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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Change in the 24-hour Pad Weight Test [Срок оценки: 3 months post-device activation]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 2 центра

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

Чехия · 1 центр

• Thomayer hospital — Prague

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗