ARTUS MONO Artificial Urinary Sphincter

Urinary Incontinence,Stress Clinical Trial

Official title:

Feasibility of ARTUS MONO Artificial Urinary Sphincter Implant in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03703843
• Other study ID #: ARTUS00
• Status: Completed
• Phase: N/A
• Start date: May 23, 2018
• Est. completion date: September 26, 2018

Study information

• Verified date: October 2018
• Source: Myopowers Medical Technologies France SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: September 26, 2018
• Est. primary completion date: September 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence,Stress

Intervention

Device:
• ARTUS MONO
Temporarily implant and activation of the medical device

Locations

Country	Name	City	State
Czechia	Thomayer hospital	Prague
France	Cochin Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Myopowers Medical Technologies France SAS

Countries where clinical trial is conducted

Czechia,  France, 

Outcome

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