diagnosis on IC of the bladder.

2. Patients may catheterize either thru the urethra or a stoma (e.g. Mitrofanoff).

3. A history of recurrent symptomatic UTI's (at least 3 per year).

4. Patient must be able to travel to Gillette's Lifetime clinic for quarterly urine
cultures

5. Patient must have an "informed other" that can supplement any missing study
information (incident UTI, treatment information, etc.)

Exclusion Criteria:

1. Patients currently on oral or intravesical antibiotic prophylaxis refusing to or not
able to discontinue prophylaxis.

2. Patients colonized with gentamicin-resistant bacteria on baseline urine culture or a
gentamicin allergy.
We found this trial at
1
site
Saint Paul, Minnesota 55130
?
mi
from
Saint Paul, MN
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