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Bacterial Properties With LoFric® Catheters During Clean Intermittent Catheterization

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Nationwide Children's Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Dentsply Implants
Information provided by (Responsible Party):
Brian VanderBrink, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01305681
First received: February 28, 2011
Last updated: November 2, 2011
Last verified: November 2011
  Purpose

The primary objective of our study is to examine characteristics of bacteria that are discovered in urine from pediatric patients that utilize either LoFric® or non-LoFric® catheters for self intermittent catheterization. The investigators hypothesize that the hydrophilic nature of the LoFric® catheter will alter the microbial environment and reduce clinically significant urinary tract infections in patients with neurogenic bladder compared to a similar population using standard catheters.

Secondary outcomes will be comparing the incidence of clinical urinary tract infections between patients that use standard catheters and those that use LoFric catheters.

Lastly, patient satisfaction using LoFric catheters compared to standard catheters will be assessed.


Condition Intervention Phase
Neurogenic Bladder
Urinary Retention
Device: LoFric® catheters during clean intermittent catheterization
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Characteristics of bacteria discovered in urine of pediatric patients using LoFric® catheters during clean intermittent catheterization [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LoFric® catheters
LoFric® catheters during clean intermittent catheterization will be compared to non-LoFric® catheters during clean intermittent catheterization
Device: LoFric® catheters during clean intermittent catheterization
LoFric® catheters during clean intermittent catheterization

Detailed Description:

The investigators will randomize patients with neurogenic bladder into 2 groups after the have been matched for age, gender and mobility.

The first group will continue with their current intermittent catheterization system (a non-LoFric® catheter) while the second group will receive sufficient LoFric® catheters to complete the study. The investigators will collect the urine at the start of the study, and then at 3, 6, 12, and 18 months and sent for culture. If a child develops a urinary tract infection, the investigators will have the patient collect the urine and the urine will be cultured and the organism will be identified.

Using an existing bladder cell line, the investigators will inoculate the bladder cells with any bacteria that grows from any sample and then determine the interleukin-6 response of the bladder cell line following inoculation with the bacteria. This will determine if the initiate a high or low cytokine response which the investigators have correlated to clinical risk of symptomatic urinary tract infection

The investigators will provide a patient satisfaction survey at the start of the study, prior to randomization and at the completion of the study to determine satisfaction with LoFric® catheters.

  Eligibility

Ages Eligible for Study:   up to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who perform clean intermittent catheterization on a regular basis

Exclusion Criteria:

  • Patients on daily continuous antibiotic therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305681

Contacts
Contact: Brian A VanderBrink, MD 614-722-3114 brian.vanderbrink@nationwidechildrens.org

Locations
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Brian A VanderBrink, MD    614-722-3114    brian.vanderbrink@nationwidechildrens.org   
Sponsors and Collaborators
Nationwide Children's Hospital
Dentsply Implants
  More Information

No publications provided

Responsible Party: Brian VanderBrink, Urologist, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01305681     History of Changes
Other Study ID Numbers: IRB10-00458
Study First Received: February 28, 2011
Last Updated: November 2, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Urinary Retention
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Urination Disorders
Urologic Diseases

ClinicalTrials.gov processed this record on November 27, 2014