Evaluation of a New Female Urinary Intermittent Catheter

Not Applicable

Completed

• Conditions: Female Intermittent Urethral Catheterization
• Interventions: Device: LoFric Elle

• Registration Number: NCT04304599
• Lead Sponsor: Wellspect HealthCare

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-11
• Study Start: 2020-03-13
• Primary Completion: 2023-01-03
• Study Completion: 2023-02-27
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LoFric Elle	LoFric Elle	New hydrophilic female urinary catheter for single use. Ready-to-Use.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.
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 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.

Trial Locations

Locations (4)

Urologiska kliniken, mottagning Universitetssjukhuset Örebro; 🇸🇪 Örebro, Örebro Län, Sweden

Alicante University General Dr. Balmis Hospital; 🇪🇸 Alicante, Spain

Carlanderska Hospital; 🇸🇪 Göteborg, Sweden

Hospital Clinic Barcelona; 🇪🇸 Barcelona, Spain