Urinary Incontinence , StressSPHIN-XNCT07641218
Pilot Study of the ARTUS® Artificial Urinary Sphincter on Women
A study testing Artificial Urinary Sphincter ARTUS in people with Urinary Incontinence , Stress, run by Myopowers Medical Technologies France SAS at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence , Stress
- What is being tested?
- Artificial Urinary Sphincter ARTUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Jun 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 contraception
- Subject with urge incontinence due to hyperactive bladder not adequately controlled by drug therapy
Show all 25Show fewer
- Subject with overflow urinary incontinence
- Subject with Significant Neuro-urological disorders: elevated detrusor pressure, Detrusor sphincter desinergy
- Subject with history of pelvic radiotherapy
- Subject with any planned procedure requiring urethral catheterization 12 months after implant procedure (include intermittent catheterization) except for diagnostic purposes
- Subject with known allergy to any components of the device
- Subject with history of Artificial Urinary Sphincter
- Subject with severe congenital or acquired haemorrhagic disease, haemophilia, or another coagulopathy
- Subject under anti-coagulation or anti-platelet medication that cannot be discontinued at least 5 days prior to surgery and restarted at least 5 days after surgery
- Subject having a Body Mass Index (BMI) > 40
- Subject with uncontrolled diabetes, defined as HbA1c > 9.0% within the past 6 months
- Subject with history of urethral fistula
- Subject with history of bladder tumor
- Subject with severe urethral stenosis.
- Subject with currently active infection, including urinary tract infection
- Subject with severe renal failure or obstructive pathologies of the upper urinary tract with severe renal failure
- Subject with congenital or acquired immunodeficiency, including those who are immunocompromised or immunosuppressed
- Subject with post void residual volume greater than 200 mL within the past 6 months
- Subject with history of recurrent bladder stones or history of failed bladder stone treatment within the past 12 months
- Subject in emergency situation (caused by a sudden life threatening or other sudden serious medical condition including but not limited to heart attack, stroke, coma, epileptic seizure, heavy bleeding, severe pain, trouble breathing…)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Federica Azzimonti contact
France2 sites
Cochin Hospital, APHP
Paris
Nicolas Barry Delonghchamps, MD, PHD, +33 1 58 41 27 83, nicolas.barry-delongchamps@aphp.fr
Tenon Hospital, APHP
Paris
Véronique Phé, MD, PHD, +33 01 56 01 70 00, veronique.phe@aphp.fr
About this study
Official title: Pilot Clinical Investigation of the ARTUS® Artificial Urinary SPHincter (AUS) for the Treatment of Stress UrInary iNcontinence (SUI) in Women
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.
- Conditions
- Urinary Incontinence , Stress
- Being tested
- Artificial Urinary Sphincter ARTUS
- Keywords
- Urinary Incontinence, Artificial Urinary Sphincter, Women, Stress Urinary Incontinence
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Urinary Sphincter ARTUSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ARTUS | Experimental | The subjects will be implanted with the ARTUS Artificial Urinary Sphincter to treat Stress Urinary Incontinence Receives: Device: Artificial Urinary Sphincter ARTUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after implantation
Secondary outcomes (12)
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
Measured: 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
Measured: 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
Measured: Day 30, 3 months, 6 months, 12 months and 24 months after implantation
Evolution of Renal Function
Measure of the serum creatinine
Measured: 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)
Measured: 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
Measured: Baseline, 3 months after implantation
Bladder Drainage
measure of the post-void residual volume
Measured: Baseline, Day 1, 3 months, 6 months, 12 months and 24 months after implantation
Device Deficiency
Number of device deficiencies
Measured: 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
Measured: Baseline, 3 months, 6 months, 12 months and 24 months after implantation
Pads Usage
Number of pads used per day
Measured: 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).
Measured: 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.
Measured: Baseline, 3 months, 6 months, 12 months, 24 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence , StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The subjects will be enrolled and implanted with the ARTUS Artificial Urinary Sphincter and followed up to 2 years after implantation.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myopowers Medical Technologies France SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolas Barry Delongchamps, MD, PHD, Principal investigator, Hôpital Cochin, APHP, Université Paris Cité, Paris, France.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641218
- Sponsor's protocol ID
- SPHIN-X
- Other IDs
- 2025-A00257-42
- Acronym
- SPHIN-X
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Investigation of the ARTUS® Artificial Urinary SPHincter (AUS) for the Treatment of Stress UrInary iNcontinence (SUI) in Women
- ClinicalTrials.gov ID
- NCT07641218
- Acronym / sponsor ID
- SPHIN-X / SPHIN-X
- Conditions
- Urinary Incontinence , Stress
- Keywords
- Urinary Incontinence, Artificial Urinary Sphincter, Women, Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Myopowers Medical Technologies France SASIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The subjects will be enrolled and implanted with the ARTUS Artificial Urinary Sphincter and followed up to 2 years after implantation.
| Arm | Type | Receives |
|---|---|---|
| ARTUS | Experimental | Device: Artificial Urinary Sphincter ARTUSThe subjects will be implanted with the ARTUS Artificial Urinary Sphincter to treat Stress Urinary Incontinence |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female subject over 18 years of age at the time of consent signature
- Subject with persistent severe urinary incontinence:
- 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
Key exclusion criteria (25 listed)
- 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 contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial Urinary Sphincter ARTUSThe 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. | Device | ARTUS |
Primary outcome
Adverse Device Effect Incidence
Time frame: 3 months after implantation
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.
12 secondary outcomes
Adverse Events Incidence
Time frame: Day 30, 3 months, 6 months, 12 months and 24 months after implantation
Revision Rate
Time frame: 30 days, 3 months, 6 months, 12 months and 24 months after implantation
Explantation Rate
Time frame: Day 30, 3 months, 6 months, 12 months and 24 months after implantation
Evolution of Renal Function
Time frame: Baseline, Day 1
Evolution of the pain
Time frame: Day 1, Day 45, 3 months, 6 months, 12 months and 24 months after implantation
Evolution of uroflowmetry
Time frame: Baseline, 3 months after implantation
Bladder Drainage
Time frame: Baseline, Day 1, 3 months, 6 months, 12 months and 24 months after implantation
Device Deficiency
Time frame: Implantation, Day 1, Day 45, 3 months, 6 months, 12 months, 24 months after implantation
Pad Weight Test
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months after implantation
Pads Usage
Time frame: Baseline, Day 45, 3 months, 6 months, 12 months and 24 months after -implantation
Evolution of Stress Urinary Symptoms
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months after implantation
Evolution of Urinary Symptoms
Time frame: Baseline, 3 months, 6 months, 12 months, 24 months after implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Federica Azzimonti contact
Nicolas Barry Delongchamps, MD, PHD principal investigator
Hôpital Cochin, APHP, Université Paris Cité, Paris, France.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Urinary Sphincter ARTUS in people with Urinary Incontinence , Stress, run by Myopowers Medical Technologies France SAS at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Christophe PERLES (+33 04 42 95 12 20, jcperles@carvolix.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Device Effect Incidence (time frame: 3 months after implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.