Safety and Clinical Performance Study of the ARTUS® Artificial Urinary Sphincter (AUS) (DRY)

Safety and Clinical Performance Study of the ARTUS® Artificial Urinary Sphincter (AUS) for the Treatment of Stress Urinary Incontinence (SUI) Due to Intrinsic Sphincter Deficiency

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:

• pilot phase (with safety analysis on the 10 first included subjects in 3 investigational sites),
• pivotal phase (in up to 16 investigational sites with a follow-up until the 12-month post-device activation visit, including an interim analysis at 3-month post-device activation visit on performance and safety),
• long-term phase (with a long-term follow-up until 10 years post implantation in up to 16 investigational sites).

The objectives is to assess safety and clinical performance of the ARTUS® for the treatment of Stress Urinary Incontinence at short and long-term.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: Artificial Urinary Sphincter implantation

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Phrakorhnkham; Phone Number: +33 (0)4 42 95 12 20; Email: david.phrakornkham@affluentmedical.com
• Study Contact Backup: Name: Anne-Claire Thieulin; Phone Number: +33 (0)2 31 93 21 18; Email: anne-claire.thieulin@evamed.fr

Study Locations

• Czechia
  • Prague, Czechia
    • Thomayer Hospital
• Spain
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
    • Contact: Luis RESEL FOLKERSMA, Dr; Phone Number: + 91 330 30 00; Email: urolog.hcsc@salud.madrid.org
  • Badalona
    • Barcelona, Badalona, Spain, 08916
      • Hospital Germans Trias i Pujol
      • Contact: José Luis Gago, Dr; Phone Number: +34 934 65 12 00; Email: jlgago.germanstrias@gencat.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Male subject between 18 and 80 years (inclusive) of age at the time of consent signature
2. Subject with persistent urinary incontinence, defined as >12 months
3. Subject with severe Stress Urinary Incontinence, defined as a mean value of 3 consecutive 24-hour Pad Weight Test > 75 grams
4. Subject willing and able to provide written informed consent
5. Subject willing and able to comply with all clinical study requirements, including the ability to independently operate the device remote control
6. Subject willing and able to comply with follow-up visits
7. 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
8. Subject having signed the informed consent

Exclusion Criteria:

1. Subject with documented neurological bladder or history of neurological disease liable to interfere with urinary symptoms
2. Subject with history of Artificial Urinary Sphincter or male sling implantation
3. Subject with history of pelvic radiotherapy
4. Subject with history of Artificial Urinary Sphincter-related urethral erosion
5. Subject with history of urethral fistula
6. Subject with history of bladder tumour
7. Subject with severe urethral stenosis
8. Subject with urge incontinence due to hyperactive bladder not adequately controlled by drug therapy
9. Subject with severe congenital or acquired haemorrhagic disease, haemophilia, or another coagulopathy
10. 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
11. Subject with currently active infection, including urinary tract infection
12. Subject with severe renal failure or obstructive pathologies of the upper urinary tract with severe renal failure
13. Subject with a current vesicourethral reflux
14. Subject with congenital or acquired immunodeficiency, including those who are immunocompromised or immunosuppressed
15. Subject with bladder or urethral foreign body or calculus
16. Subject with allergy to any components of the device
17. Subject deprived of liberty by administrative or judicial decision or under legal guardianship
18. Subject having a Body Mass Index (BMI) > 40
19. Subject with post void residual volume greater than 200 mL, within the past 6 months
20. Subject with uncontrolled diabetes, defined as HbA1c > 9.0%, within the past 6 months
21. Subject with history of recurrent bladder stones or history of failed bladder stone treatment within the past 12 months
22. 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
23. Subject who underwent any surgical procedure in the last 3 months, or with planned surgical procedure within the next 3 months
24. Subject who is unwilling or deemed by the Investigator to be unwilling to comply with the Clinical Investigation Plan, or subject with a history of non-compliance
25. Subject unable to understand and sign the ICF in absence of legal representative
26. Subject with a lack of capacity to consent
27. Subject unable to read and write
28. Subject in emergency situation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: ARTUS®; 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.

Device: Artificial Urinary Sphincter implantation; Device preparation (recharge, settings, pairing) Patient preparation Calibration procedure (to verify the device is in full working prior to implantation) Implantation procedure which includes: Perineal approach and bulbar urethral dissection; Inguinal approach; Cuff implantation around the urethra; Transmission cable passing; Surgery test procedure; Implantation of the Control Unit; Closure of the inguinal incision; Closure of the perineal incision; "Implant disabled mode" activation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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 : Voiding symptoms subscales from 0 (no symptom) to 20; Incontincence symptoms subscales from 0 (no symptom) to 24	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: Erection scale: 0-15 (higher score =higher sexual functioning); Ejaculation scale: 1-35 (higher score =higher sexual functioning); Satisfaction scale: 6-30 (higher score =higher level of satisfaction)	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

Collaborators and Investigators

• Sponsor: Myopowers Medical Technologies France SAS
• Collaborators: EVAMED; Affluent Medical
• Investigators: Principal Investigator: Roman Zachoval, Pr, Thomayerova nemocnice; Study Director: Marion Melot, Myopowers Medical Technologies France SAS

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2022
• Primary Completion (ANTICIPATED): April 1, 2024
• Study Completion (ANTICIPATED): December 1, 2034

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (ACTUAL): April 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Artificial Urinary Sphincter
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: DRY; CIV-CZ-22-01-038768 (OTHER: EUDAMED)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No