A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)

Обзор

A prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the eCoin® implanted tibial nerve stimulator in subjects with urgency urinary incontinence (UUI).

Подробное описание

The goal of this prospective, multicenter, single-arm study is to assess the long-term safety and effectiveness of the FDA approved eCoin® implanted tibial nerve stimulator in a real world setting. Eligible subjects having overactive bladder (OAB) with urgency urinary incontinence (UUI) will be implanted with the eCoin® implanted tibial stimulator and complete voiding diaries and questionnaires at follow-up visits through 5 years.

Вмешательства

• Устройство eCoin Tibial Nerve Stimulation
  Subcutaneous stimulation of the tibial nerve using the eCoin device.

Первичные конечные точки

• Responder Rate [Срок оценки: 12 months]
• Safety: 12 months rate of all device or procedure related AEs. [Срок оценки: 12 months]

Вторичные конечные точки (3)

• Responder Rate [Срок оценки: 24 months]
• Safety Data [Срок оценки: 24 months]
• Safety data through 7 months post-reimplantation. [Срок оценки: 7 months post reimplantation]

Критерии участия

Критерии включения

• Women and men above 18 years old with gender percentages reflective of disease prevalence in the U.S. population
• Individual with diagnosis of overactive bladder with urgency urinary incontinence.
• Individual has at least one urgency urinary incontinence episode on each of three days as determined on a 3-day voiding diary.
• Individual gives written informed consent.
• Individual is mentally competent and able to understand all study requirements.
• Individual is willing and able to complete a 3-day voiding diary and quality of life questionnaire.
• Individual is without pharmacological treatment of overactive bladder (anticholinergic and β3-adrenoceptor agonists) for 2 weeks prior to baseline or longer if the physician judges that the therapeutic effect is still present.
• Individual is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or who have undergone percutaneous tibial nerve stimulation (PTNS).
• Individual is determined to be a suitable surgical candidate by physician.
• Individual is appropriate for eCoin treatment based on the US FDA-approved IFU requirements.

Критерии исключения

• Individual is not appropriate for eCoin therapy based upon the US FDA-approved IFU requirements.
• Individual has clinically significant bladder outlet obstruction. (Suspected bladder outlet obstruction will be initially assessed by uroflow study with those having a maximum flow rate < 15mL/s requiring additional evaluation.)
• Individual has predominantly stress urinary incontinence (greater than 1/3 of leaks on baseline diary are stress).
• Individual has an active urinary tract infection at time of enrollment.
• Individual has known polyuria.
• Individual has significant lower urinary tract pain or has been diagnosed with interstitial cystitis or bladder pain syndrome.
• Individual has abnormal post void residual (i.e. greater than 200 cc initially and on repeat testing after double voiding)
• Individual has clinically significant urethral stricture disease or bladder neck contracture. (Suspected disease or contracture will be initially assessed by uroflow study with those having a maximum flow rate < 15mL/s requiring additional evaluation.)
• Individual has chronic venous insufficiency with a history of skin change (hyperpigmentation, lipodermatosclerosis, ulceration) in the ankle region.
• Individual has morbid obesity and in the opinion of the investigator is not a good candidate for the study.
• Individual has had diagnosis of bladder, urethral, or prostate cancer.
• Individual has had a prior anti-stress incontinence sling surgery within the last year.
• Individual is pregnant or intends to become pregnant during the study.
• Individual has the presence of urinary fistula, bladder stone, or interstitial cystitis.
• Individual has uncontrolled diabetes mellitus (Hemoglobin A1C>7) or diabetes with significant peripheral complications. (Uncontrolled diabetes will be ruled out by blood test excluding those with Hemoglobin A1C>7).
• Individual has an implantable neurostimulator, pacemaker, or implantable cardiac defibrillator (ICD).
• Individual has been treated with onabotulinumtoxinA in the previous 9 months prior to enrollment, or more time if the principal investigator judges that the therapeutic effect is present.
• Individual has been treated with percutaneous tibial nerve stimulation (PTNS) within the previous 4 weeks prior to enrollment or more time if the principal investigator judges that the therapeutic effect is present.
• Individual is currently using transcutaneous electrical nerve stimulation (TENS) in the pelvic region, back, or legs.
• Individual is aware that he or she will need an MRI scan other than a head/neck/shoulder MRI during the study period.
• Individual has a clotting or bleeding disorder or is using anticoagulant therapies and in the opinion of the investigator is not a good candidate for the study (antiplatelet and anticoagulant therapy may be continued or held at the discretion of the investigator).
• Individual is neutropenic or immune-compromised.
• Individual has had previous surgery and/or significant scarring at the implant location.
• Individual has ongoing dermatologic condition at the implant site, including but not limited to dermatitis and autoimmune disorders.
• Individual has a clinically significant peripheral neuropathy in the lower extremities.
• Individual has neurogenic bladder dysfunction.
• Individual has pitting edema at implant location (≥ 2+ is excluded).
• Individual has inadequate skin integrity or any evidence of an infection or inflammation in either lower leg.
• Individual has varicose veins and is symptomatic.
• Individual has open wounds, trauma, or prior surgery in the lower extremities.
• Individual has arterial disease in the lower extremities.
• Individual has vasculitis in the lower extremities.
• Individual has bladder stones or neoplasia. (Suspected bladder stones or neoplasia will be ruled out with a urine dipstick showing no more than trace blood, and microscopic analysis (which should be done in that case) shows ≥3 PBC's /HPF unless that subject has been worked up and found negative for clinically significant disease such as malignant neoplasm or stones.)
• In the opinion of the investigator, Individual is not a good candidate for participation in the study.

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

США · 22 центра

• Urology Centers of Alabama — Homewood
• USA Health — Mobile
• Arkansas Urology — Little Rock
• University of California, Irvine — Irvine
• AIR Research — Los Angeles
• Stanford Health — Stanford
• Urological Research Network Corp — Hialeah
• The Emory Clinic — Atlanta
• … и ещё 14 центров

Идентификаторы

NCT: NCT05685433 · 111-5702

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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