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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-CZ-22-01-038768 | Other Identifier | EUDAMED |
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| Name | Class |
|---|---|
| EVAMED | OTHER |
| Affluent Medical | INDUSTRY |
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This clinical investigation is designed as an interventional, prospective, non-randomized, open-label, single arm, multicentric and international study for obtaining CE marking.
The study will be the first performed with the ARTUS® medical device aiming to assess safety and performance and will be composed of three phases:
The objectives is to assess safety and clinical performance of the ARTUS® for the treatment of Stress Urinary Incontinence at short and long-term.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARTUS® | Experimental | The subjects will be implanted with the experimental medical device ARTUS® Artificial Urinary Sphincter (AUS) during the surgical procedure and will be trained to the use of the Remote Control to control themselves the micturition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Urinary Sphincter implantation | Device | Device preparation (recharge, settings, pairing) Patient preparation Calibration procedure (to verify the device is in full working prior to implantation) Implantation procedure which includes:
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the 24-hour Pad Weight Test | Proportion of subjects with at least 50% reduction in 24-hour Pad Weight Test at 3 months post-device activation compared to baseline. | 3 months post-device activation |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (including adverse device effect) occurred from the implantation to the 10-year follow-up period | All adverse events (including adverse device effect) occurred from the implantation to the 10-year follow-up period, with their occurrence, severity and nature. All adverse events will be analysed and classified using the Clavien-Dindo classification grading system | Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Phrakorhnkham | Contact | +33 (0)4 42 95 12 20 | david.phrakornkham@affluentmedical.com | |
| Anne-Claire Thieulin | Contact | +33 (0)2 31 93 21 18 | anne-claire.thieulin@evamed.fr |
| Name | Affiliation | Role |
|---|---|---|
| Roman Zachoval, Pr | Thomayerova nemocnice | Principal Investigator |
| Marion Melot | Myopowers Medical Technologies France SAS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomayer hospital | Prague | Czechia | ||||
| Hospital Germans Trias i Pujol |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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The subjects will be implanted with the ARTUS® medical device and then be followed up for 10 years post-implant, with the primary endpoints measured at 3-month post-device activation visit.
As there is no comparator, there is no randomization and no blinding in the study.
Clinical performance outcomes will be measured for each subject at baseline (before implantation) and post-implantation.
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|
| Revision rate | Proportion of subjects who have been concerned with a revision between the implantation and each visit (or scheduled visit date), until the 10-year follow-up period | Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op |
| Explantation rate | Proportion of subjects who have been concerned with an explantation of the medical device between the implantation and each visit (or scheduled visit date), until the 10-year follow-up period | Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op |
| Renal function | Assessed using the serum creatinine | Baseline, Implantation, discharge, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op |
| Pain assessed by numeric rating scale | Pain assessed using a 10-point numeric rating scale where 0 is no pain and 10 is the worst pain imaginable | Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op |
| Voided urine assessed with uroflowmetry | Voided urine assessed with uroflowmetry per unit of time (mL/s) | Baseline, 3, 6 and 12-month post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op |
| Voided volume assessed with uroflowmetry | Voided volume assessed with uroflowmetry in mL and maximum flow rate (Qmax) | Baseline, 3, 6 and 12-month post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op |
| Maximum flow rate assessed with uroflowmetry | Maximum flow rate assessed with uroflowmetry (Qmax) | Baseline, 3, 6 and 12-month post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op |
| Bladder drainage | Assessed using post-void residual volume | Baseline, 3, 6 and 12-month post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op |
| Usability assessed by a 5-point scale | Usability assessed by a 5-point scale from 1 (strongly agree) to 5 (strongly disagree) | Implantation |
| Device deficiencies occurred from the implantation to the 10-year follow-up period | Device deficiencies occurred from the implantation to the 10-year follow-up period with their occurrence and nature. | Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op |
| Change in the 24-hour Pad Weight Test | 24-hour Pad Weight Test | Baseline, 3, 6 and 12-month post-device activation |
| Reduction in the 24-hour Pad Weight Test | Proportion of subjects with at least 50% reduction in 24-hour Pad Weight Test | Baseline, 6 and 12-month post-device activation |
| Pad Usage | Number of pads/day | Baseline, 3, 6, and 12-month post-device activation visit,2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op |
| Urinary symptoms assessed with ICIQ-MLUTS subscales | Urinary symptoms assessed with ICIQ-MLUTS subscales :
| Baseline, 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op |
| Urinary incontinence Quality of Life assessed with ICIQ-LUTSQoL questionnaire | Urinary incontinence Quality of Life assessed with ICIQ-LUTSQoL questionnaire score from 19 to 76 with greater values indicating increased impact on quality of life | Baseline, 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op |
| General Quality of Life assessed with EQ-5D-5L questionnaire | The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) of 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. | Baseline, 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op |
| Sexual Quality of Life assessed with the Male Sexual Health Questionnaire (MHSQ) | The MSHQ is a 25-item self-administered questionnaire. It encompasses 3 scales: Erection scale (3 items), Ejaculation scale (7 items), Satisfaction scale (6 items), and 9 additional items addressing sexual activity, time since last sexual encounter, level and changes in sexual activity, and bother associated with sexual dysfunction. Response options consist of dichotomous (Yes/No) scales, as well as 5 and 6- point likert scales. Scores by dimension:
| Baseline, 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op |
| Subject usability assessed by a 5-point scale | Subject usability questionnaire completed by the subject from 1 (strongly agree) to 5 (strongly disagree) | 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op |
| Subject satisfaction assessed by the PGI-I | Subject satisfaction assessed by the PGI-I questionnaire which includes a unique 7-point scale to describe how the post-operative condition is now, compared with how it was before the surgery and where 1 = Very much better and 7 = very much worse | 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op |
| Subject satisfaction assessed by 5-point scale | Subject satisfaction assessed by the question "Are you satisfied with the use of ARTUS" with the 5-point scale answers where 1 = strongly agree and 5 = Strongly disagree | 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op |
| Subject recommendation assessed by 5-point scale | Subject recommendation assessed by the question "Would you recommend ARTUS to a friend" with the 5-point scale answers where 1 = strongly agree and 5 = Strongly disagree | 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op |
| Investigator usability assessed by a 5-point scale | Investigator usability questionnaire completed by the investigator from 1 (strongly agree) to 5 (strongly disagree) | Device activation visit (6 weeks post-operative visit), 3 months post-device activation |
| Barcelona |
| Badalona |
| 08916 |
| Spain |
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| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |