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

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: Not yet recruiting
• Conditions: Urinary Incontinence , Stress
• Intervention / Treatment: Device: Artificial Urinary Sphincter ARTUS

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Christophe PERLES; Phone Number: +33 04 42 95 12 20; Email: jcperles@carvolix.eu
• Study Contact Backup: Name: Federica Azzimonti; Email: federica.azzimonti@carvolix.eu

Study Locations

• France
  • Paris, France
    • Cochin Hospital, APHP
    • Contact: Nicolas Barry Delonghchamps, MD, PHD; Phone Number: +33 1 58 41 27 83; Email: nicolas.barry-delongchamps@aphp.fr
  • Paris, France
    • Tenon Hospital, APHP
    • Contact: Véronique Phé, MD, PHD; Phone Number: +33 01 56 01 70 00; Email: veronique.phe@aphp.fr

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	3 months after implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	Day 30, 3 months, 6 months, 12 months and 24 months after implantation
Evolution of Renal Function	Measure of the serum creatinine	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)	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	Baseline, 3 months after implantation
Bladder Drainage	measure of the post-void residual volume	Baseline, Day 1, 3 months, 6 months, 12 months and 24 months after implantation
Device Deficiency	Number of device deficiencies	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	Baseline, 3 months, 6 months, 12 months and 24 months after implantation
Pads Usage	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	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	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

• Sponsor: Myopowers Medical Technologies France SAS
• Investigators: Principal Investigator: Nicolas Barry Delongchamps, MD, PHD, Hôpital Cochin, APHP, Université Paris Cité, Paris, France.

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Women; Stress Urinary Incontinence; Urinary Incontinence; Artificial Urinary Sphincter
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence; Urinary Incontinence, Stress; Surgical Equipment; Equipment and Supplies; Prostheses and Implants; Artificial Organs; Urinary Sphincter, Artificial
• Other Study ID 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