Female Intermittent Urethral Catheterization Clinical Trial
Official title:
Evaluation of a New Female Urinary Catheter Used for Intermittent Catheterization
| Verified date | April 2023 |
| Source | Wellspect HealthCare |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | February 27, 2023 |
| Est. primary completion date | January 3, 2023 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Alicante University General Dr. Balmis Hospital | Alicante | |
| Spain | Hospital Clinic Barcelona | Barcelona | |
| Sweden | Carlanderska Hospital | Göteborg | |
| Sweden | Urologiska kliniken, mottagning Universitetssjukhuset Örebro | Örebro | Örebro Län |
| Lead Sponsor | Collaborator |
|---|---|
| Wellspect HealthCare |
Spain, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Compliance when practicing IC with LoFric Elle. | Used study catheter entire study period with the handle at least 10 times: Y/N. | 2 weeks | |
| Secondary | Satisfaction when practicing IC with LoFric Elle. | PRO variables (Wellspect questionnaire). | 2 weeks | |
| Secondary | Versatility as in use of the angulated handle when practicing IC with LoFric Elle. | PRO variables (Wellspect questionnaire). | 2 weeks | |
| Secondary | Perception when practicing IC with LoFric Elle. | PRO variables (Wellspect questionnaire). | 2 weeks | |
| Secondary | The catheter is perceived as slim and discreet which makes it easy to bring, store, and dispose of without obviously being a catheter. | ISC-Q domains convenience and discreetness. | 2 weeks | |
| Secondary | The catheter with or without the angulated handle has an ergonomic design which makes it easy to use. | ISC-Q domain ease of use. | 2 weeks | |
| Secondary | The catheter is perceived as ready to use. | ISC-Q question 1; it is easy to prepare my catheter for use each time I need it. | 2 weeks |