Female Intermittent Urethral Catheterization
Conditions
Brief summary
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.
Interventions
DEVICELoFric Elle
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.
Sponsors
Wellspect HealthCare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary objective of this study is to evaluate the subjects' Quality of Life when practicing IC using LoFric Elle catheters. | 2 weeks | Primary objective variable is measured by the Intermittent Self-Catheterization Questionnaire (ISC-Q) total score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance when practicing IC with LoFric Elle. | 2 weeks | Used study catheter entire study period with the handle at least 10 times: Y/N. |
| Satisfaction when practicing IC with LoFric Elle. | 2 weeks | PRO variables (Wellspect questionnaire). |
| Versatility as in use of the angulated handle when practicing IC with LoFric Elle. | 2 weeks | PRO variables (Wellspect questionnaire). |
| Perception when practicing IC with LoFric Elle. | 2 weeks | PRO variables (Wellspect questionnaire). |
| The catheter is perceived as slim and discreet which makes it easy to bring, store, and dispose of without obviously being a catheter. | 2 weeks | ISC-Q domains convenience and discreetness. |
| The catheter with or without the angulated handle has an ergonomic design which makes it easy to use. | 2 weeks | ISC-Q domain ease of use. |
| The catheter is perceived as ready to use. | 2 weeks | ISC-Q question 1; it is easy to prepare my catheter for use each time I need it. |
Countries
Spain, Sweden
Outcome results
None listed