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

NCT04827199 | Not Yet Recruiting DMC

• 2 other identifiers: DRYCIV-CZ-22-01-038768
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Stress Urinary Incontinence

Keywords

Artificial Urinary Sphincter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

• Adverse events (including adverse device effect) occurred from the implantation to 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

• Revision rate

  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

  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

  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

  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

Study Arms (1)

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.

Device: Artificial Urinary Sphincter implantation

Interventions

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: * 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

ARTUS®

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subject with documented neurological bladder or history of neurological disease liable to interfere with urinary symptoms
• Subject with history of Artificial Urinary Sphincter or male sling implantation
• Subject with history of pelvic radiotherapy
• Subject with history of Artificial Urinary Sphincter-related urethral erosion
• Subject with history of urethral fistula
• Subject with history of bladder tumour
• Subject with severe urethral stenosis
• Subject with urge incontinence due to hyperactive bladder not adequately controlled by drug therapy
• 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 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 a current vesicourethral reflux
• Subject with congenital or acquired immunodeficiency, including those who are immunocompromised or immunosuppressed
• Subject with bladder or urethral foreign body or calculus

Sponsors & Collaborators

• Myopowers Medical Technologies France SAS: lead
• EVAMED: collaborator
• Affluent Medical: collaborator

Study Sites (3)

Thomayer hospital

Prague, Czechia

Location

Hospital Germans Trias i Pujol

Barcelona, Badalona, 08916, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Study Officials

• Roman Zachoval, Pr

  Thomayerova nemocnice

  PRINCIPAL INVESTIGATOR

• Marion Melot

  Myopowers Medical Technologies France SAS

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: April 1, 2021
• Study Start: December 1, 2022
• Primary Completion: April 1, 2024
• Study Completion (Estimated): December 1, 2034
• Last Updated: September 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); CZ (1)