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OpenTrials
Completed

NCT Number: NCT04304599

Evaluation of a New Female Urinary Intermittent Catheter

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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Key information

Conditions

Female Intermittent Urethral Catheterization

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Alicante University General Dr. Balmis Hospital, Alicante, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LoFric Elle

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.

Primary outcomes

  1. The primary objective of this study is to evaluate the subjects' Quality of Life when practicing IC using LoFric Elle catheters.

    Time frame: 2 weeks

    Primary objective variable is measured by the Intermittent Self-Catheterization Questionnaire (ISC-Q) total score.

Secondary outcomes

  1. Compliance when practicing IC with LoFric Elle.

    Time frame: 2 weeks

    Used study catheter entire study period with the handle at least 10 times: Y/N.

  2. Satisfaction when practicing IC with LoFric Elle.

    Time frame: 2 weeks

    PRO variables (Wellspect questionnaire).

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

    Time frame: 2 weeks

    PRO variables (Wellspect questionnaire).

  4. Perception when practicing IC with LoFric Elle.

    Time frame: 2 weeks

    PRO variables (Wellspect questionnaire).

  5. The catheter is perceived as slim and discreet which makes it easy to bring, store, and dispose of without obviously being a catheter.

    Time frame: 2 weeks

    ISC-Q domains convenience and discreetness.

  6. The catheter with or without the angulated handle has an ergonomic design which makes it easy to use.

    Time frame: 2 weeks

    ISC-Q domain ease of use.

  7. The catheter is perceived as ready to use.

    Time frame: 2 weeks

    ISC-Q question 1; it is easy to prepare my catheter for use each time I need it.

Sponsors and collaborators

Lead sponsor

Wellspect HealthCare

Industry

Registry information

Official study title

Evaluation of a New Female Urinary Catheter Used for Intermittent Catheterization

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 11, 2020
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.