Bacterial Properties With LoFric® Catheters During Clean Intermittent Catheterization

NCT ID: NCT01305681

Last Updated: 2019-08-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-06
• Study Completion Date: 2012-02-21

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.

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.

Conditions

Neurogenic Bladder; Urinary Retention

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LoFric® catheters

LoFric® catheters during clean intermittent catheterization will be compared to non-LoFric® catheters during clean intermittent catheterization

Group Type: ACTIVE_COMPARATOR

LoFric® catheters during clean intermittent catheterization

Intervention Type: DEVICE

LoFric® catheters during clean intermittent catheterization

Interventions

LoFric® catheters during clean intermittent catheterization

LoFric® catheters during clean intermittent catheterization

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients who perform clean intermittent catheterization on a regular basis

Exclusion Criteria

• Patients on daily continuous antibiotic therapy

• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dentsply Sirona Implants and Consumables

INDUSTRY

Sponsor Role: collaborator

Nationwide Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

Other Identifiers

IRB10-00458

Identifier Type: -

Identifier Source: org_study_id