Catheterization (Clean, Intermittent Urinary Catheterization)
Conditions
Brief 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. 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.
Interventions
DEVICELoFric POBE 2.0
To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
DEVICELoFric PVC
To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
Sponsors
Wellspect HealthCare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Discomfort | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perception of Burning Sensation | 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. |
| Presence of Bleeding | 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. |
| Perception of Other Discomfort | 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). |
| Perception of Stiffness/ Rigidity | 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. |
| Perception of Catheter Eyes | 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. |
| Perception of Pain | 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. |
| Perception of Catheter Tip | 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. |
| Perception of Slipperiness | 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. |
| Perception of Smoothness | 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. |
| Perception of Resistance | 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. |
| Perception of Discomfort Due to Other Causes | 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). |
| Perception of Catheter Adherence | 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. |
Countries
Sweden
Participant flow
Pre-assignment details
107 subjects were enrolled in the study but 105 started treatment, i.e. two subjects dropped out before start of treatment. Both these subjects missed to fulfil all inclusion criteria. 53 subjects started using LoFric Polyolefin Based Elastomer (POBE) 2.0 and 52 subjects started using LoFric Polyvinyl Chloride (PVC).
Participants by arm
| Arm | Count |
|---|---|
| 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
LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively. | 53 |
| 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.
LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively. | 52 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (7 Days) | Death | 0 | 1 |
Baseline characteristics
| Characteristic | Total | LoFric POBE 2.0 - PVC | LoFric PVC - POBE 2.0 |
|---|---|---|---|
| Age, Continuous | 72 years STANDARD_DEVIATION 10 | 71 years STANDARD_DEVIATION 10 | 72 years STANDARD_DEVIATION 10 |
| Region of Enrollment Sweden | 105 participants | 53 participants | 52 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 105 Participants | 53 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 104 | 26 / 105 |
| serious Total, serious adverse events | 1 / 104 | 2 / 105 |
Outcome results
Primary
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.
Time frame: At 7 and 14 days after randomization, respectively
Population: Since the study is cross-over, all (104) subjects evaluated both LoFric POBE 2.0 and LoFric PVC. To be able to group and describe the results the Arm/Group Titles are renamed in this section to LoFric POBE 2.0 and LoFric PVC respectively. Each Arm/Group describing the outcome for all 104 subjects (ITT analysis set).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LoFric POBE 2.0 | Number of Participants With Discomfort | 15 participants |
| LoFric PVC | Number of Participants With Discomfort | 29 participants |
Comparison: The size of the target population was estimated by calculating 95% Confidence Interval (CI) of a possible difference between the two catheter types. The width of the interval was decided on the proportion of patients who would prefer one or the other catheter. Max width was seen when both proportions were 0.5. A total of 90 evaluable subjects limited the maximum width to 0.41, which was considered narrow enough from a scientific point of view, why this sample size was used in the study.p-value: 0.0066McNemar
Secondary
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.
Time frame: At 7 and 14 days after randomization, respectively
Secondary
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.
Time frame: At 7 and 14 days after randomization, respectively
Secondary
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.
Time frame: At 7 and 14 days after randomization, respectively
Secondary
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.
Time frame: At 7 and 14 days after randomization, respectively
Secondary
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).
Time frame: At 7 and 14 days after randomization, respectively
Secondary
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).
Time frame: At 7 and 14 days after randomization, respectively
Secondary
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.
Time frame: At 7 and 14 days after randomization, respectively
Secondary
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.
Time frame: At 7 and 14 days after randomization, respectively
Secondary
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.
Time frame: At 7 and 14 days after randomization, respectively
Secondary
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.
Time frame: At 7 and 14 days after randomization, respectively
Secondary
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.
Time frame: At 7 and 14 days after randomization, respectively
Secondary
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.
Time frame: At 7 and 14 days after randomization, respectively