Evaluation of a New Female Urinary Intermittent Catheter (NCT04304599) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of a New Female Urinary Intermittent Catheter
Spain, Sweden20 participantsStarted 2020-03-13
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary objective of this study is to evaluate the subjects' Quality of Life when practicing IC using LoFric Elle catheters.