Catheterization (Clean, Intermittent Urinary Catheterization)NCT01295281
Evaluation of a New Catheter Material for Intermittent Catheterization
A study testing LoFric POBE 2.0 and LoFric PVC in people with Catheterization (Clean, Intermittent Urinary Catheterization), run by Wellspect HealthCare at 6 sites in Sweden.
Trial summary
The hypothesis to be investigated is if the tolerability of intermittent catheterization with Polyolefin Based Elastomer (POBE) 2.0 and Polyvinyl Chloride (PVC) is clinically equal - i.e. clinically non-inferior when using POBE 2.0 compared to PVC. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Catheterization (Clean, Intermittent Urinary Catheterization)
- What is being tested?
- LoFric POBE 2.0 and LoFric PVC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 6 sitesSweden
- Study dates
- Mar 2011to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Practice intermittent self-catheterization at least 2 times daily
- Using catheters in the length of 40 cm and size charrière (Ch) 12 or Ch 14
- Experienced practitioners of intermittent self-catheterization defined as a minimum of three months on therapy
- Experience of using LoFric catheter within the last 12 months prior to study entry
- Adults able to read, write and understand information given to them regarding the study
Who cannot join
- Ongoing, symptomatic urinary tract infection (UTI) at enrolment as judged by investigator
- Known urethral stricture at enrolment as judged by investigator
- Involvement in the planning and/or conduct of the study (applies to both Astra Tech staff or staff at the study site)
- Previous enrolment or randomisation of treatment in the present study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Sweden6 sites
Kirurg och Urologmottagningen, Alingsås lasarett
Alingsås, 441 33
Urologcentrum
Borås, 501 32
Kirurg- och urologmottagningen, Gävle Sjukhus
Gävle, 801 87
Urologmottagningen, Lundby Sjukhus
Gothenburg, 417 17
Uroterapimottagningen Kärnsjukhuset Skövde
Skövde, 541 85
Urologmottagningen Uddevalla sjukhus
Uddevalla, 451 80
About this study
Official title: A Prospective, Randomized, Cross-over Study - Evaluation of a New Catheter Material for Intermittent Catheterization
The hypothesis to be investigated is if the tolerability of intermittent catheterization with Polyolefin Based Elastomer (POBE) 2.0 and Polyvinyl Chloride (PVC) is clinically equal - i.e. clinically non-inferior when using POBE 2.0 compared to PVC.
Secondary objectives are to evaluate the safety and the subject's perception associated with the use of the catheters, assessed by the recording of adverse events and the ease of handling by means of a subjective assessment scale.
- Being tested
- LoFric POBE 2.0, LoFric PVC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoFric POBE 2.0Device
To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
LoFric PVCDevice
To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
| Study group | Role | What they receive |
|---|---|---|
| LoFric POBE 2.0 - PVC | Experimental | First period (7 days) use of LoFric POBE 2.0 followed by second period (7 days) use of LoFric PVC Receives: Device: LoFric POBE 2.0; Device: LoFric PVC |
| LoFric PVC - POBE 2.0 | Experimental | First period (7 days) use of LoFric PVC followed by second period (7 days) use of LoFric POBE 2.0. Receives: Device: LoFric POBE 2.0; Device: LoFric PVC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Discomfort
The primary objective of this study is to compare the subject's tolerability, with regards to perceived discomfort, when using two different urinary catheters. Perception of discomfort (yes/ no) will be assessed in patient questionnaire for each subject. The frequency of discomfort will be compared between the treatments.
Measured: At 7 and 14 days after randomization, respectively
Secondary outcomes (12)
Perception of Pain
To compare subject's tolerability with regards to perceived pain, when using two different urinary catheters; PVC vs. POBE 2.0. 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: At 7 and 14 days after randomization, respectively
Perception of Burning Sensation
To compare subject's tolerability with regards to perceived burning sensation, when using two different urinary catheters; PVC vs. POBE 2.0. 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: At 7 and 14 days after randomization, respectively
Presence of Bleeding
To compare subject's tolerability with regards to presence of bleeding, when using two different urinary catheters; PVC vs. POBE 2.0. 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: At 7 and 14 days after randomization, respectively
Perception of "Other Discomfort"
To compare subject's tolerability with regards to perceived "other discomfort", when using two different urinary catheters; PVC vs. POBE 2.0. 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: At 7 and 14 days after randomization, respectively
Perception of Stiffness/ Rigidity
To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. 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: At 7 and 14 days after randomization, respectively
Perception of Catheter Eyes
To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. 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: At 7 and 14 days after randomization, respectively
Perception of Catheter Adherence
To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. 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: At 7 and 14 days after randomization, respectively
Perception of Catheter Tip
To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. 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: At 7 and 14 days after randomization, respectively
Perception of Slipperiness
To evaluate subject perception related to the properties of the catheter's coating/surface, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. 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: At 7 and 14 days after randomization, respectively
Perception of Smoothness
To evaluate subject perception related to the properties of the catheter's coating/surface, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. 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: At 7 and 14 days after randomization, respectively
Perception of Resistance
To evaluate subject perception related to the properties of the catheter's coating/surface, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. 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: At 7 and 14 days after randomization, respectively
Perception of Discomfort Due to Other Causes
To compare subject's tolerability with regards to perceived discomfort due to other causes, when using two different urinary catheters 2.0. Frequency of discomfort due to other causes (yes/ no) will be assessed in patient questionnaire. The frequency of discomfort due to other causes will be compared between the treatments. Discomfort due to other causes 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: At 7 and 14 days after randomization, respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Catheterization (Clean, Intermittent Urinary Catheterization)Studies 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
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wellspect HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Birgit Johansson, Urotherapist, Principal investigator, Kärnsjukhuset Skövde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295281
- Sponsor's protocol ID
- LOF-0018
- Status last verified
- Nov 2021
- First submitted
- 21 Jan 2011
- Last updated
- 11 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Cross-over Study - Evaluation of a New Catheter Material for Intermittent Catheterization
- ClinicalTrials.gov ID
- NCT01295281
- Acronym / sponsor ID
- LOF-0018
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Wellspect HealthCareIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 14 Feb 2011 (estimated)
- Results
- Posted 3 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis to be investigated is if the tolerability of intermittent catheterization with Polyolefin Based Elastomer (POBE) 2.0 and Polyvinyl Chloride (PVC) is clinically equal - i.e. clinically non-inferior when using POBE 2.0 compared to PVC.
Secondary objectives are to evaluate the safety and the subject's perception associated with the use of the catheters, assessed by the recording of adverse events and the ease of handling by means of a subjective assessment scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LoFric POBE 2.0 - PVC | Experimental | Device: LoFric POBE 2.0, Device: LoFric PVCFirst period (7 days) use of LoFric POBE 2.0 followed by second period (7 days) use of LoFric PVC |
| LoFric PVC - POBE 2.0 | Experimental | Device: LoFric POBE 2.0, Device: LoFric PVCFirst period (7 days) use of LoFric PVC followed by second period (7 days) use of LoFric POBE 2.0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of informed consent
- Males, aged 18 years and over
- Maintained urethra sensibility
- Practice intermittent self-catheterization at least 2 times daily
- Using catheters in the length of 40 cm and size charrière (Ch) 12 or Ch 14
Key exclusion criteria (4 listed)
- Ongoing, symptomatic urinary tract infection (UTI) at enrolment as judged by investigator
- Known urethral stricture at enrolment as judged by investigator
- Involvement in the planning and/or conduct of the study (applies to both Astra Tech staff or staff at the study site)
- Previous enrolment or randomisation of treatment in the present study
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 POBE 2.0To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively. | Device | LoFric POBE 2.0 - PVC, LoFric PVC - POBE 2.0 |
| LoFric PVCTo be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively. | Device | LoFric POBE 2.0 - PVC, LoFric PVC - POBE 2.0 |
Primary outcome
Number of Participants With Discomfort
Time frame: At 7 and 14 days after randomization, respectively
The primary objective of this study is to compare the subject's tolerability, with regards to perceived discomfort, when using two different urinary catheters. Perception of discomfort (yes/ no) will be assessed in patient questionnaire for each subject. The frequency of discomfort will be compared between the treatments.
12 secondary outcomes
Perception of Pain
Time frame: At 7 and 14 days after randomization, respectively
Perception of Burning Sensation
Time frame: At 7 and 14 days after randomization, respectively
Presence of Bleeding
Time frame: At 7 and 14 days after randomization, respectively
Perception of "Other Discomfort"
Time frame: At 7 and 14 days after randomization, respectively
Perception of Stiffness/ Rigidity
Time frame: At 7 and 14 days after randomization, respectively
Perception of Catheter Eyes
Time frame: At 7 and 14 days after randomization, respectively
Perception of Catheter Adherence
Time frame: At 7 and 14 days after randomization, respectively
Perception of Catheter Tip
Time frame: At 7 and 14 days after randomization, respectively
Perception of Slipperiness
Time frame: At 7 and 14 days after randomization, respectively
Perception of Smoothness
Time frame: At 7 and 14 days after randomization, respectively
Perception of Resistance
Time frame: At 7 and 14 days after randomization, respectively
Perception of Discomfort Due to Other Causes
Time frame: At 7 and 14 days after randomization, respectively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Birgit Johansson, Urotherapist principal investigator
Kärnsjukhuset Skövde
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LoFric POBE 2.0 and LoFric PVC in people with Catheterization (Clean, Intermittent Urinary Catheterization), run by Wellspect HealthCare at 6 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 8 inclusion and 4 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 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Yes. Results are posted in the registry (first posted 3 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Discomfort (time frame: At 7 and 14 days after randomization, respectively). 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 11 Nov 2021.