Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LoFric POBE 2.0 | Device | To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 7 and 14 days after randomization, respectively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 7 and 14 days after randomization, respectively |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Birgit Johansson, Urotherapist | Kärnsjukhuset Skövde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kirurg och Urologmottagningen, Alingsås lasarett | Alingsås | 441 33 | Sweden | |||
| Urologcentrum |
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).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (7 Days) |
|
| ||||||||||||||||||
| Second Intervention (7days) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Number | participants | At 7 and 14 days after randomization, respectively |
|
From signing of Informed Consent until End of Study, up to 14 days.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LoFric POBE 2.0 | Single use LoFric POBE 2.0 catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Vascular disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding in connection to catheterization | Renal and urinary disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dikran Shamoun | Wellspect HealthCare | +46313764275 | dikran.shamoun@wellspect.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| LoFric PVC | Device | To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | At 7 and 14 days after randomization, respectively |
| Borås |
| 501 32 |
| Sweden |
| Kirurg- och urologmottagningen, Gävle Sjukhus | Gävle | 801 87 | Sweden |
| Urologmottagningen, Lundby Sjukhus | Gothenburg | 417 17 | Sweden |
| Uroterapimottagningen Kärnsjukhuset Skövde | Skövde | 541 85 | Sweden |
| Urologmottagningen Uddevalla sjukhus | Uddevalla | 451 80 | Sweden |
| NOT COMPLETED |
|
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | LoFric PVC | Single use LoFric PVC catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting. |
|
|
|
| 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. | Not Posted | At 7 and 14 days after randomization, respectively | Participants |
| 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. | Not Posted | At 7 and 14 days after randomization, respectively | Participants |
| 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. | Not Posted | At 7 and 14 days after randomization, respectively | Participants |
| 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). | Not Posted | At 7 and 14 days after randomization, respectively | Participants |
| 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. | Not Posted | At 7 and 14 days after randomization, respectively | Participants |
| 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. | Not Posted | At 7 and 14 days after randomization, respectively | Participants |
| 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. | Not Posted | At 7 and 14 days after randomization, respectively | Participants |
| 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. | Not Posted | At 7 and 14 days after randomization, respectively | Participants |
| 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. | Not Posted | At 7 and 14 days after randomization, respectively | Participants |
| 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. | Not Posted | At 7 and 14 days after randomization, respectively | Participants |
| 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. | Not Posted | At 7 and 14 days after randomization, respectively | Participants |
| 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). | Not Posted | At 7 and 14 days after randomization, respectively | Participants |
| 1 |
| 104 |
| 14 |
| 104 |
| EG001 | LoFric PVC | Single use LoFric PVC catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting. | 2 | 105 | 26 | 105 |
| Abnormal potassium level during planned cytostatic treatment | Surgical and medical procedures |
|
| Snakebite | Injury, poisoning and procedural complications |
|
| Burning sensation in connection to catheterization | Renal and urinary disorders |
|
| Pain in connection to catheterization | Renal and urinary disorders |
|
Not provided