ARTUS MONO Artificial Urinary Sphincter

Not Applicable

Completed

• Conditions: Urinary Incontinence,Stress
• Interventions: Device: ARTUS MONO

• Registration Number: NCT03703843
• Lead Sponsor: Myopowers Medical Technologies France SAS

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-23
• Study First Submitted: 2018-05-25
• Primary Completion: 2018-09-26
• Study Completion: 2018-09-26
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-09
• Study First Posted: 2018-10-12
• Last Update Submitted: 2018-10-18
• Last Update Posted: 2018-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active	ARTUS MONO	ARTUS MONO

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Thomayer hospital; 🇨🇿 Prague, Czechia

Cochin Hospital; 🇫🇷 Paris, France