Bladder Voiding DysfunctionNCT04703413
User Satisfaction When Catheterizing With Hydrophilic Urinary Catheters From a More Sustainable Manufacturing Process.
A study testing LoFric® OrigoTM and LoFric® SenseTM in people with Bladder Voiding Dysfunction, run by Wellspect HealthCare at 3 sites in Germany.
Trial summary
An open, prospective, single arm, multicenter clinical investigation. All subjects will use the investigational device for 30 days each. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Voiding Dysfunction
- What is being tested?
- LoFric® OrigoTM and LoFric® SenseTM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesGermany
- Study dates
- 17 Dec 2020to 15 Apr 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For inclusion in the study, subjects must fulfil all of the following criteria:
- Provision of informed consent i.e. subject must be able to understand and sign the Informed Consent Form
- Aged 18 years and over, both gender
- Bladder dysfunction, all diagnosis practicing IC at least 2 times daily
- Using catheters in the sizes available in the investigation (15 cm, CH 12 or 40 cm CH 12/14, Nelaton tip)
- Experienced users of IC defined as a minimum of 4 weeks on therapy prior investigation start
- Adults able to read, write and understand information given to them regarding the investigation
Who cannot join
- Any of the following is regarded as a criterion for exclusion from the study:
- Ongoing, symptomatic UTI at enrolment as judged by investigator. The definition of UTI, is a positive urine culture of ≥103 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 investigation (applies to both Wellspect/site staff).
- Previous enrolment in the present investigation.
- Simultaneous participation in another clinical investigation that may impact the primary endpoint.
- Expected or severe non-compliance to the CIP as judged by the investigator and/or Wellspect.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Leitung der Neuro-Urologie Klinik der Urologie und Kinderurologie Universitätsklinikum Bonn
Bonn, 53127
Gemeinschaftspraxis für Urologie
Dierdorf, 56269
Zentrum für Kontinenz und Neuro-Urologie Kliniken Maria Hilf GmbH Akademisches Lehrkrankenhaus der Uniklinik RWTH Aachen, Mönchengladbach
Mönchengladbach, 41063
About this study
Official title: User Satisfaction When Catheterizing With Hydrophilic Urinary Catheters From a More Sustainable Manufacturing Process. An Open, Prospective, Post-market Clinical Follow-up Investigation.
An open, prospective, single arm, multicenter clinical investigation. All subjects will use the investigational device for 30 days each.
- Conditions
- Bladder Voiding Dysfunction
- Being tested
- LoFric® OrigoTM and LoFric® SenseTM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoFric® OrigoTM and LoFric® SenseTMDevice
The investigational device is either a CE-marked LoFric® OrigoTM , 40 cm, CH12/CH14 or LoFric® SenseTM, 15 cm, CH12. They are all intermittent urinary catheters with a Nelaton tip from a more sustainable manufacturing process. All subjects will use the investigational device for 30 days each.
| Study group | Role | What they receive |
|---|---|---|
| LoFric® OrigoTM or LoFric® SenseTM | Experimental | Hydrophilic male (LoFric Origo) and female (LoFric Sense) urinary catheters for single use. Target subject population are subjects suffering from bladder voiding dysfunction and are experienced in intermittent catheterization (IC). Receives: Device: LoFric® OrigoTM and LoFric® SenseTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects' satisfaction, when practicing IC (insertion/withdrawal) using study device.
The subject's assessment of satisfaction using a five-level scale in a pPRO (Wellspect Follow-up questionnaire): How satisfied have you been with the catheterization (insertion/withdrawal) when using the investigational device?
- = completely unsatisfied
- = unsatisfied
- = neutral
- = satisfied
- = completely satisfied
Measured: 30 days
Secondary outcomes (4)
Reason for dissatisfaction (if any) when practicing IC with study device.
The proportion of subjects that are unsatisfied/completely unsatisfied and specifying the reason in free text. pPRO (Wellspect questionnaire)
Measured: 30 days
Experience of any problems before, during and after catheterization with investigational device.
The proportion of subjects that experienced any problems. A yes/no scale, if yes, a specification (free text) is required.
pPRO (Wellspect questionnaire)
Measured: 30 days
Catheter usability (incl. ease of use) when practicing IC with investigational device.
The mean of all subject's answers/domain score of ISC-Q (ease of use) completed at the end of investigation visits. pPRO (Wellspect questionnaire) and ISC-Q - domain ease of use.
Measured: 30 days
QoL when practicing IC with investigational device.
ISC-Q total mean score The mean of all subjects' total score of ISC-Q completed at the end of investigation visits.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start17 Dec 2020
- Primary completion15 Apr 2023
- Study completion15 Apr 2023
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Voiding DysfunctionStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wellspect HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Markus Wittebo, M.Sc. Pharm., Study director, Wellspect HealthCareRuth Kirschner-Hermanns, Univ.-Prof. Dr. med., Principal investigator, Universitätsklinikum Bonn, GermanyAntje Foresti, Dr. med., Principal investigator, Zentrum für Kontinenz und Neuro-Urologie, Kliniken Maria Hilf GmbH, MönchengladbachAlexander Höinghaus, Dr. med., Principal investigator, Gemeinschaftspraxis für Urologie, Dierdorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703413
- Sponsor's protocol ID
- LOF-0036
- Status last verified
- Apr 2023
- First submitted
- 7 Jan 2021
- 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
- User Satisfaction When Catheterizing With Hydrophilic Urinary Catheters From a More Sustainable Manufacturing Process. An Open, Prospective, Post-market Clinical Follow-up Investigation.
- ClinicalTrials.gov ID
- NCT04703413
- Acronym / sponsor ID
- LOF-0036
- Conditions
- Bladder Voiding Dysfunction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Wellspect HealthCareIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 11 Jan 2021 (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.
An open, prospective, single arm, multicenter clinical investigation. All subjects will use the investigational device for 30 days each.
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® OrigoTM or LoFric® SenseTM | Experimental | Device: LoFric® OrigoTM and LoFric® SenseTMHydrophilic male (LoFric Origo) and female (LoFric Sense) urinary catheters for single use. Target subject population are subjects suffering from bladder voiding dysfunction and are experienced in intermittent catheterization (IC). |
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 i.e. subject must be able to understand and sign the Informed Consent Form
- Aged 18 years and over, both gender
- Bladder dysfunction, all diagnosis practicing IC at least 2 times daily
- Using catheters in the sizes available in the investigation (15 cm, CH 12 or 40 cm CH 12/14, Nelaton tip)
- Experienced users of IC defined as a minimum of 4 weeks on therapy prior investigation start
Key exclusion criteria (7 listed)
- Ongoing, symptomatic UTI at enrolment as judged by investigator. The definition of UTI, is a positive urine culture of ≥103 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 investigation (applies to both Wellspect/site staff).
- Previous enrolment in the present investigation.
- Simultaneous participation in another clinical investigation 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® OrigoTM and LoFric® SenseTMThe investigational device is either a CE-marked LoFric® OrigoTM , 40 cm, CH12/CH14 or LoFric® SenseTM, 15 cm, CH12. They are all intermittent urinary catheters with a Nelaton tip from a more sustainable manufacturing process. All subjects will use the investigational device for 30 days each. | Device | LoFric® OrigoTM or LoFric® SenseTM |
Primary outcome
Subjects' satisfaction, when practicing IC (insertion/withdrawal) using study device.
Time frame: 30 days
The subject's assessment of satisfaction using a five-level scale in a pPRO (Wellspect Follow-up questionnaire): How satisfied have you been with the catheterization (insertion/withdrawal) when using the investigational device? 1. = completely unsatisfied 2. = unsatisfied 3. = neutral 4. = satisfied 5. = completely satisfied
4 secondary outcomes
Reason for dissatisfaction (if any) when practicing IC with study device.
Time frame: 30 days
Experience of any problems before, during and after catheterization with investigational device.
Time frame: 30 days
Catheter usability (incl. ease of use) when practicing IC with investigational device.
Time frame: 30 days
QoL when practicing IC with investigational device.
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
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.
Markus Wittebo, M.Sc. Pharm. study director
Wellspect HealthCare
Ruth Kirschner-Hermanns, Univ.-Prof. Dr. med. principal investigator
Universitätsklinikum Bonn, Germany
Antje Foresti, Dr. med. principal investigator
Zentrum für Kontinenz und Neuro-Urologie, Kliniken Maria Hilf GmbH, Mönchengladbach
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LoFric® OrigoTM and LoFric® SenseTM in people with Bladder Voiding Dysfunction, run by Wellspect HealthCare at 3 sites in Germany.
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 7 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: stopped early, 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 3 sites in Germany. 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 was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
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?
Subjects' satisfaction, when practicing IC (insertion/withdrawal) using study device. (time frame: 30 days). 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.