Bacterial Properties With LoFric® Catheters During Clean Intermittent Catheterization
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01305681|
Recruitment Status : Unknown
Verified November 2011 by Brian VanderBrink, Nationwide Children's Hospital.
Recruitment status was: Recruiting
First Posted : March 1, 2011
Last Update Posted : November 3, 2011
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||December 2012|
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
- Characteristics of bacteria discovered in urine of pediatric patients using LoFric® catheters during clean intermittent catheterization [ Time Frame: 18 months ]
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
|Contact: Brian A VanderBrink, MDemail@example.com|
|United States, Ohio|
|Nationwide Children's Hospital||Recruiting|
|Columbus, Ohio, United States, 43205|
|Contact: Brian A VanderBrink, MD 614-722-3114 firstname.lastname@example.org|