- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01295281
Evaluation of a New Catheter Material for Intermittent Catheterization
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Alingsås, Sweden, 441 33
- Kirurg och Urologmottagningen, Alingsås lasarett
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Borås, Sweden, 501 32
- Urologcentrum
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Gävle, Sweden, 801 87
- Kirurg- och urologmottagningen, Gävle Sjukhus
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Göteborg, Sweden, 417 17
- Urologmottagningen, Lundby Sjukhus
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Skövde, Sweden, 541 85
- Uroterapimottagningen Kärnsjukhuset Skövde
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Uddevalla, Sweden, 451 80
- Urologmottagningen Uddevalla sjukhus
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: LoFric POBE 2.0 - PVC
First period (7 days) use of LoFric POBE 2.0 followed by second period (7 days) use of LoFric PVC
|
To be used at least twice daily, during 7 days.
Treatment period 1 and 2 last 7 days, respectively.
To be used at least twice daily, during 7 days.
Treatment period 1 and 2 last 7 days, respectively.
|
EXPERIMENTAL: LoFric PVC - POBE 2.0
First period (7 days) use of LoFric PVC followed by second period (7 days) use of LoFric POBE 2.0.
|
To be used at least twice daily, during 7 days.
Treatment period 1 and 2 last 7 days, respectively.
To be used at least twice daily, during 7 days.
Treatment period 1 and 2 last 7 days, respectively.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At 7 and 14 days after randomization, respectively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perception of Pain
Time Frame: At 7 and 14 days after randomization, respectively
|
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.
|
At 7 and 14 days after randomization, respectively
|
Perception of Burning Sensation
Time Frame: At 7 and 14 days after randomization, respectively
|
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.
|
At 7 and 14 days after randomization, respectively
|
Presence of Bleeding
Time Frame: At 7 and 14 days after randomization, respectively
|
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.
|
At 7 and 14 days after randomization, respectively
|
Perception of "Other Discomfort"
Time Frame: At 7 and 14 days after randomization, respectively
|
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).
|
At 7 and 14 days after randomization, respectively
|
Perception of Stiffness/ Rigidity
Time Frame: At 7 and 14 days after randomization, respectively
|
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.
|
At 7 and 14 days after randomization, respectively
|
Perception of Catheter Eyes
Time Frame: At 7 and 14 days after randomization, respectively
|
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.
|
At 7 and 14 days after randomization, respectively
|
Perception of Catheter Adherence
Time Frame: At 7 and 14 days after randomization, respectively
|
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.
|
At 7 and 14 days after randomization, respectively
|
Perception of Catheter Tip
Time Frame: At 7 and 14 days after randomization, respectively
|
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.
|
At 7 and 14 days after randomization, respectively
|
Perception of Slipperiness
Time Frame: At 7 and 14 days after randomization, respectively
|
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.
|
At 7 and 14 days after randomization, respectively
|
Perception of Smoothness
Time Frame: At 7 and 14 days after randomization, respectively
|
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.
|
At 7 and 14 days after randomization, respectively
|
Perception of Resistance
Time Frame: At 7 and 14 days after randomization, respectively
|
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.
|
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
|
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).
|
At 7 and 14 days after randomization, respectively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Birgit Johansson, Urotherapist, Kärnsjukhuset Skövde
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LOF-0018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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