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Gentamicin Bladder Instillation Trial

Information source: Gillette Children's Specialty Healthcare
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Urinary Tract Infections

Intervention: Gentamicin (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Gillette Children's Specialty Healthcare

Official(s) and/or principal investigator(s):
Sean P Elliott, MD, MS, FACS, Principal Investigator, Affiliation: Gillette Children's Specialty Healthcare

Overall contact:
Meghan E Munger, MPH, Phone: 651-229-1757, Email: MeghanEMunger@gillettechildrens.com

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 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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome: Symptomatic UTI

Secondary outcome: Asymptomatic UTI

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 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.

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Meghan E Munger, MPH, Phone: 651-229-1757, Email: MeghanEMunger@gillettechildrens.com

Gillette Lifetime Specialty Healthcare, Saint Paul, Minnesota 55130, United States; Recruiting
Ronna Linroth, PhD, Phone: 651-634-1920, Email: RLinroth@gillettechildrens.com
Sean P Elliott, MD, MS, FACS, Principal Investigator
Additional Information

Starting date: May 2013
Last updated: April 8, 2015

Page last updated: August 23, 2015

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