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Pilot Study of the ARTUS® Artificial Urinary Sphincter on Women

NCT07641218 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-06-11

No results posted yet for this study

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.

Conditions

  • Urinary Incontinence , Stress

Interventions

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.

Sponsors & Collaborators

  • Myopowers Medical Technologies France SAS

    lead INDUSTRY

Principal Investigators

  • Nicolas Barry Delongchamps, MD, PHD · Hôpital Cochin, APHP, Université Paris Cité, Paris, France.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-03-30
Completion
2028-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07641218 on ClinicalTrials.gov