UROtainer for Bladder Catheter Maintenance, Infection Prevention and Quality of Life

Study Overview
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Brief Summary
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The purpose of the current study is to investigate whether catheter flushing with Uro-Tainer® with citric acid and Uro-Tainer® Polihexanide can: Reduce catheter changes due to incrustation and blockage. In addition, a list of secondary aims inclusive of cost-effectiveness analysis in collaboration with the Centre for Innovative Medical Technology (CIMT) at OUH.

Detailed Description
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The purpose of the current study is to investigate whether catheter flushing with Uro-Tainer® with citric acid and Uro-Tainer® Polihexanide can: Reduce catheter changes due to incrustation and blockage. In addition, a list of secondary aims inclusive of cost-effectiveness analysis in collaboration with the Centre for Innovative Medical Technology (CIMT) at OUH. This randomised study will be performed in two phases: a pilot and the main study. There is a need for a randomised study to justify if Uro-Tainer® flushing will have an advantage instead of the cheaper and normally used Saline flushing. Standard therapies vary depending on the blockage type and severity. Saline Solution can be used daily for a shorter period and 1-2 times a week for long-time catheter maintenance. Pilot study: Uro-Tainer® Polihexanide twice a week for 12 weeks and compared to saline flushing in the same regime. Main study: Uro-Tainer® Polihexanide two weekly rinses compared to two weekly rinses with saline for 6 months. Uro-Tainer® with citric acid: Two weekly rinses compared to two weekly rinses with saline for 6 months. Clinical benefits: Less catheter blockage -> less need for catheter replacement outside the regular schedule -> Fewer infections and better QoL It is expected that cost-effectiveness analysis will show a better economic outcome for the society No unknown adverse effects are expected The risk of participation in this study is very small compared to the expected effect of fewer catheter replacements, fewer infections and better QoL which justifies the selection of clinical endpoints.

Official Title
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Study of Uro-Tainer® Polihexanide and Uro-Tainer® With Citric Acid on Catheter Blockage, Infection Prevention, Cost-effectiveness and Quality of Life (UROBIQ): a Prospective Randomized Single-blinded Clinical Study

Conditions
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Catheter Blockage

Intervention / Treatment
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* Device: UroTainer®
* Device: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Citizen not previously flushed A permanent catheter (suprapubic and urethral) Male and female > 18 years of age Acute or previous catheter stop because of blocking or incrustations. The pilot project does not include clogging due to incrustations Voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Ethics Committee (EC) before all evaluations. Citizen previously flushed with NaCl or UroTainer® A permanent catheter (suprapubic and urethral) Male and female > 18 years of age Willingness to take a rinse break for a minimum of 4 weeks. In the event of 2 catheter stops during the flushing break, assessed on the basis of an urgent need for catheter flushing with NaCl or catheter change, the citizen can be included. The pilot project does not include clogging due to incrustations If there is no catheter stop during the rinsing break, the citizen will continue without rinsing until a possible catheter stop. Voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Ethics Committee (EC) before all evaluations. Exclusion Criteria: Urothelial cancer Bladder and kidney stones requiring treatment Age < 18 years of age Pregnant and / or breastfeeding women Not able to understand Danish Dementia, where relatives can / will not give consent Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 arms with randomization 1:1 Uro-Tainer® Polihexanide two weekly rinses compared to two weekly rinses with saline for 6 months. Uro-Tainer® with citric acid: Two weekly rinses compared to two weekly rinses with saline for 6 months.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uro-Tainer® catheter flushing<br>Uro-Tainer® catheter flushing two times weekly for 6 months. | Device: UroTainer®<br>* Clinical effect of preventive treatment - catheter flushing with UroTainer®<br>|
| Placebo Comparator: Saline catheter flushing<br>Saline solution catheter flushing two times weekly for 6 months. | Device: Saline<br>* Clinical effect of preventive treatment - catheter flushing with saline solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of catheter changes during the treatment and follow-up period. | Number of catheter changes | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UTI events | The number of prescriptions | 1 year | 
| Urine culture | Urine culture performed if UTI is suspected | 1 year | 
| Odour | Odour nuisance is to be assessed on a 5-point scale. A high score is a worse outcome. No odour Discreet odour nuisance after catheter care Odour that is noticed once in a while. Noticed by the participant and relatives Odour that is present all the time around the participant Solid odour that is felt in all rooms. It hangs on the participant | 1 year | 
| Quality of life by SF-36 | SF-36 (Health Survey Short Form 36) The SF-36 consists of 36 items - that are grouped into 8 subscales or domains: Physical functioning (10 items); Role limitations due to physical health (4 items); Role limitations due to emotional problems (4 items); Energy/fatigue; Emotional well-being; Social functioning (2 items); Pain (2 items); General health. Aggregate scores for each domain range from 0 to 100, compiled as a percentage - where the higher the score, the more favourable the health state. | 1 year | 
| Quality of life by ICIQ-LTCqol | Living with a long term catheter (ICIQ-LTCqol 12/12 ) The questionnaire consists of three scales yielding two summary measures catheter function and concern score, lifestyle impact and unscored items. Possible scores range from 1 to 530, with lower scores representing better catheter function, concern score and life impact. | 1 year | 
| Cost effectiveness analyses 1 | Costs of used catheters in DDK pr participant | 1 year | 
| Cost effectiveness analyses 2 | Costs of used solutions for the maintenance of indwelling urethral and suprapubic catheters in DKK pr participant | 1 year | 
| Cost effectiveness analyses 3 | Costs of used time of the health care professionals used for catheter maintenance and control in primary care in DKK pr participant | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheter maintenance, UroTainer, prophylactic, catheter flushing