Gentamicin Bladder Instillation Trial

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gillette Children's Specialty Healthcare
• Treatments: Gentamicins

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.