ARTUS MONO Artificial Urinary Sphincter

Myopowers Medical Technologies France SAS3 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Urinary Incontinence,Stress

Interventions

ARTUS MONODEVICE

Temporarily implant and activation of the medical device

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Thomayer hospital

Prague, Czechia

Cochin Hospital

Paris, France

Outcomes

Primary Outcomes

Bladder catheterization in presence of ARTUS MONO cuff

Injection then re-aspiration of 50 cc of saline water through 18 Fr Foley catheter

Time frame: Day 0

Secondary Outcomes

ARTUS MONO cuff implant

Visual analogic scale (from worst to best imaginable easiness and safety)

Time frame: Day 0

ARTUS MONO cuff activation

Cuff closing to reach 10, 20 and 30% of urethral perimeter reduction

Time frame: Day 0

Data from ClinicalTrials.gov

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