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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
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.
Alicante University General Dr. Balmis Hospital
Alicante, Spain
Hospital Clinic Barcelona
Barcelona, Spain
Carlanderska Hospital
Gothenburg, Sweden
Urologiska kliniken, mottagning Universitetssjukhuset Örebro
Örebro, Örebro County, Sweden
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.
Time frame: 2 weeks
Compliance when practicing IC with LoFric Elle.
Used study catheter entire study period with the handle at least 10 times: Y/N.
Time frame: 2 weeks
Satisfaction when practicing IC with LoFric Elle.
PRO variables (Wellspect questionnaire).
Time frame: 2 weeks
Versatility as in use of the angulated handle when practicing IC with LoFric Elle.
PRO variables (Wellspect questionnaire).
Time frame: 2 weeks
Perception when practicing IC with LoFric Elle.
PRO variables (Wellspect questionnaire).
Time frame: 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.
Time frame: 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.
Time frame: 2 weeks
The catheter is perceived as ready to use.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
ISC-Q question 1; it is easy to prepare my catheter for use each time I need it.
Time frame: 2 weeks