Female Intermittent Urethral CatheterizationNCT04304599
Evaluation of a New Female Urinary Intermittent Catheter
A study testing LoFric Elle in people with Female Intermittent Urethral Catheterization, run by Wellspect HealthCare at 4 sites in 2 countries.
Trial summary
A prospective, multi-centre, interventional study. All subjects will use the study device for two weeks and the angulated handle available with the device must be used by each subject at least 10 times. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Intermittent Urethral Catheterization
- What is being tested?
- LoFric Elle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 13 Mar 2020to 27 Feb 2023
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent.
- Females aged 18 years and over.
- Maintained urethra sensibility as judged by the subject. (Can you feel the catheter during catheterization? Yes.).
- Practice intermittent catheterization at least 2 times daily.
- Use catheter size available in the study
- Experienced practitioners of intermittent catheterization defined as a minimum of three months on therapy, but not more than approximately 5 years on therapy.
- Adults able to read, write and understand information given to them regarding the study.
Who cannot join
- Ongoing, symptomatic UTI at enrolment as judged by investigator. The definition of UTI, is a positive urine culture of ≥10^3 CFU/ml of ≥1 bacterial species and presence of symptoms or signs compatible with UTI with no other identified source of infection.
- Known urethral stricture which, in the opinion of the investigator, could influence the subject's evaluation of the catheters.
- Involvement in the planning and conduct of the study (applies to both Wellspect staff and staff at the study site).
- Previous enrolment in the present study.
- Simultaneous participation in another clinical study that may impact the primary endpoint
- Expected or severe non-compliance to protocol as judged by the investigator and/or Wellspect.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Spain2 sites
Alicante University General Dr. Balmis Hospital
Alicante
Hospital Clinic Barcelona
Barcelona
Sweden2 sites
Carlanderska Hospital
Gothenburg, SE-405 45
Urologiska kliniken, mottagning Universitetssjukhuset Örebro
Örebro, Örebro County, 701 85
About this study
Official title: Evaluation of a New Female Urinary Catheter Used for Intermittent Catheterization
A prospective, multi-centre, interventional study. All subjects will use the study device for two weeks and the angulated handle available with the device must be used by each subject at least 10 times.
- Being tested
- LoFric Elle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoFric ElleDevice
The study device is commercially available (CE-marked). It is a device for female intermittent catheterization. Treatment Period will last for 2 weeks. The angulated handle available with the device must be used by each subject at least 10 times.
| Study group | Role | What they receive |
|---|---|---|
| LoFric Elle | Experimental | New hydrophilic female urinary catheter for single use. Ready-to-Use. Receives: Device: LoFric Elle |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to evaluate the subjects' Quality of Life when practicing IC using LoFric Elle catheters.
Primary objective variable is measured by the Intermittent Self-Catheterization Questionnaire (ISC-Q) total score.
Measured: 2 weeks
Secondary outcomes (7)
Compliance when practicing IC with LoFric Elle.
Used study catheter entire study period with the handle at least 10 times: Y/N.
Measured: 2 weeks
Satisfaction when practicing IC with LoFric Elle.
PRO variables (Wellspect questionnaire).
Measured: 2 weeks
Versatility as in use of the angulated handle when practicing IC with LoFric Elle.
PRO variables (Wellspect questionnaire).
Measured: 2 weeks
Perception when practicing IC with LoFric Elle.
PRO variables (Wellspect questionnaire).
Measured: 2 weeks
The catheter is perceived as slim and discreet which makes it easy to bring, store, and dispose of without obviously being a catheter.
ISC-Q domains convenience and discreetness.
Measured: 2 weeks
The catheter with or without the angulated handle has an ergonomic design which makes it easy to use.
ISC-Q domain ease of use.
Measured: 2 weeks
The catheter is perceived as ready to use.
ISC-Q question 1; it is easy to prepare my catheter for use each time I need it.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start13 Mar 2020
- Primary completion3 Jan 2023
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wellspect HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pernilla Sundqvist, MD, PhD, Principal investigator, Örebro University Hospital, SwedenKaj Stenlöf, Dr., Principal investigator, Carlanderska Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304599
- Sponsor's protocol ID
- LOF-0035
- Status last verified
- Apr 2023
- First submitted
- 9 Mar 2020
- Last updated
- 28 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Female Urinary Catheter Used for Intermittent Catheterization
- ClinicalTrials.gov ID
- NCT04304599
- Acronym / sponsor ID
- LOF-0035
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wellspect HealthCareIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 11 Mar 2020 (actual)
- 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.
A prospective, multi-centre, interventional study. All subjects will use the study device for two weeks and the angulated handle available with the device must be used by each subject at least 10 times.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LoFric Elle | Experimental | Device: LoFric ElleNew hydrophilic female urinary catheter for single use. Ready-to-Use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of signed and dated informed consent.
- Females aged 18 years and over.
- Maintained urethra sensibility as judged by the subject. (Can you feel the catheter during catheterization? Yes.).
- Practice intermittent catheterization at least 2 times daily.
- Use catheter size available in the study
Key exclusion criteria (6 listed)
- Ongoing, symptomatic UTI at enrolment as judged by investigator. The definition of UTI, is a positive urine culture of ≥10^3 CFU/ml of ≥1 bacterial species and presence of symptoms or signs compatible with UTI with no other identified source of infection.
- Known urethral stricture which, in the opinion of the investigator, could influence the subject's evaluation of the catheters.
- Involvement in the planning and conduct of the study (applies to both Wellspect staff and staff at the study site).
- Previous enrolment in the present study.
- Simultaneous participation in another clinical study that may impact the primary endpoint
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 ElleThe study device is commercially available (CE-marked). It is a device for female intermittent catheterization. Treatment Period will last for 2 weeks. The angulated handle available with the device must be used by each subject at least 10 times. | Device | LoFric Elle |
Primary outcome
The primary objective of this study is to evaluate the subjects' Quality of Life when practicing IC using LoFric Elle catheters.
Time frame: 2 weeks
Primary objective variable is measured by the Intermittent Self-Catheterization Questionnaire (ISC-Q) total score.
7 secondary outcomes
Compliance when practicing IC with LoFric Elle.
Time frame: 2 weeks
Satisfaction when practicing IC with LoFric Elle.
Time frame: 2 weeks
Versatility as in use of the angulated handle when practicing IC with LoFric Elle.
Time frame: 2 weeks
Perception when practicing IC with LoFric Elle.
Time frame: 2 weeks
The catheter is perceived as slim and discreet which makes it easy to bring, store, and dispose of without obviously being a catheter.
Time frame: 2 weeks
The catheter with or without the angulated handle has an ergonomic design which makes it easy to use.
Time frame: 2 weeks
The catheter is perceived as ready to use.
Time frame: 2 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 28 Apr 2023.
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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.
Pernilla Sundqvist, MD, PhD principal investigator
Örebro University Hospital, Sweden
Kaj Stenlöf, Dr. principal investigator
Carlanderska Hospital
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LoFric Elle in people with Female Intermittent Urethral Catheterization, run by Wellspect HealthCare at 4 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 6 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 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, Sweden. 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?
The primary objective of this study is to evaluate the subjects' Quality of Life when practicing IC using LoFric Elle catheters. (time frame: 2 weeks). 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 28 Apr 2023.