NCT04304599

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

March 13, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2023

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

2.8 years

First QC Date

March 9, 2020

Last Update Submit

April 26, 2023

Conditions

Female Intermittent Urethral Catheterization

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Compliance when practicing IC with LoFric Elle.

    2 weeks

  • Satisfaction when practicing IC with LoFric Elle.

    2 weeks

  • Versatility as in use of the angulated handle when practicing IC with LoFric Elle.

    2 weeks

  • Perception when practicing IC with LoFric Elle.

    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.

    2 weeks

  • +2 more secondary outcomes

Study Arms (1)

LoFric Elle

EXPERIMENTAL

New hydrophilic female urinary catheter for single use. Ready-to-Use.

Device: LoFric Elle

Interventions

LoFric ElleDEVICE

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.

LoFric Elle

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Alicante University General Dr. Balmis Hospital

Alicante, Spain

Location

Hospital Clinic Barcelona

Barcelona, Spain

Location

Carlanderska Hospital

Gothenburg, SE-405 45, Sweden

Location

Urologiska kliniken, mottagning Universitetssjukhuset Örebro

Örebro, Örebro County, 701 85, Sweden

Location

Study Officials

  • Pernilla Sundqvist, MD, PhD

    Örebro University Hospital, Sweden

    PRINCIPAL INVESTIGATOR

  • Kaj Stenlöf, Dr.

    Carlanderska Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2020

First Posted

March 11, 2020

Study Start

March 13, 2020

Primary Completion

January 3, 2023

Study Completion

February 27, 2023

Last Updated

April 28, 2023

Record last verified: 2023-04

Locations

ES(2)SE(2)