Bacterial Properties With LoFric® Catheters During Clean Intermittent Catheterization

Sponsor

Nationwide Children's Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01305681

Collaborator

Dentsply Sirona Implants (Industry)

Enrollment

Location

Arm

9.6

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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.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 :

Feb 21, 2012

Actual Study Completion Date :

Feb 21, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Characteristics of bacteria discovered in urine of pediatric patients using LoFric® catheters during clean intermittent catheterization [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients who perform clean intermittent catheterization on a regular basis

Exclusion Criteria:

Patients on daily continuous antibiotic therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nationwide Children's Hospital	Columbus	Ohio	United States	43205

Sponsors and Collaborators

Nationwide Children's Hospital
Dentsply Sirona Implants

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nationwide Children's Hospital

ClinicalTrials.gov Identifier:

NCT01305681

Other Study ID Numbers:

IRB10-00458

First Posted:

Mar 1, 2011

Last Update Posted:

Aug 7, 2019

Last Verified:

Nov 1, 2011

Additional relevant MeSH terms:

Urinary Bladder, Neurogenic

Urinary Retention

Study Results

No Results Posted as of Aug 7, 2019