Trial record 13 of 45 for:    Spina Bifida

Gentamicin Bladder Instillation in Augmented Bladders

This study is currently recruiting participants.
Verified June 2013 by Gillette Children's Specialty Healthcare
Sponsor:
Information provided by (Responsible Party):
Sean P. Elliott, M.D., M.S., Gillette Children's Specialty Healthcare
ClinicalTrials.gov Identifier:
NCT01884467
First received: June 18, 2013
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

In the Gillette Lifetime Urology clinic, gentamicin bladder instillation (GBI) for urinary tract infection (UTI) prophylaxis is common practice among our Spina bifida (SB) patients. We seek to define the evidence for or against this practice by completing a double-blind randomized controlled trial of GBI vs. normal saline instillation.

Specific aims:

  1. Compare rates of symptomatic UTIs and asymptomatic bacteriuria among a population of Gillette SB patients with previous bladder augmentation on intermittent catheterization (IC) with and without gentamicin bladder instillation.
  2. Compare antibiotic resistance rates among a population of Gillette SB patients with previous bladder augmentation on IC with and without gentamicin bladder instillation.

Condition Intervention Phase
Urinary Tract Infections
Spina Bifida
Drug: Gentamicin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Placebo-Controlled Trial of Gentamicin Bladder Instillation for the Prevention of Urinary Tract Infection in Adults at High Risk for Cystitis Due to Prior Bladder Augmentation and Intermittent Catheterization

Resource links provided by NLM:


Further study details as provided by Gillette Children's Specialty Healthcare:

Primary Outcome Measures:
  • Symptomatic UTI [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Asymptomatic UTI [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 24
Study Start Date: May 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Garamycin solution
Placebo Comparator: Placebo
Drug: Normal saline; Dosage form: N/A; Dosage: 30 mL; Frequency: nightly bladder instillation; Duration: 1 year
Drug: Placebo

Detailed Description:

In the Gillette Lifetime Urology clinic, gentamicin bladder instillation (GBI) for urinary tract infection (UTI) prophylaxis is common practice among our Spina bifida (SB) patients. However, as previously shown, the evidence supporting this practice is mixed. 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. normal saline instillation. Such a trial would benefit our Gillette patients and the community of intermittent catheterization (IC) patients worldwide.

Recurrent UTIs are common among SB 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 SB 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 SB urology clinic and for practitioners at large we will pursue the following specific aims:

  1. Compare rates of symptomatic UTI and asymptomatic bacteriuria among a population of Gillette SB patients with previous bladder augmentation on IC with and without gentamicin bladder instillation.
  2. Compare antibiotic resistance rates among a population of Gillette SB patients with previous bladder augmentation on IC with and without gentamicin bladder instillation.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patients (>=18 years of age) with a diagnosis of SB on IC of the bladder.
  2. Patients may catheterize either thru the urethra or a stoma (e.g. Mitrofanoff).
  3. Patients with an augmented bladder who are currently on an instillation or irrigation regimen.
  4. A history of recurrent symptomatic UTI's (at least 3 per year).
  5. Patient must be able to travel to Gillette's Lifetime clinic for quarterly urine cultures
  6. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01884467

Contacts
Contact: Meghan E Munger, MPH 651-229-1757 MeghanEMunger@gillettechildrens.com
Contact: Kari A Williams, MPH, CCRC 651-324-2316 KariAWilliams@gillettechildrens.com

Locations
United States, Minnesota
Gillette Lifetime Specialty Healthcare Recruiting
Saint Paul, Minnesota, United States, 55130
Contact: Ronna Linroth, PhD    651-634-1920    RLinroth@gillettechildrens.com   
Principal Investigator: Sean P Elliott, MD, MS, FACS         
Sponsors and Collaborators
Gillette Children's Specialty Healthcare
Investigators
Principal Investigator: Sean P Elliott, MD, MS, FACS Gillette Children's Specialty Healthcare
  More Information

No publications provided

Responsible Party: Sean P. Elliott, M.D., M.S., Associate Professor and Vice Chair, Director of Reconstructive Urology, University of Minnesota, Gillette Children's Specialty Healthcare
ClinicalTrials.gov Identifier: NCT01884467     History of Changes
Other Study ID Numbers: 1210M21603
Study First Received: June 18, 2013
Last Updated: June 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Gillette Children's Specialty Healthcare:
Urinary Tract Infections
Spina bifida
Gentamicin

Additional relevant MeSH terms:
Spinal Dysraphism
Urinary Tract Infections
Infection
Urologic Diseases
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014