Not yet recruiting NCT04827199

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

No phase Interventional Stress Urinary Incontinence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Artificial Urinary Sphincter implantation.
Who it may be relevant to: Registry conditions: Stress Urinary Incontinence. Basic parameters: 18 years — 80 years · Male.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Czechia, Spain
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

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" activatio

Primary outcome measures

Change in the 24-hour Pad Weight Test [Time frame: 3 months post-device activation]

Secondary outcome measures (12)

Adverse events (including adverse device effect) occurred from the implantation to the 10-year follow-up period [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Implantation]
Device deficiencies occurred from the implantation to the 10-year follow-up period [Time frame: 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 [Time frame: Baseline, 3, 6 and 12-month post-device activation]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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
Subject with allergy to any components of the device
Subject deprived of liberty by administrative or judicial decision or under legal guardianship
Subject having a Body Mass Index (BMI) > 40
Subject with post void residual volume greater than 200 mL, within the past 6 months
Subject with uncontrolled diabetes, defined as HbA1c > 9.0%, 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 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 who underwent any surgical procedure in the last 3 months, or with planned surgical procedure within the next 3 months
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
Subject unable to understand and sign the ICF in absence of legal representative
Subject with a lack of capacity to consent
Subject unable to read and write
Subject in emergency situation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

Spain · 2 centers

Hospital Germans Trias i Pujol — Barcelona
Hospital Clinico San Carlos — Madrid

Czechia · 1 center

Thomayer hospital — Prague

Identifiers

NCT: NCT04827199 · DRY · CIV-CZ-22-01-038768

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗