Recruiting

Gentamicin

Sponsor:

Gillette Children's Specialty Healthcare

Code:

NCT01884467

Conditions

Urinary Tract Infections

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

Gentamicin

Placebo

Study Details

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.

Conditions

Urinary Tract Infections

Study ID

NCT01884467

Start date

May, 2013

Status verified date

Apr, 2015

Completion date

Dec, 2016

Anticipated

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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 Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

placebo comparator: Placebo

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

Interventions

Gentamicin

Comparison of Gentamicin versus placebo

Placebo

Primary outcome measure

  • Symptomatic UTI [ Time Frame: one year ]

Central Contacts and Locations

Central contacts

Meghan E Munger, MPH

651-229-1757MeghanEMunger@gillettechildrens.com

Kari A Williams, MPH, CCRC

651-324-2316KariAWilliams@gillettechildrens.com

Locations

Gillette Lifetime Specialty Healthcare

Recruiting

Saint Paul, Minnesota, United States, 55130

Contacts

Ronna Linroth, PhD

651-634-1920RLinroth@gillettechildrens.com

Principal Investigator:

Sean P Elliott, MD, MS, FACS

More Information

Sponsor

Gillette Children's Specialty Healthcare

Last update posted

Apr 9, 2015

Last verified

Apr, 2015

Keywords

  • Urinary Tract Infections
  • Gentamicin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Gillette Children's Specialty Healthcare on 2015-04-09.