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

Stress Urinary Incontinence Clinical Trial

— DRY  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04827199
• Other study ID #: DRY
• Secondary ID: CIV-CZ-22-01-038
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2022
• Est. completion date: December 2034

Study information

• Verified date: September 2022
• Source: Myopowers Medical Technologies France SAS
• Contact: David Phrakorhnkham
• Phone: +33 (0)4 42 95 12 20
• Email: david.phrakornkham[@]affluentmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 2034
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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

Locations

Country	Name	City	State
Czechia	Thomayer hospital	Prague
Spain	Hospital Germans Trias i Pujol	Barcelona	Badalona
Spain	Hospital Clinico San Carlos	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Myopowers Medical Technologies France SAS	Affluent Medical, EVAMED

Countries where clinical trial is conducted

Czechia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Usability assessed by a 5-point scale	Usability assessed by a 5-point scale from 1 (strongly agree) to 5 (strongly disagree)	Implantation
Secondary	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
Secondary	Change in the 24-hour Pad Weight Test	24-hour Pad Weight Test	Baseline, 3, 6 and 12-month post-device activation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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