ARTUS MONO Artificial Urinary Sphincter

Feasibility of ARTUS MONO Artificial Urinary Sphincter Implant in Women

The ARTUS MONO implant is an active implantable medical device (AIMD) that assist the urethral sphincter function of female patients suffering from moderate to severe urinary incontinence, by remotely opening and closing a cuff placed around the bladder neck. The purpose of this clinical investigation is to evaluate the feasibility of implantation of the device, its safety and its efficacy, when temporarily implanted in female patients scheduled for anterior pelvic exenteration for bladder cancer.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence,Stress
• Intervention / Treatment: Device: ARTUS MONO

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia
    • Thomayer Hospital
• France
  • Paris, France, 75014
    • Cochin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Female patients aged ≥ 18 yo
2. BMI > 18,5 and < 35
3. Patient scheduled for an anterior pelvic exenteration with ileal conduit urinary diversion
4. Signed informed consent

Exclusion Criteria:

1. Advanced bladder cancer with bladder neck and/or urethral extension
2. Past pelvic radiation therapy
3. Patient previously treated with an artificial urinary sphincter or other urogenital implant
4. Positive urine culture during the past 2 weeks
5. Indwelling bladder catheter during the past 2 weeks
6. Documented history of sensitivity to silicone
7. History of connectivitis disease
8. Immunosuppressive therapy in the last 3 months
9. Vulnerable subjects
10. Participation in any other clinical investigation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• 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: Active; ARTUS MONO	Device: ARTUS MONO; Temporarily implant and activation of the medical device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bladder catheterization in presence of ARTUS MONO cuff	Injection then re-aspiration of 50 cc of saline water through 18 Fr Foley catheter	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ARTUS MONO cuff implant	Visual analogic scale (from worst to best imaginable easiness and safety)	Day 0
ARTUS MONO cuff activation	Cuff closing to reach 10, 20 and 30% of urethral perimeter reduction	Day 0

Collaborators and Investigators

• Sponsor: Myopowers Medical Technologies France SAS
• Investigators: Principal Investigator: Nicolas BARRY DELONGCHAMPS, PR, Hôpital Cochin

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2018
• Primary Completion (Actual): September 26, 2018
• Study Completion (Actual): September 26, 2018

Study Registration Dates

• First Submitted: May 25, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2018
• Last Update Submitted That Met QC Criteria: October 18, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: AUS; Artificial Urinary Sphincter
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: ARTUS00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No