Clinical trial NCT04304599: Evaluation of a New Female Urinary Intermittent Catheter
Official title: Evaluation of a New Female Urinary Catheter Used for Intermittent Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Intermittent Urethral Catheterization
Lead sponsor: Wellspect HealthCare
Sponsor class: INDUSTRY
First posted: 2020-03-11
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The primary objective of this study is to evaluate the subjects' Quality of Life when practicing IC using LoFric Elle catheters.
timeFrame: 2 weeks
Secondary outcomes:
measure: Compliance when practicing IC with LoFric Elle.
timeFrame: 2 weeks
measure: Satisfaction when practicing IC with LoFric Elle.
timeFrame: 2 weeks
measure: Versatility as in use of the angulated handle when practicing IC with LoFric Elle.
timeFrame: 2 weeks
measure: Perception when practicing IC with LoFric Elle.
timeFrame: 2 weeks
measure: The catheter is perceived as slim and discreet which makes it easy to bring, store, and dispose of without obviously being a catheter.
timeFrame: 2 weeks
measure: The catheter with or without the angulated handle has an ergonomic design which makes it easy to use.
timeFrame: 2 weeks
measure: The catheter is perceived as ready to use.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Alicante University General Dr. Balmis Hospital
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Göteborg
country: Sweden
facility: Carlanderska Hospital
city: Örebro
country: Sweden
facility: Urologiska kliniken, mottagning Universitetssjukhuset Örebro
state: Örebro Län
Study officials:
affiliation: Örebro University Hospital, Sweden
name: Pernilla Sundqvist, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carlanderska Hospital
name: Kaj Stenlöf, Dr.
role: PRINCIPAL_INVESTIGATOR
References: