Bacterial Properties With LoFric® Catheters During Clean Intermittent Catheterization
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Overactive Bladder, Neurology, Urology |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology, Neurology, Other |
| Healthy: | No |
| Age Range: | Any - 35 |
| Updated: | 4/2/2016 |
| Start Date: | February 2011 |
| Contact: | Brian A VanderBrink, MD |
| Email: | brian.vanderbrink@nationwidechildrens.org |
| Phone: | 614-722-3114 |
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.
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.
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.
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.
Inclusion Criteria:
- Patients who perform clean intermittent catheterization on a regular basis
Exclusion Criteria:
- Patients on daily continuous antibiotic therapy
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