NCT03703843

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 12, 2018

Completed
Last Updated

October 19, 2018

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

May 25, 2018

Last Update Submit

October 18, 2018

Conditions

Urinary Incontinence,Stress

Keywords

AUSArtificial Urinary Sphincter

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • ARTUS MONO cuff implant

    Day 0

  • ARTUS MONO cuff activation

    Day 0

Study Arms (1)

Active

EXPERIMENTAL

ARTUS MONO

Device: ARTUS MONO

Interventions

ARTUS MONODEVICE

Temporarily implant and activation of the medical device

Active

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • History of connectivitis disease
  • Immunosuppressive therapy in the last 3 months
  • Vulnerable subjects
  • Participation in any other clinical investigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Thomayer hospital

Prague, Czechia

Location

Cochin Hospital

Paris, 75014, France

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nicolas BARRY DELONGCHAMPS, PR

    Hôpital Cochin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2018

First Posted

October 12, 2018

Study Start

May 23, 2018

Primary Completion

September 26, 2018

Study Completion

September 26, 2018

Last Updated

October 19, 2018

Record last verified: 2018-10

Locations

FR(1)CZ(1)