search
Back to results

ARTUS MONO Artificial Urinary Sphincter

Primary Purpose

Urinary Incontinence,Stress

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ARTUS MONO
Sponsored by
Myopowers Medical Technologies France SAS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Urinary Incontinence,Stress focused on measuring AUS, Artificial Urinary Sphincter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Thomayer hospital
  • Cochin Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active

Arm Description

ARTUS MONO

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 25, 2018
Last Updated
October 18, 2018
Sponsor
Myopowers Medical Technologies France SAS
search

1. Study Identification

Unique Protocol Identification Number
NCT03703843
Brief Title
ARTUS MONO Artificial Urinary Sphincter
Official Title
Feasibility of ARTUS MONO Artificial Urinary Sphincter Implant in Women
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
May 23, 2018 (Actual)
Primary Completion Date
September 26, 2018 (Actual)
Study Completion Date
September 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Myopowers Medical Technologies France SAS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence,Stress
Keywords
AUS, Artificial Urinary Sphincter

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
ARTUS MONO
Intervention Type
Device
Intervention Name(s)
ARTUS MONO
Intervention Description
Temporarily implant and activation of the medical device
Primary Outcome Measure Information:
Title
Bladder catheterization in presence of ARTUS MONO cuff
Description
Injection then re-aspiration of 50 cc of saline water through 18 Fr Foley catheter
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
ARTUS MONO cuff implant
Description
Visual analogic scale (from worst to best imaginable easiness and safety)
Time Frame
Day 0
Title
ARTUS MONO cuff activation
Description
Cuff closing to reach 10, 20 and 30% of urethral perimeter reduction
Time Frame
Day 0

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas BARRY DELONGCHAMPS, PR
Organizational Affiliation
Hôpital Cochin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomayer hospital
City
Prague
Country
Czechia
Facility Name
Cochin Hospital
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

ARTUS MONO Artificial Urinary Sphincter

We'll reach out to this number within 24 hrs