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| Name | Class |
|---|---|
| Wellspect HealthCare | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment Period One | Device | LoFric Origo urinary catheter, 40-cm length, CH12/CH14 diameter, with Nelaton tip |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urologcentrum Borås | Borås | 503 32 | Sweden | |||
| Urologkliniken vid Carlanderska AB |
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| Treatment Period Two | Device | CE-marked LoFric Origo urinary catheter, 40-cm length, CH12/CH14 diameter, with Nelaton tip |
|
| 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. | 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). | 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. | 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. | 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. | 2 weeks in total. |
| Gothenburg |
| 405 45 |
| Sweden |
| Specialistmottagningen i Urologi, Halmstad | Halmstad | 302 46 | Sweden |
| Urologmottagningen, Centralsjukhuset Karlstad | Karlstad | 651 85 | Sweden |
| Urologiska kliniken, Urologmottagningen Universitetssjukhuset Örebro | Örebro | 701 85 | Sweden |
| GHP Urologcentrum Stockholm | Stockholm | 117 94 | Sweden |
| Uroterapimottagningen, Sjukhuset Torsby | Torsby | 685 34 | Sweden |
| Urologmottagningen, Akademiska sjukhuset | Uppsala | 751 85 | Sweden |