Evaluation of a New Female Urinary Intermittent Catheter

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-13

Study Completion Date

2023-02-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Female Intermittent Urethral Catheterization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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LoFric Elle

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

Group Type EXPERIMENTAL

LoFric Elle

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No