Pilot Study of the ARTUS® Artificial Urinary Sphincter on Women (SPHIN-X)

June 8, 2026 updated by: Myopowers Medical Technologies France SAS

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 contraception
  • Subject with urge incontinence due to hyperactive bladder not adequately controlled by drug therapy
  • 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…)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ARTUS
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months after implantation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse Events Incidence
Time Frame: Day 30, 3 months, 6 months, 12 months and 24 months after implantation
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
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
Proportion of subjects with a revision of the Artificial Urinary Sphincter
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
Proportion of subjects with a definitive explantation of the Artificial Urinary Sphincter
Day 30, 3 months, 6 months, 12 months and 24 months after implantation
Evolution of Renal Function
Time Frame: Baseline, Day 1
Measure of the serum creatinine
Baseline, Day 1
Evolution of the pain
Time Frame: Day 1, Day 45, 3 months, 6 months, 12 months and 24 months after implantation
Measure of the pain using a 10-point numerical scale (from 0 no pain to 10 the maximum pain)
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
measure of the voided urine per unit of time, the voided volume and the maximum flow rate
Baseline, 3 months after implantation
Bladder Drainage
Time Frame: Baseline, Day 1, 3 months, 6 months, 12 months and 24 months after implantation
measure of the post-void residual volume
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
Number of device deficiencies
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
Measure of the daily urine loss in pads during 3 consecutive days
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
Number of pads used per day
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 the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF). The score ranges from 0 (no impact) to 21 (maximal impact).
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
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.
Baseline, 3 months, 6 months, 12 months, 24 months after implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Myopowers Medical Technologies France SAS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicolas Barry Delongchamps, MD, PHD, Hôpital Cochin, APHP, Université Paris Cité, Paris, France.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPHIN-X
  • 2025-A00257-42 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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