Evaluation of a New Female Urinary Intermittent Catheter

Wellspect HealthCare

Status

Completed

Conditions

Female Intermittent Urethral Catheterization

Treatments

Device: LoFric Elle

Study type

Interventional

Funder types

Industry

Identifiers

NCT04304599

LOF-0035

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.