Evaluation of a New Female Urinary Intermittent Catheter

Evaluation of a New Female Urinary Catheter Used for Intermittent Catheterization

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 Overview

• Status: Completed
• Conditions: Female Intermittent Urethral Catheterization
• Intervention / Treatment: Device: LoFric Elle

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain
    • Alicante University General Dr. Balmis Hospital
  • Barcelona, Spain
    • Hospital Clínic Barcelona
• Sweden
  • Göteborg, Sweden, SE-405 45
    • Carlanderska Hospital
  • Örebro Län
    • Örebro, Örebro Län, Sweden, 701 85
      • Urologiska kliniken, mottagning Universitetssjukhuset Örebro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LoFric Elle; New hydrophilic female urinary catheter for single use. Ready-to-Use.	Device: LoFric 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wellspect HealthCare
• Collaborators: Wellspect HealthCare

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2020
• Primary Completion (Actual): January 3, 2023
• Study Completion (Actual): February 27, 2023

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 11, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: LOF-0035

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No