Gentamicin Bladder Instillation Trial

NCT01884467 | Unknown Phase 4

• 1 other identifier: 1210M21603
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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. 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. 2.Compare antibiotic resistance rates among a population of Gillette patients on IC with and without gentamicin bladder instillation.

Conditions

Urinary Tract Infections

Keywords

Urinary Tract Infections; Gentamicin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Asymptomatic UTI

  one year

Study Arms (2)

Gentamicin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Gentamicin DRUG

Comparison of Gentamicin versus placebo

Also known as: Garamycin solution

Gentamicin

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (\>=16 years of age) with any diagnosis on IC of the bladder.
• Patients may catheterize either thru the urethra or a stoma (e.g. Mitrofanoff).
• A history of recurrent symptomatic UTI's (at least 3 per year).
• Patient must be able to travel to Gillette's Lifetime clinic for quarterly urine cultures
• Patient must have an "informed other" that can supplement any missing study information (incident UTI, treatment information, etc.)

You may not qualify if:

• Patients currently on oral or intravesical antibiotic prophylaxis refusing to or not able to discontinue prophylaxis.
• Patients colonized with gentamicin-resistant bacteria on baseline urine culture or a gentamicin allergy.

Sponsors & Collaborators

• Gillette Children's Specialty Healthcare: lead

Study Sites (1)

Gillette Lifetime Specialty Healthcare

Saint Paul, Minnesota, 55130, United States

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Gentamicins

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Sean P Elliott, MD, MS, FACS

  Gillette Children's Specialty Healthcare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meghan E Munger, MPH

CONTACT

651-229-1757; MeghanEMunger@gillettechildrens.com

Kari A Williams, MPH, CCRC

CONTACT

651-324-2316; KariAWilliams@gillettechildrens.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Vice Chair, Director of Reconstructive Urology, University of Minnesota

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: June 24, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: April 9, 2015

Record last verified: 2015-04

Locations

US (1)