Urinary Incontinence,StressNCT03703843
ARTUS MONO Artificial Urinary Sphincter
A study testing ARTUS MONO in people with Urinary Incontinence,Stress, run by Myopowers Medical Technologies France SAS at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence,Stress
- What is being tested?
- ARTUS MONO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 May 2018to 26 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female patients aged ≥ 18 yo
- BMI > 18,5 and < 35
- Patient scheduled for an anterior pelvic exenteration with ileal conduit urinary diversion
- Signed informed consent
Who cannot join
- Advanced bladder cancer with bladder neck and/or urethral extension
- Past pelvic radiation therapy
- Patient previously treated with an artificial urinary sphincter or other urogenital implant
- Positive urine culture during the past 2 weeks
- Indwelling bladder catheter during the past 2 weeks
- Documented history of sensitivity to silicone
Show all 10Show fewer
- History of connectivitis disease
- Immunosuppressive therapy in the last 3 months
- Vulnerable subjects
- Participation in any other clinical investigation
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
- Conditions
- Urinary Incontinence,Stress
- Being tested
- ARTUS MONO
- Keywords
- AUS, Artificial Urinary Sphincter
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTUS MONODevice
Temporarily implant and activation of the medical device
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | ARTUS MONO Receives: Device: ARTUS MONO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder catheterization in presence of ARTUS MONO cuff
Injection then re-aspiration of 50 cc of saline water through 18 Fr Foley catheter
Measured: Day 0
Secondary outcomes (2)
ARTUS MONO cuff implant
Visual analogic scale (from worst to best imaginable easiness and safety)
Measured: Day 0
ARTUS MONO cuff activation
Cuff closing to reach 10, 20 and 30% of urethral perimeter reduction
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start23 May 2018
- Primary completion26 Sep 2018
- Study completion26 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence,StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myopowers Medical Technologies France SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolas BARRY DELONGCHAMPS, PR, Principal investigator, Hôpital Cochin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703843
- Sponsor's protocol ID
- ARTUS00
- Status last verified
- Oct 2018
- First submitted
- 25 May 2018
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of ARTUS MONO Artificial Urinary Sphincter Implant in Women
- ClinicalTrials.gov ID
- NCT03703843
- Acronym / sponsor ID
- ARTUS00
- Conditions
- Urinary Incontinence,Stress
- Keywords
- AUS, Artificial Urinary Sphincter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Myopowers Medical Technologies France SASIndustry (pharma, biotech, devices)
- Study start
- 23 May 2018 (actual)
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 26 Sep 2018 (actual)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: ARTUS MONOARTUS MONO |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients aged ≥ 18 yo
- BMI > 18,5 and < 35
- Patient scheduled for an anterior pelvic exenteration with ileal conduit urinary diversion
- Signed informed consent
Key exclusion criteria (10 listed)
- Advanced bladder cancer with bladder neck and/or urethral extension
- Past pelvic radiation therapy
- Patient previously treated with an artificial urinary sphincter or other urogenital implant
- Positive urine culture during the past 2 weeks
- Indwelling bladder catheter during the past 2 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARTUS MONOTemporarily implant and activation of the medical device | Device | Active |
Primary outcome
Bladder catheterization in presence of ARTUS MONO cuff
Time frame: Day 0
Injection then re-aspiration of 50 cc of saline water through 18 Fr Foley catheter
2 secondary outcomes
ARTUS MONO cuff implant
Time frame: Day 0
ARTUS MONO cuff activation
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas BARRY DELONGCHAMPS, PR principal investigator
Hôpital Cochin
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARTUS MONO in people with Urinary Incontinence,Stress, run by Myopowers Medical Technologies France SAS at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder catheterization in presence of ARTUS MONO cuff (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2018; AzTrials last refreshed its copy on 29 Oct 2026.