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Completed

NCT Number: NCT03703843

ARTUS MONO Artificial Urinary Sphincter

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.

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Key information

Conditions

Urinary Incontinence,Stress Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Thomayer hospital, Prague, Czechia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARTUS MONO

Device

Temporarily implant and activation of the medical device

Primary outcomes

  1. 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

Secondary outcomes

  1. ARTUS MONO cuff implant

    Time frame: Day 0

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

  2. ARTUS MONO cuff activation

    Time frame: Day 0

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

Sponsors and collaborators

Lead sponsor

Myopowers Medical Technologies France SAS

Industry

Registry information

Official study title

Feasibility of ARTUS MONO Artificial Urinary Sphincter Implant in Women

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 12, 2018
Registry last updated
Oct 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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