NCT01884467

Gentamicin Bladder Instillation Trial

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Gillette Children's Specialty Healthcare · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	Gentamicin	Comparison of Gentamicin versus placebo
DRUG	Placebo

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-12-01
• Completion: 2016-12-01
• First posted: 2013-06-24
• Last updated: 2015-04-09

Locations

1 site across 1 country: United States