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Bacterial Properties With LoFric® Catheters During Clean Intermittent Catheterization

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ClinicalTrials.gov Identifier: NCT01305681
Recruitment Status : Withdrawn (It appears Dr. Vanderbrink left Nationwide Children's Hospital in 2011 and efforts to reach Dr. Vanderbrink have been unsuccessful.)
First Posted : March 1, 2011
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Dentsply Sirona Implants
Information provided by (Responsible Party):
Nationwide Children's Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Neurogenic Bladder Urinary Retention Device: LoFric® catheters during clean intermittent catheterization Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: It appears Dr. Vanderbrink left Nationwide Children's Hospital in 2011 and efforts to reach Dr. Vanderbrink have been unsuccessful. The study expired with the NCH IRB before it was ever approved for a 2nd year.
Masking: None (Open Label)
Masking Description: Please close this study at ct.gov as we have not further data at NCH as Dr. Vanderbrink left NCH in 2011.
Primary Purpose: Treatment
Actual Study Start Date : May 6, 2011
Actual Primary Completion Date : February 21, 2012
Actual Study Completion Date : February 21, 2012

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Characteristics of bacteria discovered in urine of pediatric patients using LoFric® catheters during clean intermittent catheterization [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01305681


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Dentsply Sirona Implants
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Responsible Party: Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01305681    
Other Study ID Numbers: IRB10-00458
First Posted: March 1, 2011    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: November 2011
Additional relevant MeSH terms:
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Urinary Bladder, Neurogenic
Urinary Retention
Urination Disorders
Urologic Diseases
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases