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
2 other identifiers
interventional
6
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2026
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 11, 2026
CompletedStudy Start
First participant enrolled
June 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
June 11, 2026
June 1, 2026
9 months
June 1, 2026
June 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (12)
Adverse Events Incidence
Day 30, 3 months, 6 months, 12 months and 24 months after implantation
Revision Rate
30 days, 3 months, 6 months, 12 months and 24 months after implantation
Explantation Rate
Day 30, 3 months, 6 months, 12 months and 24 months after implantation
Evolution of Renal Function
Baseline, Day 1
Evolution of the pain
Day 1, Day 45, 3 months, 6 months, 12 months and 24 months after implantation
- +7 more secondary outcomes
Study Arms (1)
ARTUS
EXPERIMENTALThe subjects will be implanted with the ARTUS Artificial Urinary Sphincter to treat Stress Urinary Incontinence
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cochin Hospital, APHP
Paris, France
Tenon Hospital, APHP
Paris, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas Barry Delongchamps, MD, PHD
Hôpital Cochin, APHP, Université Paris Cité, Paris, France.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2026
First Posted
June 11, 2026
Study Start
June 30, 2026
Primary Completion (Estimated)
March 30, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
June 11, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share