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Gentamicin Bladder Instillation Trial

NCT01884467 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-04-09

No results posted yet for this study

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

Interventions

DRUG

Gentamicin

Comparison of Gentamicin versus placebo

DRUG

Placebo

Sponsors & Collaborators

  • Gillette Children's Specialty Healthcare

    lead OTHER

Principal Investigators

  • Sean P Elliott, MD, MS, FACS · Gillette Children's Specialty Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01884467 on ClinicalTrials.gov