Bacterial Properties With LoFric® Catheters During Clean Intermittent Catheterization
Primary Purpose
Neurogenic Bladder, Urinary Retention
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LoFric® catheters during clean intermittent catheterization
Sponsored by
About this trial
This is an interventional treatment trial for Neurogenic Bladder
Eligibility Criteria
Inclusion Criteria:
- Patients who perform clean intermittent catheterization on a regular basis
Exclusion Criteria:
- Patients on daily continuous antibiotic therapy
Sites / Locations
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
LoFric® catheters
Arm Description
LoFric® catheters during clean intermittent catheterization will be compared to non-LoFric® catheters during clean intermittent catheterization
Outcomes
Primary Outcome Measures
Characteristics of bacteria discovered in urine of pediatric patients using LoFric® catheters during clean intermittent catheterization
Secondary Outcome Measures
Full Information
NCT ID
NCT01305681
First Posted
February 28, 2011
Last Updated
August 5, 2019
Sponsor
Nationwide Children's Hospital
Collaborators
Dentsply Sirona Implants and Consumables
1. Study Identification
Unique Protocol Identification Number
NCT01305681
Brief Title
Bacterial Properties With LoFric® Catheters During Clean Intermittent Catheterization
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Withdrawn
Why Stopped
It appears Dr. Vanderbrink left Nationwide Children's Hospital in 2011 and efforts to reach Dr. Vanderbrink have been unsuccessful.
Study Start Date
May 6, 2011 (Actual)
Primary Completion Date
February 21, 2012 (Actual)
Study Completion Date
February 21, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nationwide Children's Hospital
Collaborators
Dentsply Sirona Implants and Consumables
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Bladder, Urinary Retention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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.
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.
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LoFric® catheters
Arm Type
Active Comparator
Arm Description
LoFric® catheters during clean intermittent catheterization will be compared to non-LoFric® catheters during clean intermittent catheterization
Intervention Type
Device
Intervention Name(s)
LoFric® catheters during clean intermittent catheterization
Intervention Description
LoFric® catheters during clean intermittent catheterization
Primary Outcome Measure Information:
Title
Characteristics of bacteria discovered in urine of pediatric patients using LoFric® catheters during clean intermittent catheterization
Time Frame
18 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who perform clean intermittent catheterization on a regular basis
Exclusion Criteria:
Patients on daily continuous antibiotic therapy
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bacterial Properties With LoFric® Catheters During Clean Intermittent Catheterization
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