ARTUS MONO Artificial Urinary Sphincter

Feasibility of ARTUS MONO Artificial Urinary Sphincter Implant in Women

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03703843

Enrollment

Registered

2018-10-12

Start date

2018-05-23

Completion date

2018-09-26

Last updated

2018-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence,Stress

Keywords

AUS, Artificial Urinary Sphincter

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.

Interventions

DEVICEARTUS MONO

Temporarily implant and activation of the medical device

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Czechia, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026