User Satisfaction When Catheterizing With Hydrophilic Urinary Catheters From a More Sustainable Manufacturing Process.

Study Overview
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Brief Summary
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An open, prospective, single arm, multicenter clinical investigation. All subjects will use the investigational device for 30 days each.

Official Title
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User Satisfaction When Catheterizing With Hydrophilic Urinary Catheters From a More Sustainable Manufacturing Process. An Open, Prospective, Post-market Clinical Follow-up Investigation.

Conditions
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Bladder Voiding Dysfunction

Intervention / Treatment
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* Device: LoFric® OrigoTM and LoFric® SenseTM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For inclusion in the study, subjects must fulfil all of the following criteria: Provision of informed consent i.e. subject must be able to understand and sign the Informed Consent Form Aged 18 years and over, both gender Bladder dysfunction, all diagnosis practicing IC at least 2 times daily Using catheters in the sizes available in the investigation (15 cm, CH 12 or 40 cm CH 12/14, Nelaton tip) Experienced users of IC defined as a minimum of 4 weeks on therapy prior investigation start Adults able to read, write and understand information given to them regarding the investigation Exclusion Criteria: Any of the following is regarded as a criterion for exclusion from the study: Ongoing, symptomatic UTI at enrolment as judged by investigator. The definition of UTI, is a positive urine culture of ≥103 CFU/ml of ≥1 bacterial species and presence of symptoms or signs compatible with UTI with no other identified source of infection. Known urethral stricture which, in the opinion of the investigator, could influence the subject's evaluation of the catheters. Involvement in the planning and conduct of the investigation (applies to both Wellspect/site staff). Previous enrolment in the present investigation. Simultaneous participation in another clinical investigation that may impact the primary endpoint. Expected or severe non-compliance to the CIP as judged by the investigator and/or Wellspect.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LoFric® OrigoTM or LoFric® SenseTM<br>Hydrophilic male (LoFric Origo) and female (LoFric Sense) urinary catheters for single use. Target subject population are subjects suffering from bladder voiding dysfunction and are experienced in intermittent catheterization (IC). | Device: LoFric® OrigoTM and LoFric® SenseTM<br>* The investigational device is either a CE-marked LoFric® OrigoTM , 40 cm, CH12/CH14 or LoFric® SenseTM, 15 cm, CH12. They are all intermittent urinary catheters with a Nelaton tip from a more sustainable manufacturing process. All subjects will use the investigational device for 30 days each.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects' satisfaction, when practicing IC (insertion/withdrawal) using study device. | The subject's assessment of satisfaction using a five-level scale in a pPRO (Wellspect Follow-up questionnaire): How satisfied have you been with the catheterization (insertion/withdrawal) when using the investigational device? = completely unsatisfied = unsatisfied = neutral = satisfied = completely satisfied | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reason for dissatisfaction (if any) when practicing IC with study device. | The proportion of subjects that are unsatisfied/completely unsatisfied and specifying the reason in free text. pPRO (Wellspect questionnaire) | 30 days | 
| Experience of any problems before, during and after catheterization with investigational device. | The proportion of subjects that experienced any problems. A yes/no scale, if yes, a specification (free text) is required. pPRO (Wellspect questionnaire) | 30 days | 
| Catheter usability (incl. ease of use) when practicing IC with investigational device. | The mean of all subject's answers/domain score of ISC-Q (ease of use) completed at the end of investigation visits. pPRO (Wellspect questionnaire) and ISC-Q - domain ease of use. | 30 days | 
| QoL when practicing IC with investigational device. | ISC-Q total mean score The mean of all subjects' total score of ISC-Q completed at the end of investigation visits. | 30 days |