Neurogenic BladderPhase 1/2NCT01305681
Bacterial Properties With LoFric® Catheters During Clean Intermittent Catheterization
A Phase 1/2 study testing LoFric® catheters during clean intermittent catheterization in people with Neurogenic Bladder and Urinary Retention, run by Nationwide Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 35 years
- Conditions the study is for
- Neurogenic Bladder, Urinary Retention
- What is being tested?
- LoFric® catheters during clean intermittent catheterization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2011to 21 Feb 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who perform clean intermittent catheterization on a regular basis
Who cannot join
- Patients on daily continuous antibiotic therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
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.
Read the 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
- Being tested
- LoFric® catheters during clean intermittent catheterization
- Medical subject headings
- Urinary Bladder, Neurogenic, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoFric® catheters during clean intermittent catheterizationDevice
LoFric® catheters during clean intermittent catheterization
| Study group | Role | What they receive |
|---|---|---|
| LoFric® catheters | Active comparator | LoFric® catheters during clean intermittent catheterization will be compared to non-LoFric® catheters during clean intermittent catheterization Receives: Device: LoFric® catheters during clean intermittent catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of bacteria discovered in urine of pediatric patients using LoFric® catheters during clean intermittent catheterization
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study start6 May 2011
- Primary completion21 Feb 2012
- Study completion21 Feb 2012
Why it stopped: It appears Dr. Vanderbrink left Nationwide Children's Hospital in 2011 and efforts to reach Dr. Vanderbrink have been unsuccessful.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic BladderStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305681
- Sponsor's protocol ID
- IRB10-00458
- Status last verified
- Nov 2011
- First submitted
- 28 Feb 2011
- Last updated
- 7 Aug 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Properties With LoFric® Catheters During Clean Intermittent Catheterization
- ClinicalTrials.gov ID
- NCT01305681
- Acronym / sponsor ID
- IRB10-00458
- Conditions
- Neurogenic Bladder, Urinary Retention
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It appears Dr. Vanderbrink left Nationwide Children's Hospital in 2011 and efforts to reach Dr. Vanderbrink have been unsuccessful.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Study start
- 6 May 2011 (actual)
- Primary completion
- 21 Feb 2012 (actual)
- Study completion
- 21 Feb 2012 (actual)
- First posted
- 1 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| LoFric® catheters | Active comparator | Device: LoFric® catheters during clean intermittent catheterizationLoFric® catheters during clean intermittent catheterization will be compared to non-LoFric® catheters during clean intermittent catheterization |
Who may qualify
- Ages
- Up to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients who perform clean intermittent catheterization on a regular basis
Key exclusion criteria (1 listed)
- Patients on daily continuous antibiotic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LoFric® catheters during clean intermittent catheterizationLoFric® catheters during clean intermittent catheterization | Device | LoFric® catheters |
Primary outcome
Characteristics of bacteria discovered in urine of pediatric patients using LoFric® catheters during clean intermittent catheterization
Time frame: 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LoFric® catheters during clean intermittent catheterization in people with Neurogenic Bladder and Urinary Retention, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics of bacteria discovered in urine of pediatric patients using LoFric® catheters during clean intermittent catheterization (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.