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

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.

Study Overview

• Status: Unknown
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Drug: Placebo; Drug: Gentamicin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Meghan E Munger, MPH; Phone Number: 651-229-1757; Email: MeghanEMunger@gillettechildrens.com
• Study Contact Backup: Name: Kari A Williams, MPH, CCRC; Phone Number: 651-324-2316; Email: KariAWilliams@gillettechildrens.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Gentamicin; Comparison of Gentamicin versus placebo; Other Names: Garamycin solution
Placebo Comparator: Placebo; Drug: Normal saline; Dosage form: N/A; Dosage: 30 mL; Frequency: nightly bladder instillation; Duration: 1 year	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptomatic UTI	Our primary outcome will be febrile or symptomatic UTI, defined as fever or abdominal pain or new bladder symptoms such as pain, urinary incontinence, hematuria or more frequent bladder spasms plus urine culture demonstrating >103 CFUs of a single dominant bacteria or >105 of multiple bacteria.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asymptomatic UTI	A quarterly urine culture will be performed at Gillette's Lifetime Clinic to assess asymptomatic bacteriuria. Asymptomatic bacteriuria will be defined as an asymptomatic patient with urine sample culture positive for typical bacteria.	one year

Collaborators and Investigators

• Sponsor: Gillette Children's Specialty Healthcare
• Investigators: Principal Investigator: Sean P Elliott, MD, MS, FACS, Gillette Children's Specialty Healthcare

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: June 18, 2013
• First Submitted That Met QC Criteria: June 20, 2013
• First Posted (Estimate): June 24, 2013

Study Record Updates

• Last Update Posted (Estimate): April 9, 2015
• Last Update Submitted That Met QC Criteria: April 8, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Urinary Tract Infections; Gentamicin
• Additional Relevant MeSH Terms: Urologic Diseases; Infections; Urinary Tract Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Gentamicins
• Other Study ID Numbers: 1210M21603