An interventional study of Artificial Urinary Sphincter ARTUS in Urinary Incontinence , Stress, sponsored by Myopowers Medical Technologies France SAS. Not yet recruiting at 2 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Myopowers Medical Technologies France SAS · Not applicable, Interventional, and Treatment
Among 35 studies in Urinary Incontinence, Stress with a site in France — 4 open to participants now, 10 under way, none of them phase 3. Urinary Incontinence, Stress · France.
Among the 35 studies in Urinary Incontinence, Stress with a site in France, this one is the 21st largest by planned enrollment of the 25 interventional ones that give a count, is the only one that started in 2026, is one of 18 with no phase, and was the 35th registered.
653 studies on the registry are indexed under Urinary Incontinence, Stress; 121 are open to participants now.
Browse Urinary Incontinence, Stress studies →4 of the 35 studies in Urinary Incontinence, Stress with a site in France are open now. Recruiting first, the newest first:
Ethicon, Inc. · Sites in France, United States, Austria and 4 more countries
Ages 21+ · Women only
Uromedica · Sites in France, United States
Ages 22+ · Women only
Coloplast A/S · Sites in France, Italy
Ages 18+ · Men only
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 74 Urinary Incontinence, Stress studies recruiting now, 42 (57%) set no upper age limit and 18 (24%) stop at 75 or younger; 2 take children under 18; 16 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
35 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 6 is below the median of 68 across 508 interventional studies indexed under Urinary Incontinence, Stress.
Median enrollment 88 across the 25 interventional studies, 189 across the 10 observational. Of the 21 that completed or were terminated, 3 (14%) have results posted.
This tab as a report to print or save as PDF → With an account.
20 of 35 have an industry lead sponsor. The 10 most frequent:
Myopowers Medical Technologies France SAS is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Myopowers Medical Technologies France SAS has 3 studies filed under Urinary Incontinence, Stress — fewer than ten, so there is no comparison to draw.
3 of the studies in Urinary Incontinence, Stress with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06968741UroMems SASA Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS) | 2026-12 |
| NCT07641218Myopowers Medical Technologies France SASPilot Study of the ARTUS® Artificial Urinary Sphincter on Women | 2027-03-30 |
| NCT04248283UromedicaAdjustable Continence Therapy (ACT) for the Treatment of Female SUI | 2027-05-31 |
Add all 3 to your calendar (.ics) → With an account.
Among the 35 studies in Urinary Incontinence, Stress with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subject with persistent severe urinary incontinence:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The subjects will be implanted with the ARTUS Artificial Urinary Sphincter to treat Stress Urinary Incontinence
Device: Artificial Urinary Sphincter ARTUS
The subjects will be implanted by the ARTUS Artificial Urinary Sphincter (AUS). The device will be activated 6 weeks after surgery and the tightening will be adjusted by the investigators in order to reach continence.
Adverse Device Effect Incidence
all adverse device effects (device and/or procedure related) occurring from the implantation up to the 3 months post-operative visit, with their occurrence, severity, and nature. These events will be analyzed and classified using the Clavien-Dindo classification grading system.
Time frame: 3 months after implantation
Adverse Events Incidence
all adverse events (including adverse device effect) occurring peri-operatively, 30 days after implantation and at 3, 6, 12 and 24-months post-operative with their occurrence, severity, and nature. All adverse events will be analyzed and classified using the Clavien-Dindo classification grading system
Time frame: Day 30, 3 months, 6 months, 12 months and 24 months after implantation
Revision Rate
Proportion of subjects with a revision of the Artificial Urinary Sphincter
Time frame: 30 days, 3 months, 6 months, 12 months and 24 months after implantation
Explantation Rate
Proportion of subjects with a definitive explantation of the Artificial Urinary Sphincter
Time frame: Day 30, 3 months, 6 months, 12 months and 24 months after implantation
Evolution of Renal Function
Measure of the serum creatinine
Time frame: Baseline, Day 1
Evolution of the pain
Measure of the pain using a 10-point numerical scale (from 0 no pain to 10 the maximum pain)
Time frame: Day 1, Day 45, 3 months, 6 months, 12 months and 24 months after implantation
Evolution of uroflowmetry
measure of the voided urine per unit of time, the voided volume and the maximum flow rate
Time frame: Baseline, 3 months after implantation
Bladder Drainage
measure of the post-void residual volume
Time frame: Baseline, Day 1, 3 months, 6 months, 12 months and 24 months after implantation
Device Deficiency
Number of device deficiencies
Time frame: Implantation, Day 1, Day 45, 3 months, 6 months, 12 months, 24 months after implantation
Pad Weight Test
Measure of the daily urine loss in pads during 3 consecutive days
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months after implantation
Pads Usage
Number of pads used per day
Time frame: Baseline, Day 45, 3 months, 6 months, 12 months and 24 months after -implantation
Evolution of Stress Urinary Symptoms
Evolution of the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF). The score ranges from 0 (no impact) to 21 (maximal impact).
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months after implantation
Evolution of Urinary Symptoms
Evolution of the Urinary Symptom Profile (USP). The score ranges from 0 (no symptom) to 9 (maximal symptoms) for the subscore linked to the Stress Urinary Incontinence; from 0 (no symptom) to 21 (maximal symptoms) for the subscore linked to the overactive bladder; from 0 (no symptom) to 9 (maximal symptoms) for the subscore linked to the dysuria.
Time frame: Baseline, 3 months, 6 months, 12 months, 24 months after implantation
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Mar 2027, 9 months later.
Of 41 industry-sponsored interventional studies with no phase under Urinary Incontinence, Stress, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 46. This study's planned 9 months is below that.
Counting every sponsor, half of 267 studies reached it within 19 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Urinary Incontinence, Stress →
Myopowers Medical Technologies France SAS