Gentamicin Bladder Instillation Trial

NCT ID: NCT01884467

Last Updated: 2015-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Gentamicin

Intervention: Gentamicin; Dosage form: 120mg reconstituted in 250cc of normal saline; Dosage: 30mL; Frequency: nightly instillation into bladder (to remain overnight until draining it out in morning); Duration: 1 year

Group Type: EXPERIMENTAL

Gentamicin

Intervention Type: DRUG

Comparison of Gentamicin versus placebo

Placebo

Drug: Normal saline; Dosage form: N/A; Dosage: 30 mL; Frequency: nightly bladder instillation; Duration: 1 year

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Gentamicin

Comparison of Gentamicin versus placebo

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Garamycin solution

Eligibility 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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gillette Children's Specialty Healthcare

OTHER

Sponsor Role: lead

Responsible Party

Sean P. Elliott, M.D., M.S.

Associate Professor and Vice Chair, Director of Reconstructive Urology, University of Minnesota

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sean P Elliott, MD, MS, FACS

Role: PRINCIPAL_INVESTIGATOR

Gillette Children's Specialty Healthcare

Locations

Gillette Lifetime Specialty Healthcare

Saint Paul, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Meghan E Munger, MPH

Role: CONTACT

MeghanEMunger@gillettechildrens.com

651-229-1757

Kari A Williams, MPH, CCRC

Role: CONTACT

KariAWilliams@gillettechildrens.com

651-324-2316

Facility Contacts

Ronna Linroth, PhD

Role: primary

RLinroth@gillettechildrens.com

651-634-1920

Other Identifiers

1210M21603

Identifier Type: -

Identifier Source: org_study_id