Evaluation of a New Female Urinary Intermittent Catheter

Study Overview
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Brief Summary
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A prospective, multi-centre, interventional study. All subjects will use the study device for two weeks and the angulated handle available with the device must be used by each subject at least 10 times.

Official Title
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Evaluation of a New Female Urinary Catheter Used for Intermittent Catheterization

Conditions
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Female Intermittent Urethral Catheterization

Intervention / Treatment
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* Device: LoFric Elle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent. Females aged 18 years and over. Maintained urethra sensibility as judged by the subject. (Can you feel the catheter during catheterization? Yes.). Practice intermittent catheterization at least 2 times daily. Use catheter size available in the study Experienced practitioners of intermittent catheterization defined as a minimum of three months on therapy, but not more than approximately 5 years on therapy. Adults able to read, write and understand information given to them regarding the study. Exclusion Criteria: Ongoing, symptomatic UTI at enrolment as judged by investigator. The definition of UTI, is a positive urine culture of ≥10^3 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 study (applies to both Wellspect staff and staff at the study site). Previous enrolment in the present study. Simultaneous participation in another clinical study that may impact the primary endpoint Expected or severe non-compliance to protocol 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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Female

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LoFric Elle<br>New hydrophilic female urinary catheter for single use. Ready-to-Use. | Device: LoFric Elle<br>* The study device is commercially available (CE-marked). It is a device for female intermittent catheterization. Treatment Period will last for 2 weeks. The angulated handle available with the device must be used by each subject at least 10 times.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to evaluate the subjects' Quality of Life when practicing IC using LoFric Elle catheters. | Primary objective variable is measured by the Intermittent Self-Catheterization Questionnaire (ISC-Q) total score. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance when practicing IC with LoFric Elle. | Used study catheter entire study period with the handle at least 10 times: Y/N. | 2 weeks | 
| Satisfaction when practicing IC with LoFric Elle. | PRO variables (Wellspect questionnaire). | 2 weeks | 
| Versatility as in use of the angulated handle when practicing IC with LoFric Elle. | PRO variables (Wellspect questionnaire). | 2 weeks | 
| Perception when practicing IC with LoFric Elle. | PRO variables (Wellspect questionnaire). | 2 weeks | 
| The catheter is perceived as slim and discreet which makes it easy to bring, store, and dispose of without obviously being a catheter. | ISC-Q domains convenience and discreetness. | 2 weeks | 
| The catheter with or without the angulated handle has an ergonomic design which makes it easy to use. | ISC-Q domain ease of use. | 2 weeks | 
| The catheter is perceived as ready to use. | ISC-Q question 1; it is easy to prepare my catheter for use each time I need it. | 2 weeks |