Urinary Incontinence , Stress
Conditions
Keywords
Urinary Incontinence, Artificial Urinary Sphincter, Women, Stress Urinary Incontinence
Brief summary
The subjects will be implanted with the ARTUS® medical device and then be followed up to 2 years post-implantation, with the primary endpoints measured at 3-month post-implantation. Safety and Clinical performance outcomes will be measured for each subject at baseline (before implantation) and post-implantation.
Interventions
DEVICEArtificial Urinary Sphincter ARTUS
The subjects will be implanted by the ARTUS Artificial Urinary Sphincter (AUS). The device will be activated 6 weeks after surgery and the tightening will be adjusted by the investigators in order to reach continence.
Sponsors
Myopowers Medical Technologies France SAS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The subjects will be enrolled and implanted with the ARTUS Artificial Urinary Sphincter and followed up to 2 years after implantation.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female subject over 18 years of age at the time of consent signature * Subject with persistent severe urinary incontinence: * at least 3 months after failed pelvic floor muscle training OR * at least 6 months after a failed surgical treatment (e.g. slings) * Subject with severe Stress Urinary Incontinence, defined as a mean value of 3 consecutive 24-hour Pad Weight Test \> 100 grams * Subject willing and able to provide written informed consent and having signed the informed consent * Subject having understood and accepted to be unable to proceed to an MRI examination after the surgical procedure due to the non-MRI compatibility of the device * Subject having a life expectancy ≥ 5 years as assessed by the investigator
Exclusion criteria
* Subject currently enrolled or plans to participate in another investigational study of a drug, biologic, or medical device from the point of enrolment through the 12 months post device activation period * Subject deprived of liberty by administrative or judicial decision or under legal guardianship * Subject who is unwilling or deemed by the investigator to be unwilling to comply with the clinical study requirements, including attending follow-up visits. * Subject having inadequate cognitive or capabilities to use the Artus device as assessed by the investigator * Pregnant subject, or subject willing to be pregnant during the study duration, or subject of child-bearing potential with non-stable medication contraception * Subject with urge incontinence due to hyperactive bladder not adequately controlled by drug therapy * Subject with overflow urinary incontinence * Subject with Significant Neuro-urological disorders: elevated detrusor pressure, Detrusor sphincter desinergy * Subject with history of pelvic radiotherapy * Subject with any planned procedure requiring urethral catheterization 12 months after implant procedure (include intermittent catheterization) except for diagnostic purposes * Subject with known allergy to any components of the device * Subject with history of Artificial Urinary Sphincter * Subject with severe congenital or acquired haemorrhagic disease, haemophilia, or another coagulopathy * Subject under anti-coagulation or anti-platelet medication that cannot be discontinued at least 5 days prior to surgery and restarted at least 5 days after surgery * Subject having a Body Mass Index (BMI) \> 40 * Subject with uncontrolled diabetes, defined as HbA1c \> 9.0% within the past 6 months * Subject with history of urethral fistula * Subject with history of bladder tumor * Subject with severe urethral stenosis. * Subject with currently active infection, including urinary tract infection * Subject with severe renal failure or obstructive pathologies of the upper urinary tract with severe renal failure * Subject with congenital or acquired immunodeficiency, including those who are immunocompromised or immunosuppressed * Subject with post void residual volume greater than 200 mL within the past 6 months * Subject with history of recurrent bladder stones or history of failed bladder stone treatment within the past 12 months * Subject in emergency situation (caused by a sudden life threatening or other sudden serious medical condition including but not limited to heart attack, stroke, coma, epileptic seizure, heavy bleeding, severe pain, trouble breathing…)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Device Effect Incidence | 3 months after implantation | all adverse device effects (device and/or procedure related) occurring from the implantation up to the 3 months post-operative visit, with their occurrence, severity, and nature. These events will be analyzed and classified using the Clavien-Dindo classification grading system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events Incidence | Day 30, 3 months, 6 months, 12 months and 24 months after implantation | all adverse events (including adverse device effect) occurring peri-operatively, 30 days after implantation and at 3, 6, 12 and 24-months post-operative with their occurrence, severity, and nature. All adverse events will be analyzed and classified using the Clavien-Dindo classification grading system |
| Revision Rate | 30 days, 3 months, 6 months, 12 months and 24 months after implantation | Proportion of subjects with a revision of the Artificial Urinary Sphincter |
| Explantation Rate | Day 30, 3 months, 6 months, 12 months and 24 months after implantation | Proportion of subjects with a definitive explantation of the Artificial Urinary Sphincter |
| Evolution of Renal Function | Baseline, Day 1 | Measure of the serum creatinine |
| Evolution of the pain | Day 1, Day 45, 3 months, 6 months, 12 months and 24 months after implantation | Measure of the pain using a 10-point numerical scale (from 0 no pain to 10 the maximum pain) |
| Evolution of uroflowmetry | Baseline, 3 months after implantation | measure of the voided urine per unit of time, the voided volume and the maximum flow rate |
| Bladder Drainage | Baseline, Day 1, 3 months, 6 months, 12 months and 24 months after implantation | measure of the post-void residual volume |
| Device Deficiency | Implantation, Day 1, Day 45, 3 months, 6 months, 12 months, 24 months after implantation | Number of device deficiencies |
| Pad Weight Test | Baseline, 3 months, 6 months, 12 months and 24 months after implantation | Measure of the daily urine loss in pads during 3 consecutive days |
| Pads Usage | Baseline, Day 45, 3 months, 6 months, 12 months and 24 months after -implantation | Number of pads used per day |
| Evolution of Stress Urinary Symptoms | Baseline, 3 months, 6 months, 12 months and 24 months after implantation | Evolution of the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF). The score ranges from 0 (no impact) to 21 (maximal impact). |
| Evolution of Urinary Symptoms | Baseline, 3 months, 6 months, 12 months, 24 months after implantation | Evolution of the Urinary Symptom Profile (USP). The score ranges from 0 (no symptom) to 9 (maximal symptoms) for the subscore linked to the Stress Urinary Incontinence; from 0 (no symptom) to 21 (maximal symptoms) for the subscore linked to the overactive bladder; from 0 (no symptom) to 9 (maximal symptoms) for the subscore linked to the dysuria. |
Countries
France
Contacts
CONTACTJean-Christophe PERLES
CONTACTFederica Azzimonti
PRINCIPAL_INVESTIGATORNicolas Barry Delongchamps, MD, PHD
Hôpital Cochin, APHP, Université Paris Cité, Paris, France.
Outcome results
None listed