Evaluation of a New Catheter Material for Intermittent Catheterization

Study Overview
=================
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.

Official Title
-----------------
A Prospective, Randomized, Cross-over Study - Evaluation of a New Catheter Material for Intermittent Catheterization

Conditions
-----------------
Catheterization (Clean, Intermittent Urinary Catheterization)

Intervention / Treatment
-----------------
* Device: LoFric POBE 2.0
* Device: LoFric PVC


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LoFric POBE 2.0 - PVC<br>First period (7 days) use of LoFric POBE 2.0 followed by second period (7 days) use of LoFric PVC | Device: LoFric POBE 2.0<br>* To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.<br>Device: LoFric PVC<br>* To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.<br>|
| Experimental: LoFric PVC - POBE 2.0<br>First period (7 days) use of LoFric PVC followed by second period (7 days) use of LoFric POBE 2.0. | Device: LoFric POBE 2.0<br>* To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.<br>Device: LoFric PVC<br>* To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |