Intermittent Urethral CatheterizationNCT02129738
Reuse of Intermittent Urethral Catheters
A study testing LoFric catheters in people with Intermittent Urethral Catheterization, run by Wellspect HealthCare at 7 sites in 2 countries.
Trial summary
The purpose of this study is to investigate and document real life safety and satisfaction of re-use of urethral catheters for intermittent self catheterization. The study will collect re-used catheters from included patients and compare those to a control group with regard to bacterial contamination and mechanical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intermittent Urethral Catheterization
- What is being tested?
- LoFric catheters
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 20 Jun 2014to 23 Mar 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent
- Female and/or male aged 18 years and over
- Intermittent self-catheterization as primary bladder management method, defined as a normal catheterization frequency of at least 4 times daily
- Reuse of the same silicon, rubber (latex) or plastic (e.g. vinyl, PVC) catheter
- Accustomed intermittent catheterization user, defined as intermittent catheterization use for at least 3 months
- Able to use catheters of size:
- 40 cm, CH12 or CH14; 16'', FR12 or FR14; 15 cm, CH10 or CH12; 6'', FR10 or FR12;
Who cannot join
- Antibiotic treatment within 4 weeks prior study inclusion
- Drug or alcohol abuse or other disease of addiction
- Immunocompromising diseases or medications
- Known urological/renal anatomical abnormalities with potential impact on subject´s compliance as judged by the investigator
- Diagnosis of severe fecal incontinence that may compromise study participation as judged by the investigator
- Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
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- Previous enrollment in the present study
- Simultaneous participation in another clinical study that may interfere with the present study, as judged by the investigator
- Severe non-compliance to protocol as judged by the investigator and/or Wellspect HealthCare
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Australia4 sites
Caulfield Hospital, Spinal Rehabilitation Unit
Melbourne, Victoria, 3162
Royal Rehab
Ryde, New South Wales, 1680
Prince of Wales Hospital Spinal Unit
Sydney, New South Wales, 2031
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
United States3 sites
North Idaho Urology
Coeur d'Alene, Idaho, 83814
Froedtert Medical College and Specialty Clinic
Milwaukee, Wisconsin, 53226
University of Pennsylvania, Penn Urology
Philadelphia, Pennsylvania, 19104
About this study
Official title: Is Reuse of Intermittent Urethral Catheters Safe and Preferred? A Prospective, Observational Study Evaluating Reuse of Catheters and Switch to Single-use.
The purpose of this study is to investigate and document real life safety and satisfaction of re-use of urethral catheters for intermittent self catheterization. The study will collect re-used catheters from included patients and compare those to a control group with regard to bacterial contamination and mechanical properties. A four week prospective evaluation will follow where the patients will be given catheters intended for single-use.
- Conditions
- Intermittent Urethral Catheterization
- Being tested
- LoFric catheters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoFric cathetersDevice
LoFric single use catheters to be used 4-6 times daily for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| LoFric | Experimental | LoFric catheters Receives: Device: LoFric catheters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of catheters with bacterial contamination (Y/N)
Proportion of catheters with bacterial contamination verified by culturing/incubation and visual inspection by Scanning Electron Microscope (SEM).
Measured: At Baseline (Visit 1)
Secondary outcomes (5)
Bacterial quantification by incubation.
Measured: At Baseline (Visit 1)
Pathogen identification by incubation.
Measured: At Baseline (Visit 1)
Material properties and bacteria/particle/tissue visualization by SEM.
Measured: At Baseline (Visit 1)
Presence of reuse found in medical records, patient reported questionnaires and patient interviews.
Measured: At Baseline (Visit 1) and at 4 weeks (Visit 2)
Bacterial level in urine sample
Measured: At Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study start20 Jun 2014
- Primary completion17 Feb 2017
- Study completion23 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intermittent Urethral CatheterizationStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wellspect HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bonne Lee, Dr, Principal investigator, Prince of Wales Hospital, Randwick, AustraliaDiane Newman, Professor, Principal investigator, University of Pennsylvania, Philadelphia, US
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129738
- Sponsor's protocol ID
- LOF-0028
- Status last verified
- Oct 2017
- First submitted
- 30 Apr 2014
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Newman DK, New PW, Heriseanu R, Petronis S, Hakansson J, Hakansson MA, Lee BB. Intermittent catheterization with single- or multiple-reuse catheters: clinical study on safety and impact on quality of life. Int Urol Nephrol. 2020 Aug;52(8):1443-1451. doi: 10.1007/s11255-020-02435-9. Epub 2020 Mar 14.
PubMed 32172456
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Reuse of Intermittent Urethral Catheters Safe and Preferred? A Prospective, Observational Study Evaluating Reuse of Catheters and Switch to Single-use.
- ClinicalTrials.gov ID
- NCT02129738
- Acronym / sponsor ID
- LOF-0028
- Conditions
- Intermittent Urethral Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Wellspect HealthCareIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2014 (actual)
- Primary completion
- 17 Feb 2017 (actual)
- Study completion
- 23 Mar 2017 (actual)
- First posted
- 2 May 2014 (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 purpose of this study is to investigate and document real life safety and satisfaction of re-use of urethral catheters for intermittent self catheterization. The study will collect re-used catheters from included patients and compare those to a control group with regard to bacterial contamination and mechanical properties. A four week prospective evaluation will follow where the patients will be given catheters intended for single-use.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LoFric | Experimental | Device: LoFric cathetersLoFric catheters |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of informed consent
- Female and/or male aged 18 years and over
- Intermittent self-catheterization as primary bladder management method, defined as a normal catheterization frequency of at least 4 times daily
- Reuse of the same silicon, rubber (latex) or plastic (e.g. vinyl, PVC) catheter
- Accustomed intermittent catheterization user, defined as intermittent catheterization use for at least 3 months
Key exclusion criteria (9 listed)
- Antibiotic treatment within 4 weeks prior study inclusion
- Drug or alcohol abuse or other disease of addiction
- Immunocompromising diseases or medications
- Known urological/renal anatomical abnormalities with potential impact on subject´s compliance as judged by the investigator
- Diagnosis of severe fecal incontinence that may compromise study participation as judged by the investigator
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 cathetersLoFric single use catheters to be used 4-6 times daily for 4 weeks. | Device | LoFric |
Primary outcome
Proportion of catheters with bacterial contamination (Y/N)
Time frame: At Baseline (Visit 1)
Proportion of catheters with bacterial contamination verified by culturing/incubation and visual inspection by Scanning Electron Microscope (SEM).
5 secondary outcomes
Bacterial quantification by incubation.
Time frame: At Baseline (Visit 1)
Pathogen identification by incubation.
Time frame: At Baseline (Visit 1)
Material properties and bacteria/particle/tissue visualization by SEM.
Time frame: At Baseline (Visit 1)
Presence of reuse found in medical records, patient reported questionnaires and patient interviews.
Time frame: At Baseline (Visit 1) and at 4 weeks (Visit 2)
Bacterial level in urine sample
Time frame: At Baseline and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Derived from this study: PubMed 32172456Newman DK, New PW, Heriseanu R, Petronis S, Hakansson J, Hakansson MA, Lee BB. Intermittent catheterization with single- or multiple-reuse catheters: clinical study on safety and impact on quality of life. Int Urol Nephrol. 2020 Aug;52(8):1443-1451. doi: 10.1007/s11255-020-02435-9. Epub 2020 Mar 14.
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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.
Bonne Lee, Dr principal investigator
Prince of Wales Hospital, Randwick, Australia
Diane Newman, Professor principal investigator
University of Pennsylvania, Philadelphia, US
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LoFric catheters in people with Intermittent Urethral Catheterization, run by Wellspect HealthCare at 7 sites in 2 countries.
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 7 inclusion and 9 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: finished, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of catheters with bacterial contamination (Y/N) (time frame: At Baseline (Visit 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02129738, which also lists 1 linked publication.
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 12 Oct 2017.