Bacterial Properties With LoFric® Catheters During Clean Intermittent Catheterization

Urinary Retention Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01305681
• Other study ID #: IRB10-00458
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: May 6, 2011
• Est. completion date: February 21, 2012

Study information

• Verified date: November 2011
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 21, 2012
• Est. primary completion date: February 21, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 35 Years

Eligibility

Inclusion Criteria:

• Patients who perform clean intermittent catheterization on a regular basis

Exclusion Criteria:

• Patients on daily continuous antibiotic therapy

Related Conditions & MeSH terms

• Neurogenic Bladder
• Urinary Bladder, Neurogenic
• Urinary Retention

Intervention

Device:
• LoFric® catheters during clean intermittent catheterization
LoFric® catheters during clean intermittent catheterization

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Nationwide Children's Hospital	Dentsply Sirona Implants

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characteristics of bacteria discovered in urine of pediatric patients using LoFric® catheters during clean intermittent catheterization		18 months