Intermittent Urethral CatheterizationNCT03684941
Evaluation of a New Catheter Coating Process for Urinary Catheters Used for Intermittent Catheterization.
A study testing Treatment Period One and Treatment Period Two in people with Intermittent Urethral Catheterization, run by Dentsply International at 8 sites in Sweden.
Trial summary
This is a prospective, double-blinded, randomized, multi-centre, cross-over study. All subjects will use both the study device (test catheter) and the comparator (control catheter) for one week each. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Intermittent Urethral Catheterization
- What is being tested?
- Treatment Period One and Treatment Period Two
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 8 sitesSweden
- Study dates
- 29 Aug 2018to 19 Nov 2018
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent.
- Males, aged 18 years and over.
- Maintained urethra sensibility as judged by the subject. (Can you feel the catheter during catheterization? Yes.).
- Practice CIC at least 2 times daily.
- Using catheters in the size CH 12 or CH 14, Nelaton tip, and able to use catheter length of 40 cm.
- Experienced users of CIC defined as a minimum of three months 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 ≥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 study (applies to both WHC staff and staff at the study site).
- Previous enrolment or randomisation of treatment in the present study.
- Simultaneous participation in another clinical study that may impact the primary endpoint.
- Severe non-compliance to protocol as judged by the investigator
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Sweden8 sites
Urologcentrum Borås
Borås, 503 32
Urologkliniken vid Carlanderska AB
Gothenburg, 405 45
Specialistmottagningen i Urologi, Halmstad
Halmstad, 302 46
Urologmottagningen, Centralsjukhuset Karlstad
Karlstad, 651 85
Urologiska kliniken, Urologmottagningen Universitetssjukhuset Örebro
Örebro, 701 85
GHP Urologcentrum Stockholm
Stockholm, 117 94
Uroterapimottagningen, Sjukhuset Torsby
Torsby, 685 34
Urologmottagningen, Akademiska sjukhuset
Uppsala, 751 85
About this study
Official title: Evaluation of a New Catheter Coating Process for Urinary Catheters Used for Intermittent Catheterization - A Prospective, Blinded, Randomized, Cross-over, Multicenter Study
This is a prospective, double-blinded, randomized, multi-centre, cross-over study. All subjects will use both the study device (test catheter) and the comparator (control catheter) for one week each.
- Conditions
- Intermittent Urethral Catheterization
- Being tested
- Treatment Period One, Treatment Period Two
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment Period OneDevice
LoFric Origo urinary catheter, 40-cm length, CH12/CH14 diameter, with Nelaton tip
Treatment Period TwoDevice
CE-marked LoFric Origo urinary catheter, 40-cm length, CH12/CH14 diameter, with Nelaton tip
| Study group | Role | What they receive |
|---|---|---|
| Treatment Period One | Experimental | LoFric, hydrophilic urinary catheter for single use. The study device is based on commercially available hydrophilic urinary catheters for intermittent catheterization, but with a different coating process than the comparator. Treatment Period One will last 1 week. Receives: Device: Treatment Period One |
| Treatment Period Two | Active comparator | CE-marked LoFric®, hydrophilic urinary catheter for single use. The comparator product is today commercially available and produced by WHC. Treatment Period Two will last 1 week. Receives: Device: Treatment Period Two |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of practicing CIC by using two urinary catheters produced with different coating processes measuring change over time by means of subjective assessment scales
The primary objective of this study is to compare the subjects' tolerability of practising CIC by using two urinary catheters produced with different coating processes by means of subjective assessment scales.
Measured: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two
Secondary outcomes (6)
Tolerability with regards to perceived pain, when using two different urinary catheters; test vs control catheter.
AE/SAE/ADE/SADE reporting/PRO variables. Assessed in patient questionnaire for each subject. A 5 graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.
Measured: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
Tolerability with regards to presence of bleeding, when using two different urinary catheters; test vs control catheter
AE/SAE/ADE/SADE reporting /PRO variables. Assessed in patient questionnaire for each subject. A 5 graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.
Measured: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
Tolerability with regards to perceived "other discomfort", when using two different urinary catheters; test vs. control catheter
PRO variables. Frequency of "other discomfort" (yes/ no) will be assessed in patient questionnaire. The frequency of "other discomfort" will be compared between the treatments. "Other discomfort" will be further specified using 5 graded scale (as for the other variables on the 5 graded scale the difference between the treatments will be calculated for each subject).
Measured: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
Perception of the catheter's slipperiness, smoothness, flexibility, usability, and resistance, when practicing intermittent self-catheterization with urinary catheters; test vs. control catheter
PRO variables. Assessed in patient questionnaire for each subject. A 5 graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.
Measured: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
To evaluate subject satisfaction with catheter; test vs. control catheter.
PRO variables. Assessed in patient questionnaire for each subject. A 5 graded scale will be used to determine the satisfaction. The difference between the treatments will be calculated for each subject.
Measured: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
Total number of DD/AE/SAE/ADE/SADE/ USADE.
Total number of DD/AE/SAE/ADE/SADE/ USADE observed by the study personnel or spontaneously reported from subject will be calculated. The frequency of DD/AE/SAE/ADE/SADE/ USADE will be calculated for each treatment group.
Measured: 2 weeks in total.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start29 Aug 2018
- Primary completion19 Nov 2018
- Study completion19 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wellspect HealthCare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684941
- Sponsor's protocol ID
- LOF-0034
- Status last verified
- Dec 2018
- First submitted
- 17 Sep 2018
- Last updated
- 5 Dec 2018
- 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 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Catheter Coating Process for Urinary Catheters Used for Intermittent Catheterization - A Prospective, Blinded, Randomized, Cross-over, Multicenter Study
- ClinicalTrials.gov ID
- NCT03684941
- Acronym / sponsor ID
- LOF-0034
- Conditions
- Intermittent Urethral Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dentsply InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Wellspect HealthCare
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 19 Nov 2018 (actual)
- Study completion
- 19 Nov 2018 (actual)
- First posted
- 26 Sep 2018 (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.
This is a prospective, double-blinded, randomized, multi-centre, cross-over study. All subjects will use both the study device (test catheter) and the comparator (control catheter) for one week each.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Period One | Experimental | Device: Treatment Period OneLoFric, hydrophilic urinary catheter for single use. The study device is based on commercially available hydrophilic urinary catheters for intermittent catheterization, but with a different coating process than the comparator. Treatment Period One will last 1 week. |
| Treatment Period Two | Active comparator | Device: Treatment Period TwoCE-marked LoFric®, hydrophilic urinary catheter for single use. The comparator product is today commercially available and produced by WHC. Treatment Period Two will last 1 week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of informed consent.
- Males, aged 18 years and over.
- Maintained urethra sensibility as judged by the subject. (Can you feel the catheter during catheterization? Yes.).
- Practice CIC at least 2 times daily.
- Using catheters in the size CH 12 or CH 14, Nelaton tip, and able to use catheter length of 40 cm.
Key exclusion criteria (6 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 study (applies to both WHC staff and staff at the study site).
- Previous enrolment or randomisation of treatment 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 |
|---|---|---|
| Treatment Period OneLoFric Origo urinary catheter, 40-cm length, CH12/CH14 diameter, with Nelaton tip | Device | Treatment Period One |
| Treatment Period TwoCE-marked LoFric Origo urinary catheter, 40-cm length, CH12/CH14 diameter, with Nelaton tip | Device | Treatment Period Two |
Primary outcome
Tolerability of practicing CIC by using two urinary catheters produced with different coating processes measuring change over time by means of subjective assessment scales
Time frame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two
The primary objective of this study is to compare the subjects' tolerability of practising CIC by using two urinary catheters produced with different coating processes by means of subjective assessment scales.
6 secondary outcomes
Tolerability with regards to perceived pain, when using two different urinary catheters; test vs control catheter.
Time frame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
Tolerability with regards to presence of bleeding, when using two different urinary catheters; test vs control catheter
Time frame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
Tolerability with regards to perceived "other discomfort", when using two different urinary catheters; test vs. control catheter
Time frame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
Perception of the catheter's slipperiness, smoothness, flexibility, usability, and resistance, when practicing intermittent self-catheterization with urinary catheters; test vs. control catheter
Time frame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
To evaluate subject satisfaction with catheter; test vs. control catheter.
Time frame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
Total number of DD/AE/SAE/ADE/SADE/ USADE.
Time frame: 2 weeks in total.
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 5 Dec 2018.
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment Period One and Treatment Period Two in people with Intermittent Urethral Catheterization, run by Dentsply International at 8 sites in Sweden.
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 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in 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?
Tolerability of practicing CIC by using two urinary catheters produced with different coating processes measuring change over time by means of subjective assessment scales (time frame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two). 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 5 Dec 2018.