Pilot Study of the ARTUS® Artificial Urinary Sphincter on Women (NCT07641218) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pilot Study of the ARTUS® Artificial Urinary Sphincter on Women
France6 participantsStarted 2026-06-30
Plain-language summary
The subjects will be implanted with the ARTUS® medical device and then be followed up to 2 years post-implantation, with the primary endpoints measured at 3-month post-implantation. Safety and Clinical performance outcomes will be measured for each subject at baseline (before implantation) and post-implantation.
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:
* Female subject over 18 years of age at the time of consent signature
* Subject with persistent severe urinary incontinence:
* at least 3 months after failed pelvic floor muscle training OR
* at least 6 months after a failed surgical treatment (e.g. slings)
* Subject with severe Stress Urinary Incontinence, defined as a mean value of 3 consecutive 24-hour Pad Weight Test \> 100 grams
* Subject willing and able to provide written informed consent and having signed the informed consent
* Subject having understood and accepted to be unable to proceed to an MRI examination after the surgical procedure due to the non-MRI compatibility of the device
* Subject having a life expectancy ≥ 5 years as assessed by the investigator
Exclusion Criteria:
* Subject currently enrolled or plans to participate in another investigational study of a drug, biologic, or medical device from the point of enrolment through the 12 months post device activation period
* Subject deprived of liberty by administrative or judicial decision or under legal guardianship
* Subject who is unwilling or deemed by the investigator to be unwilling to comply with the clinical study requirements, including attending follow-up visits.
* Subject having inadequate cognitive or capabilities to use the Artus device as assessed by the investigator
* Pregnant subject, or subject willing to be pregnant during the study duration, or subject of child-bearing potential with non-stable medication contr…
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.